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Printed Hearing The Committee on Energy and Commerce Can Tobacco Cure Smoking? - A Review of Tobacco Harm Reduction. <DOC>
[108th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:87489.wais]
CAN TOBACCO CURE SMOKING? A REVIEW OF TOBACCO HARM REDUCTION
=======================================================================
HEARING
before the
SUBCOMMITTEE ON
COMMERCE, TRADE, AND CONSUMER PROTECTION
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
FIRST SESSION
__________
JUNE 3, 2003
__________
Serial No. 108-31
__________
Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
U.S. GOVERNMENT PRINTING OFFICE
WASHINGTON : 2003
87-489PDF
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpr.gov Phone: toll free (866) 512-1800; (202) 512-1800
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas Ranking Member
FRED UPTON, Michigan HENRY A. WAXMAN, California
CLIFF STEARNS, Florida EDWARD J. MARKEY, Massachusetts
PAUL E. GILLMOR, Ohio RALPH M. HALL, Texas
JAMES C. GREENWOOD, Pennsylvania RICK BOUCHER, Virginia
CHRISTOPHER COX, California EDOLPHUS TOWNS, New York
NATHAN DEAL, Georgia FRANK PALLONE, Jr., New Jersey
RICHARD BURR, North Carolina SHERROD BROWN, Ohio
Vice Chairman BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
CHARLIE NORWOOD, Georgia BOBBY L. RUSH, Illinois
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
JOHN SHIMKUS, Illinois BART STUPAK, Michigan
HEATHER WILSON, New Mexico ELIOT L. ENGEL, New York
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES W. ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
STEVE BUYER, Indiana LOIS CAPPS, California
GEORGE RADANOVICH, California MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania TOM ALLEN, Maine
MARY BONO, California JIM DAVIS, Florida
GREG WALDEN, Oregon JAN SCHAKOWSKY, Illinois
LEE TERRY, Nebraska HILDA L. SOLIS, California
ERNIE FLETCHER, Kentucky
MIKE FERGUSON, New Jersey
MIKE ROGERS, Michigan
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho
Dan R. Brouillette, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Commerce, Trade, and Consumer Protection
CLIFF STEARNS, Florida, Chairman
FRED UPTON, Michigan JAN SCHAKOWSKY, Illinois
BARBARA CUBIN, Wyoming Ranking Member
JOHN SHIMKUS, Illinois HILDA L. SOLIS, California
JOHN B. SHADEGG, Arizona EDWARD J. MARKEY, Massachusetts
Vice Chairman EDOLPHUS TOWNS, New York
GEORGE RADANOVICH, California SHERROD BROWN, Ohio
CHARLES F. BASS, New Hampshire JIM DAVIS, Florida
JOSEPH R. PITTS, Pennsylvania PETER DEUTSCH, Florida
MARY BONO, California BART STUPAK, Michigan
LEE TERRY, Nebraska GENE GREEN, Texas
ERNIE FLETCHER, Kentucky KAREN McCARTHY, Missouri
MIKE FERGUSON, New Jersey TED STRICKLAND, Ohio
DARRELL E. ISSA, California DIANA DeGETTE, Colorado
C.L. ``BUTCH'' OTTER, Idaho JOHN D. DINGELL, Michigan,
W.J. ``BILLY'' TAUZIN, Louisiana (Ex Officio)
(Ex Officio)
(ii)
C O N T E N T S
__________
Page
Testimony of:
Burton, Steven L., Vice President, Smoking Controls Strategic
Development and Switch, Glaxo SmithKline Consumer Health
Care....................................................... 96
Carmona, Vice Admiral Richard H., U.S. Surgeon General,
Public Health Service, Department of Health and Human
Services................................................... 40
Muris, Hon. Timothy, Chairman, Federal Trade Commission...... 34
Myers, Matthew L., President and CEO, National Center for
Tobacco Free Kids.......................................... 116
Rodu, Brad, Professor, Department of Pathology, University of
Alabama at Birmingham...................................... 86
Sweanor, David T., Counsel, Non-Smokers Rights Association... 122
Tomar, Scott L., Editor, Journal of Public Health Dentistry,
University of Florida College of Dentistry, Division of
Public Health Services and Research........................ 81
Verheij, Richard H., Executive Vice President, U.S. Smokeless
Tobacco Company............................................ 103
Wallace, Robert B., Vice Chairman, Committee to Assess the
Science Base for Tobacco Harm Reduction, Institute of
Medicine................................................... 78
Additional material submitted for the record:
Alliance for Health Economic and Agriculture Development,
prepared statement of...................................... 157
Eisele, David W., prepared statement of...................... 167
Healton, Cheryl G., President and CEO, American Legacy
Foundation, letter dated June 10, 2003..................... 155
Landrith, George, President, Frontiers of Freedom, letter
dated May 29, 2003......................................... 156
Marzulla, Nancie G., prepared statement on behalf of
Defenders of Property Rights............................... 159
Myers, Matthew L., President and CEO, National Center for
Tobacco Free Kids, letter dated June 20, 2003, enclosing
response for the record.................................... 168
Phillips, Carl V., Assistant Professor, University of Texas
School of Public Health, prepared statement of............. 163
(iii)
CAN TOBACCO CURE SMOKING? A REVIEW OF TOBACCO HARM REDUCTION
----------
TUESDAY, JUNE 3, 2003
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Commerce, Trade,
and Consumer Protection
Washington, DC.
The subcommittee met, pursuant to notice, at 10 a.m., in
room 2123, Rayburn House Office Building, the Hon. Cliff
Stearns (chairman) presiding.
Members present: Representatives Stearns, Whitfield, Cubin,
Shimkus, Shadegg, Bass, Terry, Fletcher, Ferguson, Issa, Otter,
Tauzin (ex officio), Schakowsky, Solis, Markey, Brown, Davis,
Stupak, Green, McCarthy, and Strickland.
Also present: Representative Waxman.
Staff present: Kelly Zerzan, majority counsel; Ramsen
Betfarhad, majority counsel; Jon Tripp, deputy communications
director; Jill Latham, legislative clerk; and Jonathan J.
Cordone, minority counsel.
Mr. Stearns. Good morning. The subcommittee will come to
order.
Without objection, the subcommittee will proceed pursuant
to Committee Rule 4(e). So ordered.
The Chair recognizes himself for an opening statement.
I am pleased to welcome all of you to the Commerce, Trade,
and Consumer Protection Subcommittee hearing on tobacco harm
reduction.
No one disputes the harm to human health from cigarette
smoking. Smokers are at a 16-fold increased risk of lung
cancer, 12-fold increased risk of chronic obstructive pulmonary
disease, and a twofold increased risk of mild cardio-
infarction. Oncologists estimate that smoking related illnesses
were responsible for 100 million deaths in the 20th century.
Those ilnesses killed some 400,000 Americans every year.
Over the last few decades this country has invested
substantial public and private resources to encourage smokers
to quit using tobacco. That investment has paid off. We have
made great gains in reducing the use of cigarettes.
While in 1965, 42 percent of Americans smoked cigarettes,
today only 26 percent of men and 22 percent of women are
smokers. While this is the good news, as noted in the Institute
of Medicine report, ``Clearing the Smoke,'' the decline in the
rates of smoking among adults has leveled off during the
1990's.
So where do we go from here? Today we are here to discuss
tobacco harm reduction. Harm reduction strategies have been
used for a number of years for a variety of different societal
problems. For example, clean needle programs are used to
prevent the spread of HIV. Methadone programs are employed to
prevent the use of elicit drugs, and sex education is provided
to stem the rising tide of teen pregnancy and disease.
The title of our hearing, ``Can Tobacco Cure Smoking?'' at
first blush seems counterintuitive. However, there is an
increasing amount of research suggesting that some tobacco
products are less harmful than others. For those smokers who
can't seem to quit smoking, switching to a less hazardous
product could save lives.
Today we will hear from a diverse group of experts
espousing a range of opinions on issues of tobacco harm
reduction. We worked closely with the minority to insure a fair
and balance panel of witnesses that can speak to the science of
this issue.
One of our witnesses today, Dr. Brad Rodu, will assert that
smokeless tobacco products are 98 percent safer than
cigarettes, and that by switching committed smokers to
smokeless products, we can save lives, reducing the potential
societal harms that may result from the promotion of tobacco
harm reduction claims.
Some believe that switching from one tobacco product to
another does nothing to solve the tobacco problem. The Federal
Trade Commission has general regulatory authority over
misleading and deceptive advertising, as well as specific
authority over the advertising and marketing of tobacco
products.
As tobacco companies attempt to market their products as
reduced risk, as one company has already tried to do, the
Federal Trade Commission will be in the position of evaluating
these claims.
So I look forward to hearing from Chairman Muris, how his
Commission plans to deal with these, shall we say, vexing
issues.
We also hear from the Surgeon General, who is the principal
advisor to the Secretary of Health and Human Services on public
health and scientific issues. Tobacco has long been a subject
of Surgeon General reports. As we move into a new era of
tobacco debates, we welcome Vice Admiral Carmona to the
Commerce, Trade, and Consumer Protection Subcommittee.
Our goal should always be to reduce the use of tobacco. In
that light, today's hearing provides an opportunity to examine
the efficacy of the tobacco harm reduction approach which calls
for minimizing and decreasing death among cigarette smokers
without completely eliminating tobacco and nicotine use.
In closing, I want to thank the witnesses for appearing
before the committee. I look forward to their testimony, and I
seek, in addition, unanimous consent to enter into the record
the written testimony of Mike Szymanczyk, Chairman and Chief
Executive Office, Philip Morris USA.
Without objection, so ordered.
[The prepared statement of Michael Szymanczyk follows:]
Prepared Statement of Mike Szymanczyk, Chairman and Chief Executive
Officer, Philip Morris USA
i. introduction
On behalf of the more than 12,000 employees of Philip Morris USA, I
am honored to submit these remarks regarding reduced exposure and
reduced risk tobacco products, including their potential health impact
and the challenges of sensibly regulating them. In particular, I'd like
to emphasize our strong support for passage by the 108th Congress of
meaningful and effective regulation of tobacco products by the Food and
Drug Administration. We believe that legislation empowering the FDA to
act should fully implement the thoughtful, comprehensive and rigorous
regulatory principles articulated by the Institute of Medicine in its
landmark report, Clearing the Smoke, which was commissioned by the FDA
itself.
We applaud the subcommittee for its leadership in holding this
hearing. We agree with its interest in seeking a bipartisan way to
fashion a coherent national tobacco policy. We look forward to working
with you and your colleagues in the full House towards the passage of
legislation that is designed to benefit adult consumers by reducing the
harm caused by tobacco consumption, and to establish clear rules that
will be applied to, and enforced uniformly throughout the tobacco
industry.
We hope to convey three critical points that we believe are
relevant to the issues the subcommittee is considering:
<bullet> Philip Morris USA strongly supports legislation that would
provide the FDA with comprehensive, meaningful and effective
authority to regulate tobacco products. The FDA should have the
power to fully implement all of the 11 regulatory principles--
including those relating to potentially reduced exposure/
reduced risk products--recommended by the IOM Report.
<bullet> For many years now, we have been hard at work trying to
develop and consider ways to successfully market innovative
tobacco products that have the potential to reduce smokers'
exposure to harmful compounds in cigarette smoke. Our progress
has been encouraging thus far, and we have high hopes for these
products as we move forward.
<bullet> We would like very much to be able to bring these products to
market in the regulated environment contemplated by the IOM
Report, subject to FDA review of both the underlying science
and the communications about this science that we would make to
consumers. In the absence of FDA authority in this area, we are
forced into making a difficult choice between making claims
that haven't been validated by a government agency, on the one
hand, and not providing smokers with information that may be
important to them, on the other. Neither of these alternatives
would be ideal, in our view, either from our own perspective or
as a matter of public policy. Clearly, FDA regulation would be
the best approach.
We hope that today will mark the beginning of a new and much better
chapter in our nation's effort to feel confident that tobacco products,
and the tobacco industry, are properly regulated, given both the
dangers of the products and the acknowledgement that adults should
continue to be able to make informed decisions about smoking for
themselves.
We are mindful that it has been nearly eight years since Dr.
Kessler made his initial rulemaking proposal, and two years since the
IOM published its report. Yet today, there is still no FDA authority to
regulate tobacco products. My company wants very much to be a part of
resolving the impasse and is convinced that the remaining policy
differences can be resolved through mutually respectful discussions
that seek such a resolution. We believe that a coherent, national
tobacco policy can be crafted that will effectively deal with tobacco
issues, without unintended consequences for the millions of consumers,
employees, tobacco growers and retailers who will be dramatically
affected by the results of Congressional action.
ii. our support of tobacco products regulation by the fda, including
authorities based on iom's 11 regulatory principles
The Importance of FDA Regulation of Tobacco Products
FDA regulation of tobacco products is an important Federal
initiative that is certainly needed. For more than three years now, we
have urged passage of an effective and comprehensive FDA regulatory
policy, and we remain determined to be a constructive force in the
effort that lies ahead to shape this policy.
When we say that we strongly support ``effective'' regulation by
the FDA, we mean it. We're not playing word games or referring to a
weak or watered-down plan. ``Effective'', to Philip Morris USA, means a
regulatory plan that is designed and funded in a way that can fully
accomplish its stated objectives, including:
<bullet> Providing smokers with additional information about what's in
their cigarettes, and about the dangers of smoking--both now
and on an ongoing basis--as the science evolves and new
information becomes available;
<bullet> Aiding in the development of products that meaningfully reduce
the harm caused by smoking;
<bullet> And guiding the accurate communication of any implications of
switching to reduced risk or reduced exposure products that may
be developed, which includes being sure to communicate that
there is no ``safe'' cigarette, and the best thing to do from a
health standpoint is to quit smoking.
``Effective'' to us does not mean regulations that are loophole-ridden
or intentionally weak, punitively cumbersome, or likely to generate
unintended negative consequences--it means real reforms that get the
stated and agreed upon job done.
We believe that additional regulation makes sense for a number of
reasons. Although these efforts are not often the focus of public
attention, the fact is that we at Philip Morris USA devote enormous
resources to developing products that have the potential of reducing
the harm caused by smoking, running our factories, working with our
suppliers, making our payroll and paying our taxes. We are asking for
new regulation because today there are simply not sufficiently clear
and consistent guidelines for the manufacture and performance of
cigarettes. It is not clear, for example, how we and the rest of the
tobacco industry should communicate to consumers about our products.
What rules there are increasingly arise at the state level, which will
inevitably lead to conflicting standards that could confuse consumers,
disrupt interstate commerce and significantly complicate orderly and
uniform manufacturing and distribution processes.
Meaningful, effective and uniform FDA regulation would better align
our business practices with society's expectations, and would further
our goal of being a responsible, effective and respected manufacturer
and marketer of tobacco products for adults who smoke. We believe
Americans support meaningful and effective new regulation of tobacco
product manufacturing processes, performance standards and how we
communicate with consumers, especially about potentially reduced
exposure and reduced risk products. The public also supports efforts to
continue to build the momentum that has developed toward reducing the
incidence of youth smoking. However, we don't believe that there is
strong support in the country for the new rules to go too far, and
significantly intrude on adults' continued ability to smoke if they
want to.
When Philip Morris USA first announced its support for FDA
regulation of cigarettes, some were understandably surprised and
skeptical, in part because our company--along with other major
manufacturers, retailers and advertising groups--had opposed the
agency's assertion of jurisdiction over tobacco products under the
medical device statute in 1996. Our opposition to FDA's unilateral
initiative was not disagreement with regulation per se, but rather
disagreement with that specific kind of regulation. We continue to
believe that regulation of tobacco products as medical products would
be a mistake--despite the fact that nicotine is a drug, and we agree
that cigarette smoking, and nicotine in cigarette smoke, are addictive
``because tobacco regulation needs to focus on how we can reduce the
harm to society of a dangerous, agriculturally-based product that is
nonetheless legal for adults to use, and the medical device rules
simply are not suited to that purpose.
That is why we believe it is most appropriate that both major
legislative proposals that have attracted attention in the past year--
H.R. 140, sponsored by Representatives Davis and McIntyre, and S. 2626
from the last Congress, sponsored by Senators Kennedy, DeWine and
others--regulate tobacco products under a new chapter of the Food, Drug
& Cosmetic Act designed especially for such products. We're convinced
that this is the right approach, and are extremely encouraged by the
enormous similarities between the two bills. We believe that there is
far more common ground in our views than there are differences. And,
although on some issues there are some important divergences of opinion
among the various stakeholders on a few issues, they are truly
differences in degree only.
Our Support of Regulation by the FDA of Potentially Reduced-Exposure
and Reduced-Risk Products, Based on IOM's 11 Regulatory
Principles
The IOM Report ``recommends strengthened federal regulation of all
modified tobacco products with risk reduction or exposure reduction
claims, explicit or implicit'', and proposes 11 regulatory principles
to ``build on the foundation of existing food and drug law, with
appropriate adaptations to take into account the unique toxicity of
tobacco products.''
Philip Morris USA has, for more than three years, been advocating
many of the elements encompassed by the 11 regulatory principles
contained in the IOM Report; many of these elements are already
contained in bills such as H.R. 140 from this Congress and S. 2626 from
the 107th Congress. As a step in moving forward to a thorough
discussion of what we believe are the best components of an FDA
regulatory process, we respectfully offer the following observations
about IOM's 11 principles, the degree to which they are already
reflected in bills like H.R. 140 and S. 2626, and ways in which we
think that the legislation can be improved so as to better translate
the IOM Report's principles into legislative language:
IOM Principle #1
The Principle. Manufacturers of tobacco products, whether
conventional or modified, should be required to obtain quantitative
analytical data on the ingredients of each of their products and to
disclose such information to the regulatory agency.
<bullet> Philip Morris USA's Position. We support the principle of
providing quantitative information about the ingredients used in the
manufacture of our cigarettes, with appropriate safeguards to protect
trade secrets. We think that the FDA should be able to provide smokers
with confidence that the ingredients added to cigarettes do not
increase the inherent health risks of smoking, including increasing
addiction. And, as discussed below regarding Principle #8, we have no
objection to disclosing the results of our own ingredients testing to
the FDA, so it can assess every ingredient we use.
<bullet> Translation into Legislative Language. This principle is
specifically covered by section 904 of the new FDA title in both H.R.
140 and S. 2626, which require all tobacco product manufacturers to
provide to the agency, on an annual basis, ``A listing of all tobacco
ingredients, substances and compounds that are, on such date, added by
the manufacturer to the tobacco, paper, filter, or other component of
each tobacco product by brand and by quantity in each brand and
subbrand'', as well as ``All documents (including underlying scientific
information) relating to research activities, and research findings,
conducted, supported, or possessed by the manufacturer . . .''
IOM Principle #2
The Principle. All tobacco products should be assessed for yields
of nicotine and other tobacco toxicants according to a method that
reflects actual circumstances of human consumption; when necessary to
support claims, human exposure to various tobacco smoke constituents
should be assessed using appropriate biomarkers. Accurate information
regarding yield range and human exposure should be communicated to
consumers in terms that are understandable and not misleading.
<bullet> Philip Morris USA's Position. We support this principle.
We believe that the FDA should be authorized to require the disclosure
of information about individual compounds in cigarette smoke, in
addition to tar and nicotine, that it believes would be meaningful to
consumers, as long as the information can be generated according to
validated, standardized and commercially feasible test methods that
reflect actual circumstances of human exposure, or reliably calculated
on the basis of the test results obtained from such methods.
<bullet> Translation into Legislative Language. There are a number
of provisions in H.R. 140 and S. 2626 that specifically embody this
principle. Section 511(b) of H.R. 140 and section 917(b) of S. 2626,
for example, both require the FDA--within 24 months--to create rules
covering ``the testing, reporting, and disclosure of tobacco product
smoke constituents and ingredients that the Secretary determines should
be disclosed to the public in order to protect the public health. Such
constituents shall include tar, nicotine, carbon monoxide, and such
other smoke constituents or ingredients as the Secretary may determine
to be appropriate.'' In addition, the bills' provisions empowering the
FDA to assess health claims are discussed in more detail in several of
the Principles below.
IOM Principle #3
The Principle. Manufacturers of all potential reduced-exposure
products should be required to conduct appropriate toxicological
testing in preclinical laboratory and animal models as well as
appropriate clinical testing in humans to support the health-related
claims associated with each product and to disclose the results of such
testing to the regulatory agency.
<bullet> Philip Morris USA's Position. We support this principle.
In order to support marketing claims relating to reduced exposure or
reduced risk, we believe that the best approach would be for a
manufacturer to (i) design a cigarette that significantly reduces
various harmful compounds in the inhaled smoke; (ii) provide scientific
evidence that this change reduces biological activity in appropriate
cellular and laboratory animal models; (iii) measure or model adult
smoker exposure to the smoke from these cigarettes; (iv) share these
results with the scientific and public health communities to seek to
gain their agreement that the test results are scientifically valid and
relevant to adult smokers, and also support a conclusion that the new
cigarette design may, in fact, reduce the risks of smoking; and (v)
work with regulatory agencies to appropriately communicate these
results and their significance to adult smokers.
<bullet> Translation into Legislative Language. This principle is
largely embodied in the two major FDA bills, where section 912(a)(2) of
H.R. 140 and section 913(a)(2) of S. 2626 both authorize the FDA to
designate a tobacco product as ``reduced risk'' based on a
manufacturer's application that, among other things, ``demonstrates
through testing on animals and short-term human testing that use of
such product results in ingestion or inhalation of a substantially
lower yield of toxic substances'' than other tobacco products, and ``if
required by the Secretary, includes studies of the long-term health
effects of the product.'' We believe that this language would more
fully reflect the IOM Report's principle if, in addition to referring
to ``reduced risk'' products, it specifically mentioned ``reduced
exposure'' products. Clearly, as the IOM Report indicates and as its
principles as a whole demonstrate, it is likely that the scientific
data will support reduced-exposure claims before the FDA, or the
scientific community in general, is prepared to conclude that a
particular new cigarette will actually reduce the risk of contracting a
tobacco-related disease.
IOM Principle #4
The Principle. Manufacturers should be permitted to market tobacco-
related products with exposure-reduction or risk-reduction claims only
after prior agency approval based on scientific evidence (a) that the
product substantially reduces exposure to one or more tobacco toxicants
and (b) if a risk reduction claim is made, that the product can
reasonably be expected to reduce the risk of one or more specific
diseases or other adverse health effects, as compared with whatever
benchmark product the agency requires to be stated in the labeling. The
``substantial reduction''' in exposure should be sufficiently large
that measurable reduction in morbidity and/or mortality (in subsequent
clinical or epidemiological studies) would be anticipated, as judged by
independent scientific experts.
<bullet> Philip Morris USA's Position. As noted above, we support
the principle that the FDA should regulate ``reduced risk'' claims. In
addition, we support the principle that claims about reduced exposure
to specific tobacco toxicants (i.e., harmful compounds in cigarette
smoke) should be subject to FDA oversight. We agree with the IOM Report
that government analysis of proposed exposure-reduction claims, and the
data that should be required from manufacturers to support them, should
be different than with respect to claims of actual risk reduction.
<bullet> Translation into Legislative Language. Section 912(a)(3)
of H.R. 140 and section 913(a)(3) of S. 2626 both partially reflect
this principle, as they provide the FDA with full authority to regulate
risk-reduction (but not specifically exposure-reduction) claims,
including requiring that the product carry ``a label prescribed by the
Secretary concerning the product's contribution to reducing harm to
health'' and comply ``with requirements prescribed by the Secretary
relating to marketing and advertising of the product.'' H.R. 140 also
reflects the IOM Report's judgment that accurate, non-misleading claims
should be permitted rather than suppressed. We would respectfully
suggest that the language in both bills could be improved by adding
clauses that would both specifically incorporate IOM's exposure-
reduction concept, and adopt this Principle's specific language
regarding the proper standard for what evidence would support either an
exposure-reduction or risk-reduction claim.
We also note that S. 2626 could be interpreted to permit FDA to
refuse to permit any truthful, non-misleading claim regarding ``reduced
risk'' or ``reduced exposure''--even if a valid scientific showing has
been made--if the agency speculates that the claim could, for example,
discourage quitting at some point in the future. This is a legitimate
concern, but it is contrary to IOM Principle #4, and, we believe,
should be addressed by clearly communicating the claim so that
consumers are not misled, and accompanying the claim with a clear
reminder that the best option from a health perspective is to quit. IOM
also proposes dealing with this concern through post-market
surveillance, which is discussed in Principle #6 below. Finally in this
regard, both the Supreme Court and several Courts of Appeals have
strongly indicated that the kind of suppression of truthful information
advocated by some in the tobacco control community cannot withstand
scrutiny under the First Amendment. A white paper discussing these
cases in greater detail is attached to this Statement as Annex 1.
IOM Principle #5
The Principle. The labeling, advertising, and promotion of all
tobacco-related products with exposure-reduction or risk-reduction
claims must be carefully regulated under a ``not false or misleading''
standard with the burden of proof on the manufacturer, not the
government. The agency should have the authority and resources to
conduct its own surveys of consumer perceptions relating to these
claims.
<bullet> Philip Morris USA's Position. We support this principle
for the reasons stated regarding Principle # 4 above.
<bullet> Translation into Legislative Language. In addition to the
analysis above regarding Principle #4, we note that H.R. 140--through
its linkage of FDA regulation to a tobacco quota buyout and a user fee
that would fund both the buyout and the new regulatory regime--is the
only major legislative proposal currently under consideration that
would ensure that, as the IOM Report's Principle #5 urges, the FDA will
in fact have ``the resources to conduct its own surveys of consumer
perceptions relating to these claims.'' We would also respectfully
suggest that both section 912(a)(3) of H.R. 140 and section 913(a)(3)
of S. 2626 be amended so as to specifically incorporate IOM's ``not
false or misleading'' standard for all claims regarding exposure or
risk-reduction.
IOM Principle #6
The Principle. The regulatory agency should be empowered to require
manufacturers of all products marketed with claims of reduced risk of
tobacco-related disease to conduct post-marketing surveillance and
epidemiological studies as necessary to determine the short-term
behavioral and long-term health consequences of using their products
and to permit continuing review of the accuracy of their claims.
<bullet> Philip Morris USA's Position. We support this principle as
articulated and further believe it should be expanded to clearly
include application to products with reduced exposure claims. As noted
above, the effects of these products on the overall harm caused by
tobacco is a legitimate and valid public health concern, and one which
needs to be monitored and studied. And, as we believe that the FDA
should be able to determine which marketing claims are appropriate, it
is sensible that it should make use of the sort of surveillance and
studies noted in this principle.
<bullet> Translation into Legislative Language. Both major FDA
bills contain provisions that fully embody this principle. Section
912(e)(1) of H.R. 140 and section 912(a) of S. 2626 broadly empower the
FDA to ``require a tobacco product manufacturer to conduct postmarket
surveillance for reduced risk [of] a tobacco product of the
manufacturer if the Secretary determines that postmarket surveillance
of the tobacco product is necessary to protect the public health or is
necessary to provide information regarding the health risks and other
safety issues involving the tobacco product.'' For clarity, as
indicated above regarding other provisions, we would suggest also
adding an explicit reference to exposure-reduction claims, to ensure
that the FDA is authorized to require post-market surveillance of them,
too.
IOM Principle #7
The Principle. In the absence of any claim of reduced exposure or
reduced risk, manufacturers of tobacco products should be permitted to
market new products or modify existing products without prior approval
of the regulatory agency after informing the agency of the composition
of the product and certifying that the product could not reasonably be
expected to increase the risk of cancer, heart disease, pulmonary
disease, adverse reproductive effects or other adverse health effects,
compared to similar conventional tobacco products, as judged on the
basis of the most current toxicological and epidemiological
information.
<bullet> Philip Morris USA's Position. We support this principle.
As IOM notes in its report, it is logical that the regulatory agency
charged with evaluating the relative risks presented by different
tobacco products--which we believe is most appropriately the FDA--
should not be overwhelmed with what would be the enormous task of pre-
approving every introduction of a new line extension using existing
product designs, when such products do not make reduced risk or reduced
exposure claims, and are certified by the manufacturer to present the
same issues of public health as predicate tobacco products. Requiring
pre-market approval of such products would not serve the public health
interests identified by the IOM Report, and would pose substantial
burdens on both the regulators and the manufacturers.
Moreover, we support the IOM Report's concept of placing the burden
on manufacturers to certify that any new product (including any
existing brand which is introduced with changed characteristics) would
not present increased risk, and then, on the basis of such
certification, to introduce the product (without reduced risk or
exposure claims) into the marketplace. As the IOM Report suggests, the
FDA would then have the authority, if upon investigation it disagrees
with the manufacturer's certification and concludes that there is in
fact an increased risk, to seek the product's removal from the market.
We do not advocate--and we do not believe Principle #7 would require--
that pre-market approval provisions ``grandfather'' today's tobacco
products from further regulation. In whatever form they eventually
take, performance standards (see Principle #9 below) would apply to all
tobacco products (whether on the market today or introduced in the
future).
<bullet> Translation into Legislative Language. All of the existing
legislative proposals relating to pre-market approval are very complex,
but we believe that the provisions of section 910 of H.R. 140 come the
closest to fully embodying this principle. First, section 910 reflects
the IOM Report's suggestion that products carrying exposure-reduction
or risk-reduction claims be treated separately from new products that
do not. Second, it requires manufacturers to submit extensive
information about any such new product to the FDA at least 90 days
prior to commercial introduction, and empowers the agency to ``suspend
the distribution of the tobacco product that is the subject of that
report if the Secretary determines that there is a reasonable
likelihood that the tobacco product is not substantially equivalent to
a tobacco product commercially marketed (other than for test marketing)
in the United States . . .'' Finally, the concept of ``substantial
equivalence'' is defined in section 910(a)(2) of H.R. 140--consistent
with IOM's ``no increased risk'' concept--as being a product that
either ``has the same characteristics as the predicate tobacco
product'' or, in the alternative, ``has different characteristics and
the information submitted contains information, including clinical data
if deemed necessary by the Secretary, that demonstrates that it is not
appropriate to regulate the product under this section because the
product could not reasonably be expected to increase the health risks
to consumers compared to a conventional tobacco product that is
commercially marketed in the United States . . .''
IOM Principle #8
The Principle. All added ingredients in tobacco products, including
those already on the market, should be reported to the agency and
subject to a comprehensive toxicological review.
<bullet> Philip Morris USA's Position. We support this principle
for the reasons stated regarding Principle #1 above and Principle #9
below.
<bullet> Translation into Legislative Language. From a legislative
perspective in the major FDA bills, toxicological assessment of
ingredients is part and parcel of the agency's performance standard
authority, which is discussed below in the context of IOM Principle #9.
IOM Principle #9
The Principle. The regulatory agency should be empowered to set
performance standards (e.g., maximum levels of contaminants;
definitions of terms such as ``low tar'') for all tobacco products,
whether conventional or modified, or for classes of products.
<bullet> Philip Morris USA's Position. We support this principle,
and have been actively advocating a Congressional grant of authority to
the FDA to reduce harm by imposing mandatory performance standards on
tobacco products, even including those that would require design
changes that consumers might not like. Our main concern with this
concept is that, if not translated carefully into legislative language,
it could permit--or even require--the agency to do what nobody should
want: to impose performance standards requiring changes that are so
radical that tobacco products are effectively banned, or consumers are
driven away from the legitimate market and towards illicit, completely
unregulated products. We think that consumers, tobacco growers and many
other stakeholders support our view that these standards should not
make tobacco products unpalatable for adult smokers; no one would
benefit from performance standards so radical that they further
increase the demand for counterfeit or other illicit products.
Specifically, we believe that the FDA should have the authority to
ensure that ingredients used in the manufacture of tobacco products do
not increase their inherent health risk or addictiveness; because the
ingredients are under the manufacturers' control, this authority
should, in our view, include the power to prohibit the use of any
ingredient shown to increase health risks even if the ban would impact
the product's taste. Apart from ingredients, we also support authority
for the FDA to impose changes to the other design or inherent
characteristics of a tobacco product--including the inherent properties
of tobacco leaf itself--that it finds will protect public health, so
long as the changes are technically feasible and would not negatively
impact adult consumers' enjoyment of the product in a significant way.
There is no public consensus supporting FDA actions that force radical
changes on the design or inherent characteristics of today's tobacco
products that adult smokers may not be prepared to accept. We believe
that instead, FDA should use its enormous persuasive powers and
regulatory tools to encourage consumers to quit, or--by utilizing the
reduced risk/reduced exposure authorities contemplated by IOM's other
principles--to switch to products whose design and composition the
agency favors from a public health perspective.
Ingredients. The major legislative proposals currently under
consideration--including both H.R. 140 and S. 2626--contemplate the use
of ``performance standard'' authority by the FDA to regulate
ingredients used in the manufacture of tobacco products based on its
belief of what would be appropriate to protect public health. We
believe that this is a legitimate role for the agency to the extent it
is used to ensure that ingredients do not increase the inherent risk of
cigarette smoking, including by increasing its addictiveness. Tobacco
products are inherently dangerous, but the government should have
authority to make sure that nothing is used by manufacturers to make
them even more so. Philip Morris USA stands ready to submit all of its
ingredients to rigorous FDA review and testing, to share the results of
testing it has previously conducted, and to work with the agency as it
makes its own assessment of any added risks they may present.
An approach that focuses on increased risk from ingredients has
been explicitly adopted by the IOM Report, which asserts that ``. . .
[FDA] should . . . have the authority to remove from the market
ingredients . . . that do not meet [a] test of no increased risk . .
.'' To be clear, we think that FDA authority to test and, if necessary,
prohibit the use of specific ingredients it finds to increase the
inherent risks of smoking should apply to ingredients currently in use
as well as to new ones. There should be no ``grandfathering.''
However, FDA authority over ingredients should not, in our view,
extend beyond the concept of ``increased risk''. A broader scope--for
example, based purely on what would be ``appropriate to protect public
health''--could permit the agency, for example, to prohibit specific
ingredients solely because they improve the taste of a tobacco product,
on the theory that, by trying to make the products taste bad,
consumption will drop and public health will be benefited. Under such
an approach, the FDA could even order that bad-tasting ingredients be
added to cigarettes, so as to decrease their palatability. These powers
would be, we respectfully submit, simply incompatible with the
principle that tobacco products are legitimate and that adults should
continue to be permitted to consume them if they wish. To quote from
the preamble to the FDA's own proposed tobacco rule from 1996:
Black market and smuggling would develop to supply smokers with
these products . . . [which] would be even more dangerous than
those currently marketed, in that they could contain even
higher levels of tar, nicotine, and toxic additives.
If regulation of cigarettes is to be based purely on eliminating
their known inherent dangers, we readily agree that it would be best if
nobody smoked at all. But Americans want to see a new regulatory regime
that incorporates other values as well--tolerance, adults' continued
ability to make their own decisions about issues that affect their
health, law enforcement considerations, and the degree to which
government should intrude generally into the realm of personal
issues.<SUP>1</SUP> If Congress is to reflect this consensus and
balance these competing concerns, it will need to tailor FDA's
authority so that it is focused on encouraging quitting and harm
reduction for adults who continue to smoke, rather than trying to force
Americans to adopt tobacco-free lifestyles.
---------------------------------------------------------------------------
\1\ Indeed, the reason that the Supreme Court rejected FDA's
initial ``medical device'' tobacco rule is that it determined that,
under that approach, the agency would have been required to ban tobacco
products, and that such a ban could not be squared with the overall
national tobacco policy already put in place by Congress.
---------------------------------------------------------------------------
Smoke Constituents and Other Performance Standards. For the same
reasons, we believe that the FDA should have broad power to require the
reduction or elimination of smoke constituents (the compounds produced
by tobacco when burned), that will seek to reduce harm while ensuring
that the agency will not order mandatory performance standards that are
technically infeasible, or could only be met by design changes in
tobacco products that adult smokers find unacceptable. For example, if
there is no limitation whatsoever contained in the performance standard
authority, the agency could force rapid, radical reductions in tar and
nicotine yields, or require that manufacturers utilize filters that
would eliminate the products' taste. Strategies such as these may well
be legitimate in the effort to reduce harm, but we respectfully suggest
that the strategies are best dealt with under the FDA's authority over
reduced exposure and reduced risk tobacco products, discussed above.
<bullet> Translation into Legislative Language. H.R. 140 and S.
2626 both fully embody--with one important difference between them--
IOM's suggestion that the FDA be provided with specific authority to
impose performance standards, including those relating to added
ingredients and smoke constituents. Section 907(a) of both bills
empower the agency to
adopt performance standards for a tobacco product if the
Secretary finds that a performance standard is appropriate for
the protection of the public health. This finding shall be
determined with respect to the risks and benefits to the
population as a whole, including users and non-users of the
tobacco product, and taking into account--(A) the increased or
decreased likelihood that existing users of tobacco products
will stop using such products; and (B) the increased or
decreased likelihood that those who do not use tobacco products
will start using such products. A performance standard
established under this section for a tobacco product shall
include provisions to provide performance that is appropriate
for the protection of the public health, including provisions,
where appropriate--(i) for the reduction [or elimination]
<SUP>2</SUP> of nicotine yields of the product; (ii) for the
reduction or elimination of other harmful constituents or
harmful components of the product . . .
---------------------------------------------------------------------------
\2\ This bracketed language appears only in S. 2626.
---------------------------------------------------------------------------
The authority this language confers over ingredients extends beyond
the concept of ``increased risk''. By permitting the FDA to change any
ingredient if it concludes that such action is ``appropriate to protect
public health'' (so long as the removal does not render the tobacco
product ``unacceptable for adult consumption''), H.R. 140 would appear
to permit FDA, for example, to prohibit or reduce specific ingredients
solely because they improve the taste of a tobacco product, on the
theory that, by trying to reduce the product's palatability,
consumption will decline and public health will benefit. We're pleased
that the notion of adult acceptability appears in H.R. 140, because it
is compatible with the principle that tobacco products are legitimate
and that adults should continue to be permitted to consume them if they
wish. We respectfully suggest, however, that Congress consider revising
this language, insofar as it relates to ingredients, to more fully
reflect IOM's ``no increased risk'' concept.
For the same reasons, we appreciate the fact that H.R. 140's
performance standard authority applies the concept of adult
acceptability to FDA's power to require the reduction or elimination of
smoke constituents, or to order other mandatory design changes in
tobacco products. Sensibly, the bill appears to contemplate that the
FDA will use its authority regarding reduced risk and reduced exposure
products--including those with low initial consumer acceptability--to
encourage the proliferation of new product designs that have the
potential of reducing the harm caused by smoking. Using this authority,
the agency will have enormous ability to use its credibility with the
American people to persuade adult smokers to switch to any alternative
product designs of its choosing. New products that achieve a critical
mass of adult consumer acceptance would then be ready to move to the
next regulatory phase. If FDA concludes, after monitoring the
marketplace in the manner suggested by IOM, that such a product
innovation has been proven to reduce harm in the long term, the agency
could--and, in our view, should--incorporate the results of the
technology into a performance standard so that it becomes the new
baseline for the entire category of tobacco products.
The performance standard authority in S. 2626 does not contain any
concept of adult acceptability, or any other limitation on the FDA's
authority to radically re-design tobacco products ``to protect the
public health.'' There is clearly a difference of opinion between those
who believe that there needs to be specific policy direction from
Congress to the FDA regarding consumer acceptability, and others who
view health impact as the sole issue that the agency should be
permitted to consider when it sets performance standards for tobacco
products. We would note in this regard that every regulated consumer
product is governed by a statutory standard reflecting Congress' policy
judgment as to the values governing the rulemaking process. Just as
medical devices need to be ``safe and effective'', a motor vehicle
standard may only be imposed if it is ``reasonable, practicable, and
appropriate for the particular type of motor vehicle . . .'', and
standards under the Consumer Products Safety Act require a finding
regarding ``. . . the probable effect of such rule upon the utility,
cost, or availability of such products to meet such need.''
Our view is that FDA's performance standard authority should
recognize tobacco products as legitimate for adults to use if they
wish; that the agency should operate within some reasonable boundaries
making it clear that its mission is not to phase them out entirely. To
us it seems entirely plausible that, under a pure ``public health''
standard, FDA could (or could be forced to) conclude that it is better
for public health overall to ban tobacco products; that Prohibition
would result in millions of people quitting, and that having millions
more seeking black market products is an acceptable trade-off. Even if
valid from a health perspective, this conclusion would not be good
policy.
The opposition by some to any notion of ``consumer acceptability''
for tobacco products has been justified by concerns that the term's
vagueness will lead to ``endless litigation'', and that ``a reduction
of tobacco consumption by 1% or less could be the basis for an industry
claim that a new performance standard has left the product unacceptable
to adults.'' <SUP>3</SUP> There are responses to these concerns: many
countries around the world have clearly demonstrated that it is
possible to gradually impose performance standards on cigarettes that
governments deem beneficial within the realm of what adults will
accept; for example, the European Union has, over the past several
years and taking a step-by-step approach, established increasingly
lower ceilings on tar, nicotine and, more recently, carbon monoxide
yields as measured by machine tests. Moreover, it is unclear why
``consumer acceptability'' should be any more susceptible to court
challenge than equally-vague standards endorsed by the same advocates
(and included in both S. 2626 and H.R. 140), such as ``the increased or
decreased likelihood that existing users of tobacco products will stop
using such products'', and, under the well-known Chevron doctrine, FDA
would be afforded substantial deference by the courts in determining
what the language means. In any case, there surely ought to be some
language that can be worked out that would introduce some notion of
reasonableness into the FDA's performance standard calculus, avoid
unintended consequences, and serve the public health objective of
tough, meaningful authority that will lead over time to real changes in
tobacco products, and a significant reduction in the harm that they
cause.
---------------------------------------------------------------------------
\3\ Written statement of Matthew L. Myers, President, Campaign for
Tobacco-Free Kids, to Senate HELP Committee (September 19, 2002).
---------------------------------------------------------------------------
IOM Principle #10
The Principle. The regulatory agency should have enforcement powers
commensurate with its mission, including power to issue subpoenas.
<bullet> Philip Morris USA's Position. We support this principle.
We have spoken extensively about the need for meaningful and effective
regulation of tobacco products; such regulation can be neither
``meaningful'' nor ``effective'' without adequate enforcement powers
for the FDA.
<bullet> Translation into Legislative Language. H.R. 140, like S.
2626 before it, fully incorporates the existing enforcement authorities
that the FDA is provided under the Food, Drug & Cosmetic Act, and
applies those powers to enforcement of the new tobacco products chapter
that the bill would create. We would respectfully suggest, in light of
the recent influx of inexpensive foreign tobacco products--some of
which are not in compliance with existing Federal and State laws
applicable to all tobacco products, domestic or foreign--into our
country, that these mechanisms be examined to ensure that the FDA will
be both authorized and directed to ensure that all manufacturers and
importers are required to fully comply with the full panoply of
restrictions, requirements and standards that the agency decides to
impose.
IOM Principle #11
The Principle. Exposure reduction claims for drugs that are
supported by appropriate scientific and clinical evidence should be
allowed by the FDA.
<bullet> Philip Morris USA's Position. We support this principle.
Our belief in the ability of adults to make their own decisions about
smoking--and not smoking--encompasses cessation of tobacco use,
including the use of pharmaceutical therapies for those smokers who
want to quit, are having difficulty, and believe that the treatments
might help.
<bullet> Translation into Legislative Language. IOM correctly notes
that, under current U.S. law, the FDA already has authority in this
area for drugs and medical devices; this issue need not be addressed
legislatively as Congress considers a new chapter of the law relating
to tobacco products. We believe strongly that cigarettes should be
regulated as cigarettes, and not as medical products. This means that,
as both H.R. 140 and S. 2626 provide, cigarettes should be regulated by
FDA, but under a separate chapter of its governing statute. We're
convinced that any legislation that attempts to shoehorn tobacco
products into the existing medical categories is, as the Supreme Court
has already found, simply taking the wrong approach.
iii. our efforts to develop tobacco products that could eventually
reduce the harm caused by smoking
Having described the regulatory regime that we believe should be
built to apply to all tobacco products--both conventional and novel--we
now turn to the status of Philip Morris USA's efforts to develop
products that we hope will be subject to these new regulations. One of
our highest priorities today continues to be the development of
cigarettes that have the potential to reduce the harm caused by
smoking. The IOM Report exhaustively examines many of the issues
involved in attempting to achieve this goal by reducing smokers'
exposure to harmful compounds in cigarette smoke.
Simply put, the public health community has identified a number of
compounds--out of the thousands present in cigarette smoke--that are
potentially harmful to smokers, without definitively settling on any
specific one (or combination of them) as the recognized cause of lung
cancer or other smoking-related disease. Accordingly, our basic
strategy is to reduce smokers' exposure to as many of these compounds
as we can, by means of products that will provide continued enjoyment
to our consumers. If we're successful in finding ways of both reducing
potentially harmful compounds and reducing smokers' actual exposure to
them under real-world conditions, we believe that--although it will
take some time--the FDA will be in position to help us evaluate whether
our product development efforts are actually reducing the risk of
tobacco-related diseases among current smokers. Then, determinations
can ultimately be made about whether any reduced-risk tobacco product
results in overall harm reduction across the population, because its
risk-reduction potential is not offset by other factors, such as
changes in smoking behavior, discouraging current smokers from quitting
or encouraging nonsmokers to start.
Our goal--which we believe provides both societal and shareholder
value--is to design the best products that we can, and then, ideally
under the regulatory oversight of the FDA, to convince as many adult
smokers (who don't quit) as possible to use them. It seems clear to us
that we will not be able to make progress in this area unless two
critical conditions are met: first, that manufacturers such as
ourselves are successful at developing and making available tobacco
products that reduce smokers' exposure to harmful compounds compared to
conventional cigarettes, and second, that current smokers are given a
reason--through the communication of truthful, non-misleading
information that avoids unintended consequences--to switch to these
products, even though they may be less enjoyable than the cigarettes
that most adults smoke today. For people who continue to smoke, we
believe that this is the best way to assure that the overall harm
caused by smoking will be meaningfully reduced.
We have extensive research programs, both external and internal,
that are focused on advancing our knowledge about tobacco smoke,
including the compounds of smoke and smokers' actual exposure to them,
to support our efforts to develop new product designs. We are
continuing to devote substantial research and development efforts to
develop and launch cigarettes that significantly reduce smokers'
exposure to compounds that have been identified by public health
authorities as harmful or potentially harmful. We are making progress
in this area, and hope to introduce new products with appropriate
consumer communications as quickly as possible.
For example, one current result of our efforts is the introduction
of an electrically heated cigarette smoking system (EHC), called
Accord, in a limited test market without communications to consumers
regarding reductions in potentially harmful compounds. The specially-
designed lighter heats the EHC to a lower temperature than that at
which a lit cigarette burns; the lower the temperature of the tobacco,
the lower the quantities of certain harmful compounds. In comparing the
EHC to a standard lit-end industry reference cigarette, we first made
evaluations of smoke chemistry, Ames activity (a measure of damage to
DNA), cytotoxicity (a measure of cell damage and tissue irritation),
and inhalation exposure in laboratory rats. Philip Morris USA
scientists have shared many of these results with their colleagues in
the scientific community; examples of their presentations are available
on online at http://www.ehcss-science.com.
More recently, we have conducted tests--including both clinical
studies to assess the levels of potentially harmful compounds that
smokers are actually exposed to, and machine tests that we believe more
closely approximate actual smokers' behavior than the existing FTC
method--comparing the results of smoking the EHC to those of smoking
various commercially available conventional cigarettes. While we are
still in the process of evaluating these tests, we hope that they will
show that smokers of the EHC were exposed to substantially lower
amounts of certain harmful compounds present in tobacco smoke than
smokers of the conventional brand styles that were tested.
In addition, we are working very hard on the development of a
conventional lit-end cigarette which includes a state-of-the-art
filter, that uses activated carbon that we hope will be shown to reduce
certain harmful compounds in smoke. It works like a carbon water
filter, which reduces some of the unwanted things in the water that
people drink. This prototype cigarette design also includes flavor
components to add flavor to replace tobacco flavors trapped by the
carbon.
Neither the EHC nor the cigarette with the new filter has been
proven to reduce the risk of smoking-related disease, and smokers of
these products would still be inhaling many compounds that are
potentially harmful. But we believe that these product technologies
show promise for the future, and that the FDA should be empowered as
quickly as possible so that the agency can begin to work with us to
evaluate their potential for reducing the risk of contracting smoking-
related disease, and the overall harm to the population caused by
smoking.
As we consider the details of the various legislative proposals
that are active today, we respectfully urge Congress to keep in mind
that innovation in developing new products are crucial to their
ultimate success. In order to have any real impact, reduced exposure
products must be acceptable to adult smokers. We see little overall
benefit to consumers or society if harm reduction is not pursued in the
context of cigarettes that adult consumers will continue to enjoy
smoking. As the 1998 Canadian Experts' Committee on this subject
concluded, ``[i]f smokers would not buy these products, product
modification initiatives would fail.''
iv. the wisdom of the iom principles, and the need for action.
We now turn to a general overview of the policy issues relating to
potentially reduced exposure and reduced risk tobacco products. This
portion of our statement discusses our strong belief that FDA
regulation--in line with the IOM Report's recommendations--is an
essential component to an effective overall harm reduction strategy,
the debate over whether this strategy is a good one, and the
consequences of simply preserving the status quo.
The Need for FDA Regulation of Innovative Tobacco Products
We strongly agree with the IOM Report that governments should help
determine what is, and what is not, a ``reduced exposure'' or ``reduced
risk'' tobacco product. Clearly, the best approach is for regulatory
authorities to make such determinations, based on the best available
scientific information. As the IOM Report indicates, a product should
be designated and marketed as ``reduced exposure'' or ``reduced risk''
upon an adequate showing of potential exposure or risk reduction to
current smokers. Whether a product offers potentially reduced exposure
or risk to an individual smoker is a purely scientific (as opposed to a
policy) question that FDA should determine based on the data; the
policies of encouraging quitting, discouraging nonsmokers from starting
and assessing overall harm reduction across populations is a separate
question, and can and should be dealt with through post-market
surveillance, educational programs and appropriate labeling.
Moreover, we believe that the purpose of regulation in this area--
and the specific details of the FDA's legislative mandate--should be to
encourage innovation, not to stifle competition and the development of
potentially beneficial new technologies. We hope that everyone can
agree that the FDA should not inadvertently be directed or permitted to
actually inhibit the development of these products, and in the process
to deny millions of today's smokers a genuine opportunity to
potentially reduce their chance of contracting smoking-related
diseases.
Once, as a matter of science, the FDA concludes that a new product
has the potential to offer reduced exposure or reduced risk, the best
approach would be for the agency to play an important role in
overseeing any claims--explicit or implied--made about it by its
manufacturer regarding exposure or risk-reduction.
Crafting appropriate claims regarding these tobacco products is an
undertaking requiring great care and attention; we are mindful of the
critical need for manufacturers to work with the FDA so that marketing
messages clearly communicate that all smoking can be harmful, and that
the best option from a health perspective is to quit. Once again, as
with determinations regarding the scientific issues of potential
exposure and risk-reduction, we believe that the best approach is for
the FDA to decide what communications to consumers are appropriate on
this subject.
On the one hand, regulation should ensure that consumers are not
mistakenly led to believe that a particular product may be an
acceptable alternative to quitting from a health perspective. On the
other hand, regulation should not be utilized as a tool to suppress
legitimate, accurate and objective information about product
developments that individuals may find to be beneficial or important.
The key here is for all communications to consumers to be truthful and
not misleading in the context of the fact that there is no safe
cigarette.
The Debate Over Harm Reduction as a Strategy
The IOM Report was commissioned by the FDA to (in the Report's
words) ``address the science base for harm reduction from tobacco. The
committee concluded early in its deliberations that the science base
for harm reduction will evolve over time.''
We're keenly aware that some members of the public health community
are opposed to the very concept of developing and offering ``reduced
exposure'' or ``reduced risk'' tobacco products, because they are
concerned that their availability might discourage smokers from
quitting or encourage them to start smoking. These advocates appear to
believe that the only acceptable message for the government to
communicate, irrespective of potential alternatives, is a directive to
not consume tobacco products at all. Philip Morris USA respectfully
disagrees with this way of thinking, and strongly believes that it
would be wrong, if products that could ultimately reduce the harm
caused by smoking are developed, to deny adult smokers access to
information about their potential benefits. We're convinced that
information about potentially reduced-exposure or reduced-risk
products--that is truthful and not misleading--should be disclosed to
consumers, so that they can consider the information and then decide
for themselves which path to take.
The IOM Report has some important things to say about the debate
over whether ``reduced exposure'' and ``reduced risk'' tobacco products
should be pursued:
Some public health officials oppose the adoption of harm
reduction strategies because of concerns that promoting this
approach will not, over the long term, prove to be beneficial
to public health or to the individual tobacco users who might
otherwise have quit. Whatever the merits of this position,
marketplace forces already at work have put this issue on the
policy agenda, and new products are being developed and offered
as harm-reducing alternatives to conventional tobacco products
. . . Manufacturers should be permitted to market tobacco-
related products with exposure reduction or risk reduction
claims only after [FDA] approval based on scientific evidence
(a) that the product substantially reduces exposure to one or
more tobacco toxicants and (b) if a risk reduction claim is
made, that the product can reasonably be expected to reduce the
risk of one or more specific diseases or other adverse health
effects, compared with whatever benchmark product [FDA]
requires to be stated in the labeling . . . [The] regulatory
process should not discourage or impede scientifically grounded
claims of reduced exposure, so long as steps are taken to
ensure that consumers are not misled . . .
The IOM Report recommends, among other things, that manufacturers be
given ``the necessary incentive to develop and market products that
reduce exposure to tobacco toxicants''; that consumers be ``fully and
accurately informed'' about the health consequences of these products;
that claims about their potential for reducing harm be regulated; and
that research be conducted to ascertain the products' ``potential for
harm reduction for individuals and populations.''
In the absence of the regulatory oversight recommended by the IOM
Report, Philip Morris USA is, as discussed in section III of this
statement, making a genuine effort to develop potentially reduced
exposure products in accordance with the Report's recommendations,
recognizing that there is currently no regulatory agency to validate
Philip Morris USA's research and development efforts, or any
independent scientific experts available to fully assess these efforts
without funding from either the government or ourselves.
The Status Quo is Unacceptable
The questions regarding the IOM Report's recommendations and harm
reduction as a strategy are important ones, worthy of thorough
discussion, and we urge Congress to find the common ground and to pass
legislation which will finally resolve them.
Without Congressional action, Philip Morris USA will continue to
face a genuine dilemma. We're aware that it would not be ideal to begin
to communicate to consumers about our new products' potential benefits
in the absence of FDA regulation; this is an important reason that we
have been seeking it for such a long period of time. However, without
new legislation and the regulatory oversight that would follow, we are
faced with the choice of making good faith communications about our new
products based solely on our rigorous internal and external scientific
processes and our scientists' engagement with external stakeholders, or
not communicating information that may prove to be important to over 40
million consumers across the country. We note in this regard that time
is not standing still--many of Philip Morris USA's competitors are
already communicating directly with consumers about their new product
designs; as the IOM itself said in its report, ``marketplace forces
already at work have put this issue on the public policy agenda, and
new products are being developed and offered as harm-reducing
alternatives to conventional tobacco products.''
Without new legislation that implements the IOM Report's
principles, we would undoubtedly face criticism no matter which path we
choose to take--but it is truly the millions of adult smokers in this
country who have the most at stake here; we strongly believe that we
would all be doing them a real disservice if we fail to come together
to support the passage of legislation that will implement the IOM
Report's recommendations, and place the FDA in the center of the
critical decisions about tobacco products that, with or without
regulation, are going to need to be made in the months and years ahead.
v. conclusion
We believe that Congress has the opportunity to forge a new
national tobacco policy that will create substantial new authority for
the FDA to adopt regulations for tobacco products in accordance with
the principles articulated in the IOM Report, while continuing to
permit adults who wish to use them to do so legally. The issues you are
considering today could make a substantial contribution to progress
towards that goal. We hope this statement provides you with helpful
input, and makes it clear that our company truly is supportive of a
comprehensive and effective new regulatory regime that includes every
area addressed by the IOM Report, and in practice will actually result
in what we think everyone should be able to agree upon as a primary
objective: reduced harm from tobacco consumption for both current and
future generations.
We also hope that you agree with our conclusion that the status quo
simply is not serving the needs of American smokers, and that, as the
IOM Report has noted, novel tobacco products are being--and will
continue to be--marketed under whatever regulatory regime is in place.
The issue before us is not whether such products will come into being;
but rather what the degree of the governmental oversight of them will
be. These issues are complex and controversial, but we pledge to work
with anyone and everyone who wishes to join in this challenge, and
commend this subcommittee for the progress this hearing represents as a
critical next step.
Annex 1
the debate over reduced-exposure and reduced-risk tobacco products:
full disclosure vs. government suppression of truthful and non-
misleading information
Competing proposals to give FDA regulatory authority over tobacco
products take different approaches to regulating potentially ``reduced-
exposure'' and ``reduced-risk'' tobacco products. These products have
the potential to reduce the health risks associated with conventional
tobacco products by, for example, lowering the smoker's exposure to
toxic substances in the smoke. This paper takes the view that the
approach most consistent with sound public policy and First Amendment
protections is that which provides consumers with more information,
rather than less or none at all. The public health safeguard in this
approach is that FDA would decide both whether a product does indeed
present reduced exposure or reduced risks, and what marketing claims
may be made about the product. But once this determination is made,
neither FDA nor any other government body could gag truthful and non-
misleading information about the product.
Executive Summary
The debate over how to regulate these products has resulted in a
debate over consumer communications. On one side are those who share
the view that the government should simply evaluate claims based on
their scientific merits and deal with any public health concerns by
providing for full disclosure to consumers and through other public
health measures. On the other side are those who fear that the very
existence of these products, despite the fact that FDA would review,
approve and regulate any accompanying claims, would have a net adverse
public health impact by encouraging more people to start smoking in the
first place and/or by discouraging from quitting people who adopt the
misguided view that smoking is now ``safe.'' Therefore, this contingent
supports giving the government authority to suppress reduced-exposure
and reduced-risk claims about tobacco products.
The government suppression tact flies in the face of the First
Amendment and sound public policy. The Supreme Court has made clear
that suppression of information is not a useful or suitably tailored
restriction on commercial speech.
The notion that benefits would result from suppressing truthful and
non-misleading information tobacco products is premised on the
speculation that adults might use this information in a manner that is
disfavored by the government. A benefit deriving from this kind of
paternalistic assumption, however, is not one that the Constitution
recognizes as legitimate. Further, even if suppressed by the
government, information concerning novel tobacco products is likely to
reach consumers through any number of alternative sources. And FDA or
another government agency will not have scientifically vetted this
information.
Moreover, suppressing information on reduced-exposure and reduced-
risk tobacco products would not necessarily advance the government's
interest in protecting public health. In order to provide this
speculative benefit to certain individuals, the government would have
to impose clear harms on others--specifically, on those people who will
use tobacco products regardless and who, because of the suppression of
information, would be denied the ability to select products with
demonstrated potential benefits. Thus, a significant part of the
population may be denied crucial information in order to ``protect'' a
speculative segment of the population.
In addition, the government has available to it more narrowly
tailored means of advancing its public health interests. For example,
it could:
<bullet> ensure that consumers are given all necessary information to
ensure that they are not misled regarding the health risks that
remain with reduced-exposure and reduced-risk tobacco products,
or that quitting or not starting is still the most risk-free
approach; and
<bullet> stress other public health programs to encourage smoking
cessation and prevention.
In short, to quote the Supreme Court, ``the preferred remedy is
more disclosure, rather than less,'' Bates v. State Bar of Arizona, 433
U.S. 350, 375 (1977) (emphasis added), and ``[i]f the First Amendment
means anything, it means that regulating speech must be a last--not
first--resort.'' Thompson v. Western States Medical Center, 122 S.Ct.
1497, 1507 (2002) (emphasis added). Indeed, ``if the [g]overnment [can]
achieve its interests in a manner that does not restrict speech, or
that restricts less speech, the [g]overnment must do so.'' Id. at 1506
(emphasis added). Accordingly, legislation should task FDA with
reviewing claims based on their scientific merits. FDA also should have
ample authority to ensure that consumers are provided with full
disclosure regarding such products. Other public health tools should
supplement these efforts by continuing to encourage smoking cessation
and prevention. This approach is consistent with the approach outlined
by the Institute of Medicine: ``The regulatory process should not
discourage or impede scientifically grounded claims of reduced
exposure, as long as steps are taken to ensure that consumers are not
misled . . .'' Institute of Medicine, ``Clearing the Smoke: Assessing
the Science Base for Tobacco Harm Reduction'' (2001), at 7-13.
i. background
In 2001, the Committee to Assess the Science Base for Tobacco Harm
Reduction (the ``Committee'') of the Institute of Medicine (``IOM'')
issued a report on reduced-exposure and reduce-risk tobacco products
commissioned by the Food and Drug Administration (``FDA'').
The Committee made clear that it recommends a regulatory approach
based on sound science and full consumer disclosure. Prior to detailing
its principles for the regulation of reduced-exposure and reduced-risk
tobacco products (which the Committee referred to as ``potential
reduced-exposure products,'' or ``PREPs''), the Committee stated:
``The committee did come to conclude that regulation of PREPs
is necessary and feasible . . . [R]egulation is needed to
ensure that the product labeling and advertising do not mislead
consumers and accurately describe the products' risks,
including the uncertainties that can only be resolved after
long-term use. Consumers should not use these new products on
the basis of explicit or implicit claims that these products
carry less risk than traditional tobacco products unless such
claims are true. Absent careful regulation of industry claims
about these products, informed choices by consumers will not be
possible, the potential benefit of harm reduction strategy is
likely to go unrealized, and the long and unsettling saga of
light cigarettes may well be repeated.''
IOM Report, at 7-2 (emphasis added).
Notwithstanding IOM's recommendations, however, certain legislative
proposals to grant FDA authority to regulate tobacco products appear to
authorize FDA to suppress information about PREPs even if FDA has
verified that these products actually have the potential to present
potential benefits for consumers. For example, some proposals would
permit manufacturers to make reduced-exposure or reduced-risk health
claims only if FDA determines that the product actually reduces the
risk of harm to individuals as a matter of science and is otherwise
``appropriate'' for the ``public health.'' <SUP>4</SUP>
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\4\ See e.g., H.R. 936, 108th Cong. Sec. 572(a)(1), (2) (stating
that FDA must determine that ``based on the best available scientific
evidence the product significantly reduces the overall health risk to
the public when compared to other tobacco products,'' and that in
approving reduced-risk claims, FDA must ``ensure [the claim's] accuracy
and, in the case of advertising, . . . prevent such statement from
increasing, or preventing the contraction of, the size of the overall
market for tobacco products'' (emphasis added).
---------------------------------------------------------------------------
This type of two-prong standard--with a ``scientific merits
prong''' and an ``appropriateness'' prong--appears to respond to those
segments of the public health community that have called for FDA
discretion to suppress reduced-risk claims, notwithstanding their
veracity, based on their potential effect on consumer behavior. See,
e.g., National Cancer Society et al., Why the FDA Should Regulate
Tobacco Products (June 27, 2002) (stating that FDA should have the
authority ``to prohibit or restrict . . . claims that discourage people
from quitting or encourage them to start using tobacco''); Campaign for
Tobacco Free Kids, Critical Elements of FDA Authority Over Tobacco
(Feb. 18, 2000) (``FDA should have the authority to prohibit . . .
health claims that have an adverse effect on the overall risk to the
American public . . .'').<SUP>5</SUP>
---------------------------------------------------------------------------
\5\ For example, H.R. 936 provides that FDA must prevent reduced-
risk advertising claims from ``increasing, or preventing the
contraction of, the size of the overall market for tobacco products.''
H.R. 936 Sec. 575(a)(2).
---------------------------------------------------------------------------
Thus, under this two-prong standard, even if valid scientific
evidence demonstrates to FDA's satisfaction that a product presents
potential benefits, the agency could prohibit truthful and non-
misleading information about the product's reduced-exposure or reduced-
risk potential from being communicated to consumers in the marketplace.
ii. the first amendment precludes this kind of suppression of
information
This approach to the regulation of PREPs would violate the First
Amendment and sound public policy. First, the suppression of
information would not materially and directly advance the government's
legitimate interests in encouraging tobacco cessation and prevention.
Instead, the suppression of information would harm a clearly
identifiable group of individuals. Second, the government has far more
tailored means at its disposal to address any impact of PREPs on the
rates of smoking cessation and initiation. Such alternatives include
the mandatory use of public health disclaimers to ensure that PREPs are
not perceived as safe, and the pursuit of other public health programs
to encourage tobacco cessation and prevention.
The Supreme Court repeatedly has held that once a product is
legally sold in the United States, the government may not deny adults
truthful and non-misleading information about the product. Rather, the
government must adopt more tailored restrictions to achieve its
legitimate purposes. As the Supreme Court stated in its seminal
commercial speech case:
``There is, of course, an alternative to [a] highly
paternalistic approach [to regulating commercial speech]. That
alternative is to assume that this information is not in itself
harmful, that people will perceive their own best interests if
only they are well enough informed, and that the best means to
that end is to open the channels of communication rather than
to close them . . . It is precisely this kind of choice,
between the dangers of suppressing information, and the dangers
of its misuse if it is freely available, that the First
Amendment makes for us.''
Virginia Bd. of Pharmacy v. Virginia Citizens Consumer Council, Inc.,
425 U.S. 748, 770 (1976).
``[B]ans against truthful, nonmisleading commercial speech . . .
usually rest solely on the offensive assumption that the public will
respond ``irrationally'' to the truth. The First Amendment directs us
to be especially skeptical of regulations that seek to keep people in
the dark for what the government perceives to be their own good.''
Thompson v. Western States Medical Center, 122 S.Ct. 1497, 1508 (2002),
citing 44 Liquormart v. Rhode Island, 517 U.S. 484, 503 (1996)
(plurality opinion).
In Lorillard Tobacco Co. v. Reilly, 533 U.S. 525 (2001), the
Supreme Court struck down certain restrictions on the advertising of
tobacco products because those restrictions were not sufficiently
tailored to fit the government's objective of protecting children. This
holding reaffirmed that the Court will carefully scrutinize commercial
speech restrictions, including in the case of tobacco products, to
determine if less restrictive means are available to achieve the
government's purpose. The Reilly Court also made clear that commercial
speech restrictions continue to be subject to the following four-part
inquiry developed by the Supreme Court in the Central Hudson case:
``For commercial speech to come within [the First Amendment],
it at least must concern a lawful activity and not be
misleading. Next, we ask whether the asserted government
interest is substantial. If both inquiries yield positive
answers, we must determine whether the regulation directly
advances the government interest asserted, and whether it is
not more extensive than is necessary to serve that interest.''
447 U.S. 557, 566 (1980). ``We have said that the last two steps of the
Central Hudson analysis basically involve a consideration of the `fit'
between the legislature's ends and the means chosen to accomplish those
ends.'' Rubin v. Coors Brewing Co., 514 U.S. 476, 486 (1995).
Simply put, the suppression of information about PREPs does not fit
the government's interest in encouraging tobacco cessation and
prevention.
A. The Suppression of Reduced-Risk Information Would Elevate Presumed
Paternalistic Benefits for Some Over Real Harms for Others
The premise behind providing FDA with authority to suppress
truthful and non-misleading information appears to be that the costs
associated with the possible changes in the rates of cessation and
initiation might outweigh the benefits resulting from communications
about PREPs. To tilt the balance in this fashion, however, one would
have to value the presumed benefits that may be provided to some
individuals over the real costs that would be imposed on others. Such
conjecture, however, cannot justify the suppression of truthful and
non-misleading commercial speech under the First Amendment. ``Such
speculation certainly does not suffice when the [government] takes aim
at accurate commercial information for paternalistic ends.'' 44
Liquormart, 517 U.S. at 507.
Moreover, as detailed below, an abstract discussion about costs and
benefits fails to illuminate the serious consequences of suppressing
truthful information about PREPs.
1. The Paternalistic and Speculative Benefits Provided by the
Suppression of Information Are Insufficient to Pass
Constitutional Muster
The suppression of information presumably would be intended to
benefit that segment of the population that would quit or never
initiate smoking if information about PREPs is not available, but who
would choose to switch to or begin using them if they were made aware
of these products. Viewed from a ``paternalistic'' perspective, this
segment of the population would be benefited by the suppression of
information. Attempting to justify the suppression of information on
this basis, however, is at odds with the Constitution, because
paternalism is not a legitimate governmental interest, and because the
realization of this paternalistic benefit would be impermissibly
speculative.
The government ``does not have the broad discretion to suppress
truthful, nonmisleading information for paternalistic purposes . . . ''
44 Liquormart, 517 U.S. at 510. Indeed, the Supreme Court has
``rejected the notion that the [g]overnment has an interest in
preventing the dissemination of truthful commercial information in
order to prevent members of the public from making bad decisions with
the information.'' Western States, 122 S.Ct. at 1507. ``[T]he argument
[for suppression] assumes that the public is not sophisticated enough
to realize the limitations of advertising, and that the public is
better kept in ignorance than trusted with correct but incomplete
information. We suspect the argument rests on an underestimation of the
public . . . [W]e view as dubious any justification that is based on
the benefits of public ignorance.'' Bates v. State Bar of Arizona, 433
U.S. 350, 374-375 (1977). ``To endeavor to support a restriction upon
speech by alleging that the recipient needs to be shielded from that
speech for his or her own protection . . . is practically an engraved
invitation to have the restriction struck.'' Wash. Legal Found. v.
Friedman, 13 F. Supp. 2d 51, 70 (D.D.C. 1998) (judgment vacated on
other grounds). ``[T]he government may not restrict speech because it
fears, however justifiably, that the speech will persuade those who
hear it to do something of which the government disapproves.'' David A.
Strauss, Persuasion, Autonomy, and Freedom of Expression, 91 Colum. L.
Rev. 334, 334 (1991).
Moreover, this justification for suppression of information would
fail the third prong of the Central Hudson test because it would
require the court ``to engage in the sort of ``speculation or
conjecture'' that is an unacceptable means of demonstrating that a
restriction on commercial speech directly advances the [government's]
asserted interest.'' 44 Liquormart, 517 U.S. at 507. For example, in
Rubin v. Coors Brewing Co., 514 U.S. 476 (1995), the Court concluded
that the government's prohibition on displaying alcohol content on beer
labels failed the third prong of Central Hudson because it would not
sufficiently advance the government's interests in preventing
``strength wars'' in the marketing of alcoholic beverages. The Court
reasoned that the government's burden ``is not satisfied by mere
speculation or conjecture; rather, a governmental body seeking to
sustain a restriction on commercial speech must demonstrate the harms
it recites are real and that its restriction will in fact alleviate
them to a material degree.'' Id. at 487, quoting Edenfield v. Fane, 507
U.S. 761, 770-771 (1993).<SUP>6</SUP>
---------------------------------------------------------------------------
\6\ When viewed from a more ``utilitarian'' perspective, these
individuals are not benefited at all by the suppression of information.
From this perspective, adults are better off if they are left free to
make their own decisions based on full information. As University of
Chicago Law School Professor Cass Sunstein puts it, ``people should be
allowed to select their preferred mixes of risk, employment, salary,
medical care, and so forth.'' Cass R. Sunstein, Informing America:
Risk, Disclosure, and the First Amendment, 20 Fla. St. U. L. Rev. 653,
659 (1993); see also Martin H. Redish, Tobacco Advertising and the
First Amendment, 81 Iowa L. Rev. 589, 592 (1996) (``The asserted
justifications for such regulation of the truthful promotion of a
lawful product derive exclusively from a premise of governmental
paternalism that is fundamentally inconsistent with both the purposes
served by free speech and the democratic system of which free speech is
a central element.'')
---------------------------------------------------------------------------
It is far from clear that suppressing information would ``in fact
alleviate'' the perceived harms that might arise from the introduction
of PREPs. Any information suppressed by the government likely would
find its way to consumers through other channels, though almost
certainly in a less accurate form that has not been subject to
scientific verification. As the IOM Report notes, ``marketplace forces
already at work have put this issue on the public policy agenda,'' and
consumers will seek out PREPs ``with or without scientific guidance.''
IOM Report at 7-1, 7-2. Moreover, as discussed below, any advance in
the public health that purportedly results from the suppression of
information would be undermined by the adverse effects of such
suppression on individuals who would have used PREPs had the suppressed
information been available to them.
2. Real Harms Would Be Imposed by the Suppression of Information
Though the benefits to be derived from the suppression of
information about PREPS are speculative, it is clear that a separate
group of individuals would be harmed by the suppression of such
information. This group consists both of smokers who would have
switched to PREPs instead of continuing to use conventional tobacco
products, and nonsmokers who would have begun using PREPs instead of
conventional tobacco products if they had been provided with
information about PREPs. Regardless of one's philosophical bent,
everyone should agree that this group, which ends up taking on more
risks solely because of the suppression of information, is
substantially harmed by that suppression.
It is neither sound public policy nor constitutionally permissible
for the government knowingly to harm a certain group of individuals by
suppressing information for the presumed benefit of others. The Supreme
Court held in the Western States decision that such a suppression of
commercial speech cannot be reconciled with the First Amendment.
Western States, 122 S.Ct. at 1508-09. In this decision, the Court
invalidated provisions of the Food and Drug Modernization Act
(``FDAMA'') that prohibited advertising of ``compounded drugs,''
<SUP>7</SUP> which the government argued were necessary to ensure that
drug compounding was not used to circumvent the new drug approval
requirements of the Federal Food, Drug, and Cosmetic Act (``FDCA'').
Id. at 1504-06.
---------------------------------------------------------------------------
\7\ Drug compounding, a ``traditional component of the practice of
pharmacy,'' is a process by which a pharmacist or doctor combines or
alters drug ingredients to create a medication typically not
commercially available and which is tailored to the needs of a
particular individual, e.g., an individual that is allergic to an
ingredient in a mass-produced product. Id. at 1500.
---------------------------------------------------------------------------
The Supreme Court found that the prohibition on advertising of
compounded drugs was impermissible, inter alia, because of ``the amount
of beneficial speech'' that it prohibited without furthering the
asserted governmental objective. Id. at 1508.<SUP>8</SUP> Specifically,
the Court pointed out that the prohibition would prevent pharmacists
with ``no interest in mass-producing medications'' in circumvention of
FDCA from telling doctors about alternative drugs available through
compounding that would be useful in treating patients with special
medical needs. Id. at 1508-09. The fact that such ``useful speech''
would be suppressed even though doing so would not ``directly further''
the government's asserted objective was ``enough to convince'' the
Court that the challenged provisions were unconstitutional. Id. at
1509.
---------------------------------------------------------------------------
\8\ In response to the Western States decision, FDA issued a
Federal Register notice seeking comments to ``ensure that its
regulations, guidances, policies, and practices continue to comply with
the governing First Amendment case law.'' 67 Fed. Reg. 34,942 (May 16,
2002).
---------------------------------------------------------------------------
Following Western States, the suppression of information about
PREPs would be unconstitutional because it would result in real harm
for certain groups of people without furthering a substantial
governmental interest. The suppression of truthful, non-misleading
claims clearly would redound to the detriment of certain individuals--
i.e., those who, had they been exposed to the claims, would have
switched to PREPs from conventional tobacco products. Moreover, the
only motivation for suppressing truthful and non-misleading reduced-
risk information would be the government's desire to prevent people
from using the information to make choices that the government
disfavors. Yet, as discussed above, the Constitution does not recognize
such a motivation as a legitimate basis for restricting commercial
speech. Under these circumstances, not only would the government
impermissibly be saying that it knows what is best for certain of its
citizens, but in doing so, it would affirmatively harm other citizens.
The government's decision to suppress reduced-risk information also
has severe consequences for the individual and, indeed, for our system
of government as a whole:
[T]he fundamental premise of the First Amendment--indeed, of
the very democratic system of which the First Amendment is such
an important part--is that citizens must be trusted to make
their own lawful choices on the basis of a free and open
competition of ideas, opinions, and information. If government
is permitted paternalistically to shield its citizens from such
open debate as a means of controlling their behavioral choices,
it will have simultaneously affronted individual dignity and
stunted the individual's personal and intellectual growth, a
developmental process that lies at the heart of the free speech
right. It will simultaneously have contributed to an
intellectual atrophy of the citizen that ultimately will
undermine her effective participation in the democratic system.
Redish, Tobacco Advertising and the First Amendment, supra, at 636.
B. More Targeted Approaches Are Available to Address Public Health
Concerns About PREPs
Far more targeted approaches are available for the government to
address concerns about the impact that PREPs might have on the rates of
smoking cessation and initiation. FDA should ensure that information
about the product's reduced-exposure or reduced-risk potential is
presented to consumers in a truthful and non-misleading manner. Indeed,
authority to prevent false and misleading product information is a
standard FDA regulatory tool that currently applies to all product
labeling and promotional materials regulated under FDCA, and that would
be extended to tobacco products by proposals granting FDA authority to
regulate such products. In addition, other public health tools to
encourage tobacco cessation and prevention are available and currently
in use.
1. FDA Should Consider Appropriate Use of Disclaimers to Address Public
Health Concerns
The Supreme Court held in Western States that ``if the [g]overnment
can achieve its interests in a manner that does not restrict speech, or
that restricts less speech, the [g]overnment must do so.'' Western
States, 122 S.Ct. at 1506-07 (emphasis added) (holding that the
government failed to demonstrate that preserving the integrity of the
FDCA drug approval process could not be achieved through means that
imposed a lesser burden on speech than the FDAMA prohibition on
advertising compounded drugs). Consequently, the advertising
prohibition challenged in that case failed to satisfy the fourth prong
of the Central Hudson test requiring that the restrictions not be more
extensive than is necessary to serve the governmental interest. Id. See
also Pearson v. Shalala, 164 F.3d 650, 655 (D.C. Cir. 1999) (there
cannot be ``an absolute prohibition on . . . potentially misleading
information . . . if the information also may be presented in a way
that is not deceptive''); Wash. Legal Found. v. Friedman, 13 F. Supp.
2d at 73 (FDA restrictions on particular forms of manufacturer
promotion of off-label uses for FDA-approved drugs were considerably
more extensive than necessary, and ``[t]he most obvious alternative is
full, complete, and unambiguous disclosure by the manufacturer'').
In Western States, the Supreme Court identified the use of so-
called ``disclaimers'' as an alternative way to ensure that consumers
are not misled by advertisements. Western States, 122 S.Ct. at 1508 (a
governmental interest in preventing misleading advertising could be
achieved by ``the far less restrictive alternative'' of requiring
compounded drugs to bear warnings stating that the drugs are not FDA-
approved and that their risks are unknown). The D.C. Circuit made the
same conclusion in Pearson, stating that ``we are skeptical that the
government could demonstrate with empirical evidence that disclaimers .
. . would bewilder consumers and fail to correct for deceptiveness . .
. ''. Pearson, 164 F.3d at 659-660; see also In re R.M.J., 455 U.S.
191, 203 (1982) (``[T]he remedy in the first instance is not
necessarily a prohibition but preferably a requirement of disclaimers
or explanation.''). Furthermore, this principle is ``consistent with a
well-established body of law that points to First Amendment limits on
federal agencies' restrictions on commercial speech where less
restrictive alternatives are available.'' Steven B. Steinborn & Kyra A.
Todd, The End of Paternalism: A New Approach to Food Labeling, 54 Food
& Drug L.J. 401, 402 (1999). ``Pearson stands as [a] reminder that
regulatory agencies in general, and FDA in particular, must adopt a
regulatory approach that recognizes the consumer's right to receive
pertinent information.'' Id. at 413-414.
Indeed, the Federal Trade Commission has long supported the
position that disclaimers must be considered as an alternative when
determining whether health claims about a product are misleading. See
Nat'l Comm'n on Egg Nutrition v. FTC, 570 F.2d 157, 164 (7th Cir.
1977); Margaret Gilhooley, Constitutionalizing Food and Drug Law, 74
Tul. L. Rev. 815, 827 (2000); see also FTC Enforcement Policy Statement
on Food Advertising, 59 Fed. Reg. 28,388, 28,393 (1994) (noting that
the ``significant scientific agreement'' standard in the Nutrition
Labeling and Education Act of 1990 (NLEA) is the appropriate standard
to determine if health claims are misleading only in situations where
the claims are unqualified).
Providing consumers with additional information, such as through
the use of disclaimers, is thus a more tailored means to address the
potential impact of PREPs on smoking cessation and initiation. ``Any
`interest' in restricting the flow of accurate information because of
the perceived danger of that knowledge is anathema to the First
Amendment; more speech and a better informed citizenry are among the
central goals of the Free Speech Clause.'' Rubin, 514 U.S. at 497
(Stevens, J., concurring) (emphasis added). FDA could require, for
example, that every tobacco product designated as a PREP include
labeling that reminds consumers that no tobacco product is safe and
that the best option is to quit or not to start in the first
place.<SUP>9</SUP>
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\9\ Of course, FDA could prohibit any reduced-risk or health claims
for tobacco products that have not been approved by FDA. See, e.g.,
Whitaker v. Thompson, 239 F.Supp. 2d 43, 54 (D.D.C. Jan. 3, 2003)
(holding that claims concerning the therapeutic effects of a dietary
supplement on an existing disease condition that were not approved as
permissible reduced-risk claims for the product were unlawful health
claims).
---------------------------------------------------------------------------
2. Other Public Health Tools are Available to Address Concerns Related
to Smoking Cessation and Prevention
An FDA-imposed restriction on the communication of information
about PREPs is not the only policy tool available to address concerns
related to tobacco use. As the Institute of Medicine noted, the
regulatory system should not be viewed in isolation, but rather ``as an
essential component of a package of public policy initiatives
(including research, education and surveillance) that this committee
believes is necessary to realize whatever benefit tobacco or
pharmaceutical product innovation can offer in reducing the nation's
burden of tobacco-related illness and death.'' IOM Report at 7-21, 22.
``Harm reduction [should be] implemented as a component of a
comprehensive national tobacco control program that emphasizes
abstinence-oriented prevention and treatment.'' Id. at 7-21.
In this regard, Congress appropriated more than $100 million to the
Centers for Disease Control for its tobacco control efforts in FY--
2003. Further, many states have increased their spending on tobacco
control efforts in the wake of the state attorneys general tobacco
settlements (the ``MSA''). These state and federal tobacco control
programs are in addition to the $1.5 billion that was earmarked in the
MSA to fund tobacco control efforts through a national public health
foundation, the American Legacy Foundation, which is overseen by the
state attorneys general.
Indeed, the government would have the burden of demonstrating that
programs such as these could not adequately address the public health
concerns raised by PREPs, which would obviate the need to suppress
truthful, non-misleading information. ``If the First Amendment means
anything, it means that regulating speech must be a last--not first--
resort.'' Western States, 122 S.Ct. at 1507.<SUP>10</SUP>
---------------------------------------------------------------------------
\10\ The Supreme Court ruled in Western States that the government
must consider non-speech related alternatives before resorting to
restrictions on commercial speech. In the decision, the Court
identified several non-speech alternatives to FDAMA's compounded drug
advertising prohibition that might be effective in achieving the
government's interest of ensuring the integrity of FDCA's drug approval
process. Id. at 1506. These were (1) banning the use of commercial
scale manufacturing or testing equipment for compounding drug products;
(2) prohibiting pharmacists from compounding more drugs in anticipation
of receiving prescriptions than in response to prescriptions already
received; (3) prohibiting pharmacists from offering compounded drugs at
wholesale to other state licensed persons or commercial entities for
resale; (4) limiting the amount of compounded drugs that a pharmacist
may sell out of State or sell or make in a given period of time; or (5)
relying on the non-speech related provisions of FDAMA, which include
requiring that compounding only be conducted in response to a
prescription or a history of receiving a prescription, and limiting the
percentage of a pharmacy's total sales that out-of-state sales of
compounded drugs may represent. Id. at 1506. The government's failure
to explain why these alternatives would not be adequate led the Court
to conclude that FDAMA's advertising prohibition was more extensive
than necessary. Id. at 1506-07.
---------------------------------------------------------------------------
iii. conclusion
Based on these precedents and the IOM Report's recommendations,
proposals to grant FDA authority over tobacco products should ensure
that adult consumers are provided with truthful and non-misleading
information about PREPs. ``[P]erhaps the first and most basic problem
is that Americans lack the necessary information . . . [P]erhaps the
first goal ought to be to ensure genuinely informed choices, rather
than to dictate outcomes from Washington.'' Sunstein, supra, at 654.
An outright ban on such information concerning PREPs would be
inappropriate and unconstitutional. Instead, FDA should be empowered to
assess and approve PREPs based on the scientific merits of the claims
and then ensure that consumers are not misled about the risks
associated with those products. Additional public health programs
should continue to encourage smoking cessation and prevention.
Mr. Stearns. At this point I would invite other members to
do the same if they wish to enter documents into the record,
and with that, I welcome my ranking member for an opening
statement.
Ms. Schakowsky. Thank you, Mr. Chairman. It is good to see
you again.
Well, you have got to hand it to the tobacco lobby. If
there were such a thing as a chutzpa award, which roughly
translates into brazen gall, the effort today, in my humble
opinion, would be worthy of a prize.
Under the guise of concern for public health, the tobacco
industry has us here to discuss its efforts to gain advanced
government approval or a marketing campaign that would promote
tobacco products and their bottom line.
``Smokeless tobacco''--I put that in quotes--is a dressed
up name for dip, chew or spit tobacco, U.S. Tobacco, UST, wants
to market its spit tobacco as a safer alternative to smoking
cigarettes. Smokeless tobacco is a threat to our Nation's
public health and especially to the health of our children. Any
type of claim that spit tobacco as a safer alternative to
smoking requires a substantive body of evidence and an
independent regulatory body capable of examining the claims.
Such evidence and regulation does not exist. UST cannot
back up their campaign slogans, and that is why they have asked
the FTC, not the FDA, the FTC being a nonscientific regulatory
agency, to review the claims they want to make.
Tobacco causes cancer and other diseases, whether you smoke
it, chew it, suck it, put it up your nose. It can and after
sustained use probably will kill you.
UST's argument that smokeless tobacco use is a healthier
alternative to smoking is analogous to suggesting that one is
better off jumping off the fifth floor of the building rather
than the 20th because, of course, both are likely to cost you
your life. They want to convince smokers who may be trying to
quit or have quit, nonsmokers, children and others that their
product is okay to use.
If we allow them to make these false claims, then the
Congress will share the blame for more lives lost to tobacco
related diseases.
The government has no business endorsing media campaigns
for products like spit tobacco that lead to disease and
premature death. First we should do no harm. If we send a
message to the American public that it is okay to chew tobacco,
we will be doing harm. If we, instead, want to truly discuss
ways to reduce harm and promote health, we should spend time
and money on legitimate ways to end the use of tobacco in any
form, period.
Today, along with Congressman Waxman, I will be releasing a
report entitled ``The Lessons of `Light' and Low Tar
Cigarettes.'' Without effective regulation, reduced risk
tobacco products, so-called reduced risk tobacco products,
threaten the public health.
Mr. Chairman, I ask unanimous consent to insert this report
into the record.
Mr. Stearns. Without objection, so ordered.
Ms. Schakowsky. Thank you.
[The report appears at the end of the hearing.]
Ms. Schakowsky. I think it is an important document to
include in the official record because it underscores parallels
documented by the Government Reforms Committee Democratic staff
between the efforts of the tobacco industry to mislead the
public into believing that so-called light and low tar
cigarette products are a healthy alternative to regular
cigarettes and the efforts currently underway by UST to
convince the Congress the FTC, and the public of the virtues of
its spit tobacco products.
This report includes previously undisclosed internal
industry documents and demonstrates that the products that are
marketed as light and low tar are, in fact, not. We know that
the tobacco industry duped the FTC's tests by designing
cigarettes that only appeared healthier when tested by
machines, but did not provide lower amounts of tar and nicotine
to smokers.
We know that the industry has for some time been well aware
of the dangers these products pose. An internal company E-mail
included in this report, a senior research scientists at
British-American Tobacco stated, ``Our main problem appears to
be the notion that the technology exists to make cigarettes
which are appreciably less lethal. The technology does not
exist. It will not exist.''
The report also demonstrates that tobacco industry
officials continue to deceive the public with information from
industry, the National Cancer Institute, and the Department of
Justice. The report provides clear examples of current
``reduced risk'' product marketing, including the marketing of
spit tobacco specifically designed to counter health fears,
deceive consumers, deter quitting, and exploit the absence of
effective regulation.
The FTC allowed for the marketing of light and low tar
products in the past, and the public was harmed. Now major
lawsuits have ensued. In my home State of Illinois, a court
recently ruled against Philip Morris and found that its
creation of these brands was ``immoral, unethical, oppressive,
and unscrupulous.''
And UST is here today trying to present a case that their
spit tobacco products are not as harmful as smoking and,
therefore, the company should be allowed to make such
statements on their packaging. UST's representatives want us to
believe that they are offering a product that will improve
overall health in the United States.
Quite the opposite is true. We know from industry documents
that UST has purposely targeted tobacco consumers in an effort
to promote ``dual consumption,'' not cessation of smoking.
We should not even be entertaining UST's claims absent a
comprehensive review and serious regulation by the FDA. The FDA
should have authority over all tobacco products, including spit
tobacco, and authority to oversee the content, manufacture,
sale, and marketing of the product. Absent this regulation,
allowing marketing strategies that include comparative health
claims will lure more kids into smokeless tobacco use and
addiction, discourage current users from quitting, and may
increase the overall amount of tobacco products being used in
the United States.
Mr. Chairman, I thank you for your indulgence in letting me
go over. I think this is a very, very serious issue, and I
appreciate the opportunity to discuss this important issue
today with our witnesses.
Mr. Stearns. I thank the gentlelady, and I will now
recognize the Chairman of the full committee, who probably will
not agree with you when you mention Tabasco sauce. The
chairman, distinguished chairman of the committee, Mr. Tauzin.
Chairman Tauzin. Thank you, Mr. Chairman.
I would not recommend you smoke Tabasco sauce though. It is
not necessarily a good idea.
Let me thank you, Mr. Chairman, for convening this hearing,
and I want to thank the Chairman of the Federal Trade
Commission and the Surgeon General for coming to join us, and I
hope it will be a very instructive session, particularly as we
move to the second panel as well and get some insights as to
this extraordinary issue.
We have held hearings, as you know, in this committee on
tobacco in the past, but this particular issue of tobacco harm
reduction is not one I think that has been the subject of a
great deal of congressional debate, frankly, a good
understanding yet. It was back in 1964 that the Surgeon General
released a report finding that cigarette smoking is a health
hazard of sufficient importance to the United States to warrant
appropriate remedial action.
And we now know that smoking kills over 400,000 people
annually in the United States alone, and that is more deaths
each year than from AIDS, from alcohol, cocaine, heroin,
homicide, suicide, motor vehicle crashes, and fires combined.
You cannot ignore those kinds of statistics.
And during the past 4 decades we have made unprecedented
gains in preventing and controlling tobacco use. However,
despite the massive education campaigns and years of
litigation, and substantial price hikes designed to curb
smoking, it has picked up. And when asked, most smokers say
they want to quit. I think over 80 percent will say that in
most surveys. Unfortunately very few of them are able to break
the habit.
There is no debate that the best option for any person
using tobacco products is to stop, to stop using tobacco
products, and particularly we need to continue to do all we can
to discourage the use of these products by children.
But we also know that nicotine is a remarkably addictive
drug. Some have likened the addictive qualities of nicotine to
the intense grip of cocaine or heroin. Unfortunately there are
people who, try as they may, are unable or unwilling to kick
the smoking addiction.
Some in the medical community argue that we are giving
these hardened smokers only one uninviting option: quit or die.
Increasingly there are calls for options other than the quit or
die approach, such as tobacco harm reduction. There are studies
now that have found that some tobacco products, such as
smokeless tobacco, are less hazardous than cigarettes, not
unhazardous or safe, but less hazardous.
These studies have resulted in a call for campaigns that
would encourage smokers to switch from cigarettes to smokeless
tobacco, which arguably could save many of the 400,000 people
who will die every year, and that is an intriguing concept, and
if science bears out these conclusions, we are faced with a
myriad of questions that I hope we begin to think about and
perhaps begin to answer today or at least set up a process
whereby we might have the type of forums and discussions with
officials and citizens of our country to find the answers to
these questions.
They include: should we communicate this reduced risk
information to the consumer? Is a person who is faced with a
quit or die option one of my children? Is that person to
entitled to know that there is another option that can reduce
the risk of death and perhaps even be a bridge to stopping
smoking?
If so, how should we communicate this information.
Obviously the concern is if you communicate it improperly, you
might encourage people to continue using tobacco, and that is
not the goal obviously. So how do you do it properly?
Will promotion of certain tobacco products as reduced risk
dilute the anti-tobacco, anti-smoking message that we are
sending children, in particular? And that is a deep concern.
Finally, does a consumer have a right to know about safer
tobacco products, about reduced risk products? We know in other
countries, such as Sweden, they made that decision, that
consumers were entitled to know, and there have been some
remarkable results as a result of simply communicating that
information to people who were faced with the quit or die
option.
So these are questions I hope we will answer today. The
hearing is especially timely because the Federal Trade
Commission is currently faced with a petition from the United
States Tobacco Company that requests an advisory opinion on
whether, based on current science, it may advertise its
smokeless product as a safer alternative to smoking. I hope the
Federal Trade Commission examines the issue carefully.
I urge Chairman Muris to invest the commission's time and
energy in a tobacco harm reduction workshop to more thoroughly
evaluate these claims. I think it is time for that, just to
have a very open and informative workshop so that we can
understand whether we need to make some new policy decisions in
this country.
Few medical questions have stirred more public interest or
created more scientific debate than the tobacco health
controversy. The relationship between tobacco and health does
not lead to easy answers.
Nevertheless, there are 400,000 deaths in the United States
attributed to smoking. It is increasingly apparent that we must
continue to search for new and novel solutions.
I want to thank you again, Mr. Chairman, for holding the
hearing and look forward to hearing from our two distinguished
witnesses today.
Mr. Stearns. And I thank the Chairman.
The gentleman from Massachusetts is recognized.
Mr. Markey. Thank you, Mr. Chairman, very much and thank
you for holding this hearing.
To say that smokeless tobacco is a safer alternative to
smoking cigarettes is very misleading. Smokeless tobacco
products have known carcinogens and that are linked to oral
cancer and they are addictive. This method of harm reduction
may simply be trading one vice for another.
A few years ago I introduced the Cigars Are No Safe
Alternative Act that would impose restrictions on the sale of
cigars because cigar use is not a safe alternative to smoking
cigarettes either. People need to be informed of all of the
risks of tobacco products.
Just as with cigars and cigarettes, children especially
must not be influenced by misleading advertising that glorifies
the use or these tobacco products. Three thousand young people
begin smoking in the United States every day. One thousand of
these 3,000 will die from some lung related disease. Twenty
percent of all Americans who die each year, die from some lung
related smoking related disease. Obviously our goal should be
to just stop it dead in its tracks.
I believe that people should make informed decisions for
themselves as to which is a better alternative and safer for
them. However, people cannot make informed decisions about
smokeless tobacco products because we do not even know all of
the additives that these products contain and what harm they
may cause.
In fact, when the State of Massachusetts asked that these
ingredients be disclosed, the tobacco industry sued them and
won. So we do not even know all of the ingredients in these
products.
There are safe, FDA approved nicotine based products that
are safe, and when Massachusetts used them in an advertising
campaign it helped to reduce smoking from 20 percent to 14
percent in the male population. But I do not believe that any
governmental agency, the food and drug agency, the Department
of Health and Human Services, or the Federal Trade Commission,
should promote the use of tobacco products, especially when we
know they are addictive, cancer causing, and gateways to
further tobacco use.
The U.S. Smokeless Tobacco Company continued to advertise
in youth magazines despite signing a master settlement
agreement in 1998 which prohibited indirect or direct
advertising that targets youth. In Massachusetts, the Attorney
General was sued by the tobacco industry after trying to
implement regulations that would prevent advertising of
smokeless tobacco products near schools or playgrounds.
It is immoral to enhance a company's sales by targeting
children to use an addictive substance that is detrimental to
their health and is also illegal.
I think that we have a very important subject that we are
debating here today, but there is no greater cause of illness
in the United States than tobacco. It is central to the
responsibilities of this committee that we do nothing that
enhances the likelihood that young people will embrace this as
a life style habit.
I thank you, Mr. Chairman.
[The prepared statement of Hon. Edward J. Markey follows:]
Prepared Statement of Hon. Edward Markey, a Representative in Congress
from the State of Massachusetts
Mr. Chairman thank you for holding a hearing on such an important
issue. To say that smokeless tobacco is a ``safer'' alternative to
smoking cigarettes is misleading. Smokeless tobacco products have known
carcinogens, are linked to oral cancer, and are addictive. This method
of ``harm reduction'' may simply be trading one vice for another.
A few years ago I introduced the CANSA Act (Cigar Are No Safe
Alternative Act) that would impose restrictions on the sale of cigars,
because cigar use is not a safe alternative to smoking cigarettes
either. People need to be informed of all the health risks for all
tobacco products. Just as with cigars and cigarettes, children
especially must not be influenced by misleading advertising that
glorifies the use of these tobacco products.
I believe that people should make informed decisions for themselves
as to which is a better alternative and safer for them. However, people
can not make informed decisions about smokeless tobacco products
because we do not even know all the additives that these products
contain and what harm they may cause. In fact when the Commonwealth of
Massachusetts asked that these ingredients be disclosed, the tobacco
industries sued them and won, so we still do not know of all the
ingredients in these products.
There are safe FDA approved nicotine based products on the market
which are made for the purpose of terminating a smoking habit. When
Massachusetts promoted the use of these nicotine-based products to stop
smoking the number of males who smoked daily was reduced from 20% to
14%. The nicotine-based products are also more likely to be used by
women, who make up a very small portion of the users of smokeless
tobacco products. These nicotine-based products are a safe and
effective way to end smoking. Let's work to enhance and promote this
safe alternative instead of cancer-causing smokeless tobacco products.
Smoking and tobacco use is a tremendous public health problem.
Studies have shown that smokeless tobacco use is a gateway to smoking.
We must end smoking, not shift the use of tobacco products.
I do not believe that any governmental agency, the Food and Drug
Agency, The Department of Health and Human Services, or the Federal
Trade Commission should promote the use of a tobacco products,
especially when we know they are addictive, cancer causing, and
gateways to further tobacco use.
The U.S. Smokeless Tobacco Company (USSTC) continued to advertise
in youth magazine despite signing a Master's Settlement Agreement in
1998 which prohibited indirect or direct advertising that targets
youth. In Massachusetts the Attorney General was sued by the tobacco
industries after trying to implement regulations that would prevent
advertising of smokeless tobacco products near schools or playgrounds.
It is immoral to enhance a companies' sales by targeting children to
use an addictive product that is detrimental to their health and it is
illegal.
Promoting alternatives to smoking is a truly important endeavor and
worthy cause but only when these products are safe, and will not
enhance the use of tobacco products.
I am glad that we are having this hearing today and happy to hear
the testimony from our witnesses. I hope that we continue to work
together to stop smoking by the most effective but safest means.
Thank you.
Mr. Stearns. I thank the gentleman.
And the gentleman, Mr. Whitfield.
Mr. Whitfield. Mr. Chairman, I guess we still have the
policy of 8 minutes if you forego your----
Mr. Stearns. We do if you want to forego your opening
statement.
Mr. Whitfield. I forego my opening statement.
Mr. Stearns. Okay. The gentleman forgoes his opening
statement.
Ms. McCarthy.
MS. McCarthy. Thank you, Mr. Chairman.
I am going to be very brief and put my remarks in the
record.
I do want to thank you for this hearing, and I am glad to
see the panel that we have before us.
I am personally shocked by the tobacco industry and their
gross misunderstanding of what an addiction is, and I certainly
hope today that we can shed some light on that gross
misunderstanding. I really believe their commitment should be
to just fund program that dissuade our children from this
addiction that their product causes and that they should be
leading the effort to find and produce funds to help with
programs that will actually get individuals to quit.
You cannot address an addiction successfully by saying,
``Just have a little bit.'' It will not work.
And so I look forward to the panel's testimony, and
hopefully that will help us help the industry understand that
their gross misunderstanding of what an addiction is is not
acceptable to this Congress.
Thank you, Mr. Chairman.
Mr. Stearns. I thank the gentlelady.
The gentleman from New Hampshire, Mr. Bass.
Mr. Bass. Thank you very much, Mr. Chairman, and I
appreciate this interesting and quite controversial hearing.
First of all, I do not smoke cigarettes and I do not chew
tobacco. In fact, as a State senator, I introduced a bill to
tax smokeless tobacco.
However, from my perspective there are policymakers in
government and in Congress who, if they had their choice, would
chisel off the tobacco leaves on the podium in the Congress
because somehow it would pollute and kill Members of Congress
who happened to walk nearby. And the issue that we are going to
have a hearing on today is not whether tobacco is safe for
somebody to pick up and take up, but whether or not somebody
who is smoking cigarettes, who may die of lung cancer, who
other remedial means such as stopping smoking completely or
using some of these other products which are advertised all
over the place, whether those individuals ought to be able or
ought to at least know that if you have a cigarette or a pack
or two of cigarettes a day or you have a can of smokeless
tobacco, which is going to be better for you?
Now, they both may not be good for you, but I do not think
you can escape the conclusion that if you have a choice between
these two products that smokeless tobacco is probably going to
be a better alternative that will prolong your life.
And as I understand it, the Federal Trade Commission has a
procedure underway to address this issue as to whether or not
this industry can advertise in this manner, not bringing
children in, not talking about lung cancer. Nobody ever
suggested that chewing tobacco caused lung cancer or anything
like that, but whether or not individuals who are addicted to
cigarettes and have no other option might be able to see
advertising that indicates that chewing tobacco might be a
better alternative.
I think it is a fair issue, and I am looking forward to
hearing testimony from both our Surgeon General and the FTC, as
well as the succeeding panels.
And I will yield back, Mr. Chairman.
Mr. Stearns. The gentleman yields back the balance of his
time.
The gentleman from Texas, Mr. Green.
Mr. Green. Thank you, Mr. Chairman, and I would like to
thank you and our ranking member for holding this hearing on
tobacco harm reduction and the Federal Trade Commission's role
in determining the appropriate advertising of smokeless
tobacco.
There is no question that smoking and tobacco use is
hazardous to our health. That is hopefully one issue that all
of us in the room can agree on. I represent an area where
smokeless tobacco is used by a lot of our young men as a right
of passage. Now, this may not be the case in New York or San
Francisco, but when we discuss how to help Americans quit
smoking and what warnings our tobacco products should display,
the debate is bound to heat up.
One thing is certain in my mind. Our efforts to discourage
Americans from smoking cigarettes should not include advocating
the use of smokeless tobacco products. Tobacco kills, whether
it is inhaled or whether it is chewed, and that is a message
that I think most folks would want our FTC and our government
to send.
Since the mid-1980's we have known that smokeless tobacco
causes oral cancer, and to decrease one's risk of lung cancer
by increasing his or her risk of oral cancer is not in the
interest of public health.
In resolving this marketing issue, the FTC is charged with
ensuring that we do not send mixed messages to the consumer.
Currently three rotating warning labels appear on smokeless
tobacco packages, and they read:
One, the warning ``this product may cause mouth cancer.''
Another warning, ``this product may cause gum disease and
tooth loss.''
A warning, ``this product is not a safe alternative to
cigarettes.''
These warnings all send the same message. Smokeless tobacco
is hazardous to your health. For the FTC to consider a label
effectively promoting smokeless tobacco as a lower risk
alternative to cigarette smoking, however, sends a very
different message. It says that if you are going to use tobacco
products but you also worry about your health, smokeless
tobacco is the way to go.
Not only is this message mixed. It also is based on
questionable science. A policy shift of this magnitude should
not be based on the study of the Swedish smokeless tobacco
which contains fewer cancer causing agents, is regulated by the
government and cannot be advertised. There simply are no
parallels to be drawn.
While the FTC has limited jurisdiction over tobacco, its
mission is clear. It ensures that companies do not market their
products in misleading or deceptive ways. To advertise
smokeless tobacco as healthier for you than cigarettes is, in
my mind, both misleading and deceptive because it holds the
consumer's hand as it leaps to the rationalization that
smokeless tobacco use is somehow okay. I do not believe that we
should be in the business of promoting that mindset.
Mr. Chairman, a former Speaker of the House, Jim Wright, a
few years ago had reconstructive surgery at M.D. Anderson in
Texas because of jaw cancer. I happened to see Speaker Wright
after that and talked to him while he was in the hospital.
I do not know the reason, like a lot of times things
develop, but having been to M.D. Anderson and some of our great
cancer facilities, I also know that cancer is not something we
want to see, whether it is in a former Speaker of the House or
in our children.
And I yield back the balance of my time.
Mr. Stearns. The gentleman yields back the balance of his
time.
The gentleman from Arizona, the Vice Chairman of the
committee, Mr. Shadegg.
Mr. Shadegg. Thank you, Mr. Chairman.
And other than to express my appreciation for your holding
this hearing to enlighten us all on this subject and to welcome
Dr. Carmona, who is a resident of my State of Arizona and who
came to his current position from the faculty of the University
of Arizona, my alma mater, I will waive my opening statement
and take my 8 minutes of questioning.
Mr. Stearns. The gentleman waives his opening statement.
The gentleman from Florida, Mr. Davis.
Mr. Davis. Thank you, Mr. Chairman.
I will reserve my time for questions.
Mr. Stearns. The gentleman reserves the balance of his
time.
Mr. Terry, welcome. An opening statement?
Mr. Terry. No opening statement.
Mr. Stearns. No opening statement.
Mr. Fletcher.
Mr. Fletcher. I reserve.
Mr. Stearns. Reserve the balance.
The gentlelady, Mrs. Cubin.
Mrs. Cubin. I will submit my statement for the record.
Mr. Stearns. By unanimous consent, so ordered.
[The prepared statement of Hon. Barbara Cubin follows:]
Prepared Statement of Hon. Barbara Cubin, a Representative in Congress
from the State of Wyoming
Thank you, Mr. Chairman, for holding this hearing today and
sparking continued Congressional debate over what is right in educating
consumers, reducing public health risks and proper regulation in
communicating the truth about tobacco.
I would also like to thank the distinguished panelists for joining
us. Your diverse insight and expertise will certainly guide the
continued examination of the tobacco harm reduction debate.
The issue of tobacco related death and disease is one that deserves
a fair, honest and scientifically-based debate. It is probable that
each one of us here has a story to tell of a friend or loved one
negatively affected by the dangers of smoking.
Progress undoubtedly has been made in the research on the impacts
of tobacco use. We have come a long way in educating consumers--both
young and old--about the risks involved and ways to quit.
There are also a growing number of options available to those
addicted to nicotine with a desire to end their smoking habit by way of
gradual or immediate means. These breakthroughs have opened new doors
in overcoming addiction and new ground lies ahead that is worth
continued exploration.
Regardless of what product there is to sell or potential profit
that exists, we must hold in the highest regard the human lives at
stake here. Knowledge is power and should not be withheld in the
constraints of perhaps an outdated paradigm in the battle to reduce
smoking related fatalities and disease.
According to the Centers for Disease Control, hundreds of
Wyomingites die from diseases caused by smoking every year. If there is
information available that would save the lives of hundreds of my
constituents who smoke, then we have a responsibility to disseminate
this life saving knowledge. To refrain from doing so would be
deceitful.
Today I hope the debate will be balanced, passionate and committed
to the scientific data available to us. The people of my home state
deserve to know all of the facts about tobacco use, further empowering
their decisions as consumers and potentially saving their lives. I look
forward to determining how best this should be done.
I thank the Chairman again and yield back the remainder of my time.
Mr. Stearns. Mr. Ferguson, an opening statement?
Mr. Ferguson. I will make an opening statement, Mr.
Chairman.
Mr. Stearns. Okay.
Mr. Ferguson. Thank you very much.
I would like to begin by thanking you for holding this
hearing on a subject that is really terribly important to the
public health of our Nation. It is an undisputed fact that
smoking is a killer, and according to the American Lung
Association, smoking related diseases claim an estimated
430,700 American lives each year, and it is directly
responsible for 87 percent of lung cancer cases and causes most
cases of emphysema and chronic bronchitis.
I have had several family members, including grandparents,
who have died of lung disease, emphysema, lung cancer, and
other ailments related to their smoking. This list of ailments
that smoking causes or hastens is well founded and it is
alarming, and it has proven that smoking contributes to cancer
of the lungs, the oral cavity, the esophagus, the larynx, and
is a contributing cause of cancer in the pancreas, bladder,
kidney, and cervix.
Finally, smoking costs the United States approximately $97
billion each year in health care costs and lost productivity.
We need to do all that we can to help current smokers to quit
and to insure that our children do not fall victim to this
deadly habit.
Increased education and various other public health
initiatives have brought a gradual decline in smoking rates
over the past 20 years. Studies have shown that 70 percent of
smokers say that they are interested in quitting. Thirty-four
percent of smokers actually attempt to quit.
However, only less than 10 percent of those people and only
2.5 percent of total smokers actually end up quitting. I think
it is safe to say that if someone close to us has given up
smoking or has tried, we all know how tough it actually is to
break the habit. There are many products on the market that are
specifically designed to help smokers break the habit. It is
vital that the people of our country are fully informed of the
risks involved not only by smoking, but of the various
treatments and alternatives that help to wean someone off the
habit.
Many of the alternatives have undergone rigorous testing by
the FDA, but we must be mindful of those alternatives that may
actually lead to smoking or that actually may be harmful in
their own right.
Again, I want to thank you, Mr. Chairman, thank the members
of this committee, and I want to thank our panelists who are
here today.
I yield back.
Mr. Stearns. The gentleman yields back. I thank the
gentleman.
As is customary, we allow our colleagues who are not a
member of the subcommittee, who are a member of the full
committee for an opening statement, and that is Mr. Waxman from
California. I welcome him.
Mr. Waxman. Thank you very much, Mr. Chairman, for allowing
me to participate in this hearing.
Let me state at the outset I am not opposed in principle to
harm reduction strategies that are targeted toward addicted
smokers, but as we explore these possibilities, we need to
remember that unsubstantiated health claims for tobacco
products can have disastrous consequences, keeping smokers from
quitting and encouraging teenagers to start.
These are not abstract concerns. We have had a failed
experiment with light and low tar cigarettes, and the advent of
new reduced risk products poses similar risks. The report we
are releasing today with Representative Schakowsky finds
disturbing parallels between the public health disaster of
light and low tar cigarettes and what companies like U.S.
Smokeless Tobacco, UST, are trying to do now.
Today the subcommittee is considering their request to
market its dangerous and addictive product as safer than
cigarettes. In November 1994, I chaired the last congressional
hearing to focus on smokeless tobacco. We heard indisputable
evidence that UST manipulated nicotine levels in its products
to hook young users and then graduate them to stronger
products. And we heard UST deny that smokeless tobacco is
addictive.
Nearly 9 years later UST still argues that smokeless
tobacco is not a proven cause of disease and denies smokeless
tobacco is addictive. UST claims its goal is to help smokers
quit, but one of the company's strategic objectives is to
promote dual consumption of cigarettes and smokeless tobacco,
the very opposite of cessation.
In a recent response, UST wrote to a ``Dear Colleague'' I
sent out, they denied some of the points that I made. They said
it was baseless to suggest the company added cherry flavoring
to some of its products to appeal to children, but according to
a 1980 memo, UST's Senior Vice President said that younger and
lighter users prefer flavor and older users prefer tobacco
taste.
They wrote that they never employed a strategy to graduate
young users to a more addictive product. This same document,
however, shows that the company's objective was to provide new
users with an easy graduation process.
UST said it was misleading or inaccurate to suggest the
company ever marketed to children, but a memo from a regional
sales manager to the national sales manager indicates that UST
had marketed smokeless tobacco to children as young as 13 or 14
years of age.
Mr. Chairman, because these documents speak to the clear
need for an effective and comprehensive regulation prior to any
health claims for smokeless tobacco, I would like to ask
unanimous consent to include in the record a letter I have
written to Chairman Tauzin that describes and attaches these
documents.
Mr. Stearns. By unanimous consent, so ordered.
[The material appears at the end of the hearing.]
Mr. Waxman. And I look forward to the testimony.
Mr. Stearns. And I thank the gentleman.
No one else seeks recognition.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Ed Towns, a Representative in Congress from
the State of New York
Mr. Chairman, and fellow Members, today's hearing raises an
important issue do--``harm reduction'' products have a role in
addressing the health issues associated with smoking.
This issue of public health policy is of great importance. More
than 50 million adult Americans smoke. The question we seek to address
in this hearing is how may we, as policymakers, improve the health of
those 50 million individuals. It should go without saying that public
health policy of this nature cannot be made in a vacuum; we must take
into account the ability, and indeed the rights, of individuals to make
their own choices regarding their health.
The Constitution recognizes that individuals should be allowed to
hear and evaluate product information for themselves. In no other area
of life is this right more important than in the area of personal
behavior and health. These choices may affect not only the health and
well being of the individual, but also the health and well being of
family members. As such, those decisions should be well informed, based
on accurate, uncensored, truthful and nonmisleading information.
That is what is at the heart of this hearing today-the right of
individuals to know the facts about products that impact their behavior
and health. Today's witnesses have suggested in their written testimony
that the facts are in dispute about the ability of tobacco ``harm
reduction'' products to improve the health of those smokers who have
not been able to quit smoking. Even if the research is unsettled on
this issue, it does not mean that discussions should not begin on this
matter. Mr. Chairman, I am hopeful that today's hearing will be the
beginning of a dialogue on the question of ``harm reduction'' products
and their relationship to health improvements for smokers.
______
Prepared Statement of Hon. Sherrod Brown, a Representative in Congress
from the State of Ohio
A man is driving home on a busy boulevard, going 50 miles an hour
through a residential neighborhood, swerving from lane to lane and
blowing through stop signs. He likes to speed and has no intention of
slowing down, but when a warning light on his dashboard flashes on, he
decides to buckle his seat belt. So, is his behavior ``less harmful''
than before he buckled up? Less harmful to himself? Less harmful to the
other motorists and pedestrians on the road?
Can you imagine a public service announcement saying ``Reckless
driving is dangerous, but if you do choose to drive recklessly,
remember to wear your seat belt?''
Fundamentally, the same grim choice was implicit in the Federal
Trade Commission's consideration of a petition by U.S. Smokeless
Tobacco (UST) for an advisory opinion concerning the marketing of
smokeless tobacco products as ``less harmful'' than cigarettes.
The simple fact is that both cigarettes and smokeless tobacco
products are dangerous and often deadly. To focus exclusively on
whether one is more or less harmful than the other is to obscure the
truth that both are potentially lethal.
Because such a claim would obscure the truth, it would appear to be
a textbook case of deceptive marketing. I was pleased to learn UST has
withdrawn its petition.
I hope, should UST or another manufacturer decide to revive it, FTC
will reject it as fundamentally inconsistent with the legal prohibition
on deceptive marketing.
But the UST petition raised more than technical questions about
commercial practices. It also reinvigorated debate over America's
Quixotic and counterintuitive approach to the regulation of nicotine
delivery systems.
In the United States, the federal Food and Drug Administration
(FDA) must approve products designed and marketed to help Americans
kick the habit of nicotine addiction. FDA must--and should--verify that
such products are safe and effective, because their use is recognized
to have important public health consequences. But products designed and
marketed to feed that same nicotine addiction are not regulated by FDA,
ignoring the simple fact that their use has equal or greater
consequences for public health.
20,000 Ohioans die every year from tobacco-related illnesses,
according to the Ohio Tobacco Use Prevention and Control Foundation.
17% of Ohio's Medicaid dollars are spent on treatment for tobacco-
related disease, effectively imposing an annual tax of over $500 on
every Ohio household. With these grave costs in mind, surely we should
be working to end tobacco addiction, not perpetuate it.And approving
misleading health-related marketing claims for smokeless tobacco would
do just that: perpetuate America's addiction to tobacco.
Our experience with the marketing of filtered and ``low-tar''
cigarettes amply illustrates the perils of marketing some tobacco
products as ``safer'' alternatives to others.
Clever marketing got consumers to try these products, but because
they changed the way people smoked, they may well have been as harmful
or more harmful than traditional cigarettes. Health claims for
smokeless products may be even more dangerous, in that it is likely
some consumers--including kids--will see smokeless products as
supplements to, not substitutes for, smoking.
Claims that smokeless tobacco products are less harmful than
cigarettes raise very expansive questions with profound public health
consequences. These questions are much too sweeping a decision to
answer based only on the narrow scope of the FTC Act's unfair and
deceptive marketing standard. In addition, a meaningful evaluation of
any health claim requires technical and medical expertise well beyond
the FTC, which is chiefly a consumer protection agency.Fortunately, we
have a federal agency that has just that technical expertise: the FDA.
The Institute of Medicine has maintained for years that all tobacco
products should be regulated by the federal government, to facilitate
responsible research and meaningful evaluation of health-related
claims. If sound science and the protection of public health are our
objectives, we should take the IOM's advice and give the job to an
agency equipped to meet the challenge.
Today's hearing raises important issues with broad implications for
public health and responsible business practices. I welcome a lively
discussion of these issues, and I look forward to the testimony of our
witnesses.
Thank you, Mr. Chairman.
Mr. Stearns. Then we will welcome our two distinguished
panelists, the Honorable Timothy Muris, Chairman of the Federal
Trade Commission; Vice Admiral Richard H. Carmona, U.S. Surgeon
General and Acting Assistant Secretary for Health, U.S.
Department of Health and Human Services.
Welcome, and, Chairman Muris, we will start with you.
STATEMENTS OF HON. TIMOTHY MURIS, CHAIRMAN, FEDERAL TRADE
COMMISSION; AND VICE ADMIRAL RICHARD H. CARMONA, U.S. SURGEON
GENERAL, PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Mr. Muris. Thank you very much, Mr. Chairman.
And I would just ask that the commission's full statement
be placed in the record.
Mr. Stearns. By unanimous consent, so ordered.
Mr. Muris. I am Tim Muris, the Chairman of the Federal
Trade Commission. I am certainly pleased to appear here today
to discuss the FTC's role in the potential advertising of
reduced risk tobacco products.
The FTC's mission is to prevent unfair competition and
unfair or deceptive acts or practices in the marketplace. The
Commission does this by insuring that advertising and marketing
claims are truthful and not misleading.
Our jurisdiction over advertising and marketing claims
includes jurisdiction over claims for cigarettes, smokeless
tobacco, and other tobacco products. Indeed, the FTC's law
enforcement activities involving tobacco advertising and
promotion date back to the 1930's.
Congress has given the Commission administrative
responsibilities for the health warnings required on cigarette
packaging and advertising under the Cigarette Act. We also have
both administrative and enforcement responsibilities for the
health warning required on smokeless tobacco packaging and
advertising under the Smokeless Tobacco Act.
The Commission does not pre-screen advertising or marketing
claims for tobacco or any other product. Instead, the agency
addresses deception through post market law enforcement. Health
claims in advertising are particularly important to us, and I
welcome your interest in the role we play in the marketing of
potential reduced risk tobacco products.
This is a very important question. Despite the efforts of
the government and the public health community, millions of
Americans smoke today and are addicted to nicotine. Many of
these smokers will ultimately die of smoking related illnesses
if they do not change their behavior.
In an ideal world, we would wish that all of these people
would choose to quit smoking and would be able to do so once
they tried. The real world is quite different, however. If
truthful and substantiated, marketing claims that a product
will significantly reduce the health risk associated with
smoking while satisfying the addicted smoker's craving for
nicotine could provide a substantial health benefit to those
consumers who cannot or will not quite.
Conversely, if those claims were untruthful,
unsubstantiated, or misrepresent the extent of the benefit,
they would harm consumers.
For these reasons, we would review advertising for
potential reduced risk tobacco products on a case-by-case basis
to try to insure that the information consumers receive about
those products is accurate and substantiated. This review would
be conducted using the same legal framework that we use for all
consumer products under Section 5 of the FTC Act.
First, we ask what messages consumers take away from the
advertising in question.
The next issue is whether the claims are truthful,
including whether they are substantiated.
The Commission typically requires that health claims be
supported by reliable scientific evidence. In determining
whether harm reduction claims are substantiated, the Commission
would turn to experts, both inside and outside the government's
science-based agencies, for assistance in evaluating scientific
evidence.
Let me close by mentioning that in my view, the discussion
of potential harm reduction tobacco products should also
encompass the question of whether so-called nicotine
replacement products, which currently are marketed only for
smoking cessation purposes, have a larger role to play in the
harm reduction arena.
These products, which contain only nicotine and no tobacco,
should certainly be further evaluated for use by consumers
addicted to nicotine.
In conclusion, thank you for the opportunity to discuss the
Commission's role in this important and evolving public health
issue. I would be happy to answer any of your questions.
[The prepared statement of Hon. Timothy Muris follows:]
Prepared Statement of Hon. Timothy J. Muris, Chairman, Federal Trade
Commission
Mr. Chairman and members of the Committee, I am Timothy J. Muris,
Chairman of the Federal Trade Commission (``Commission'' or ``FTC''.
The Commission is pleased to have this opportunity to provide
information concerning the potential advertising of reduced risk
tobacco products.\1\ This statement discusses the Commission's mission,
our activities in the tobacco area, and then addresses the process the
Commission would use in examining the advertising of these products.
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\1\ The written statement presents the views of the Federal Trade
Commission. Oral testimony and responses to questions reflect my views
and do not necessarily reflect the views of the Commission or any
Commissioner.
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ftc jurisdiction over tobacco advertising and marketing
The FTC's mission is to prevent unfair competition and unfair or
deceptive acts or practices in the marketplace. The Commission
regulates national advertising, including the advertising and promotion
of cigarettes, smokeless tobacco, and other tobacco products, pursuant
to Section 5 of the Federal Trade Commission Act, 15 U.S.C. Sec. 45,
which prohibits ``unfair or deceptive acts and practices in or
affecting commerce.'' The Commission's activities promote informed
consumer choice.
The FTC's law enforcement activities involving tobacco advertising
and promotion date back to the 1930s.\2\ In 1962, the FTC's request for
technical guidance from the U.S. Public Health Service was among the
factors that led the then-Surgeon General of the United States to
establish an advisory panel to undertake a comprehensive analysis of
the data on smoking and health. The work of the advisory panel, in
turn, led to the historic 1964 Report of the Surgeon General finding
that cigarette smoking presented significant health risks. In that same
year, the Commission issued a regulation requiring tobacco companies to
include health warnings in cigarette advertising and on packages.\3\
The FTC's regulation was superseded in 1965, before it went into
effect, by the Federal Cigarette Labeling and Advertising Act
(``Cigarette Act''),\4\ which required such warnings on cigarette
packages.
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\2\ See, e.g., Julep Tobacco Co., 27 F.T.C. 1637 (1938)
(stipulation prohibiting claims that Julep cigarettes help counteract
throat irritations due to heavy smoking and never make the throat dry
or parched).
\3\ See Trade Regulation Rule for the Prevention of Unfair or
Deceptive Advertising and Labeling of Cigarettes in Relation to the
Health Hazards of Smoking, 29 Fed. Reg. 8324, 8354 (1964).
\4\ Pub. L. No. 8992, 79 Stat. 282 (1965), as amended by Pub. L.
No. 98474, 98 Stat. 2204 (1984), and by Pub. L. No. 9992, Sec. 11, 99
Stat. 393, 40204 (1985), current version at 15 U.S.C. Sec. 1331 (1994).
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In 1972, the Commission once again addressed the issue of health
warnings in cigarette advertising. Pursuant to its Section 5 authority,
the FTC issued consent orders mandating for the first time that the
major cigarette manufacturers place health warnings in cigarette
advertisements.\5\
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\5\ See Lorillard et al., 80 F.T.C. 455, 46065 (1972) (consent
orders). Under the orders entered into with six tobacco manufacturers,
the companies were required to disclose the Surgeon General's warning
in identified forms of advertising. The consent orders were modified in
1981, when the Commission sought civil penalties in federal district
court against each of the cigarette companies for failure to comply
with the 1972 orders. See United States v. Lorillard, No. 76Civ. 814
(JMC) (S.D.N.Y. July 13, 1981).
In 1982, the Bureau of Consumer Protection notified the House
Committee on Energy and Commerce that the staff supported a new system
of rotational health warnings. Letter from Timothy J. Muris, Director,
Bureau of Consumer Protection, Federal Trade Commission, to The
Honorable John D. Dingell, Chairman, Committee on Energy and Commerce,
U.S. House of Representatives (Sept. 1, 1982). In May 1984, the
Commission sent letters to Congress endorsing the concept of federal
legislation to require a system of rotational health warnings that
would appear in cigarette advertisements and on cigarette packages.
Shortly thereafter, Congress amended the Cigarette Act to require
rotational warnings for both advertising and package labeling.
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Today, the Commission administers the Cigarette Act, and
administers and enforces the Comprehensive Smokeless Tobacco Health
Education Act (``Smokeless Tobacco Act'').\6\ The Cigarette Act
instructs the Commission to take certain steps to implement the
mandated Surgeon General's health warnings.\7\ The Smokeless Tobacco
Act directs the FTC to promulgate regulations governing the health
warnings on packaging and advertising for smokeless tobacco products.
The Commission's regulations specify the placement and rotation of the
warnings, and require companies to submit plans to the Commission
setting forth their rotation schedules.\8\ Finally, the FTC enforces
the ban in the Smokeless Tobacco Act on broadcasting smokeless tobacco
advertisements on radio and television.
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\6\ 15 U.S.C. Sec. Sec. 4401-4408.
\7\ Although the Commission administers the Cigarette Act, the
Department of Justice enforces it.
\8\ 16 C.F.R. Sec. 307.
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The Commission also publishes periodic reports on advertising and
promotion activities in the cigarette and smokeless tobacco
industries.\9\ Those reports provide information on sales and on
expenditures for various categories of marketing expenditures. The
Commission issued its first report on the cigarette industry in 1967
and on the smokeless tobacco industry in 1987.
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\9\ In addition, the Commission issued a report on cigar
advertising and promotion in 1999.
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In addition to its administrative and law enforcement
responsibilities under the Cigarette Act and the Smokeless Tobacco Act,
the Commission also has authority under Section 5 of the FTC Act to
prevent unfair or deceptive acts and practices in connection with the
marketing and sale of tobacco products. Pursuant to that authority, the
Commission has taken a number of law enforcement actions against unfair
or deceptive tobacco advertising and promotional practices. For
example, in 1983, the Commission sued the Brown &Williamson Tobacco
Corporation over ads that continued to describe Barclay as a 1 mg. of
tar brand, even though the Commission had revoked Barclay's 1 mg.
rating because the cigarette's unusual design prevented the cigarette
test method from measuring Barclay's yields on a basis comparable to
other cigarettes.\10\ Moreover, in 1997, the Commission issued a
complaint against the R.J. Reynolds Tobacco Co. alleging that the
company's Joe Camel advertising campaign caused or was likely to cause
many young people to begin or continue to smoke, thereby exposing them
to significant health risks.\11\ In 1999 and 2000, the Commission
entered into consent agreements with several cigarette manufacturers,
resolving charges that their advertisements implied that their ``no
additive'' cigarettes were safer than otherwise comparable cigarettes
because they did not contain additives.\12\ In 2000, the Commission
also entered into a consent agreement with a company claiming reduced
health risks for its herbal cigarettes.\13\
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\10\ F.T.C. v. Brown & Williamson Tobacco Corp., 580 F. Supp. 981
(D.D.C. 1983), aff'd in part, remanded in part, 778 F.2d 35 (D.C. Cir.
1985).
\11\ R.J. Reynolds Tobacco Co., 127 F.T.C. 49 (1999). The
Commission's complaint was issued on May 28, 1997. On January 26, 1999,
the Commission dismissed the complaint without prejudice because the
relief sought had been achieved through, inter alia, the master
settlement between the major tobacco companies and the attorneys
general for 46 states.
\12\ Santa Fe Natural Tobacco Co., Docket No. C-3952 (2000)
(consent); Alternative Cigarettes, Inc., Docket No. C-3956 (2000)
(consent); R.J. Reynolds Tobacco Co., Docket No. C-3892 (1999)
(consent).
\13\ Alternative Cigarettes, Inc., Docket No. C-3956 (June 14,
2000) (consent). See also Alan V. Phan, 116 F.T.C. 162 (1993) (consent
order settling allegations that advertisements misrepresented the
health risks of smoking certain nontobacco cigarettes).
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Testing for the tar and nicotine yields of cigarettes is also
conducted by the tobacco industry under a methodology adopted by the
Commission in 1967. For the past several years, the FTC has also
actively sought the views of the Federal government's public health
agencies about what changes should be made in that methodology.\14\ The
agency has also recommended to Congress that authority for cigarette
testing be given to one of the government's science-based public health
agencies \15\ and we renew that recommendation here.
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\14\ Letter from Donald S. Clark, Secretary, Federal Trade
Commission to the Honorable Donna E. Shalala, Secretary, Department of
Health and Human Services (Nov. 19, 1998).
\15\ Federal Trade Commission Report to Congress For 1998 Pursuant
to the Federal Cigarette Labeling and Advertising Act 6 (2000) (``the
Commission strongly recommends that Congress give cigarette testing
authority to one of the Federal government's science-based, public
health agencies''); Federal Trade Commission Report to Congress For
1997 Pursuant to the Federal Cigarette Labeling and Advertising Act 5-6
(1999).
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``reduced risk'' tobacco claims
As with other products, the Commission's primary role for tobacco
products is to ensure that products are marketed in a manner that is
truthful, not misleading, and adequately substantiated. The Commission
does not prescreen advertising claims for tobacco or any other product.
Instead, the agency addresses deception in the marketing of tobacco
largely through postmarket law enforcement actions targeted against
specific false or misleading claims or unfair practices, just as it
does for other products.
Despite coordinated efforts of the government and the public health
community, tobacco use in the United States continues to cause
substantial health risks. Products that could significantly reduce
those risks could provide a substantial health benefit. For example,
products that satisfy a smoker's craving for nicotine with
substantially fewer risks to health than cigarettes would have the
potential to benefit consumers. At the same time, consumers may be
injured if advertisers make harm reduction claims that turn out to be
untrue or that exaggerate the benefits or safety of their products.
There are currently a variety of products being developed or
already in test markets that are intended to reduce the risks
associated with smoking. These products include Eclipse (an R. J.
Reynolds Tobacco Company product that heats, rather than burns,
tobacco) and Accord (a Philip Morris USA system in which special
cigarettes are smoked in an electronic lighter); cigarettes and other
tobacco products with reduced levels of nitrosamines (one category of
constituents in tobacco that have been classified as known
carcinogens), such as that developed by Star Scientific, Inc.; and
Omni, which Vector Tobacco, Inc. has marketed as ``the first reduced
carcinogen cigarette.''
There are also products termed ``nicotine replacement therapies''
(``NRT'') that the Food and Drug Administration currently allows to be
marketed for smoking cessation purposes: nicotine gums, transdermal
patches, lozenges, inhalers, and nasal sprays. These nicotine delivery
devices have been studied and approved only for short-term use to help
smokers quit smoking, rather than for long-term ``harm reduction'' use
by people who are unable or unwilling to quit smoking.
Finally, in February 2002, the United States Smokeless Tobacco
Company (``USST'') petitioned the Commission for an advisory opinion
regarding the acceptability of communicating in advertising a harm
reduction claim for smokeless tobacco. USST withdrew the petition in
August 2002, stating that it would provide the Commission with
information from two upcoming scientific conferences that would be
addressing issues relevant to the petition. On May 9, 2003, USST
provided this additional information to the Commission, and asked that
the Commission place this new information on the public record and hold
a ``public forum'' to discuss these issues.
In considering advertising or other marketing claims by potential
reduced risk tobacco products, the Commission would consider whether
harm reduction claims may be deceptive using the same legal framework
that it uses for all consumer products under Section 5 of the FTC Act:
whether the advertising conveys a message that is likely to mislead
reasonable consumers to their detriment, including claims for which the
advertiser did not have adequate substantiation. The Commission's
experience suggests that harm reduction claims are likely to raise
difficult questions of advertising interpretation, as well as complex
scientific and public health issues.
In examining a harm reduction claim, the first question that the
Commission would address is what messages consumers take away from the
advertising in question. Taking into account the full context of the
advertising in which the claim appears, \16\ the Commission would seek
to identify the range of messages--both express and implied--that
consumers would take from the advertisement. These would include: (1)
whether claims about a reduction in carcinogens and toxins in the
product conveys risk reduction messages; and (2) whether consumers
might take away from a harm reduction representation the message that a
product containing known carcinogens was not just safer than
cigarettes, but that it poses no risk or only a minimal risk.
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\16\ The messages consumers take away from a particular statement
in an advertisement depend on the overall context in which that
statement appears. Accordingly, the Commission ordinarily evaluates
each advertisement in its entirety. It is difficult to determine what
messages consumers take away from a generic statement about a
particular class of products without placing that statement in the
context of an actual advertisement.
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Once the Commission has determined what messages consumers take
away from a particular ad, the next issue is whether those claims are
truthful and substantiated. The FTC Act requires that objective claims
about products and services be substantiated before the ad is
disseminated. When the advertisement does not claim to have a specific
level of substantiation supporting its claims, the Commission
determines what constitutes a reasonable basis for those claims by
analyzing the so-called ``Pfizer factors'': the type of claim; the
benefits if the claim is true; the consequences if the claim is false;
the ease and cost of developing substantiation for the claim; the type
of product; and the level of substantiation experts in the field would
agree is reasonable. Pfizer, Inc., 81 F.T.C. 23 (1972). In the context
of safety claims, the FTC has typically required a substantiation
standard of ``competent and reliable scientific evidence.''
Analyzing the evidence whether any particular tobacco product is
safer than traditional cigarettes, or whether a reduction in exposure
to known carcinogens is associated with reduced health risks, requires
expertise in biology, chemistry, toxicology, and epidemiology, among
other fields. Moreover, the scientific issues raised by purported
reduced risk products are often not only extremely complex, but may
take years to develop.\17\ The Commission brings a unique market-based
expertise to its scrutiny of consumer protection matters and our work
often requires review and analysis of scientific literature. Because
the Commission is an agency of lawyers and economists, however, and not
a science-based agency, we rely on assistance from other experts in
evaluating scientific evidence.\18\ Just as the Commission has
requested the assistance of the Department of Health and Human Services
in connection with the test method that produces cigarette tar and
nicotine ratings, the Commission would require similar assistance in
evaluating the substantiation for advertising claims made for reduced-
risk tobacco products.
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\17\ The history of low tar cigarettes provides an example. One
recent survey of current evidence concludes that although low tar
cigarettes were initially marketed as safer alternatives than regular
cigarettes, recent evidence suggests that they may convey no such
benefit. See National Cancer Institute, Risks Associated with Smoking
Cigarettes with Low Machine-Measured Yields of Tar and Nicotine,
Smoking and Tobacco Control Monograph No. 13, at 9 (2001) (``When all
of the epidemiological evidence is considered in the context of what is
currently known about cigarette design and compensation, it does not
support the conclusion that a reduction in disease risks has occurred
in the population of smokers due to the design changes that have
occurred in cigarettes over the last 50 years.'').
\18\ Tobacco is not the only category of products for which the
Commission turns to other federal entities that possess specialized
scientific expertise. For example, the FTC works closely with the Food
and Drug Administration in the dietary supplement field, and with the
Environmental Protection Agency in the areas of energy conservation,
gasoline marketing, and claims for pesticides.
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Finally, although a determination that an individual risk reduction
claim is truthful and substantiated would end the Commission's
deception inquiry, broader public health issues may remain.\19\ For
example, some commenters on the USST petition focused on the overall
impact on public health from the marketing of these products; these
comments argued that smokeless tobacco promoted as a reduced risk
product might degrade overall public health, depending on how consumers
react.\20\ Similarly, some commenters questioned whether such
advertising and promotion might promote more widespread use of
smokeless tobacco, rather than just as a replacement for smoking.\21\
Others, however, believe that notwithstanding this empirical question,
the potential harm to public health is not clear enough to justify
depriving individuals of information they might use to reduce risks to
their own health.\22\ This debate on the public health effects of these
alternative tobacco products is an important one the appropriate
science-based agencies of the government need to address.
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\19\ E.g., Institute of Medicine, Clearing the Smoke: Assessing the
Science Base for Tobacco Harm Reduction 6 (2001) (potential reduced-
exposure products ``are potentially beneficial, but the net impact on
population health could, in fact, be negative. The effect on public
health will depend upon the biological harm caused by these products
and the individual and community behaviors with respect to their
use.'').
\20\ E.g., Letter from Matthew L. Myers, President, Campaign for
Tobacco-Free Kids to The Honorable Donald S. Clark, Secretary, Federal
Trade Commission (Feb. 25, 2002) (comparative health claims made for
smokeless tobacco must not only be truthful, but should promote the
public health); Letter from Henry A. Waxman, U.S. House of
Representatives and Senator Richard J. Durbin, United States Senate to
The Honorable Donald S. Clark, Secretary, Federal Trade Commission
(June 4, 2002) (noting that the potential health benefits that might
result from smokers switching to smokeless tobacco were offset by the
risks that some smokers who would have quit might, instead, switch to
smokeless tobacco; that smokeless tobacco might become more attractive
to nonsmokers; and that some of those nonsmokers--once addicted to
nicotine--might switch to cigarettes). See also, e.g., WHO Scientific
Advisory Committee on Tobacco Product Regulation, Recommendation on
Smokeless Tobacco Products 3 (2003) (listing arguments against the use
of smokeless tobacco for purposes of harm reduction).
\21\ E.g., Letter from Matthew L. Myers, supra note 17 (despite
USST's stated interest in making harm reduction claims to addicted
adult smokers, FTC approval of petition would permit it ``to
disseminate these claims in ads whose primary appeal could be to young
non-tobacco users''); Letter from Dileep G. Bal, M.D., Chief, Cancer
Control Branch, State of California Health and Human Services Agency--
Department of Health Services to The Honorable [Donald] S. Clark,
Secretary, Federal Trade Commission (March 8, 2002) (``While USSTC
[sic] claims that this health advisory is mean to claim harm reduction
for the benefit of addicted adults, it would allow USSTC [sic] and
other companies to market their products with this claim to young, non-
tobacco users as well).
\22\ L. Kozlowski, Harm reduction, public health, and human rights:
Smokers have a right to be informed of significant harm reduction
options, Nicotine & Tobacco Research S55-S60 (2002) (noting that
nicotine replacement therapies and snus [Swedish moist snuff] are much
safer than cigarettes; that there is a basic human right to information
that affects one's health; and that when the health risks from a
product are relatively small, ``the level of increased use needed to
maintain a public health equilibrium (no changes in population-level
problems) becomes very high.'') (citation omitted). See also Tobacco
Advisory Group of the Royal College of Physicians, Protecting smokers,
saving lives: The case for a tobacco and nicotine regulatory authority
2-5 (2002) (supporting comprehensive regulatory approach to tobacco in
order to promote public health and noting that emergence of reduced
risk products presents multiple challenges for regulators; smokeless
tobacco is ``10-1,000 times less hazardous than smoking, depending on
the product'' but its potential marketing as a harm reduction option
raises various questions that must be addressed, including minimizing
its use as a starter product for young smokers).
---------------------------------------------------------------------------
Health claims in advertising, including tobacco advertising, are of
particular importance to the Commission. The Commission welcomes the
Committee's interest in the role that this agency will play in ensuring
that the marketplace works efficiently to provide consumers with
information that may enable them to reduce their risks of smoking-
related disease, while protecting them from claims that are not
supported by sound scientific evidence. The agency is committed to
reviewing advertising for potential reduced risk tobacco products on a
case-by-case basis to try to ensure that the information consumers
receive about reduced risk products is truthful and non-misleading.
conclusion
The Commission thanks this Committee for focusing attention on this
important and evolving public health issue, and for giving us an
opportunity to present our views.
Mr. Stearns. I thank the Chairman, and we welcome the U.S.
Surgeon General.
STATEMENT OF VICE ADMIRAL RICHARD H. CARMONA
Mr. Carmona. Thank you, Mr. Chairman, distinguished members
of the subcommittee. Thank you for the opportunity to
participate in this important hearing.
My name is Richard Carmona, and I am the Surgeon General of
the United States.
Let me start with a few statements that were once accepted
throughout society that have now been relegated to the status
of myth.
Men do not suffer from depression.
Domestic violence is a family or private matter.
The HIV/AIDS epidemic is of no concern to most Americans.
All of us here know that these three statements are very
dangerous public health myths. My remarks today will focus on a
fourth public health myth which could have severe consequences
in our Nation, especially amongst our youth. Smokeless tobacco
is a good alternative to smoking. It is a myth. It is not true.
As the Nation's Surgeon General, my top responsibility is
to insure that Americans are getting the best science based
information to make decisions about their health. So I very
much appreciate the opportunity to come before this
subcommittee today and help refute this dangerous idea.
First, let me emphasize this. No matter what you may hear
today or read in the press reports later, I cannot conclude
that the use of any tobacco product is a safer alternative to
smoking. This message is especially important to communicate to
young people who may perceive smokeless tobacco as a safe form
for tobacco use.
Smokeless tobacco is not a safe alternative to cigarettes.
Smokeless tobacco does cause cancer. Our Nation's experience
with low tar cigarettes yields valuable lessons for the debate
over smokeless tobacco.
Tobacco use is the leading preventable cause of death in
the United States. Each year 440,000 people die of diseases
caused by smoking or other forms of tobacco use. That is about
20 percent of all deaths in the United States.
The office I lead as Surgeon General has long played a key
role in exposing the risks of tobacco use. In 1986, the Surgeon
General's report, the Health Consequences of Using Smokeless
Tobacco, reached four major conclusions about the oral use of
smokeless tobacco.
First, smokeless tobacco represents a significant health
risk.
Next, smokeless tobacco can cause cancer in a number of
non-cancerous oral conditions.
Third, smokeless tobacco can lead to nicotine addiction and
dependence.
And, fourth, smokeless tobacco is not a safe substitute for
cigarette smoking.
Recognizing these serious health consequences, Congress
passed a Comprehensive Smokeless Tobacco Health Education Act
in 1986. This law required the placement of Surgeon General's
warnings on all smokeless tobacco products.
Mr. Chairman and members of this subcommittee, I
respectfully submit that smokeless tobacco remains a known
threat to public health just as it was when Congress acted in
1986. Time has only brought more disease, death, and destroyed
lives.
A national toxicology program of the National Institutes of
Health continues to classify smokeless tobacco as a known human
carcinogen, proven to cause cancer in people. As Surgeon
General, I cannot recommend use of a product that causes
disease and death as a lesser evil to smoking. My commitment
and that of my office to safeguard the health of the American
people demands that I provide information on safe alternatives
to smoking where they exist.
I cannot recommend the use of smokeless tobacco products
because there is no scientific evidence that smokeless tobacco
products are both safe and effective aids to quitting smoking.
Smokers who have taken the courageous step of trying to
quit should not trade one carcinogenic product for another, but
instead could use Food and Drug Administration approved
methods, such as nicotine gum, nicotine patches, or counseling.
While it may be technically feasible to create a reduced
harm tobacco product, the Institute of Medicine recently
concluded that no such product exists today.
When and if such a product ever is constructed, we would
then have to take a look at the hard scientific data of that
particular product. Our Nation's experience with low tar, low
nicotine cigarettes is instructive to the issue at hand. Low
tar, low nicotine cigarettes were introduced in the late 1960's
and widely endorsed as a potentially safer substitute for the
typical cigarette on the market at that time.
Within a decade the low tar brands dominated the cigarette
market. Many smokers switched to them for their perceived
health benefits.
Unfortunately, the true health effects of these products
did not become apparent for another ten to 20 years. We now
know that low tar cigarettes not only did not provide a public
health benefit, but they also may have contributed to a natural
increase in death and disease among smokers.
This has taught us that we must move cautiously in
recommending any supposedly safer alternative for people trying
to quit smoking because now with more knowledge and the benefit
of hindsight, the science does not support early
recommendations on low tar cigarettes.
Mr. Chairman, in the interest of time I will shortly ask
that the remainder of my statement and the scientific
information contained in it be considered as read and made part
of the record.
Mr. Stearns. Without objection, so ordered.
Mr. Carmona. But before I do that, I would like to ask for
this subcommittee and the Congress to help in getting the
message out about the dangers and myths of smokeless tobacco.
All of us in this rom are very concerned about our Nation's
youth. Kids growing up today have a tough time of it. In
addition to the normal struggles of puberty, many kids are
facing a host of other challenges. Many, especially minority
kids, must struggle to find their way in unsafe neighborhoods.
So the temptation to engage in behavior that is not healthy
and the opportunity to do so is very hard for our young people
to resist. According to a 2000 survey by the Substance Abuse
and Mental Health Services Administration, SAMHSA, and this is
the national household survey on drug abuse, about 1 million
kids from ages 12 to 17 smoke every day. Another 2 million kids
smoke occasionally.
And we know that smoking is often not a stand-alone risk
behavior. It travels with others. The SAMHSA found that youth
who were daily cigarette smokers or heavy drinkers were more
likely to use illicit drugs than either daily smokers or heavy
drinkers from other age groups. More than half of 12 to 17 year
olds who were daily smokers had also used illicit drugs within
the past month.
Every day more than 2,000 kids in the U.S. will start to
smoke, and more than 1,000 adults will die because of smoking.
We have to get youth to stop starting, but the answer is not
smokeless tobacco. We have evidence to suggest that instead of
smokeless tobacco being a less dangerous alternative to
smoking, just as smoking is a gateway to other drugs, smokeless
tobacco is a gateway to smoking.
So we must redouble our efforts to get our youth to avoid
tobacco in all forms.
We have some real work to do on the culture of smokeless
tobacco, which is glamorized by some sports stars. Chicago Cub
Sammy Sosa, who has made a public commitment to avoiding
smokeless tobacco, is a great example for kids. Past baseball
great Joe Garagiola is now Chairman of the National Spit
Tobacco Education Program and regularly lectures young players
against the dangers of smokeless tobacco.
As Members of Congress, you can lead by example, too, not
just in legislation, but in your own lives. I encourage you to
avoid tobacco in all of its forms. Do not fall for the myth, a
very dangerous public health myth that smokeless tobacco is
preferable to smoking.
Do not let America's youth fall to this myth either.
Mr. Chairman, I ask that my written testimony be made part
of the record and I thank you and I would be happy to answer
any questions.
[The prepared statement of Richard Carmona follows:]
Prepared Statement of Richard H. Carmona, Surgeon General, U.S. Public
Health Service, Acting Assistant Secretary for Health, Department of
Health and Human Services
Mr. Chairman, distinguished members of the Subcommittee, thank you
for the opportunity to participate in this important hearing. My name
is Richard Carmona and I am the Surgeon General of the United States of
America.
Let me start with a few statements that were once accepted
throughout society that have now been relegated to the status of myth.
<bullet> Men do not suffer from depression.
<bullet> Domestic violence is a ``family'' or ``private'' matter.
<bullet> The HIV-AIDS epidemic is of no concern to most Americans.
All of us here know that these three statements are very dangerous
public health myths.
My remarks today will focus on a fourth public health myth which
could have severe consequences in our nation, especially among our
youth: smokeless tobacco is a good alternative to smoking. It is a
myth. It is not true.
As the nation''s Surgeon General, my top responsibility is to
ensure that Americans are getting the best science-based information to
make decisions about their health. So I very much appreciate the
opportunity to come before this Subcommittee today and help refute this
dangerous idea.
First, let me emphasize this:
<bullet> No matter what you may hear today or read in press reports
later, I cannot conclude that the use of any tobacco product is
a safer alternative to smoking. This message is especially
important to communicate to young people, who may perceive
smokeless tobacco as a safe form of tobacco use.
<bullet> There is no significant scientific evidence that suggests
smokeless tobacco is a safer alternative to cigarettes.
<bullet> Smokeless tobacco does cause cancer.
<bullet> Our nation's experience with low-tar cigarettes yields
valuable lessons for the debate over smokeless tobacco.
<bullet> Tobacco use is the leading preventable cause of death in the
United States.
Each year, 440,000 people die of diseases caused by smoking or
other form of tobacco useCthat is about 20 percent of all deaths in our
nation.
The office I lead as Surgeon General has long played a key role in
exposing the risks of tobacco use. In 1986, the Surgeon General's
Report The Health Consequences of Using Smokeless Tobacco reached four
major conclusions about the oral use of smokeless tobacco:
1. Smokeless tobacco represents a significant health risk;
2. Smokeless tobacco can cause cancer and a number of non-cancerous
oral conditions;
3. Smokeless tobacco can lead to nicotine addiction and dependence; and
4. Smokeless tobacco is not a safer substitute for cigarette smoking.
Recognizing these serious health consequences, Congress passed the
Comprehensive Smokeless Tobacco Health Education Act in 1986. This law
required the placement of Surgeon General's warnings on all smokeless
tobacco products.
Mr. Chairman and Members of the Subcommittee, I respectfully submit
that smokeless tobacco remains a known threat to public health just as
it was when Congress acted in 1986.
Conversely, time has only brought more disease, death and destroyed
lives.
The National Toxicology Program of the National Institutes of
Health continues to classify smokeless tobacco as a known human
carcinogenCproven to cause cancer in people.
As Surgeon General I cannot recommend use of a product that causes
disease and death as a ``lesser evil'' to smoking. My commitment, and
that of my office, to safeguard the health of the American people
demands that I provide information on safe alternatives to smoking
where they exist.
I cannot recommend the use of smokeless tobacco products because
there is no scientific evidence that smokeless tobacco products are
both safe and effective aids to quitting smoking.
Smokers who have taken the courageous step of trying to quit should
not trade one carcinogenic product for another, but instead could use
Food and Drug Administration -approved methods such as nicotine gum,
nicotine patches, or counseling.
While it may be technically feasible to someday create a reduced-
harm tobacco product, the Institute of Medicine recently concluded that
no such product exists today. When and if such a product is ever
constructed, we would then have to take a look at the hard scientific
data of that particular product.
Our nation's experience with low-tar, low-nicotine cigarettes is
instructive to the issue at hand. Low-tar, low-nicotine cigarettes were
introduced in the late 1960's and widely endorsed as a potentially
safer substitute for the typical cigarette on the market at that time.
Within a decade, the low-tar brands dominated the cigarette market.
Many smokers switched to them for their perceived health benefits.
Unfortunately, the true health effects of these products did not
become apparent for another 10 to 20 years. We now know that low-tar
cigarettes not only did not provide a public health benefit, but they
also may have contributed to an actual increase in death and disease
among smokers.
First, many smokers switched to these products instead of quitting,
which continued their exposure to the hundreds of carcinogens and other
dangerous chemicals in cigarettes. Second, to satisfy their bodies''
craving for nicotine, many smokers unwittingly changed the way they
smoked these low-tar cigarettes: they began inhaling more deeply,
taking more frequent puffs, or smoking more cigarettes per day.
In fact, we now believe that low-tar cigarettes may be responsible
for an increase in a different form of lung cancer, adenocarcinoma,
which was once relatively rare. This cancer is found farther down in
the lungs of smokers, indicating deeper inhalations, and appears linked
to a specific carcinogen particularly present in low-tar brands.
We must learn the lessons of the low-tar cigarette experience. Not
only did they fail to reduce an individual's risk of disease, but they
also appear to have increased population risk by delaying quitting and
potentially contributing to initiation among young people. This has
taught us that we must move cautiously in recommending any supposedly
safer alternative for people trying to quit smokingCbecause now, with
more knowledge and the benefit of hindsight, the science does not
support early recommendations on low-tar cigarettes.
Mr. Chairman, in the interest of time I will shortly ask that the
remainder of my statement and the scientific information contained in
it be considered as read and made part of the record. But before I do
that, I would like to ask for this Subcommittee and the Congress' help
in getting the message out about the dangers of the myth of smokeless
tobacco.
All of us in this room are very concerned about our nation's youth.
Kids growing up today have a tough time of it. In addition to the
normal struggles of puberty, many kids are facing a host of other
challenges. Many, especially minority kids, must struggle to find their
way in unsafe neighborhoods.
So the temptation to engage in behavior that is not healthy, and
the opportunity to do so, is very hard for our young people to resist.
According to a 2000 survey by the Substance and Mental Health
Services Administration (SAMHSA) (The National Household Survey on Drug
Abuse), about 1 million kids from age 12-17 smoke every day. Another 2
million kids smoke occasionally.
And we know that smoking is often not a ``stand-alone'' risk
behavior; it travels with others. The SAMHSA survey found that youth
who were daily cigarette smokers or heavy drinkers were more likely to
use illicit drugs than either daily smokers or heavy drinkers from
older age groups. More than half of 12-17 year olds who were daily
smokers had also used illicit drugs within the past month.
Every day, more than 2,000 kids in the U.S. will start to smoke,
and more than 1,000 adults will die because of smoking. We have to get
youth to stop starting. But the answer is not smokeless tobacco.
We have evidence to suggest that instead of smokeless tobacco being
a less dangerous alternative to smoking, just as smoking is a gateway
to other drugs, smokeless tobacco is a gateway to smoking.
So we must redouble our efforts to get our youth to avoid tobacco
in all forms.
We have some real work to do on the ``culture'' of smokeless
tobacco, which is glamorized by some sports stars. Chicago Cub Sammy
Sosa, who has made a public commitment to avoiding smokeless tobacco,
is a great example for kids. Past baseball great Joe Garagiola is now
Chairman of the National Spit Tobacco Education program, and regularly
lectures young players against the dangers of smokeless tobacco.
As Members of Congress, you can lead by example too, not just in
legislation, but in your own lives. I encourage you to avoid tobacco in
all its forms. Do not fall for the myth--a very dangerous public health
myth--that smokeless tobacco is preferable to smoking. Do not let
America's youth fall for it, either.
From the perspective of individual risk, the cumulative effect on
smokers of switching to smokeless tobacco is simply not known. But we
clearly know that use of smokeless tobacco has serious health
consequences. Overall, smokeless tobacco products have been classified
as a known human carcinogen. And limited scientific data indicate that
former smokers who switch to smokeless tobacco may not have as great a
decrease in lung cancer risks as quitters who do not use smokeless
tobacco.
From the perspective of population risk, there are even more
unanswered questions. Even if there was some decreased risk for smokers
who switch to smokeless tobacco, that benefit may be more than offset
by increased exposure of the overall population to this known
carcinogen.
The marketing of smokeless tobacco as a potentially safer
substitute for cigarettes could lead to:
<bullet> More smokers switching to smokeless tobacco instead of
quitting tobacco use completely;
<bullet> A rise in the number of lifetime smokeless tobacco users if
more youth begin using smokeless tobacco;
<bullet> A rise in the number of cigarette smokers as a result of more
youth starting to use smokeless tobacco and then switching to
cigarette use; and
<bullet> Some former smokers returning to using tobacco if they believe
that smokeless tobacco is a less hazardous way to consume
tobacco.
Concerns about youth initiation are especially troubling. The
scientific evidence is clear that use of smokeless tobacco is a gateway
to cigarette use. Young people may be especially attracted to smokeless
tobacco if they perceive it to be safer than cigarettes. Studies show
that more than one in five teenage males have used smokeless tobacco,
with age 12 being the median age of first use. Surveys also show that
more than two in five teenagers who use smokeless tobacco daily also
smoke cigarettes at least weekly. Finally, independent research and
tobacco company documents show that youth are encouraged to experiment
with low-nicotine starter products and subsequently graduate to higher-
level nicotine brands or switch to cigarettes as their tolerance for
nicotine increases.
Finally, we simply do not have enough scientific evidence to
conclude that any tobacco product, including smokeless tobacco, is a
means of reducing the risks of cigarette smoking. At this time, any
public health recommendation that positions smokeless tobacco as a
safer substitute for cigarettes or as a quitting aid would be premature
and dangerous. With the memory of our experience with low-tar
cigarettes fresh in our minds, we must move extremely cautiously before
making any statement or endorsement about the potential reduced risk of
any tobacco product.
Finally, my strong recommendation as Surgeon General is a call for
sound evidence about tobacco products and their individual and
population based health effects. We need more research. We need to know
more about the risks to individuals of switching from smoking to
smokeless; and we need to know more about the risks to the entire
population of a promotion campaign that would position smokeless
tobacco as a safer substitute for smoking.
Until we have this science base, we must convey a consistent and
uncompromised message: there is no safe form of tobacco use.
Thank you. I would be happy to answer any questions.
Mr. Stearns. Again, without objection, so ordered.
I will start the questions, and Admiral, I think I will
start with you.
The European Union has a policy on smokeless tobacco, and
it has been written by the leading tobacco control public
health advocates in the European Union, and they stated that on
the average that ``Scandinavian and American smokeless tobaccos
are at least 90 percent safer than cigarettes.''
Now, I respect your position. It is a lot different than
all of ours, but do you agree with the European Union policy
that what they said, 90 percent safer than cigarettes? I mean
just yes or no.
Mr. Carmona. No, sir, I do not.
Mr. Stearns. Okay. We know that the Institute of Medicine
report states that smokeless tobacco, ``the overall risk is
lower than for cigarette smoking and some products, such as
Swedish snus may have no increased risk.''
Now, this is the Institute of Medicine report. So I ask
you: do you agree with the Institute of Medicine?
Mr. Carmona. That particular statement, no.
Mr. Stearns. Okay. You know, the heart of our hearing today
is smokeless as an alterative for people who cannot stop
smoking, and I will give you an example. Let us say your son
just turned 16 and he had to drive a car, and you had a small
sports car in your garage and you also had a brand new Volvo.
And I think all of us in this room would agree that the Volvo
is safer than a very small sports car.
And you knew your son was just starting out and you had to
look at the two products. Would you not say the Volvo is a lot
safer for your 16 year old son to drive than a very small
sports car?
Mr. Carmona. I think it is actually an unfair analogy, sir.
In most cases, probably so.
Mr. Stearns. Yes. But, I mean, they both are dangerous, but
you know, what we are trying to do is just see if there are
degrees here, and then work off of the Institute of Medicine
report, as well as some of the European Union policy positions.
Chairman Muris, how does the FTC evaluate an advertising
claim? For example, if there is dueling science like there
might be here, and a great respect for the Surgeon General, how
do you actually reach a conclusion when there is this
advertising claim and you have dueling science involved?
Mr. Muris. Well, the first thing that we do is look to see
the message the advertising claim communicates to a reasonable
person in the intended audience, and that is a very, very
important step because, depending on how the various
disclosures would be made, it would not surprise me if an
audience understood them differently. I have not seen copy
testing of such particular advertising claims. I do not know
that they exist, but they would be viewed by the intended
audience quite differently.
Once we understand what we call the take-away is, then we
would look in terms of substantiation at what we thought was
competent and reliable scientific evidence, and again, it
partly depends on what the claim is.
If the claim is one that is unqualified, it would not
surprise me if people interpreted it as something close to a
scientific consensus or at least the majority scientific view.
So that would be relevant.
We also look at what we call the Pfizer factors. Pfizer was
an FTC opinion about the substantiation doctrine about 30 years
ago. One of the crucial factors in that case trying to balance
the impact of making mistakes, and you can make two sorts of
mistakes here. You can make the mistake of allowing false
advertising or preventing truthful advertising, and we try to
look at the consequences of those mistakes.
Mr. Stearns. The FTC has brought a number of cases against
companies making health claims related to cancer treatments,
weight loss, and cures for HIV/AIDS, arthritis, hepatitis,
Alzheimer's disease, diabetes, and many other diseases. How has
the FTC proceeded on those cases and how do these cases differ
from advertising claims made by tobacco companies?
Mr. Muris. Well, most of the cases that we brought involve
fraud where there is no scientific controversy. In weight loss
advertising, for example, we have--and the Surgeon General has
helped us in this area--we have a very aggressive campaign
against deceptive and fraudulent weight loss advertising. We
held a workshop at which we both participated last November,
where one of the things we were trying to do is to get
advertisers or--I am sorry--the media to police some of the
more obviously false claims.
So it is an area in which we spend a lot of resources, but
it is an area in which we do not have to make difficult
scientific choices.
Mr. Stearns. Just to conclude, Admiral, let us say we all
know that smoking is the leading cause of preventable death in
the United States, but I have seen some people here in the
House, Members of Congress, who cannot seem to stop smoking.
What do we do?
I mean, a person cannot stop smoking. How do we approach
those people?
Mr. Carmona. Well, I think there is a wide range of
possibilities that include substitution therapy, as I mentioned
in my opening remarks, behavioral therapy and behavioral
modification, and of course, we need to continue to do research
in that area.
But I think what we do not do is substitute one carcinogen
for another.
Mr. Stearns. Okay. Thank you.
The ranking member.
Ms. Schakowsky. Thank you, Mr. Chairman.
You referred to the Institute of Medicine, and I have that
report in front of me, and I would just like to read Conclusion
Five for Dr. Carmona.
It says, ``Regulation of all tobacco products, including
conventional ones as recommended in IOM 1994, as well all other
PREPs.,'' and PREPS. stand for potential reduced exposure
products; so we are talking about spit tobacco, ``is a
necessary precondition''--we are talking about regulation--``is
a necessary precondition for assuring a scientific basis for
judging the effects of using PREPs and for assuring that the
health of the public is protected.''
So they are making their conclusions by stating that all
tobacco should be regulated. And so I am wondering then if in
terms of the IOM report if you find any contradictions in what
they say and if you would find anything in what they say as, in
fact, recommending the use as a harm reduction alternative.
Mr. Carmona. No, ma'am. The IOM report I think is a very
good report, and I think one of its conclusions that is most
important is that they found that there really were no products
that were available today that had been scientifically tested,
such as smokeless tobacco products that would be safe to
recommend or use.
So I think their study was a very good one overall.
Ms. Schakowsky. Thank you.
Mr. Muris, if the FTC were to regulate the advertising of
spit tobacco and such an advertising campaign had an incidental
appeal to minors, would the FTC be able to regulate the
advertisements on that basis alone?
Mr. Muris. Well, first of all, the FTC has two bases to
proceed. One is on the basis of deception, and we would
obviously need to know a lot more. So this answer is
necessarily very, very qualified.
I think in terms of appeal to youth, the Commission would
be much more likely to proceed as it did in the Camel case,
based on its unfairness jurisdiction. At least in that case the
allegations were that the appeal to youth was far more than
incidental.
I think, again, I would have to know a lot more, but that
fact, the fact if the appeal was just incidental, would make it
very hard to use the unfairness jurisdiction.
Ms. Schakowsky. Right, and if such an advertising campaign
were to result in more people using smokeless tobacco in
addition to cigarettes rather than instead of using cigarettes,
would the FTC be able to regulate the advertisements on that
basis alone?
Mr. Muris. It would be very hard for us to make public
health judgments outside of the context of whether the
advertising was deceptive or not. That is primarily what we do.
On the other hand, clearly when you are balancing my answer
to the Chairman's question, when you are balancing the two
kinds of risk, the consequence here of allowing advertising
that is, in fact, fraudulent, that is part of those
consequences. So we would consider it in that sense.
Ms. Schakowsky. If such an advertising campaign were to
result in a dramatic reduction in the number of people who quit
tobacco completely, would the FTC be able to regulate the
advertisements on that basis alone?
Mr. Muris. Again, I think my answer is identical. We would
not look at this in the first instance under our statutes in
terms of a simple public health calculation. However, that
would be a very important fact in terms of weighing the
consequences of the substantiation, as I just indicated to the
last question.
Ms. Schakowsky. And would that be true then of such an
advertising campaign were to result in a dramatic increase in
the number of new tobacco users; would the FTC be able to
regulate advertisements on that basis alone?
Mr. Muris. I think my answer would be the same, and I would
direct you in more detail to our testimony, particularly page 9
where we discuss some of those issues.
Ms. Schakowsky. So despite the fact that the advertisements
were not directly aimed at children, despite the fact that they
said that you should use it as a substitute, if negative
consequences occurred, you are saying that, in fact, you could?
I do not read your mandate that way.
Mr. Muris. Well, first of all and most importantly, and
asking any question does not provide a full context of what the
advertising campaign would look like, and that full context
would be essential and possibly dispositive in what we could
do.
It is true, as our testimony states, that--let me just
quote it to you. ``Although a determination that an individual
risk reduction claim as truthful and substantiated would end
the Commission's deception inquiry, broader public health
issues may remain,'' and that is the sense in which I was
talking about how we do not under our statutes make simply a
public health determination, if that determination could ever
be simple.
It is true, however, in looking at substantiation that the
Pfizer factors require a balance of what statisticians call
Type 1 and Type 2 errors, which, as I explained, we try to look
at the consequences of us making a mistake, and the factors
that you are talking about are consequences of a mistake. We
would certainly consider those, and the presence of those
factors would require us to want a higher level of
substantiation before we allowed the claims.
Ms. Schakowsky. Thank you.
Mr. Stearns. The gentlelady's time has expired.
The Chairman of the full committee, Mr. Tauzin.
Chairman Tauzin. Thank you, Mr. Chairman.
Let me see if I can do something that I have tried with my
staff to understand. I have got the best experts in the country
here in front of me now.
Dr. Carmona, first of all, let me thank you for your strong
and, I think, extraordinary advocacy to help Americans
understand the dangers of smoking tobacco. I do not think
anybody quarrels with you on those issues today.
What we are focusing on, obviously, is a question of
whether or not there are other options other than the quit or
die option that Americans unfortunately are faced with when it
comes to tobacco.
In regard to that, I have tried to have an understanding
with my staff on the nature of nicotine. I am not a smoker. So
I have never had this addiction problem for nicotine. My body
does not crave it. I do not desire it. I do not smoke, and I do
not want to smoke. And so I am trying to understand it as a
non-smoker.
And I am trying to place nicotine in the category of
substances that are addictive that I do understand. I
understand cocaine and heroin and what it does to lives in my
district and in this country. I understand that when people
start on these kinds of addictive substances it can ruin their
lives, and they crave it to the point where it can even kill
them.
I am a caffeine addict. I drink coffee all day long. I
confess. I know what that addiction feels like. I know I have
to have my cup of coffee in the morning, and I have got to have
it all day long to keep me going.
But I also know that caffeine is not likely to kill me in
the sense that cocaine and heroin might kill me. It might not
be good for me. It might make me overactive. It might make me
hypertensive. I do not know what, but it is not likely to do
the damage that cocaine and heroin do.
Where do you place nicotine in that scale? Is it closer to
caffeine or is it closer to cocaine and heroin?
Mr. Carmona. It is hard to put it in a scale in that
comparison, but although they are both addictive, they have
different mechanisms of action, and the caffeine works by
modifying certain enzymes, xanthene oxidase, I think,
specifically, and it works through phosphodiesterase mechanism
they call it, and what it does is it works on your
cardiovascular system. It will speed up your heart, and it will
have cardiovascular effects that you become dependent on.
And so----
Chairman Tauzin. How about nicotine?
Mr. Carmona. Nicotine works by a different mechanism, but
nicotine has direct adverse cardiovascular effects that are
tied to accelerating cardiovascular disease. It has bad effects
on your heart, bad effects on the blood vessels and can
accelerate atherosclerotic disease, and so on.
So that we are not just talking about cancer here. We are
talking about other effects on the body that can be found.
Chairman Tauzin. It has other negative effects.
Mr. Carmona. Yes, sir.
Chairman Tauzin. Does it have any positive effects? I was
told by staff that there is at least some scientific evidence
that it has some positive effects on some categories of human
conditions. Is that true or false?
Mr. Carmona. Well, only if you are talking about, you know,
biochemistry of the body, but----
Chairman Tauzin. How about Tourette's syndrome?
Mr. Carmona. Oh, you are talking about as a treatment.
Chairman Tauzin. Yes.
Mr. Carmona. As a treatment now.
Chairman Tauzin. That is what I am saying. Isn't it used
positively in some cases, like treatments of----
Mr. Carmona. I have never used it, and if it is, then it is
probably not very common, but I would imagine in the literature
people have tried to use it.
Chairman Tauzin. Here is where I am going and I want your
feedback on it. If Americans who have become accustomed to,
addicted to the habit of getting nicotine into their body were
able to get it into their body in some other fashion other than
the use of tobacco, would that be a positive social development
in America in terms of the Nation's health or would it be a
negative one?
Mr. Carmona. Well, again, you know, I am less inclined to
comment on social developments than I am on science.
Chairman Tauzin. Well, on science then. Would it be good
for Americans' health, for people who need nicotine or believe
they have to have it or are addicted to it to get it in some
other fashion other than to having to burn tobacco to get it?
Mr. Carmona. Well, we have mechanisms presently available
through nicotine products that----
Chairman Tauzin. I know we do. I am asking you is that
good.
Mr. Carmona. It is an option that is available. I mean, the
best of all options obviously is not to smoke at all and not to
become addicted.
Chairman Tauzin. Nobody disagrees with that.
Mr. Carmona. Okay.
Chairman Tauzin. But if the option is quit or die, and what
I am saying is if you have to get nicotine in your system
because you are addicted to it and you cannot quit--I mean, the
quit rate is like 2 to 3 percent a year in this country, and we
know people are having a pretty difficult time quitting.
Recognizing that, knowing that we are going to lose an awful
lot of people to the effects of not quitting, if these folks
can get their nicotine in some other way other than burning
tobacco and sucking all of the nitrosamines and all of the
other substances into their lungs, would that be a positive
thing for the health of the country?
Mr. Carmona. Well, yes, and it already is where you have
patch. We have gum. We have mechanisms that have been tested
and found to be safe and effective means.
Chairman Tauzin. Right. Let me turn to the FTC Chairman.
If, in fact, people come up with products, tobacco products
or non-tobacco products that can, in fact, deliver nicotine to
folks who have been addicted to it and cannot seem to quit
using it, is your department the right agency to regulate the
truth of those ads?
Mr. Muris. Our mission is certainly to evaluate the
truthfulness of and including substantiation of advertising.
That can require us, and in this case it would, to work with
scientists both in and out of the government because the issues
here in the substantiation arena are issues on which their
experts----
Chairman Tauzin. Yes, you get thrown into the health arena
here.
Mr. Muris. And we are not, right.
Chairman Tauzin. Yes, and you are not health officials. But
nevertheless, your agency's function is to examine the
truthfulness or lack of truthfulness of advertising of American
products. Is that part of your agency's mission?
Mr. Muris. Yes, but what I am saying is the substantiation
issues here turn on scientific issues to which we----
Chairman Tauzin. Therefore, you would have to turn to
people like----
Mr. Muris. [continuing] seek help.
Chairman Tauzin. [continuing] Health Department officials
to help you.
Mr. Muris. Absolutely.
Chairman Tauzin. And if science was available to help you
understand whether or not an advertisement was, in fact,
truthful or not truthful, that gave people in America better
information about options that might be available to them when
it comes to getting nicotine, would it not be in the interest
of this country for you and our health officials to conduct
some public forums and to see whether or not all of this is a
good avenue to approach or not?
Mr. Muris. Well, in the abstract, Mr. Chairman, I certainly
think that is a good idea. Again, because the issues are
ultimately scientific, they would need to take the lead, the
scientific agencies.
Chairman Tauzin. Well, except they tell us it should be
your lead because you end up being the one to say yes or no on
the truthfulness of the ads. If they can help you understand
that and help you conduct forums that all of us in America,
scientists, consumers, advocates, pro and con, all kinds of
people can come and debate it and discuss it. Why wouldn't you
want to help create that type of forum for us?
Mr. Muris. Well, that is a different issue than taking the
lead. I would certainly think that we would--I know, speaking
for myself. Obviously my colleagues would have to vote--be
willing to participate in such fora not just to talk about
particular products, although that would be important, but to
talk about what endpoints, what kind of scientific evidence is
relevant.
I mean, I agree with the premise here that we have
somewhere near 50 million people who smoke, and it is a very
addictive product. I obviously defer to the scientists on that,
but it obviously is a very addictive product. Many people have
difficulty quitting, and I think there are potential--and the
key word is ``potential''--public health benefits from
addressing that issue, and it is one of----
Chairman Tauzin. Well, we at least ought to hear about it
and talk about it.
Mr. Chairman, my time is up. I just want to make the point.
If you do not take the lead and the Health Department says you
should take the lead and they do not want to take the lead, we
never get these forums going. Somebody has got to take the lead
to organize it, and I do not know whether you or Tommy
Thompson. We need to put you in a room together, and you all
can flip a coin to see who calls the meeting.
But my guess is it would help us immeasurably in this
country if one or both of you would take the lead.
Thank you, Mr. Chairman.
Mr. Muris. I understand. Thank you.
Mr. Stearns. I thank the Chairman.
The gentlelady, Ms. McCarthy is recognized for her
questions.
Ms. McCarthy. Thank you, Mr. Chairman. I pass.
Mr. Stearns. The gentlelady passes.
Mr. Whitfield.
Mr. Whitfield. Thank you, Mr. Chairman.
Mr. Muris, it is my understanding that UST, U.S. Tobacco,
had asked your agency, I guess back in February 2002, for an
advisory opinion to make certain statements in its advertising
about their smokeless tobacco products. Is that advisory
opinion still pending or what is the status of that?
Mr. Muris. Well, it is not what they asked us to do. They
did not give us advertising on which they asked an opinion.
They gave us a general statement without the context of
advertising, and as explained in our--I cannot obviously talk
about non-public proceedings in a public forum--but as
explained in our testimony, generically presenting something to
us in that manner caused us problems.
They withdrew the petition. They have recently sent us
additional information and asked that we hold a public forum,
but the petition has been withdrawn.
Mr. Whitfield. Now, what would be the purpose of the public
forum?
Mr. Muris. I think, although they can speak for themselves,
my understanding is the public forum would involve some of the
issues, many of the issues I was just discussing with Chairman
Tauzin.
Mr. Whitfield. One of the statements made evidently in
their letter to your agency was that the Surgeon General in
1986 concluded that smokeless tobacco is not a safe substitute
for smoking cigarettes. While not asserting that smokeless
tobacco is safe, many researchers in the public health
community have expressed the opinion that the use of smokeless
tobacco involves significantly less risk of adverse health
effects than smoking cigarettes.
Now, does your agency have the capability to render a
decision on whether or not advertising based on that type of a
statement would be accurate or truthful?
Mr. Muris. The question with such advertising would be
whether it was substantiated. We do not have expertise to
evaluate the substantiation, the scientific evidence. We would
turn to scientific experts within and without the government.
I cite a few very briefly. We cite in our footnotes to our
testimony just very brief introductions to some of the
scientific evidence, but that is where we would have to turn.
Mr. Whitfield. And you would be able to do that?
Mr. Muris. Sure. We would be able to ask for cooperation
and assistance. Obviously it would be in the discretion of the
people we asked as to how much they participated and what they
told us.
Mr. Whitfield. And going to the scientists to come up with
a scientific analysis of the claims under the current system
that you would do that, you would feel comfortable with the
conclusion said? I mean the process.
Mr. Muris. Well, let me, again, put the process in context.
When you have advertising, we look to see if the advertising in
the first instance is deceptive. Advertising of this nature
would almost certainly be advertising that contained an
explicit or implicit claim that there was substantiation for
the risk reduction.
We, again, are not experts on the science necessary to
evaluate that claim. So that is why we would turn to the
scientific community. I have confidence in the process in
general. How it would work in this particular case, you know,
we would have to see.
Mr. Whitfield. Yes. Admiral Carmona, would you support the
abolition of all tobacco products?
Mr. Carmona. I would at this point, yes, sir.
Mr. Whitfield. So you would support a law in Congress that
all tobacco products would be illegal?
Mr. Carmona. No, sir, I did not say that. You asked me
would I support banning or abolishing tobacco products. Yes.
Legislation is not my field. If Congress chose to go that
way, that would be up to them, but I see no need for any
tobacco products in society.
Mr. Whitfield. But if Congress were to pass legislation
making tobacco an illegal product, you would be comfortable
with that?
Mr. Carmona. I would have no problem with that.
Mr. Whitfield. Okay. Now, the purpose of this hearing
today, if oral tobacco is to play a role in harm reduction,
would you agree it is not necessarily to show that it does not
cause cancer, but it simply needs to be substantially less
hazardous than smoking?
Mr. Carmona. If I understand your question correctly, sir,
I would say that we already know it is a carcinogen, one. And
if we were looking to test any other theories, certainly the
fact that it is a carcinogen would be important, and in my
mind, you do not need to do any further testing. If you already
know it is a carcinogen, it would not be an acceptable
substitute.
Mr. Whitfield. So whether or not it is less harmful would
not make any difference to you then?
Mr. Carmona. I if there are those who are doing research in
this area and they have thought of unique ways that this can be
helpful, I am always willing to listen to research.
Mr. Whitfield. Okay.
Mr. Carmona. But right now substituting one carcinogen for
another, I do not see a benefit.
Mr. Whitfield. Okay, and I understand that, but you are
saying if there is scientific evidence there that shows that it
is less harmful, that that is something that you would be
willing to look at.
Mr. Carmona. I would always be willing to look at any
scientific evidence, sir.
Mr. Whitfield. Okay. Now, the Royal College of Physicians
in December 2002, which is England's oldest medical
institution, and among its functions is to advise the
government, the public, and the medical community on health
care issues, stated that as a way of using nicotine, the
consumption of noncombustible tobacco is of the order of 10 to
1,000 times less hazardous than smoking.
Would you agree with that or not?
Mr. Carmona. I would not, sir.
Mr. Whitfield. Are you aware of any scientific data that
would disagree with that statement?
Mr. Carmona. Sir, not so much disagree, but I do not think
they have enough scientific data to justify making that
statement.
Mr. Whitfield. You do not think they have enough data to
justify it?
Mr. Carmona. That statement, yes.
Mr. Whitfield. And you have read this report that they have
rendered?
Mr. Carmona. Yes, I have, sir.
Mr. Whitfield. Now, on this issue of smokeless tobacco as a
gateway to increased smoking, do you have any evidence to show
that it is a gateway to increased use of tobacco products?
Mr. Carmona. Yes, sir. There are studies to demonstrate
that it does act as a gateway and can eventually increase
smoking in all individuals.
Mr. Whitfield. Now, what about there was reference earlier
to this European Union study about smokeless tobacco, and in
that study, they make all sorts of statements. They said Sweden
has the lowest level of tobacco related mortality in the
developed world by some distance, approximately half the
tobacco related mortality of the rest of the European Union.
Sweden has the lowest male smoking prevalence in Europe. Half
of the tobacco in Sweden is now consumed as a smokeless tobacco
product, and this share has steadily grown since 1970.
They go on and on and on, and they make all sorts of
arguments that one of the reasons that there is less mortality
in Sweden is because of these so-called smokeless products, and
I am sure you have read those reports as well.
But do you have any scientific evidence that would refute
that report?
Mr. Carmona. Well, on those reports, sir, I think there are
many potential confounding factors that have not been fully
looked at. People smoke or chew for a variety of reasons, and
to assume that a decreased morbidity and mortality in a
population is solely due to the fact that somebody is chewing
tobacco, I am sure they all drink milk also or have a cup of
coffee, and you could equally attribute changes to other
variables that maybe have not been looked at.
So it is a much more complex problem.
Mr. Whitfield. I see my time has expired.
Mr. Stearns. The gentleman's time has expired.
The gentleman from Texas, Mr. Green.
Mr. Green. Thank you, Mr. Chairman.
Admiral Carmona, during the previous Congress members of
this committee have introduced legislation which would give the
FDA a broad authority to regulate tobacco products, including
strong restrictions on advertising and marketing tobacco
products, protection for young people against exposure to
environmental tobacco smoke and tough company specific
surcharges to encourage companies to reduce youth smoking. Do
you think it is important for our Congress this time to enact
legislation to give the FDA that authority to regulate these
tobacco products?
Mr. Carmona. Well, sir, I appreciate the question, but not
being in the regulation business, I think it is important that
Congress looks at this and makes determination if it is
something that they want to move ahead with that would be in
the best interest of the protection of the American public.
Whether or not the FDA does it, I think strong oversight
and scrutiny is important by whatever mechanism you all choose
to do.
Mr. Green. Okay. Thank you.
I understand the position you are in, and I appreciate the
best answer you could give.
Mr. Muris, one of the rotating warnings on packages of
smokeless tobacco reads ``Warning, this product is not a safe
alternative to cigarettes.'' Let us say that you are a
cigarette smoker who saw an ad promoting smokeless tobacco as a
product with reduced risk, if that was allowed, and you go to
your local convenience store and decide to try it out.
Yet ripping open the top of it, you read the warning that
this product is not a safe alternative to cigarettes. Would you
feel as if you received a mixed message as to the health
benefits of that package of smokeless tobacco?
Mr. Muris. Well, it obviously depends--and this is just to
preface this. This is a very important part of what we would
do, is to look at the take-away as to what a reasonable person
in the intended audience understood. It obviously depends on
what the advertising said.
It is quite possible that even though couched in the
language of ``safer,'' that people would receive, you know,
depending on how it was written and what all was in the ad and
the totality of the circumstances, it is possible that people
would receive a message of safe in which case they would be
conflicting.
Mr. Green. Okay. Thank you.
The Federal Trade Commission Act provides that an act or
practice is illegal if it ``causes or is likely to cause
substantial injury to consumers which is not outweighed by
countervailing benefits to consumers or to competition.''
Even if we were to assume that scientific evidence were
true that smokeless tobacco use can reduce the number of deaths
associated with smoking, in your opinion does this outweigh the
substantial injury caused to consumer?
Mr. Muris. Well, you are now turning to a second part of
our statute, which is unfairness, and I talked about this
briefly a little while ago.
In the context that we would be looking at, and this is
part of balancing in a different way than I was mentioning
before, but similarly of balancing the benefits and the costs,
and that is what that part of the statute requires.
I think it is a factual question on which, you know, we
would have to seek evidence.
Mr. Green. Thank you, Mr. Chairman.
And I yield back my time.
Mr. Stearns. The gentleman yields back the balance of his
time.
The gentleman from New Hampshire, Mr. Bass.
Mr. Bass. Thank you, Mr. Chairman.
As I mentioned in my opening statement, we have heard
comments about young men using smokeless tobacco as a right of
passage. We have heard a possible connection between health
problems with the former Speaker of the House and chewing
tobacco, although I do not know whether that is true or not.
The Surgeon General has recommended that perhaps Members of
Congress need behavioral modifications. I would definitely
agree with that.
But the real issue here today is a narrow one, and my first
question is for Chairman Muris.
Understanding, sir, that the FTC has a difficult mission
protecting consumers from deceptive and misleading advertising,
it involves judgment calls, and reasonable person standards.
Given that you already do this currently for weight loss
products and other such items based on a comparative advantage,
which is the subject of this hearing, could the FTC establish
guidelines that would offer needed protection and more accurate
information, in your opinion?
Mr. Muris. Well, in general I think you have to take
advertising in its context and as you find it. There is the
issue I was just mentioning, the issue of how consumers
understand claims, and then there is the issue on which we
spent most of the time in the questions you have asked me about
the substantiation.
Because one of the claims that would be in these ads would
be an explicit or an implicit claim that there is scientific
substantiation for a risk reduction claim.
I think we would have to emphasize both things. I do not
think we are ready to do guidelines particularly involving the
second issue because we would need to have a much greater
discussion with the scientific community about what risk
reduction claims mean, about the appropriate endpoints for
measuring them, about evidence from around the world, about a
whole host of issues.
Mr. Bass. But it is perfectly legitimate or reasonable for
the FTC to conduct studies involving comparative advantages of
one product over another. It does not have to be an absolute.
Mr. Muris. There is nothing in principle that prevents
comparative claims. The Commission with my predecessor, one of
the best things he did more than 30 years ago when he was at
the FTC, he got the networks to eliminate their restrictions on
comparative advertising.
Comparative claims are important kinds of claims.
Mr. Bass. Okay. Admiral Carmona, I appreciate your
testimony, and my colleague from Kentucky, Mr. Whitfield,
brought up the issue of the English or the British report that
in essence drew a conclusion regarding the relative benefit or
whatever of smokeless tobacco versus cigarettes.
I would be interested in if you would be willing to provide
the subcommittee with a further explanation as to exactly what
scientific evidence you find in that report invalid.
I will say now I have never heard of it, and I have not
read it, but you have basically disputed the claims that are
made in this report and said they are invalid and they are not
based upon adequate science and if you were an officer, you
would be willing to analyze those claims and explain exactly
what mistakes they made that led to that particular conclusion.
I would be interested to read about it.
Mr. Carmona. We would be happy to provide you with the
information, sir, and generally it is not that it is invalid.
We felt that there was not enough information to support their
thesis, that more research needed to be done before you could
come to that conclusion.
Mr. Bass. Okay. I do not think anybody here is suggesting,
sir, that you recommend one product over the other, but
suppose, but I do not like to use hypotheticals, but would you
agree that advertising that explains the mortality rates of one
product over another, that infers a conclusion that smokeless
tobacco was less harmful than cigarette smoking, would that
fairly describe an aspect of the harm reduction that we are all
seeking?
Mr. Carmona. Well, we are all seeking harm reduction. I do
not think that fairly describes quite a complex problem because
where you might be able to argue that a product has one
component that may reduce risk, when you look at the product
broadly and all of its risk factors, there may be more harm or
less harm than others.
So I do not think, sir, it is as simple as just describing
that because there are many variables that we are looking at in
these comparisons.
Mr. Bass. Mr. Chairman, my time has expired, and the point
that I am trying to drive at in this line of questioning is
that there is no perfect product for any problem, and there is
probably no substance in this country or no issue or product
that is more controversial, with the possible exception guns,
than tobacco.
However, within the context of this debate if a public good
is being achieved, albeit not a perfect one, is it not a good
idea for policymakers and agency heads to examine this
realistically and objectively because ultimately we are all
seeking the same goal, which is reduction in deaths due to this
particular substance.
And I will yield back.
Mr. Stearns. And I thank the gentleman, and we have had a
hearing dealing with guns, too.
Mr. Bass. I know.
Mr. Stearns. The gentleman from Massachusetts.
Mr. Markey. Thank you, Mr. Chairman, very much.
I do have a bias in this field. My father died from lung
cancer, and he died 3 years ago. And although he smoked two
packs of Camels a day from the age of 12 until 67, it never
caught him until he was 89, and then it just showed up even
though he was otherwise perfectly healthy, and then he died
from lung cancer 3 years ago, although the doctor had said,
until it showed up, that he was going to live to 100.
So that is a big loss in our family to have a guy in
perfectly healthy condition mentally and physically to die
because of it.
But what I remember most is that when I was 13, he told me
because I was the oldest, that he started smoking at 12 and
that he knew I would be starting in the next couple of years
because every boy smoked, all right, but that he should not
expect him to pay for the Camels; that I was going to have to
earn the money. Just do not take the money out of his pockets
or anything.
But he knew that we would all smoke. That was his message
to me when I was a 13 year old boy.
So because of the Surgeon General's decision in the mid-
sixties and the continuation of public education, we have been
partially at least able to stem that tide of the inevitable
deaths that occur from young boys and girls starting to smoke
because they feel like they have to.
So one of my concerns here from a public health perspective
is the secret additives that are included not only in
cigarettes, but also in the smokeless tobacco kind of products
that are sold, and I know that HHS is one of the only entities
to have the secret list of ingredients.
Do you think that it would be helpful for there to be a
release of the secret additives to the public so that even if
smokeless tobacco is advertised as being safer than smoking
tobacco that the public would then still be able to see what
the additives were and to be able to judge that it is still
much too big of a risk to undertake at all and help mothers and
fathers to convince their kids not to start?
Doctor?
Mr. Carmona. Sir, I am not aware of the legal complexities
involving the release of such information, but I know that our
scientists have looked at it, and in aggregate they have
published information as to many carcinogenic agents, as well
as other factors that are contained within smoke products that
can cause not only cancer, but other disease.
But as far as the release of that, I think that it is out
of the scope of my practice, sir, and I am not sure of the
legalities of that, but certainly----
Mr. Markey. If it was within our power, would you make the
list of the secret additives public?
Mr. Carmona. I think that I would ask my colleagues who
were actually at the bench doing the research to ascertain if
there was any benefit, additional benefit to that that would be
released within the research, and then I would make my decision
on that.
Mr. Markey. Any additional benefit?
Mr. Carmona. Knowing the specifics, yes.
Mr. Markey. If the public knew what the additives were and
it was determined that they would be more likely not to start
using it if they knew, would you then be supportive of
releasing the additive information?
Mr. Carmona. Again, sir, that is one of the factors I would
consider, but also looking at the entire context of how this
information is being used by our scientists and if there was
some health status that could be achieved by releasing this
information, then certainly that would move me in that
direction.
Mr. Markey. So there are carcinogens in these additives.
You also mentioned other diseases caused by these additives.
What are they?
Mr. Carmona. Well, chronic obstructive pulmonary disease,
acceleration of cardiovascular disease, you know, stroke, heart
attacks, things like that. So not all necessarily cancer
related, but very significant diseases also.
Mr. Markey. So let me ask you, Chairman Muris. If the
public does not have access to information about secret
ingredients and additives in smokeless tobacco, aren't claims
regarding the potential health benefits of smokeless tobacco
likely to be deceptive or misleading because the information
about the additives that are in the smokeless tobacco are not
available for the public to make that determination themselves?
Mr. Muris. Well, let me preface with two general
statements.
One, I have never looked explicitly at what this
information is, but from the standpoint of what we do, there
would obviously be a heavy presumption in favor of more
information and not less, and someone would have to make a very
good argument, and you know, not having looked at it, I do not
know what that argument might be, to withhold information.
Mr. Markey. Thank you.
Mr. Stearns. The gentleman's time has expired.
Mr. Shimkus. No, Mr. Shadegg. Mr. Shadegg.
Mr. Shadegg. Thank you, Mr. Chairman, and thank you for
holding this hearing.
I will tell you I am mystified by it all, and I kind of
wonder where it is taking us.
Let me start with the issue of your jurisdiction at the
FTC. As I understand it, you have jurisdiction arising out of
the concept of deception and the concept of unfairness; is that
correct?
Mr. Muris. Yes.
Mr. Shadegg. On the concept of deception, as I understand
your testimony, before you could allow a label to say this
product is safer than, that is, smokeless tobacco is a safer
alternative to cigarette smoking, you would have to have
evidence which substantiated that point; is that correct?
Mr. Muris. Among other things, yes, sir.
Mr. Shadegg. Okay. Dr. Carmona, it is your belief that
while there have been studies done on that point, they simply
are not sufficient, that is, not enough studies or not enough
subjects, not enough contrasting information to reach that
conclusion; is that right?
Mr. Carmona. In the particular instance of smokeless
tobacco?
Mr. Shadegg. Yes, to reach the conclusion that smokeless is
safer than.
Mr. Carmona. Yes, that is correct, sir.
Mr. Shadegg. Okay. So you believe the FTC could not, in
fact, substantiate that first threshold criteria of whether or
not it is safer than; is that right?
Mr. Carmona. That is right, sir.
Mr. Shadegg. The whole topic puzzles me. For example, this
is a can of smokeless tobacco. This particular can has the
warning that says, ``This product may cause gum disease and
tooth loss.''
One of the issues I hear in the testimony here today is a
relative one, which is if we say or if we allow the claim to be
made that smokeless tobacco is safer than cigarettes, which you
believe cannot be substantiated, but others believe could be
substantiated, are we then deceiving people into using
smokeless tobacco as a safe alternative?
Now, we know that one of the labels that is already on
smokeless tobacco says this product is not a safe alternative
to cigarettes. That raises the issue of, okay, what is the
truth. If you give less than all of the truth, are you somehow
deceiving people?
And, Dr. Carmona, that is your concern, is it not?
Mr. Carmona. Yes, sir. My concern is that, you know, that
definition of the word ``safer'' as it relates to these
products, that, in fact, if you take one piece out of context
and make an assumption that, well, because there is less of a
certain chemical, therefore, it is safer where the science is
not there to support it, and we ignore the fact that, as you
just pointed out, sir, gum disease, tooth problems and so on
are also problematic, it is very difficult to say that, and
that is why I view that substitution argument as oversimplified
for a very complex problem and one that I could not support
because it is still detrimental to the American public.
Mr. Shadegg. Let me ask you both. As I read the information
I am provided, right now although the warning on cigarettes is
a Surgeon General's warning and the warning on smokeless
tobacco is not a Surgeon General's warning, it just says a
warning; both are as a result of congressional actions and
neither are as a result of FTC action standing alone or Surgeon
General action standing alone; is that correct?
Mr. Carmona. I believe so, sir.
Mr. Muris. Yes. The FTC got the ball rolling, but then
Congress stepped in 40 years ago or almost 40 years ago.
Mr. Shadegg. And so it is going to be our job to try to
spell out at least currently what should be specified on the
label, if anything.
Dr. Carmona, if the Congress does not step in and specify
what should be spelled out, do you have the jurisdiction to
issue your own warning?
Mr. Carmona. Well, I think that one of the things I have
probably that is most important is the so-called bully pulpit.
I can certainly speak out regularly on the hazards of all
tobacco products, and I would certainly intend to do that along
with my colleagues where the scientific basis allows me to do
so.
Mr. Shadegg. and I suppose it would be your position that
if someone were to propose that they wanted to advertise
smokeless tobacco as safer than cigarettes, you would want to
add ``but not, in fact, safe'' because of these other dangers;
is that right?
Mr. Carmona. I would be opposed to such advertising.
Mr. Shadegg. And you would like to see the Congress, if the
Congress were to step into this field and specify what had to
be put on claims about smokeless tobacco, to make sure if
anyone had wanted to make a claim that smokeless tobacco was
safer than cigarettes, but they would go beyond that and say,
``But, however, still not safe because it causes all of these
issues, the potential for mouth cancer, potential for gum
decay, tooth disease, other things''; is that right?
Mr. Carmona. Well, sir, my intent would never be to attempt
behavioral modification on the Congress.
Mr. Shadegg. But we look to you for expertise and we
should.
Mr. Carmona. But what I would strongly support is that
Congress take into account all of the scientific evidence
before us, some of which you have completely outlined right
now, in making their decision to protect the American public.
Mr. Shadegg. One of the things that concerns me is that of
the three labels Congress has specified for smokeless tobacco,
and I understand they rotate. So my understanding is that one
third of all cans would have to contain one of these; one third
the second; and one third the third. One of them, quite
frankly, I think you could make the claim that it is deceptive
precisely because it does not go far enough.
One of the three labels is, ``This product may cause gum
disease and tooth loss.'' I would suggest that if I were a
young kid picking up this can and read this particular can,
which says it may cause gum disease and tooth loss, I would be
a lot less concerned about its use than if read, ``This product
may cause mouth cancer,'' which raises the next question of,
well, why does it say mouth cancer. Why doesn't it say this
product may cause cancer? Because if you want to scare somebody
and you warn them this product may cause cancer, I suggest that
is going to have a greater impact on them than perhaps any of
the other three alternatives that are there.
So one of my concerns is what we will have when we start
down the slippery slope, when it is the U.S. Congress that
decides what the precise wording of any warning ought to be.
Mr. Carmona. Well, we are certainly concerned, my
colleagues and I, sir, that any references to ``safer'' that
are not clearly spelled out, are not scientifically justified
may, in fact, just do that, cause young people to start earlier
and feel that it is a safe thing to do; that there is
relatively little risk; and as you have pointed out, the whole
story is not being told.
Mr. Shadegg. Let me go back to the FTC on the issue of,
okay, one issue would be the issue of deception, and that is
would it be deceptive to claim that smokeless tobacco is safer
than cigarettes.
Your second element of jurisdiction is that of unfairness.
Under the second rubric, unfairness, would you consider it
necessary to go on and provide the disclosure however not safe?
Mr. Muris. Well, the Commission has rarely, and I mean
rarely, used unfairness to evaluate advertising. It almost
always uses deception. There is a tremendous First Amendment
problem from saying an advertisement is truthful, yet we can
stop it. So we would much more likely use on the unfair--I mean
our deceptive authority.
It is clear that in any of these ads we would be concerned
with the take-away. By that I mean an understanding by the
intended audience that no matter what the word said, that a lot
of people thought that it meant safe, and that would be a big
concern.
Mr. Shadegg. You would be concerned that an implication
that safer might cause somebody to conclude it was safe.
Mr. Muris. Sure, depending on, you know, how the disclosure
was made and what else was in the end.
Mr. Shadegg. Before my time expires, I simply want to
conclude by pointing out that according to the information that
I have in 1981, the FTC issued a report to Congress that
concluded that health warning labels had little effect on
public knowledge and attitudes about smoking. So it says public
labels do not do anything.
Congress responded by enacting a law requiring health
warning labels. I think it is quite interesting what we do
here.
Thank you very much.
Mr. Stearns. The gentleman's time has expired.
Mr. Davis is recognized.
Mr. Davis. Thank you, Mr. Chairman.
Chairman Muris, in reviewing your written statement on page
8, you suggest that in the context of safety claims, the FTC
has typically required a substantiation standard of competent
and reliable scientific evidence. In my opinion, this issue
ultimately boils down to respect. How much respect are we going
to have for our consumers, for our citizens in terms of how
high the standard we set as far as judging the accuracy and
truthfulness of any disclosure you would approve or this
Congress would approve so people can make safe decisions, not
necessarily the right decision.
Can you elaborate a little bit as to exactly how high the
standard is you would employ if you were to find yourself in a
proceeding judging the marketing of smokeless tobacco?
Mr. Muris. Well, yes, sir. The first question obviously
turns on what the ads would say in their full context and,
therefore, what the take-away from consumers would be. The more
qualified the take-away that the consumers received, the lesser
the substantiation.
On the other hand, as I mentioned, the so-called Pfizer
factors before, because I personally believe, again, just
speaking for myself--obviously my colleagues could have
different views--because the consequences of making a mistake
here are so serious in terms of, you know, the potential
adverse effects on public health, people who might otherwise
have quit, what the effects might be on children; that would
indicate that the bar should be very high.
Mr. Davis. The debate here today seems to center upon the
word ``safer.'' It seems to me as a lay person that by its very
nature in whatever context the word ``safer'' is used, and it
invariably is a vague term; it is not a qualitative
connotation.
Under what circumstances could safer ever constitute a
sufficiently acceptable standard under this very high standard
you have just described?
Mr. Muris. Well, again, there are two questions that I
think you really have to keep distinct. One is how consumers
understand the words, and I believe it is possible to
communicate safer as opposed to safe, but then the second
question is about the scientific evidence.
And the scientific evidence, I believe, would have to be
very high, but we do not even know. I mean, again, we are not
scientists. The scientific community, I think it would be very
useful for them to do more work on issues involving what sort
of evidence is it that they would want, what sort of evidence
that they would look at.
Because I do agree with the general premise that some
members have made that we do have upwards of 50 million people
who smoke. Many of them find it very difficult to quit. The
simplest place to start, if I could just end, I believe, and I
would like to explore with the FDA, the potential for broader-
based claims for the gums and the patches that the Surgeon
General mentioned.
Right now those can only be used for very narrow purposes.
They can only be marketed as part of quitting. They cannot be
marketed as sort of a long run replacement. It seems to me,
again, it would be up to the FDA ultimately because they
regulate this, but it would seem to me that there are very
large potential benefits from being able to tell people about
the longer run possibility.
Mr. Davis. And I commend you on that. I do not think we
should be afraid of the risk reduction. The Surgeon General has
said that. I think we need to be painfully objective about
this.
But it just seems to me as a lay person that the question
is not whether a safer type of marketing could ever be
acceptable under this very high standard, but that it really
would be a disclosure as to how much safer or how less safer,
don't you think?
Mr. Muris. Oh, well, absolutely you would need to
understand the question of quantity in that sense, not just the
question of a qualitative difference, and I agree with that.
It even may be true, a complication of the nicotine
products, the gums and patches, and why I used the word
``potential'' is there is some evidence, and, again, I am not a
scientist. The scientists would have to explore it. There is
some evidence of potential dangers from nicotine itself beyond
addiction.
Mr. Davis. In the Footnote 17 on page 8, you seem to
acknowledge the possibility that evidence that is presented to
you that you rely upon for approval later proves to be faulty.
That is a problem.
Do you have the authority to go back and revisit any
approval of the disclosure that has been made on a product if
subsequent scientific evidence reveals it is not sufficiently
accurate?
Mr. Muris. Absolutely, and the basis of the substantiation
doctrine by its very nature recognizes that when the science
changes, then the ability to make the claims changes.
Mr. Davis. I would like to give the Surgeon General an
opportunity to comment on any of these points if he would care
to.
Mr. Carmona. Well, sir, simply I agree with where you are
going with this. I think there is qualitative and quantitative
aspect to the word ``safe'' or ``safer,'' and certainly
quantitatively we have to be able to define that, but also in
its entirety as I alluded to earlier in my remarks.
Taking one variable out of context and simply stating that
there is an improvement or it is simply safer does not address
the spectrum of risk, of which there are many variables.
So I think it is to the public's benefit that we are very
clear on how that word is used.
Mr. Davis. Thank you, Mr. Chairman.
Mr. Stearns. The gentleman's time has expired.
Mr. Issa.
Mr. Issa. Thank you, Mr. Chairman.
I might preface this by saying I am a recovering smoker of
13-plus years. So I am very aware and every day think about the
error of my smoking in my youth and my not so youth judging
from when I finally quit, but I do have some questions because
I do not think we are dealing with tobacco here. We are dealing
with the question of a blank substance relative to other blank
substances, claims, interpretation for whether or not they are
allowed versus other claims.
And hopefully we can forget the word ``tobacco'' in the
discussion today for purposes of thinking about whether or not
safer, which does seem to be the key word, is appropriate or
inappropriate to be considered.
And what I would like to, first of all, do is ask the
Surgeon General one question, which is what is the health
benefit of butter.
Mr. Carmona. Let's see. There are nutrients within butter.
Mr. Issa. Butter is basically fat; is that right?
Mr. Carmona. No, no.
Mr. Issa. What are the benefits of fat then perhaps is a
better question.
Mr. Carmona. Fat is necessary. It is essential to our
growing everything from making steroids in your body to new
cells require fats.
Mr. Issa. And isn't the excess consumption of fat the No. 1
health problem in America, in combination with not enough
exercise.
Mr. Carmona. It certainly contributes to obesity, sir. Yes,
sir.
Mr. Issa. Okay, and yet the low fat butters and the
alternate butters appear to be able to claim that they are
better and safer. I have read enough packaging to get this idea
that this plasticized butter that tastes marginal at best, not
margarine, but marginal, gets to make that claim.
And, Chairman Muris, I guess the question is: how do they
get to make the claim that they are better if essentially the
difference is less fat, which the Surgeon General has said is
okay? It is essential.
Mr. Muris. Well, health claims are regulated by a statute
that Congress passed in 1991, the NLEA, and there are a variety
of hoops through which you have to jump. So even though we are
involved in that area and, in fact, Dr. McClellan, the head of
the FDA, and I made an announcement last year where he is
hoping, given the way science is changing, he is hoping that
advertising and labeling can keep up with the changes in
science.
But there is a special, you know, regulatory regime for
those.
Mr. Issa. Okay. So the fact that butter is essentially not
bad and fat is not bad, then if you have less of it claiming
that it is better would be probably inappropriate on the face
of it all, forgetting about the taste of butter, forgetting
about what we all put on. Then, in fact, we have a different
standard for tobacco than we have for fat.
Doctor, I guess my next question is you support banning
tobacco. Does that allow you to be an honest broker in the
question of less bad and more bad?
I would personally say that I would have a hard time if I
supported outright banning something. We would be happy to see
Congress passing a law that would do that.
And then I was asked: well, are we going to allow the good
instead of the perfect if the good might, in fact, perpetuate
consumption of this for a while?
I would probably inherently say, ``Well, geez, I do not
want to have anything that might lower a little bit the health
risk, but perpetuate the consumption.''
Is that something that you are having to deal with in your
testimony today?
Mr. Carmona. Well, no, sir, and let me elaborate. First, I
want to respectfully disagree with your analogy with butter
because it is much more complex than is presented, and I think
it is an unfair analogy.
Second, I am not having any problem with it because the
driving factor in what I have testified to is that the
substance we are talking about is a proven carcinogen. It
causes cancer. So that----
Mr. Issa. Reclaiming my time from the witness, I guess the
problem we have is we are talking about less and more and
trying to understand whether or not less or more is an honest
statement, and that is why I am trying to get to the bottom of
this.
It appears to me as though other than tobacco we have this
theory that you are innocent until proven guilty. In tobacco
you are guilty until proven innocent, and so for the Chairman,
I guess, my question to you would be, because my time is
evaporating here, we have made a big point in this country, and
accurately so, that we are concerned about second hand smoke,
sufficiently that, in fact, it has been found to be something
that one has to get rid of, and that is why we ban smoking in
public areas in State after State.
If, in fact, second hand smoke is clearly bad, then aren't
you better if you have no second hand smoke because you have no
first hand smoke? The risk to people around a smokeless tobacco
consumer is by definition zero versus whatever you have with
cigars, pipes and cigarettes.
Would that not meet the first threshold of a claim?
Mr. Muris. Well, sure, but now you are addressing a
different question. If smokeless tobacco made a claim based on
no second-hand smoke, you know, we would evaluate that on it
its merits. That is obviously different than the earlier claim
we were talking about.
Mr. Issa. So just one last follow-up. So what I am hearing
is that even though there is no smoke and anybody could figure
out that it must be safer, you are saying that if they made
that claim, then you would think about evaluating it. Do we
need science to determine----
Mr. Muris. Well, no. I am saying----
Mr. Issa. [continuing] that smoke has no second hand smoke
claim?
Mr. Muris. The evaluation could be very quick, but
obviously if someone asks us, let us go back to the premise.
The premise was we were asked about these claims. I cannot give
an answer without an evaluation, even if the evaluation occurs
in a twinkling of an eye.
Mr. Stearns. The gentleman's time has expired, and the
gentlelady from California, Ms. Solis.
Ms. Solis. Thank you, Mr. Chairman.
Thank you, Dr. Carmona for being here. It is good to see
you. I know on occasion we talked about some of these chronic
illnesses that face our communities, especially minority
communities and the Latino community.
And I wanted to ask you, and I do not know if this has come
up, what the cost is in terms of prevention for tobacco use now
that you know of in terms of government trying to combat the
use, trying to get youth to stay out of, you know, going into
that bad habit of smoking.
Mr. Carmona. I do not have a dollar amount for you. I
certainly can get that, but whatever it is, I know that when we
look at prevention across the board, we spend far, far too
little on all prevention activities in this country.
Ms. Solis. Would you say that the number of youth,
particularly minority youth in terms of smoking, has gone up in
the last 10 years or it has gone down?
Mr. Carmona. I think it has slightly increased where other
areas or other subsets have decreased. This is still a
population that is at greater risk.
Ms. Solis. I saw some information regarding, I guess, a
percentage decrease for young Latinas in terms of smoking. I
kind of understand why that is happening, because more women at
least are going in for prenatal care and are being advised of
low birth weight that their child would experience if they
continue to smoke.
Is that something that your office is also advocating?
Mr. Carmona. Well, the epidemiology and demographics of
smoking are tracked very carefully by CDC on a routine basis,
and they have all of those numbers broken down, again, by
ethnicity, by geographic location, by age, and so on.
So it really depends which group you are speaking of. In
some areas it has plateaued out, but in some there are still
subgroups, Latinos specifically, who are at slightly increased
risk, and every once in a while we see a little increase.
Ms. Solis. One of the explanations that we were given is
that, in fact, if you were advocating for use of smokeless
tobacco, that that probably or could lead to use of tobacco,
cigarettes. What is your opinion on that?
Mr. Carmona. Yes, we do look at smokeless products as being
a gateway to smoking. It can be still a sense of security that,
again, as I have said earlier, this is a lesser threat. It is a
safer means to get your nicotine and chew, and we are
definitely concerned about that for the reasons I have already
mentioned.
Ms. Solis. One of the other questions I have is women, I
think, overall, my understanding is that the rate has actually
gone up; is that correct, in terms of cigarettes?
Mr. Carmona. It depends on the age group, and I would have
to look at that data, but the aggregate, if it has, it is very
slightly in aggregate. But, again, breaking down the
populations, minority populations' age and demographics you
will have peaks and leveling off periods that are different
than the aggregate data when you just lump all women together,
for instance nationally.
Ms. Solis. The information I have is that women account now
for about 39 percent of all smoke related deaths in the U.S.
Mr. Carmona. That is correct.
Ms. Solis. I guess one of the questions I would have is if
we are trying to get women to stop smoking and using an
alternative measure here, in this case smokeless tobacco, I
cannot think of too many women who would want to chew tobacco,
you know, and I would love to hear more about that. Because I
think that is a real issue that we are really skirting the
issue here, and how do you deal with that?
Mr. Carmona. Well, I think that is, you know, a social and
cultural part of our society where young men embrace that and
most women reject it.
Ms. Solis. Well, wouldn't that have an impact on modifying
maybe their behavior?
Mr. Carmona. Oh, yes, ma'am. Absolutely, yes.
Ms. Solis. So I am still very skeptical about the direction
of where we are going with all of this because I know that in
our community, and especially in California, the State of
California is pretty progressive in terms of prevention,
tobacco smoking and all of that, and restricting where you can
use cigarettes.
In fact, we have an initiative that was passed, Prop. 10,
that you are probably aware of that is a dedicated source of
funding strictly for prevention.
So my question goes to while we are spending a lot of money
to try to treat the illness, cancer, respiratory, emphysema, at
the same time we are raising revenue to try to tell youth to
give them the message and young people not to smoke.
Mr. Carmona. Yes.
Ms. Solis. And then we are saying, on the other hand, well,
it is okay to chew tobacco when, in fact, studies, I guess, are
not clear on how severe that might be.
My question is, you know: where are we going with this in
terms of giving accurate information that smokeless tobacco may
be harmful, could be maybe in different degrees obviously.
Maybe you do not get cancer in 10 years. Maybe you suffer from
tooth decay a lot faster, which we see in our community, by the
way.
And I would ask, you know, what your opinion is on that.
Mr. Carmona. Congresswoman, my opinion is that, as I have
stated, irrespective of the debate here today, I see no
scientific evidence to support the use of smokeless products
for any reason, and they are hazardous to your health, from
causing cancer to causing oral disease, including gingivitis,
tooth decay, as well as a host of other diseases.
So without further evidence to refute that, I could not
support its use in any fashion.
Mr. Stearns. The gentlelady's time has expired.
Ms. Solis. Thank you. Thank you very much.
Mr. Stearns. Mr. Fletcher.
Mr. Fletcher. Thank you, Mr. Chairman, and thank you for
conducting this hearing.
Let me say first having spent most of my adult life up
until the political side of things encouraging people to stop
smoking and using tobacco products, I think it is interesting
that we come to today where we are talking about relative risk
of different products.
There is no question as we look at the IOM report, 180,000
deaths from the cardiovascular disease, 150,000 from cancer,
about 85,000 from respiratory disease related to tobacco use,
and so there is no question that if we had a perfect world,
that no one would smoke or use products that are harmful to
their health.
But, in fact, that is not the case. We do have a free
society, and I think in a free society it is very important to
remember that a couple of things are important.
One, I think it is extremely important to be intellectually
honest with the population so that they can make choices. Some
people choose to smoke even though they know the risk is there.
I think 75 percent of the people that are smoking would like to
quit. That means there is 25 percent that do not even want to
quit.
So outside of prohibition, which even though some may
support that, I think we probably have it nigh to impossible to
control and regulate. We went through prohibition in the early
part of the last century with some abysmal results.
But given that, let me look, and I want to present a couple
of things. I have looked over these reports, and I know the
Surgeon General has commented on that. One was the Royal
College of Physicians of London, and these are, you know,
pretty reputable folks. In fact, they have been around a lot
longer that probably most of our even Harvard and some of our
early medical institutions. I mean these are folks that spend
their life doing research.
And they come up and say a way of using nicotine, the
consumption of noncombustible tobacco is on the order of 10 to
1,000 times less hazardous than smoking, depending on the
product. Some manufacturers want to market smokeless tobacco's
harm reduction option for nicotine users, and they may find
support for that in the public health community.
But the bottom line is it is a pretty big spectrum. So the
science is pretty unclear. It is 10 to 1,000 times. Even 10 is
pretty significant if that is the low balling side.
Now, I do not support and have certainly found it
intolerable that companies in the past have made marketing
attempts toward younger individuals and maybe not always been
truthful in what they said they would market and things. And so
I think it is clear that we have some sort of guidelines for
advertising, for marketing a product.
But I also look at given the fact that Royal College is 10
to 1,000 times less, there is also the European. These are some
pretty reputable people, too, that have spent a lifetime just
in research. They said oral tobacco may play a role in harmful
reduction. It is not necessary to show that it does not cause
cancer. It just needs to be substantially less hazardous than
smoking, even allowing for the cautious assumption about health
impact.
So that is what you were talking about, the European, I
guess. The smokeless tobacco and other oral tobaccos are a very
substantially less dangerous way to use tobacco than
cigarettes, and it goes on to talk about a number of different
other things, but it does at least acknowledge, and this is a
study of some physician researchers that smokeless tobacco has
reduced health.
Now, the Scandinavian study--and I know the Surgeon General
mentioned that some of the factors were not controlled--there
was one of those studies where they were controlled fairly
well. Let me read those to you.
This was a Lagergin study. It was a case controlled study,
patients with adenocarcinoma of the esophagus, gastric, cardio,
and esophageal squamous cell carcinoma. It said many potential
confounders were considered, including age, sex, education,
cigarette smoking, alcohol consumption, dietary intakes. It did
not mention coffee specifically. Dietary intakes of fruit and
vegetables and energy intake, BMI, reflux symptoms, physical
activities.
It talked about the substantial reduction. I agree that the
science is not totally--I mean there are a lot of studies that
can be done, and the science is not totally complete in this
area. But one of the questions I have got for both of you is if
we could have certainly an initiative for regulating tobacco
products, whether it be FDA or whether it be FTC on the
marketing of it, and it was marketed in such a way that it was
very clear to not use the word ``safe'' or ``safer,'' but say
you had a relative scale from 1 to 10, and say you could say,
well, given the current knowledge that we have, you know,
filterless cigarettes, maybe a 10; smokeless, somewhere less
there.
And, by the way, I come from a district that produces
burley, which is for cigarettes, not for smokeless tobacco.
Given the fact that we live in a free society and it is
important to get information out, and given the fact that I
know some people feel that this gateway issue may promote more
people, but wouldn't it be incumbent upon us to provide that
information to them, that there is a relative risk?
And I say that because I have got a brother that I tried to
get to stop smoking. He was smoking. We got him to stop. He
started dipping snuff. Finally when we could not get him to
stop altogether, we just kind of quit, and, yes, he went back
to smoking. But I never told him about reduced risk.
And I just wonder that given the fact that even second hand
smoke causes some injuries of what we might do if we give the
public intellectually honest information about the relative
risk, and I would just like both of you to comment on that.
Mr. Carmona. Well, if I might, I will just comment on the
science first, and then I will pass off to my colleague on the
advertising.
I certainly respect your opinions as a colleague, as a
fellow physician, sir, but the Swedish study, I know that they
looked at an endpoint of oral cancer risk and not
cardiovascular disease or other causes of mortality in a more
broad sense. So it is only one endpoint.
So I think variables also in outcome, as well as the inputs
for the research I think are equally important.
Mr. Fletcher. May I interrupt you just to ask you a
question?
Mr. Carmona. Yes, sir.
Mr. Fletcher. Do you believe that smoking has the same
cardiovascular risk as smokeless tobacco, say, the Swedish
smokeless?
Mr. Carmona. I would have to review the data more
specifically, but I know there is risk. If it is the same or
lesser, then we get into that issue again of is it safer.
Mr. Fletcher. Yes, relative risk. That is what studies are
about. There is no absolute there.
Mr. Carmona. Yes, and so the other issue is when we are
talking about the amount of nicotine, for instance, and you do
not also talk about carcinogenicity, then you just negate the
fact that we know that these are cancer causing compounds, and
so if you just address the issue of, well, is this a safe way
of using this to withdraw somebody from their nicotine
addiction.
Well, again, my premise is that if I know that this is a
carcinogen, then I really could not in good faith recommend it
for any other use when I know no matter what else you are using
it for----
Mr. Fletcher. I agree. We do not recommend it for use,
period, but I am talking about a relative scale, just getting
information out to the public. It is kind of like on HPV and
cervical cancer. You know that. We talk about the use of
condoms does not totally prevent HPV and cervical cancer, but
it reduces the risk, and there are a lot of folks on different
sides of the aisle that have a different approach to that.
Mr. Carmona. Yes, I understand, and I can understand where
you are coming from and some of the research is looking at this
a little bit different as a matter of policy. But, again, it
comes back to the cancer causing effects or carcinogenicity of
this for me, that when you say on a relative risk and you say,
``Okay. Well, smoking let us say is a ten and maybe this
product is a five, but it still causes cancer.''
So if you say the relative risk is lower, all right, I
cannot argue with you if we show that statistically, but it is
still a cancer causing agent, which is why I am concerned.
Mr. Fletcher. I agree.
Mr. Chairman.
Mr. Stearns. The gentleman's time has expired.
The gentlelady, Ms. Cubin.
Ms. Cubin. Thank you, Mr. Chairman, and thank you for
calling this hearing today.
I was one of those members that did request because I
believe that knowledge is power, and I want to point out that
we are not here today talking about the ills of smoking. We all
know that. We all believe it, and we accept it.
We are also not talking about marketing tobacco products to
children. If I had three wishes and I found the bottle on the
shore and the genie popped out, I would probably wish for
enough money to take care of myself and my family and meet our
needs until we die. I would probably ask for good health for
myself and my family. And the third thing would be that I would
wish for all children to make decisions that were beneficial to
their bodies as far as health is concerned.
So, you know, I am a mother, and I actually have a son that
chews smokeless tobacco, and I hate it. When I was a little
girl, my grandfather chewed smokeless tobacco. I am from
Wyoming, and probably we have as many people that use smokeless
tobacco as anyone.
But what I am thinking about are the 10 million adults that
are going to die in the next 10 years or the next two decades I
should say, that are going to die from actions related to
smoking, conditions related to smoking.
I have a degree in chemistry, and whenever we would be
arguing an issue in science, the first thing we would always do
is challenge the studies that were cited by--I was also in
debate--the studies that were challenged by the other side.
And so, Dr. Carmona, you do not accept as valid because it
is not comprehensive enough the study by Britain's Royal
Academy of Medicine; is that correct? Was that the reason you
gave during your questioning and statement?
Mr. Carmona. Yes. Not that it was invalid, but that to make
a decision you need much more information, and my colleagues
also who study this----
Ms. Cubin. Yes. Okay. Well, then does it follow that the
same level of comprehensiveness must be followed to support the
statement you made that smokeless tobacco is a gateway to
smoking? Is there a study that you can cite that has more
comprehensive basis than the Royal Academy's?
And if so, would you please furnish that?
I would like a comparison actually of the studies
themselves and why the study that you are quoting as far as the
gateway to smoking is concerned is superior to the basis of
this study by the Royal Academy. Would you provide that to us?
Mr. Carmona. Yes, ma'am.
Ms. Cubin. Thank you.
Mr. Carmona. I did not mean to imply that it was superior,
but I would be happy to provide the information to you.
Ms. Cubin. Sure. You did not say it was superior, but you
base your opinion on something, and I am just curious to know
how you substantiate that in your own mind, and I would
appreciate it if you would provide that to us.
Another point that I wanted to bring up is that science is
changing. Mr. Muris brought that up earlier in response to a
question that science is changing. In the 1986 Comprehensive
Smokeless Tobacco Health Education Act, Congress ordered that
three messages be alternated on snus cans. You notice I call it
snus because that is what my grandpa always called it. That is
politically correct to me.
Anyway, one of those statements is this product is not a
safe alternative to cigarettes. Well, since your agency did not
come up with that language that it is not a safe alternative to
cigarettes, Mr. Muris, I wonder if you have a responsibility.
I mean, obviously the Congress did that, but trying to
decide who has a responsibility to get this information
forward, I mean, it is your agency's responsibility that the
correct information be out there. This language was done in
1986. Isn't there information that would cause you to at least
look at that and make a recommendation to the Congress if they
are the ones to do the language, which I do not think, frankly,
that Congress should be doing that? I think it should be done
in your agency.
Mr. Muris. Well, the history of this issue is many, many
years ago, in the mid-1960's, my agency tried to do something,
and Congress immediately stepped in, and my agency has had the
wisdom since the to----
Ms. Cubin. To stay out?
Mr. Muris. Well, we have issued reports and we have done
other things, but we have not tried to by rulemaking do
something that Congress has made it pretty clear that it wants
to do.
Look. In the bigger----
Ms. Cubin. But that is really not my point. My point really
is if this statement is factually wrong, I mean, if we cannot
make the statement that non-tobacco products--well, let me see.
Where did I write this down? I wish I could keep track.
Go ahead and answer what you were going to say.
Mr. Muris. Well, in the very large context, and I do not
want to lose sight of that here in the specifics, this hearing
is very important because potentially--and that is obviously
the key word--there are very large public health benefits to be
made from addressing the problem of people who cannot or will
not quit smoking.
And that is why I said a place to start where I think we
can do more, and again, it is potential, and the FDA already
regulates this, and that is why I said I would obviously need
to talk to them, is with the non-tobacco risk reduction
products, the gums and the patches.
They right now can only be marketed for a very limited
purpose. So consumers cannot be told about their potential for
that group of smokers who are unwilling to go off of nicotine
entirely.
Ms. Cubin. So what I have drawn from this hearing today so
far is that if more people were using snus instead of smoking
cigarettes, that our national health care bill would be lower;
that there would not be people suffering from second hand smoke
from other smokers; that improvement would be seen in our
national health picture.
And I just think it seems to me, General, or I mean
Admiral--excuse me.
Mr. Carmona. No problem.
Ms. Cubin. But it is something that we should consider. I
do not think anyone is saying that the use of snus is a healthy
thing to do, but I certainly do not think that we can say that
it is not a healthier thing to do than smoke cigarettes.
So my time is up, and if you would like to respond to that,
that would be great.
Mr. Carmona. I think my remarks, ma'am, have been directed
to the science that we have at hand today, that there is no
evidence at this point to use that as a substitute. What we do
know about the product is that it can cause cancer and other
diseases.
I also stated earlier though if there is research to the
contrary, if there is research that can define some role, my
colleagues and I are always happy to look at that to see if
there is a possibility, but as of this date we have seen none.
Mr. Stearns. The gentlelady's time has expired. The
gentleman from Idaho, Mr. Otter.
Mr. Otter. Thank you, Mr. Chairman.
And I along with the rest of the panel want to thank you
very much for calling this most important hearing.
I have always been adverse to putting the fist of
government into the glove of courtesy. I know many times when I
was in my State legislature we passed no smoking in public
places even though it was not a government building or was not
a government called meeting, and I always voted against those
kind of bills because I felt that I had a personal
responsibility, if I did not want to be in part of that
environment, that I should go to the restaurant owner and say,
``I am not going to eat here any longer as long as you do not
have a no smoking section or as long as I cannot avoid second
hand smoke.''
But I want to make an admission like my colleague from
California, Mr. Issa, that I, too, am a recovering smoker. I
quit for my son's first birthday 34 years ago, and it is
probably one of the smarter things that I have ever done, but I
did it because I recognized that it is personal responsibility.
And it is unfortunate that so many of the things that we do
in Congress, and I have only been here a little over 2 years
and a few months, but so many of the things that we do here in
Congress is we try to substitute the national consciousness and
the national Treasury for personal choice, and of course, I
have to look right back on the immediate past of the tobacco
lawsuits that we had.
And even when I did smoke 35 years ago, I never bought a
pack of cigarettes that probably did not have that warning on
it. And I say ``probably'' because I doubt if I read it more
than once or twice, only as a novelty, I guess, when it first
appeared.
But I made that choice. I made that choice to smoke, and I
watched as the generation just before us, as many of the folks
in my generation watched as that generation just before us that
had smoked 10 years more than we had started suffering the
consequences of that behavioral choice.
Well, I think we have sent a far more dangerous message to
our youth about smoking or not smoking or choosing to use
tobacco in any form or not to use it when we have substituted
the national Treasury and the national consciousness through
Congress action, through the Judiciary Department's action of
bringing a lawsuit against the tobacco companies.
They were warned: do not smoke. Then we go back and sue
them anyway and say we are going to hold you responsible. That
is past history. I disagree with that.
I suspect when I was in the military, and you could have
called me General, Barbara, I was in the armored calvary, and
it was not unusual for us during training or during OJT or AIT
to stop the column and break and say, ``Smoke them if you have
got them.''
And sometimes they were supplied in our food packets.
Anyway, I suspect that got a lot of people smoking.
But anyway, what I would like to ask, I guess, both of you,
it has not been unusual for the government, as Congresswoman
Cubin made the point earlier, that knowledge is power, and one
of the responsibilities this republic, this government does
have to its citizens is to make them as knowledgeable as
possible and then stay out of their way and allow them to use
that knowledge for choices.
And it seems to me that if there is evidence and whether or
not you disagree with these early on reports, it has not been
unusual, Mr. Muris, for the FTC to allow cigarette makers to
say, ``This new filter that we have got on here allows for less
tars and less nicotine. This new cigarette is a little less of
this and a little less of that,'' and thereby enhancing the
possibility that it is probably not as dangerous as the one
without a filter or is the one referred to earlier, and I don't
want to pick on any particular company, but the Camel
cigarette.
And I know when I first stated smoking if you could smoke a
camel, you were tough. You know, you probably got off a little
easier with something with a filter on it, but my point is: why
isn't it your responsibility to make people more knowledgeable
and, therefore, more free to make the right decision by adding
up and subtracting the causes and the amount of danger there is
in different products?
We do it all the time, less salt, less sugar, less fat. We
hear it all the time. Why isn't that our responsibility
irrespective of your feeling and the Admiral's feeling about
all of them being bad?
And with that I will yield back.
Mr. Stearns. The gentleman's time has expired.
Would you like to answer the question, Mr. Chairman?
Mr. Muris. Sure, if you want.
Mr. Stearns. Sure, go ahead.
Mr. Muris. I do believe in the importance of knowledge, and
as I mentioned just a few minutes ago, in the potential of
public health benefits from risk reduction products. There are
obviously important attributes here. This is a product that
used as intended causes you great damage, and I think everybody
recognizes that.
And our experience with the tar reduction has not been a
particularly happy one because of the phenomenon called
compensation by which people smoke the cigarettes harder and,
therefore, get more damage than if they smoked them on some
relative level. So that just shows us that we need caution.
Mr. Carmona. I would just briefly comment that I agree with
your premise, sir, as far as the right of people to choose, and
in a perfect world, we would hope that armed with the
appropriate information that people would make the right
decisions, but often their individual decisions have impact on
a population at large, and sometimes I think where markets fail
or common sense fails regulation sometimes is essential.
We do it with speed laws because we know people drive too
fast, and we have been able to demonstrate that by slowing them
down there are less accidents.
We know that seatbelts save lives, and in many states
people felt it was their right not to wear one. Yet the impact
to the population and the cost of health care on the whole was
significant. So we had regulation for that and helmets and a
number of other things.
And I think, again, in a perfect world I would agree with
you that it would be nice that people would make prudent
decisions based on the information before them, which is part
of my job to bring that scientific information forward.
However, they do not always make the right decisions. And their
poor decisions can adversely impact the population as a whole.
Mr. Stearns. The gentleman's time has expired.
The gentleman from Ohio, Mr. Brown, is recognized for 5
minutes.
Mr. Brown. Thank you, Mr. Chairman.
I first would like to recognize Dr. Carmona, whom I shared
a podium with at the American Public Health Association meeting
in Philadelphia and was very impressed with his words then and
all that he shared with us.
Mr. Chairman, I would like to yield my time to Mr. Waxman,
who has alerted Americans to the dangers of all forms of
tobacco more than anyone in this body. So Mr. Waxman, if I
could.
Mr. Waxman. Thank you very much, Mr. Brown.
Thirty years ago the FTC was fooled by the tobacco
companies into allowing them to advertise low tar and light
cigarettes, and as a result millions of Americans switched to
those products because they thought it would protect their
health.
As a result of that, millions of American died because they
were not safer products. In fact, they were not even what they
claimed to be.
Now I think what we have before the FTC is another attempt
by an industry to commit a fraud on the American people, and
that is to try to present smokeless tobacco as a safer
alternative. Now, the first question is: is it a safer
alternative?
And, Dr. Carmona, you have been so clear on every question
that has been raised on that point, the safer alternative. Is
that a fair statement?
Mr. Carmona. Yes, sir.
Mr. Waxman. Now, let us say for argument purposes it was
safer, slightly, harmful but safer. Well, it is only safer if
people will use it instead of smoking, not if they use it in
addition to smoking.
Is there any evidence that anybody can show that people
will give up cigarette smoking because they have got a safer
alternative? I submit there is no evidence at all, none.
Now, another theory. If you advertise this product as a
safer alternative to cigarettes, kids might start using this
product. In fact, I think this is what this is all about. Kids
are not using this smokeless tobacco as much because they have
caught onto the fact that it does them a great deal of harm.
When it says cancer of the jaw, kids start picturing what
cancer of the jaw means, and more and more of them are giving
up smokeless tobacco.
But if they are told it is a safe alternative, they might
say, ``Well, I will try this safer alternative.''
But we do have evidence, don't we, Dr. Carmona, that people
who use smokeless tobacco are starting to get the nicotine
habit and then they can move on to cigarettes? Isn't that an
accurate statement?
Mr. Carmona. Yes, sir, there is scientific evidence to
support that.
Mr. Waxman. So the question that Mr. Muris said is is there
a potential public health benefit. Well, it is hard for me to
see that there is a potential public health benefit.
So the FTC allows this advertising. We will have to see 20
years down the road what harm we have done because the FTC
operates to allow advertising, unlike the FDA, which would
screen any kind of claim in advance.
I really am struck by the fact that it has been a long time
since the Congress has held any hearings about tobacco. Today
two committees are holding hearings on tobacco. We are not
looking at the Institute of Medicine recommendations, which
said that they had a strategy. This was an HHS advisory
committee, that they thought could lead to a cessation of
smoking and lead to 3 million lives being saved. Five million
people could quit within 1 year.
Instead, what the two committees of Congress are looking at
is what the industries want. Today we are looking at what U.S.
Tobacco would like. This afternoon we are going to look at what
U.S. Tobacco and Philip Morris would like.
That is what the Congress has come to. We respond to the
industry pressure to bring this issue up. Mr. Muris, this is a
hearing for you. This is a hearing to impress you that a lot of
Members of Congress would like you to be receptive to U.S.
Tobacco's attempt to rejuvenate their market.
Well, I would hope that we rely on science, and the science
is not there. The science is not there. The politics may be
because tobacco is rich and powerful, but the science is not
there, and I would hope that you look at the science very, very
carefully.
And I am awfully nervous when a bunch of lawyers are making
the decision on science when it ought to be up to something
like the FDA or the Surgeon General or the Institute of
Medicine to make the decision. I know you will consult with
them.
I do not know if you are aware, either of you, that Philip
Morris once surveyed 85 former users of smokeless tobacco and
found that 53 were now smoking, and I would like to introduce
for the record Philip Morris' report on how people who were
using smokeless tobacco didn't wean themselves off from
cigarette smoking, that they are either back to smoking or
moved on to smoking, and I would hope we can get that in the
record.
Mr. Stearns. Fine. By unanimous consent, so order.
[The report appears at the end of the hearing.]
Mr. Waxman. Mr. Chairman, I appreciate the opportunity you
have afforded me to participate in this hearing, and I just
hope that people do not get fooled a second time the way the
FTC was fooled 30 years ago and then we look back 20 years from
now and think about all of the people that got cancer of the
jaw and moved on to cigarettes and used cigarettes and
smokeless tobacco, and rather than the potential public health
benefit, we ended up with a potential public health disaster.
Mr. Stearns. The gentleman from Ohio's time has expired.
Mr. Shimkus is recognized.
Mr. Shimkus. Thank you, Mr. Chairman, and I am going to be
brief. We have already been here a long time, and I think we
are going in cyclical debates on this issue.
I will just say that we have a debate over words, and
basically it is an agreement that there is a risk to smokeless
tobacco, but the real question is: is there a lower risk than
smoking and whether that is second hand smoke or whether that
is all of these other things?
Have we considered--and I would think I would go to Dr.
Carmona first--have we as a country considered commissioning
our own study that would address many of the questions that
were broached today to insure that we have factual, scientific
evidence?
And if we have not so far, would we consider doing so? And
if not, why?
Mr. Carmona. Well, sir, there are many studies that have
been done in the literature. I mean literally hundreds of
studies on a broad range of issues regarding smoking cessation
and so on and including smokeless products, and there are
ongoing studies now both at CDC that are ongoing as we speak
and programs that are funded throughout the United States at
universities and other areas that NIH funds that are addressing
many of these questions.
Now, if there are specific questions that are not being
answered or that you felt that needed to be addressed,
certainly we would be willing to entertain that, and I would
pass it on to my colleagues who are doing the research.
But there is a broad range of research that has taken place
and continues to take place on these subjects.
Mr. Shimkus. So I guess the question for me is based upon
the current research that you have available to review, and
obviously you do not have the information from the ongoing
research, nothing that has been said with respect to the IOM
report--that still does not provide enough information to make
a determination whether there is any significant benefit for
someone going from tobacco used in cigarettes versus smokeless?
Mr. Carmona. Well, I think the IOM report was fairly clear
and said that there was no evidence and there are no products
on the market today to advocate for that type of substitution.
So the IOM report is fairly clear, I think, in its conclusion.
Mr. Shimkus. That is all I have, Mr. Chairman.
Mr. Stearns. I thank the gentleman.
I want to thank both of you for your patience, and we
appreciate your testimony.
Mr. Whitfield. Mr. Chairman, may I just ask unanimous
consent? I would like to submit one other question to Admiral
Carmona relating to the Center for Disease Control.
Mr. Stearns. Unanimous consent request is granted.
Mr. Whitfield. Thank you.
One minute? Oh, submit it for the record, oh, by unanimous
consent.
I would say in just conclusion that Mr. Waxman talked about
a study that suggests that smokeless tobacco is a gateway to
cigarettes, but I think also he should have been fair and
pointed out that there is also a study that refutes that
gateway theory stating that the gateway study that was made was
flawed.
And Mr. Waxman, of course, will be in the second hearing
this afternoon on the same subject.
So we welcome now the second panel. The second panel
consists of Dr. Robert Wallace, M.D., Institute of Medicine,
Vice Chair, Committee to Assess the Science Base for Tobacco
Harm Reduction.
Dr. Scott L. Tomar, editor, Journal of Public Health
Dentistry, University of Florida College of Dentistry, Division
of Public Health Services and Research.
Dr. Brad Rodu, professor, Department of Pathology,
University of Alabama at Birmingham.
Mr. Steven Burton, Vice President of Smoking Controls
Strategic Development and Switch, Glaxo SmithKline Consumer
Health care.
Mr. Richard H. Verheij, Executive Vice President, U.S.
Smokeless Tobacco Company.
Mr. Matthew L. Myers, President and CEO, National Center
for Tobacco Free Kids.
And Mr. David T. Sweanor, Counsel, Non-smokers Rights
Association.
I urge the members to stay for the second panel because if
we are talking about the science, then we have people who can
actually speak to that science, and so it would be very helpful
for members if they can to come back to continue our
discussion.
We have an order in my witness list that I will use if you
do not mind, and so I am going to ask Dr. Wallace to start off
with his opening statement. Five minutes, and if you want to
take less and make your opening statement part of the record,
obviously that would be appreciated. We have a large panel
here.
So we will start off with you, Dr. Wallace, and welcome and
thank you.
STATEMENTS OF ROBERT B. WALLACE, VICE CHAIRMAN, COMMITTEE TO
ASSESS THE SCIENCE BASE FOR TOBACCO HARM REDUCTION, INSTITUTE
OF MEDICINE; SCOTT L. TOMAR, EDITOR, JOURNAL OF PUBLIC HEALTH
DENTISTRY, UNIVERSITY OF FLORIDA COLLEGE OF DENTISTRY, DIVISION
OF PUBLIC HEALTH SERVICES AND RESEARCH; BRAD RODU, PROFESSOR,
DEPARTMENT OF PATHOLOGY, UNIVERSITY OF ALABAMA AT BIRMINGHAM;
STEVEN L. BURTON, VICE PRESIDENT, SMOKING CONTROLS STRATEGIC
DEVELOPMENT AND SWITCH, GLAXO SmithKLINE CONSUMER HEALTH CARE;
RICHARD H. VERHEIJ, EXECUTIVE VICE PRESIDENT, U.S. SMOKELESS
TOBACCO COMPANY; MATTHEW L. MYERS, PRESIDENT AND CEO, NATIONAL
CENTER FOR TOBACCO FREE KIDS; AND DAVID T. SWEANOR, COUNSEL,
NON-SMOKERS RIGHTS ASSOCIATION
Mr. Wallace. Thank you, Congressman.
I was the Vice Chair of the committee that put the Clearing
the Smoke report together, and just for the record, I am a
professor of epidemiology and internal medicine at the
University of Iowa.
I am going to paraphrase my remarks, and I would like them
to be entered into the record, along with the report itself.
Mr. Stearns. Your opening statement will be part of the
record. By unanimous consent, so ordered.
Mr. Wallace. Thank you.
Let me first say in part because I responded to the earlier
testimony this morning that we dealt with a range of harm
reduction products and tobacco and not particularly related to
smokeless tobacco. In fact, we did consider smokeless, but we
also considered other tobacco devices and delivery systems, and
we also considered nicotine replacement therapy as well.
We basically had four conclusions in our report, and one is
that we think that for many diseases attributable to tobacco
use reducing the risk by reducing exposure to tobacco toxicants
is, in fact, feasible.
However, while we think that manufacturers of these
products should have an incentive to make claims, this
incentive could only be done in the context of a comprehensive
national tobacco control program that has emphasized abstinence
oriented prevention and treatment and only if the harm
reduction assessment has been thoroughly scientifically vetted.
We also concluded that these potential reduced exposure
products have not yet been evaluated, as others have said, and
certainly not comprehensively enough to provide a scientific
basis for concluding that they are associated with reduced risk
compared to convention tobacco use.
We concluded that regulation of all tobacco products is
necessary in order to assure a scientific basis for judging the
effects of particular products versus others.
We concluded also that from a public health perspective,
and it has been said several times this morning that it is very
important to understand the public health impact of introducing
new products and making claims about products, and therefore,
the health and behavioral effects of all of these products must
be monitored on a continuing basis.
We suggested a regulatory framework. It is long and
detailed, and I would just highlight just four of the many
principles. They included disclosure of product ingredients,
toxicity testing, pre-market approval of claims, and issues
relating to labeling, advertising, and promotion, and also post
marketing surveillance so that, in fact, we can find out what
happens to Americans when these products are released both in
terms of their behaviors and with respect to these products and
in terms of their health.
Finally then I just have three public health messages that
I have culled from the report. One is that the committee
strongly felt that the best strategy, of course, is to never
use tobacco at all, and if you are using it, to quit and I
think that needs emphasis.
Second, with appropriate and comprehensive research,
surveillance, education, and regulation, we do feel that these
products could possibly, emphasize ``possibly,'' reduce the
some of the risk of tobacco related disease, but the net health
impact, again, is unknown, and although the products may be
risk reducing for an individual, they may, in fact, increase
the risk to populations.
And then finally, our third public health message is that
we pled for a comprehensive and verifiable surveillance system
being the crucial link to understand the relationship between
the availability of these products and reduced risk both to
individuals and reduced harm to the public health in general.
So I very much appreciate your willingness to hear me out,
and I would be happy to answer questions.
[The prepared statement of Robert Wallace follows:]
Prepared Statement of Robert B. Wallace, Vice-Chairman, Committee to
Assess the Science Base for Tobacco Harm Reduction, Institute of
Medicine/National Academy of Sciences
Good morning, Mr. Chairman and members of the Committee. My name is
Robert Wallace. I am Professor of Epidemiology and Internal Medicine at
the College of Public Health, University of Iowa. I served as Vice-
Chairman of the Committee to Assess the Science Base for Tobacco Harm
Reduction of the Institute of Medicine. The Institute of Medicine
operates under the 1863 charter by Congress to the National Academy of
Sciences to advise the government on matters of science, technology,
and health.
The work of the committee was conducted under a contract initiated
by the Food and Drug Administration. The committee began its work in
December 1999 and released its report, Clearing the Smoke: Assessing
the Science Base for Tobacco Harm Reduction, in February 2001. For the
purposes of this report and in keeping with general definitions,
tobacco harm reduction refers to decreasing the burden of death and
disease, without completely eliminating nicotine and tobacco use. The
committee was asked to provide a framework for the assessment of
tobacco and pharmaceutical products that might be used for tobacco harm
reduction. However, the committee did not review specific products.
I'd like to emphasize several of the committee's principal
objectives, conclusions and recommendations.
1. For many diseases attributable to tobacco use, reducing the risk
of disease by reducing exposure to tobacco toxicants is feasible.
Therefore, manufacturers should have the necessary incentive to develop
and market products that reduce exposure to tobacco toxicants and that
have a reasonable prospect of reducing the risk of tobacco-related
disease.
This incentive is the ability of manufacturers to make exposure-
reduction or risk-reduction claims. However, I must note that the
report is supportive of such claims only if made in the context of a
comprehensive national tobacco control program that emphasizes
abstinence-oriented prevention and treatment, and if under the harm
reduction assessment and regulatory framework outlined by the
committee, such as illustrated in my next three points.
2. These potential reduced-exposure products have not yet been
evaluated comprehensively enough to provide a scientific basis for
concluding that they are associated with a reduced risk of disease
compared to conventional tobacco use. Consumers therefore should be
fully and accurately informed of all the known, likely, and potential
consequences of using these products. The promotion, advertising, and
labeling of these products should be firmly regulated to prevent false
or misleading claims, explicit or implicit.
3. Regulation of all tobacco products is a necessary precondition
for assuring a scientific basis for judging the effects of using the
potential reduced-exposure products and for assuring that the health of
the public is protected.
4. Finally, and most importantly, the public health impact of these
products is all but unknown. They are potentially beneficial, but the
net impact on population health, or public health, could, in fact, be
negative. Therefore, the health and behavioral effects of using these
products must be monitored on a continuing basis. Basic, clinical, and
epidemiological research must be conducted to establish their potential
for harm reduction for individuals and populations.
The committee outlined several general principles for regulating
these products. These principles address, for example:
<bullet> disclosure of product ingredients,
<bullet> toxicity testing,
<bullet> premarket approval of claims, and issues related to labeling,
advertising, and promotion, and
<bullet> postmarketing surveillance.
I'd like to conclude my testimony by summarizing three key public
health messages about the potential for improving health in the face of
the availability of the potential reduced exposure products:
1. The committee unanimously and strongly held that the best
strategy to protect human health from the dangers of tobacco is to
quit--or not to start tobacco use in the first place.
2. With appropriate and comprehensive research, surveillance,
education, and regulation, these products could possibly reduce the
risk of tobacco-related disease. However, the net health impact is all
but unknown. Claims of reduced risk to the individual may well not
translate into reduced harm to the population. Although a product might
be risk-reducing for the individual using it compared to conventional
tobacco products, the availability of these products might increase
harm to the population. This could occur if:
<bullet> tobacco users who might otherwise have quit do not,
<bullet> former tobacco users resume use, or
<bullet> some people who would have not otherwise initiated tobacco use
do so because of perceptions that the risk with these ``new''
products is minimal and therefore acceptable.
3. A comprehensive and verifiable surveillance system is the
crucial link between the availability of reduced exposure products and
reduced risk to the individual and reduced harm to public health. It is
imperative that we understand what the American people are doing with
regard to these products and what is happening to their health.
I thank you for the opportunity to address you on this important
topic. A copy of my testimony and a copy of the report, Clearing the
Smoke, have been submitted for the record. I am happy to answer any
questions about the report.
Mr. Stearns. I thank Dr. Wallace.
Dr. Tomar.
STATEMENT OF SCOTT L. TOMAR
Mr. Tomar. Good morning. My name is Scott Tomar, and for
the record, I am an associate professor with the University of
Florida College of Dentistry.
I thank you for the opportunity to testify on the issue of
marketing smokeless tobacco as a potential harm reduction
strategy for cigarette smoking. I think this is an important
public health area, but it represents a tobacco industry
marketing strategy that is both highly flawed and potentially
dangerous, and I will outline these.
First, smokeless tobacco causes cancer and is addictive. It
is a mistake to promote it as safer, as a safer alternative to
smoking while safe sources of nicotine are available, such as
gum and path.
In the mid-1980's, the U.S. Surgeon General and the
International Agency for Research on Cancer concluded that
snuff use causes oral cancer, gum disease, and nicotine
addiction. Based on available evidence, UST's products are
still carcinogenic.
More recent research suggests that snuff use may increase
the risk of cardiovascular disease, including heart attack.
Smokers should be encouraged to use proven, safe sources of
nicotine to quite smoking and not snuff.
Second, U.S. Smokeless Tobacco Company has a long history
of marketing oral snuff to young males with no history of
tobacco use, including promotion of low nicotine starter
products. Allowing them to make safety claims may increase
nicotine addiction among youth.
Heavy promotion of oral snuff led to huge increases in use
by young males from the early 1970's until the mid-1990's.
Between 1970 and 1991, the prevalence of snuff use among men 18
to 24 years old increased more than 8-fold. This increase was
no accident, but was the result of a sophisticated marketing
campaign that developed, advertised, and promoted use of oral
snuff starter products with low levels of free nicotine as part
of a graduation strategy that encouraged new users to move up
to brands higher in nicotine as tolerance developed.
The high nicotine brands are highly addictive and high in
cancer causing nitrosamines.
Public health groups work aggressively to educate young
people on the dangers of oral snuff. In 2001, 14.8 percent of
male high school students reported current use of smokeless
tobacco, which is down from 20.4 percent in 1993.
That decline was accompanied by an increase in the
proportion of high school students who perceive that regular
use of smokeless tobacco carries great risk of harm. Allowing
UST to make claims that these products are relatively safe
could reverse this trend and result in an increase in use by
youth.
Third, UST has failed to protect consumers by failing to
inform, by not lowering known cancer causing agents in its
product or informing consumers about their toxic and addictive
properties.
Oral snuff contains dangerously high levels of cancer
causing agents called tobacco specific nitrosamines, to TSNAs.
USDA does not acknowledge or inform their consumers that
conventional oral snuff causes cancer or is addictive.
In addition, UST refuses to report brand specific product
content, nicotine dosing, or the levels of TSNAs. A recent
study conducted by the American Health Foundation found that
snuff brands manufactured by UST had TSNA levels that were 15
to 23 times higher than those found in a popular Swedish brand,
and that TSNA levels in UST's products, such as Copenhagen,
increased as much as 137 percent after the products were stored
at room temperature for 6 months.
In contrast, no significant changes were observed in the
TSNA levels of brands made by Swedish Match. That study
demonstrates that it is technologically feasible to produce
oral snuff products that are significantly lower in TSNAs than
those that are currently ont he market. UST has the
manufacturing technology to reduce the level of nitrosamines in
all of its brands, yet has not done so.
UST has refused to voluntarily reveal the amount of free
nicotine in its products. When I was an epidemiologist with the
Office on Smoking and Health, we asked the company to provide
this information to the American people. They flatly refused
and denied that they were able to manipulate the nicotine
dosing properties of its snuff products.
UST's contentions are strongly contradicted by peer
reviewed science and by sworn depositions of its own chemists.
When Massachusetts passed a law requiring brand specific
disclosure of additives that affect toxicity and addiction, UST
and the other tobacco companies sued the state.
Fourth, promotion of oral snuff as a safer alternative to
smoking may have unintended public health consequences. I
recently published two studies on this topic. The first looked
at smoking initiation among U.S. males age 12 to 17 and found
that young males who were not smokers at baseline but used
smoker's tobacco were three times more likely than young males
who never used smokeless tobacco to be smokers 4 years later.
In contrast, only 2.4 percent of current smokers and 1.5
percent of ``never smokers'' became smokeless tobacco users by
the 4-year follow-up.
The second study looked at adult male tobacco users and
found that U.S. men were 2.5 times more likely to be former
snuff users who now smoked than to be former smokers who
currently use snuff. One in 5 males who were daily snuff users
also smoked, as were 40 percent of occasional snuff users.
These studies suggest that smokeless tobacco may be a
gateway for adolescent smoking. Males in the United States are
far more likely to switch from snuff to cigarette smoking than
vice versa, and many men who use snuff are still smoking.
In UST's current advertising for Revel, the brand is
marketed as a complement to smoking, not as a complete
substitute or as way to quit smoking. The product is marketed
for use in settings when smoking is barred and, therefore,
undermines the impact of clean indoor air laws on smokers'
decision to quit.
UST uses similar marketing messages for its Skoal products.
These products can actually delay or prevent smoking cessation.
Fifth, there is no evidence that the oral snuff use is
effective in helping smokers to quit either in the United
States or in Sweden. Not a single randomized controlled trial
has been reported that shows----
Mr. Stearns. Dr. Tomar, your time has expired. You are over
by a minute. You are welcome if you can to finish up.
Mr. Tomar. I will save the rest for questions.
Just concluding that smokeless tobacco causes cancer; that
its promotion might actually increase cigarette use, and many
states in the United States have actually been able to reduce
both smoking and smokeless tobacco use without promoting one
substitute for the other.
[The prepared statement of Scott L. Tomar follows:]
Prepared Statement of Scott L. Tomar, Editor, Journal of Public Health
Dentistry
1. Smokeless tobacco causes cancer and is addictive. To promote it as a
``safer'' alternative to smoking while safe sources of nicotine
(patch and gum) are available is a mistake.
Oral snuff is a finely cut, processed tobacco that the user
typically places between the lip and gum. Nicotine is released from the
tobacco and absorbed by the membranes of the mouth. In 1986, the US
Surgeon General concluded that use of this product causes oral cancer,
gum disease, and nicotine addiction. More recent research suggests that
snuff use increased the risk of cardiovascular disease, including heart
attack. Swedish research shows that male snuff users have twice the
rate of cardiovascular death as non-users. Smokers should be encouraged
to use proven, safe sources of nicotine to quit smoking not be
encouraged to use snuff. There is no evidence that smokers who switch
to oral snuff use have a lower risk of disease or death; they are still
exposed to high levels of carcinogens.
2. USSTC has a long history of marketing oral snuff to young males with
no history of tobacco use including promotion of low nicotine
``starter'' products. Allowing them to make ``safety'' claims
may increase nicotine addiction among youth.
Use of oral snuff has risen dramatically among young men. From 1970
to 1991, the prevalence of snuff use among men aged 18 and older rose
from 1.5% to 3.3%; among men 18-24 years old, it increased more than
eightfold from 0.7% to 6.2%, making this age group the heaviest users
of the product among those surveyed.
In the 1980s, USSTC operated a college marketing program on over
200 campuses. The company continues to routinely sponsor fraternity and
college events today. In 1998, U.S. Smokeless Tobacco Company (USSTC)
signed the Smokeless Tobacco Master Settlement Agreement (STMSA)
settling lawsuits against USSTC and agreed not to directly or
indirectly target youth in their advertising and promotion. USSTC
continued to heavily advertise in youth magazines after signing the
STMSA and USSTC annual advertising expenditure rose from $5.4 million
pre-STMSA to $6.1 post. It was only after the Attorney General
threatened legal action did the company drop ads in youth magazines.
When Massachusetts banned smokeless tobacco advertising in 1999 near
schools and playgrounds, USSTC and other tobacco companies successfully
sued the state.
A 1989 National Collegiate Athletic Association (NCAA) survey of
college athletes found a 40% increase (from 20% to 28%) in smokeless
tobacco use from 1985 to 1989. Among NCAA baseball players, an alarming
57% were users. There is new evidence that suggests that these
increases are no accident, but the result of a sophisticated marketing
campaign that developed, advertised, and promoted use of oral snuff
starter products with lower levels of free (un-ionized) nicotine as
part of a graduation strategy that intended new users to move up to
brands higher in nicotine as tolerance developed. The high nicotine
brands are highly addictive and high in cancer-causing nitrosamines.
Public health groups aggressively worked to educate young people on
the dangers of oral snuff. In 2001, 14.8% of male high school students
reported current use of smokeless tobacco, down from 20.4% in 1993.
According to the University of Michigan, that decline was due to an
increase in their knowledge about the dangers of smokeless tobacco.
Allowing USSTC to make claims that these products are ``safer'' than
cigarettes could reverse this and result in an increase by youth.
3. USSTC has failed to protect consumers by failing to inform by not
lowering known cancer-causing agents in its products or
informing consumers about their toxic and addictive properties.
Oral snuff contains dangerously high levels of cancer casing agents
called tobacco specific nitrosamines (TSNAs). Unlike the major
cigarette companies, who now admit that their products cause cancer and
are addictive, USSTC doesn't acknowledge or inform their consumers that
conventional oral snuff causes cancer or is addictive. In addition,
USSTC refuses to report product content, nicotine dosing, or the levels
of TSNAs by brand. In 2000, the Massachusetts Department of Public
Health contracted with the American Health Foundation to determine how
new and existing technologies affect the levels of tobacco specific
nitrosamines in six brands of oral snuff. The Department obtained
brands of snuff sold in the state as well as one brand, Ettan, sold in
Sweden. The America Health Foundation research found that the Swedish
Match brand and its U.S. subsidiary brand had total TSNA levels between
2.8 ug/g (Ettan) and 7.5 ug/g (TimberWolf). These levels were far lower
than that found for the standard brands available in the state. UST,
Swisher and Conwood brands ranged from16.6 ug/g to 127.9 ug/g. The same
study examined the effect of product aging over two, four and six
months. Product aging involves placing the tobacco product on a shelf
at room temperature and retesting the TSNA levels at the specified time
periods. The study found that certain U.S. brands had large increases
in TSNA levels. Copenhagen increased 137% over the six-month time
period and Skoal increased 20%. Silver Creek increased 9% over a four
month time period. No significant changes were observed in the levels
of Swedish Match or its subsidiary brands.
The study shows that the levels in the brands manufactured under
new technologies were significantly lower than levels of TSNAs in those
brands that were produced under the standard manufacturing processes.
Also, brands that employed the new processes show no increase in TSNAs
when aged. The study demonstrates that it is technologically feasible
to produce oral snuff products for adults that are significantly lower
in TSNAs than many of those currently on the market.
USSTC has the manufacturing technology to reduce the level of
nitrosamines to the same level as those found in Swedish products in
all of their brands, yet they have not done so. According to the 2000
Surgeon General's Report, ``if a new technology exists that can
significantly reduce levels of known carcinogens in a tobacco product,
then that technology should be used.'' Before manufacturers make claims
that oral snuff is a ``safer'' alternative to cigarette smoking, TSNA
levels should be lowered to the maximum extent possible for all
products. Biomarkers should also be developed to determine if a
reduction in TSNAs actually reduces cancer risk and the research and
any claim of reduced harm approved by an independent health regulatory
agency.
USSTC has refused to disclose the levels of TSNAs in their brands,
warn consumers about possible TSNA formation and aging or voluntarily
reveal the amount of free nicotine (additive potential) in their
product to consumers. I met with USSTC attorneys and representatives
several years ago, when I was an epidemiologist with the Office on
Smoking and Health, and asked the company to provide to this
information to the American people; they not only refused to provide
it, they denied that they are able to manipulate the nicotine dosing
properties of their snuff products. It has been firmly documented in
the scientific literature that USSTC can, and does, control the
nicotine dosing properties of its products, and has used that ability
to promote addiction among young people. When Massachusetts passed a
law requiring the disclosure by brand of additives that effect toxicity
and addiction, USSTC and the other tobacco companies successfully sued
Massachusetts.
4. Promotion of oral snuff as a ``safer'' alternative to smoking may
have unintended public health consequences.
I recently published two studies on this topic. The first looked at
a smoking initiation among U.S. males aged 12-17 and found that young
males who were not smokers at baseline but smokeless tobacco users were
three times as likely to be smokers four years later (23.9% vs. 7.6%)
as young males who never used smokeless tobacco. In contrast only a
2.4% of current smokers and 1.5% of never smokers became smokeless
tobacco users by follow-up.
The second study looked at adult male tobacco users and found that
U.S. men were 2.5 times more likely to be former snuff users who now
smoked than to be former smokers who currently used snuff. One in five
males who were daily snuff users also smoked. This combined use of
tobacco products may undermine the impact that smoke-free policies have
on quitting smoking. This research suggests that smokeless tobacco may
be a gateway for adolescent smoking and males in the United States are
far more likely to switch from snuff to cigarette smoking than vice
versa.
In USSTC's current advertising for its low TSNA snuff brand, Revel,
the brand is marketed as a complement to smoking, not as a complete
substitute or as a way to quit smoking. There is no information
included in the ads or packaging on the dangers of smoking including
lung cancer, no advice on how to quit smoking or information about
smoking cessation programs. Rather the product is marketed for use in
settings when smoking is barred and in doing so result in undermining
the impact of clean indoor air laws on smokers' decision to quit. USSTC
use similar marketing messages for its SKOAL snuff products. These
products can actually delay or prevent smoking cessation.
5. There is no evidence that oral snuff use is effective in helping
smokers to quit, either in the United States or Sweden.
Not a single randomized controlled trial has been reported that
shows that oral snuff is effective in helping smokers to quit. Such
evidence is required before the manufacturers of any other drug can
make health claims about their products. In contrast, USSTC has
presented no credible evidence that their products are effective
smoking cessation devices, yet their proposed marketing strategy
clearly implies that smokers can switch to their snuff products.
USSTC's proposed marketing strategy amounts to a widespread,
unregulated experiment on human populations. Such an experiment may
have very serious negative side-effects, including promotion of tobacco
initiation by young people and reduced rates of smoking cessation among
adult smokers.
Even in Sweden, where claims have been made that oral snuff use is
responsible for its declining smoking rates, there is no evidence that
snuff played a major role. In fact, careful examination of the data
from Sweden reveals the following: (1) per capita consumption of
cigarettes remained constant in Sweden during the 1970s while snuff use
was rapidly increasing, suggesting that the growth in snuff use was not
the result of substitution of cigarettes for snuff; (2) nearly all of
the growth in oral snuff use in Sweden since the 1970s has been among
males who started using these products when they were 16-24 years old,
the group that also had the lowest smoking cessation rates in Sweden,
and not among adult smokers trying to quit; (3) the prevalence of daily
smoking has been declining among men and women in Sweden since 1980,
although less than 2% of Swedish women use snuff and the prevalence of
daily snuff use among men has remained relatively constant; (4) several
large studies that followed cohorts of Swedish adults over time found
that smokers who also used snuff were no more likely than smokers who
did not use snuff to quit smoking; (5) a very small proportion of
Swedish smokers who quit did so by switching to snuff; and (6) tobacco
control measures implemented in Sweden, including bans on all tobacco
advertising in periodicals and electronic media, prohibition of free
products and industry sampling practices, dissemination of health
information about smoking, increased taxation on cigarettes, and
widespread clean indoor air policies are probably responsible for most
of the decline in smoking in Sweden.
6. Major health bodies have carefully looked at this issue and
recommended that smokeless tobacco not be promoted as reduced
harm products until more research is done and the research and
claims are approved by a health, regulatory agency.
The Institute of Medicine (IOM) and the World Health Organization
have both reviewed this issue and have concluded that smokeless tobacco
should not be promoted as a ``safer'' alternative to smoking. IOM
concluded that more research is needed and according to IOM, research
and claims on ``reduced'' harm products, including smokeless tobacco,
should be reviewed and approved by an independent health regulatory
agency before they are marketed.
Sweden has lowered smoking rates but this is due to the Swedish
comprehensive tobacco control program and not the availability of
snuff. Massachusetts and California have reduced male smoking far below
that of Sweden (14% MA, CA daily smoking vs. 18% Sweden). This has been
done without promoting snuff as a safe substitute to smoking. In fact,
we have been able to reduce the use of cigarettes and snuff among young
people and adults in the United States in the past decade. Safe forms
of nicotine are available including nicotine gum and patches that have
been approved as effective smoking cessation medications by the Food
and Drug Administration. These should be promoted as ways to quit
smoking, not smokeless tobacco.
7. Research on the advertising for other ``reduced risk'' tobacco
products shows that advertising may be deceptive and
misleading.
The Massachusetts Tobacco Control Program (MTCP) has conducted two
studies on advertising claims for other ``safer'' tobacco products. The
first was R.J.R's Eclipse cigarette, which made a claim that there was
no cigarette like Eclipse based on a comparison of smoke carcinogens
between Eclipse and a ``typical'' ultralight cigarette, Merit Ultra
Light. RJR claimed that the level of carcinogens was 80% lower than
Merit. MTCP commissioned research comparing Eclipse to two other ultra
light cigarettes, Now and Carlton, and found that Eclipse actually had
higher levels of certain carcinogens. Eclipse had 734% more
acetaldehyde than Now and 475% more acreolein. Also, as RJR redesigned
this product from its 1988 predecessor, Premier, to present, levels of
NNK increased by 1200% from 2.4 ng/g to 32 ng/g and NNN increased 160%.
Based on this research, MTCP has concluded that the claim by RJR that
``There is No Cigarette Like Eclipse'' is deceptive since MTCP found
two existing brands, Now and Carlton, that had similar levels of smoke
carcinogens.
A second study MTCP commissioned was a Mall Intercept Survey of 600
smokers who reviewed ads for Omni and ADVANCE cigarette brands compared
to ads for regular and light cigarettes. The Institute of Medicine has
called these products PREPS, potential reduced exposure products. Study
results are based on a convenience sample of 600 smokers 18-65 years
old. Respondents were asked to examine selected advertisements for
Regular cigarettes, Light cigarettes, and the new tobacco products
(ADVANCE, Eclipse, and Omni) and answer questions regarding their
perceptions of the products advertised and the messages conveyed by the
specific advertisements.
In side-by-side comparisons, smokers indicated that they thought
PREP products posed fewer tobacco-related health risks, lower levels of
carcinogens, and lower tar levels. Specifically:
<bullet> Smokers perceived PREP tobacco products as having lower health
risks than Light or Regular cigarettes.
<bullet> Smokers perceived PREP tobacco products as having a lower
level of things that might cause cancer than Light or Regular
cigarettes.
<bullet> Smokers perceived PREP tobacco products as having a lower
level of tar than Regular cigarettes, and a similar level to
Lights.
<bullet> Perceptions of PREP tobacco product's health risks relative to
Light cigarettes were generally consistent across subgroups of
the study population.
<bullet> Men, people with lower educational attainment, and white non-
Hispanic individuals were more likely than others to perceive
that PREP tobacco products pose lower health risks than do
Regular cigarettes.
Prior to participating in this study, only a few smokers had seen
advertisements for or had smoked PREP tobacco products. For the vast
majority, the primary source of information for assessing PREP tobacco
products' properties, including their health and safety, were the
advertisements viewed during the study. Their opinions regarding the
advertisements included the following:
<bullet> Most smokers interpreted the PREP tobacco product
advertisements as conveying positive messages about health and
safety.
<bullet> Many smokers interpreted the PREP advertisements as saying
that these products would be helpful in quitting smoking.
<bullet> Most smokers believed that claims made in cigarette
advertisements must be approved by a government agency.
In conclusion, smokeless tobacco causes oral cancer, and if
promoted as a ``safer'' alternative to smoking may actually increase
cigarette use. Florida, Massachusetts, and California have reduced
smoking rates without promoting smokeless tobacco and safe forms of
nicotine such as gum and patch already exist. These should be promoted
as ways to quit smoking as part of comprehensive tobacco control
campaigns.
Mr. Stearns. Okay, and I thank you very much, especially
coming from the University of Florida, which I represent. So I
certainly welcome you and appreciate your participating.
Dr. Rodu.
STATEMENT OF BRAD RODU
Mr. Rodu. Mr. Chairman and members of the committee, I am
honored to appear here today.
Despite limited success, the 40 year old American anti-
smoking campaign is an astounding failure in one crucial
respect. It has helped too few adult smokers to quit.
National statistics reveal the magnitude of this failure:
404,000 deaths a year. The campaign fails inveterate smokers in
two ways. First, they are counseled merely to change their
behavior. For example, a government smoking cessation manual
tells doctors to recommend ineffective coping tips, such as
``keep your hands busy, doodle, knit, type a letter.''
``Keep a daydream ready to go.''
Second, smokers are told that they must achieve nicotine
abstinence in order to quit. They are advised to use nicotine
medications temporarily. These medicines are expensive and
unsatisfying.
As a result, they rarely work. A recent review reported a 7
percent success rate for over-the-counter nicotine medications.
The authors called this result ``modest'' and even
``efficacious.''
We call programs with 7 percent success rates abject
failures.
Over the past decade we have developed an alternative quit
smoking strategy for inveterate smokers based on permanent
nicotine maintenance. Nicotine is addictive, but can be
consumed as safely as caffeine. It is tobacco smoke that kills.
Eliminate the smoke, and you eliminate virtually all the risk.
We recommend that smokers permanently switch to other
products containing nicotine, including smokeless tobacco. Ours
is a harm reduction strategy because we are focused on reducing
disease and deaths instead of tobacco and nicotine abstinence.
We recommend smokeless tobacco because it has three
attributes for long-term maintenance. First, smokeless delivers
nicotine nearly as rapidly and as efficiently as smoking. Yes,
it is just as addictive as smoking, which is why it is an
effective substitute.
Second, smokeless is 98 percent safer than smoking. Our
research documents that the average smoker loses 8 years of
life. The average smokeless user loses only 15 days. The only
consequential risk from long-term smokeless tobacco use is
mouth cancer. Even this risk is very low, proven by more than
20 epidemiologic studies over the past 50 years. In fact, the
risk of death from long-term smokeless use is about the same as
that from automobile use.
Third, smokeless actually works for smokers. In 1998, we
published the first clinical trial testing smokeless as a
cigarette substitute. Most of our subjects had failed
repeatedly to quit using gum and patches. Twenty-five percent
of them quit with smokeless.
We have 7 years of follow-up now, and the substitution is
sustainable.
Population studies from Sweden prove that smokeless is an
effective substitute. For 50 years Swedish men have had the
lowest smoking rate and the highest smokeless usage rates in
Europe. The result, rates of lung cancer, the sentinel disease
of smoking, among Swedish men are the lowest of 20 European
countries.
Not so for Swedish women whose lung cancer rate ranks fifth
highest in Europe. I understand tobacco use patterns in Sweden.
I lived there for 6 months last year, conducting research on
this subject. I published two studies with Swedish colleagues
that clearly demonstrate that smokeless was primarily
responsible for a decline in smoking among men from 19 percent
in 1986 to 11 percent in 1999.
Throughout this entire period, men smoked less frequently
than women, a pattern different from that of every other
society in the world where men invariably have higher smoking
rates.
Our strategy has evoked criticisms that are inaccurate,
irrelevant, or both. The usual complaints involve protecting
children. We emphasize that our strategy is tailored to adult
smokers. This is not a children's issue. Eliminating children's
access to tobacco is important, but the 10 million Americans
who will die from smoking over the next two decades are now
adults. Withholding life saving information from these adults
in the name of protecting children is shortsighted, even
immoral.
For 10 years we have been portrayed as lone advocates of
our harm reduction strategy, but now good company has joined
us. Last year Britain's Royal College of Physicians reported
that products like smokeless are safer than cigarettes. Their
report stated, ``As a way of using nicotine, the consumption of
noncombustible tobacco is on the order of 10 to 1,000 times
less hazardous than smoking, depending on the product.'' The
report suggested that some smokeless manufacturers may want to
market their products ``as a harm reduction options for
nicotine users, and they may find support for that in the
public health community.''
A growing number of public health experts now agree with
our harm reduction strategy because the antiquated quit or die
approach is increasingly recognized as insufficient. For 48
million American adults cigarette smoke is the problem. To
answer the question posed by this hearing, smokeless tobacco
can be part of the solution.
[The prepared statement of Brad Rodu follows:]
Prepared Statement of Brad Rodu, Professor, Department of Pathology,
School of Medicine, University of Alabama at Birmingham and Philip
Cole, Professor Emeritus, Department of Epidemiology, School of Public
Health, University of Alabama at Birmingham
The Centers for Disease Control and Prevention report that 440,000
Americans die from smoking-related illnesses every year. However, even
this enormous number does not adequately describe the extraordinary
burden that cigarette smoking imposes on American society. Our research
provides additional perspective: If smoking-related lung cancer did not
occur, cancer mortality rates in the United States would have declined
continuously since 1950 (Figure 1).\1\ Thus, for the past 50 years the
American cancer ``epidemic'' has primarily consisted of one disease,
cancer of the lung, and has been due to one dominant lifestyle factor,
cigarette smoking. It is compelling evidence that the anti-smoking
campaign in the United States, now nearly 40 years old and of ever-
increasing intensity, has failed to help adult smokers to quit.
Conventional approaches to cessation have failed because they offer
smokers only behavioral therapy. An excellent example is a 1993 NCI
smoking cessation manual, How to Help Your Patients Stop Smoking, which
advises physicians to recommend coping tips such as ``Keep your hands
busy--doodle, knit, type a letter;'' ``Cut a drinking straw into
cigarette-sized pieces and inhale air;'' ``Keep a daydream ready to
go.'' \2\ Such advice has little effect on adult smokers because they
need nicotine. Conventional programs also fail because they offer adult
smokers only temporary nicotine replacement. But these products are
expensive and provide low doses of nicotine at doses too low to prevent
craving and withdrawal. A recent review of over-the-counter nicotine
medications revealed that their success rate is 7%.\3\ The authors
characterized this result as ``efficacious'' and ``modest.'' We
characterize programs with 7% ``success'' rates as abject failures.
All these programs are failures because they require smokers to
quit nicotine completely. This is incorrect, as well as ineffective.
Over the past decade we published epidemiologic and clinical studies
that provide the scientific foundation for a new smoking cessation
strategy. It involves permanent nicotine maintenance using products
other than
cigarettes.\4\<SUP>,</SUP>\5\<SUP>,</SUP>\6\<SUP>,</SUP>\7\<SUP>,</SUP>\
8\) Our strategy is based on the fact that nicotine, while addictive,
is about as safe as caffeine, another widely consumed addictive drug.
It is tobacco smoke, with its thousands of toxic agents, that leads to
cancer, heart disease and emphysema. Eliminate the smoke, and you
eliminate virtually all of the risk.
We recommend many types of nicotine delivery systems, including
smokeless tobacco (SLT) products. These products are well suited to
replace cigarettes because they have four key characteristics: 1) They
provide nicotine levels similar to those from smoking; 2) They are
vastly safer than smoking; 3) They are socially acceptable and are
cost-comparable to cigarettes; and 4) there is evidence that they help
smokers quit. No other products have this combination of features to
help smokers quit now.
Nicotine Delivery: SLT rapidly delivers a dose of nicotine
comparable to that from smoking (Figure 2). Thus, smokeless tobacco
satisfies smokers, a necessary criterium for any agent intended as a
permanent substitute. In comparison, nicotine medications provide only
about one-third to one-half the peak nicotine levels of tobacco
products, which is unsatisfying for many smokers.
Safety: SLT use has been the subject of intensive research for over
50 years. The only consequential adverse health effect from long-term
SLT use is oral cancer. However, more than twenty epidemiologic studies
over the past 50 years have established that this risk is very low.\9\
Our research documents that SLT use imposes only about 2% of the
mortality risk of smoking.\4\<SUP>,</SUP>\7\ We found that the average
reduction in life expectancy from SLT use is only 15 days.\5\ In
contrast, the average smoker loses almost 8 years. For further context,
the risk of death from long-term use of smokeless tobacco (12 deaths in
every 100,000 users per year) is about the same as that from automobile
use (15 deaths in every 100,000 users per year).\10\
Social Acceptability: Opponents of our strategy often argue that
smokers will never use disgusting ``spit'' tobacco. That term is
insensitive and inappropriate when used by health professionals. First,
it is demeaning and degrading both to current SLT users and to smokers
who may wish to try this strategy. Second, and more importantly, the
term is incorrect, because new SLT products can be used invisibly and
are more discreet than chewing gum.
Evidence that SLT products work: In 1998 we published the first
trial assessing SLT substitution as a quit-smoking method.\11\ After
one year 25% of inveterate smokers, most of whom had failed repeatedly
to quit even with prescription nicotine gum or patches, had
successfully substituted SLT for cigarettes. We have followed this
group for seven years, and our results suggest that SLT substitution is
sustainable (manuscript submitted).
Data from Sweden support the role of SLT in harm reduction at the
population level. For 50 years men in Sweden consistently have had the
lowest smoking rate and the highest SLT usage rate in Europe. The
result: Rates of lung cancer--the sentinel disease of smoking--among
Swedish men have been the lowest in Europe for 50 years. World Health
organization statistics reveal that Swedish men have the lowest rates
of lung cancer among 20 European countries (Figure 3). Not so for
Swedish women, whose lung cancer rate ranks fifth highest in Europe
(Figure 4). One of us (BR) is very familiar with tobacco use patterns
in Sweden. He lived there for six months last year conducting research
on this subject, resulting in two published studies with Swedish
colleagues that demonstrate that SLT was primarily responsible for a
decline in smoking among men from 19% in 1986 to 11% in 1999
\12\<SUP>,</SUP>\13\ (Figure 5). This figure reveals the lower rate of
smoking among men than among women for the entire period of study. We
emphasize that this is the reverse of the pattern seen in virtually
every other society in the world, where men invariably have higher
smoking rates than those of women.
Our strategy has evoked criticisms that are inaccurate, irrelevant
or both. The usual complaint is that providing risk information about
SLT to adults will prompt children to use these products. We
painstakingly point out that our strategy is tailored to adult smokers.
This is not a children's issue. Eliminating children's access to
tobacco is important, but the 10 million Americans who will die from
smoking over the next two decades are now adults. Withholding life-
saving information from these adults, in the name of children, is
shortsighted, even immoral.
An extension of the children's theme is that SLT could serve as a
gateway to smoking. This notion never had a sound basis, and current
research shows it to be wrong. Furthermore, and most unfortunately, for
twenty years the dominant public health message has been that SLT use
and smoking are equally risky. In fact, this erroneous message is
reinforced by the mandated warning on packages of SLT (``This product
is not a safe alternative to cigarettes''). Regrettably, surveys show
that 80% of smokers believe that smokeless tobacco is as dangerous as
smoking, and continue to smoke. This message may also cause some SLT
users to switch to cigarettes, an unfortunate and lethal behavior.
Finally, for ten years we have been portrayed as lone advocates of
a flawed public health strategy. But now good company has joined us.
Last year Britain's Royal College of Physicians, one of the world's
most prestigious medical societies, issued a report on tobacco
regulation in the United Kingdom called ``Protecting Smokers, Saving
Lives''.\14\ This report marked the first time a major health
organization acknowledged that products like smokeless tobacco are
safer than cigarettes. The report stated ``As a way of using nicotine,
the consumption of non-combustible [smokeless] tobacco is on the order
of 10-1,000 times less hazardous than smoking, depending on the
product.'' The report continued with an even bolder statement,
acknowledging that some smokeless tobacco manufacturers may want to
market their products ``as a `harm reduction' option for nicotine
users, and they may find support for that in the public health
community.''
A growing number of public health experts now agree with our harm
reduction strategy, because the antiquated quit-or-die strategy is
increasingly recognized as a failure. Cigarette smoke is the problem
for 48 million adult smokers. To answer the question posed by this
hearing, smokeless tobacco can be part of the solution.
References
\1\ Rodu B, Cole P. The fifty-year decline of cancer in America.
Journal of Clinical Oncology, Volume 19: pp 239-241, 2001. UAB-TRF
\2\ Glynn TJ, Manley MW. How to help your patients stop smoking: a
National Cancer Institute manual for physicians. NIH Publication No.
93-3064. Bethesda, MD; 1993.
\3\ Hughes JR, Shiffman S, Callas P, Zhang J. A meta-analysis of
the efficacy of over-the-counter nicotine replacement. Tobacco Control,
Volume 12, pp 21-27, 2003.
\4\ Rodu B. An alternative approach to smoking control. The
American Journal of the Medical Sciences, Volume 308, pp 32-34, 1994.
\5\ Rodu B, Cole P. Tobacco-related mortality. Nature, Volume 370,
p 184, 1994.
\6\ Rodu B, Cole P. The rewards of smoking cessation. Epidemiology,
Volume 7, pp 111-112, 1996.
\7\ Rodu B, Cole P. Nicotine maintenance for inveterate smokers.
Technology, Volume 6, pp 17-21, 1999.
\8\ Rodu B. For Smokers Only: How Smokeless Tobacco Can Save Your
Life. Sumner Books, Los Angeles, ISBN 0-9666239-0-8.
\9\ Rodu B, Cole P. Smokeless tobacco use and cancer of the upper
respiratory tract. Oral Surgery, Volume 93, pp 511-515, 2002. UAB-TRF.
\10\ National Highway Traffic Safety Administration. Traffic Safety
Facts 2001. Available at: http://www-nrd.nhtsa.dot.gov/pdf/nrd-30/NCSA/
TSFAnn/TSF2001.pdf
\11\ Tilashalski K, Rodu B, Cole P. A pilot study of smokeless
tobacco in smoking cessation. The American Journal of Medicine, Volume
104, pp 456-458, 1998.
\12\ Rodu B, Stegmayr B, Nasic S, Asplund K. Impact of smokeless
tobacco use on smoking in northern Sweden. Journal of Internal
Medicine, Volume 252, pp 398-404, 2002. UAB-TRF
\13\ Rodu B, Stegmayr B, Nasic S, Cole P, Asplund K. Evolving
patterns of tobacco use in northern Sweden. Journal of Internal
Medicine, Volume 253, pp 660-665, 2003. UAB-TRF
\14\ Royal College of Physicians. Protecting Smokers, Saving Lives.
Available at: http://www.rcplondon.ac.uk/pubs/books/protsmokers/
index.asp
\15\ Sullum J. For Your Own Good: The Anti-Smoking Crusade and the
Tyranny of Public Health, pp 67-70, The Free Press, New York, 1998.
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Mr. Stearns. Thank you Dr. Rodu.
At this time, Mr. Burton, would you give your statement,
please?
STATEMENT OF STEVEN L. BURTON
Mr. Burton. Thank you, Mr. Chairman.
My name is Steve Burton, and I am responsible for the over-
the-counter stop smoking aids that are marketed by Glaxo
SmithKline Consumer Health Care. I have been involved in this
field since 1996, and currently our products include the
Niccoderm nicotine patch, Nicorette gum, and more recently the
Commit lozenge.
GSK's chief concern is that unproven health claims for
tobacco products threaten efforts to help smokers quit. The
distinction between so-called reduced risk products and FDA
approved medicines could not be clearer to us.
The reduced risk products are designed to perpetuate
tobacco use and our products are designed to end tobacco use,
and the emergency of novel tobacco products must not obscure
the fact that there is only one proven way today to reduce the
harm of tobacco use, and that is to quit completely.
I have heard the term today about the committed smoker, and
I have to tell you that in my experience with consumers and the
research that we have done, we do not have very many committed
smokers. Over 70 percent of smokers want to quit at any one
point in time, and nearly all smokers have tried to quit. And
over the past decade we have made substantial progress in
reducing the prevalence of smoking.
Prevention efforts have stopped millions of our young
people from starting to use tobacco, and courageous and
motivated smokers who make multiple quit attempts on their way
to becoming tobacco free are also heros in the fight against
tobacco use.
Our plea today is to reject the policy that would
discourage smokers from quitting. We do not accept the
proposition that smokers do not want to quit and that more
cannot be done to increase the acceptance and effectiveness of
the quitting options.
As we have already heard today, and I am not going to
repeat comments from other members of the panel, there has been
no reduction in the death and disease burden from tobacco from
the use of light cigarettes, and the same may be true of the
so-called reduced risk products that are before this panel
today.
As we learned with lights, the way in which consumers
actually use a tobacco product in the real world largely
determines its risk, as much or more than the product's
inherent toxicity.
For example, it is very plausible that smokeless products
would be used in addition to existing cigarette consumption
rates that would delay quitting, leading not to a decline, but
an increase in risk.
In fact, dual use of cigarettes of cigarettes and smokeless
tobacco products has apparently been one of the marketing
objectives of the smokeless tobacco industry.
Our own market research of Eclipse, one of the so-called
reduced risk products, brings this point home. In a consumer
survey, GSK found that most a quarter, 24 percent of smokers
considered Eclipse to be completely safe, with 3/4 expecting
that Eclipse would reduce health risks by at least 50 percent.
After hearing about Eclipse, there was a net decrease of 19
percent in smokers who were contemplating quitting within 6
months and 15 percent of young adults who had recently quit
smoking were interested in buying Eclipse.
Thus, with the emergence of so-called reduced risk tobacco
products ex-smokers may start smoking again, and likewise those
who never smoked, particularly adolescents, may take up smoking
for the first time. And millions of smokes who otherwise might
have quit completely could delay or miss opportunities to
become tobacco free.
In light of these threats we need a regulatory body that
evaluates the public health impact of so-called reduced risk
products before they enter the market. That agency must have
the in-house scientific expertise to determine the appropriate
design and evaluation of the studies to be done before
approval. That regulatory body is the Food and Drug
Administration.
It should decide whether there is an adequate scientific
basis to support the so-called reduced risk claims that tobacco
manufacturers seek sot make.
As to the treatment of tobacco dependence, we have
certainly not exhausted our opportunities collectively to
innovate in this area. Addiction experts agree that the appeal
and effectiveness of currently marketed treatments could be
enhanced dramatically. FDA should encourage sponsors to develop
new indications and uses for current products and work flexibly
with sponsors to accelerate development of new and innovative
treatments.
Promising drugs should, for example, be fast tracked under
FDA's existing authority, and there are new treatments on the
way.
On the tobacco side, GSK welcomes tobacco based products
proven to meaningfully reduce the risks of smoking. Of course,
health claims, either express or implied, must be approved by
FDA before being exposed to the most vulnerable within our
society: those who have recently quit, or are highly motivated
to quit or are tempted to begin smoking.
At GSK we stand ready to assist the subcommittee today in
any way that we can. We thank you for the opportunity to appear
before you today, and I would certainly be happy to answer any
questions that you may have for me later.
Thank you.
[The prepared statement of Steven L. Burton follows:]
Prepared Statement of Steven L. Burton, Vice President, Smoking
Control, Strategic Development and Switch, GlaxoSmithKline Consumer
Healthcare
introduction
Thank you, Chairman Stearns. My name is Steve Burton and I am the
Vice President of Smoking Control, Strategic Development and Switch for
GlaxoSmithKline Consumer Healthcare (GSK). I have had responsibility
for marketing over-the-counter nicotine replacement therapy products
(Nicorette gum, NicoDerm CQ patch, and most recently the Commit
lozenge) since they were switched from prescription status in 1996. On
behalf of GSK, let me thank you and members of the Subcommittee for the
opportunity to participate in this important hearing and to share GSK's
views on the matter before Congress and the public health community at
large. GSK applauds the subcommittee for holding this hearing titled
``Can Tobacco Cure Smoking--A Review of Tobacco Harm Reduction.'' My
testimony will concentrate on what can be done to help smokers who are
concerned about their health and interested in reducing the risk of
smoking. In particular, I want to offer what we have learned through
our research with consumers to help illustrate what they expect novel
tobacco products to provide and how they might be used in a real world
setting. I will also comment on the adverse public health consequences
that could arise when smokers have the new choice to use novel tobacco
products instead of FDA approved medicines and other scientifically
proven methods of quitting. We believe that an understanding of
consumer beliefs and behavior can play a critical role in the design
and effective implementation of public health programs and that will be
our principal contribution today.
smoking as the leading cause of preventable death and tobacco control
policy progress to date
You are familiar with the staggering statistics associated with the
use of tobacco. 440,000 Americans die prematurely each year because of
tobacco use (CDC 2002a). More than 6 million of our children alive
today will die prematurely later in life because of their use of
tobacco (CDC 2002b). The use of this deadly and addictive product
constitutes the leading preventable cause of death and disease in the
United States each year. While we need to accelerate our progress in
reducing the harm of smoking, we should be proud of the fact that
millions of smokers have been able to quit completely, youth initiation
has been on the decline, and overall prevalence of smoking is slowly
trending downward. These significant public health gains are the result
of a combination of environmental factors and changes in public health
policy led by our elected officials, our regulatory community and the
public health field. Examples of these efforts include higher tobacco
taxes, restrictions on smoking in the workplace and public places,
greater availability of proven treatments, and successful state-based
and national youth prevention programs. These and other factors have
encouraged more smokers to make serious quit attempts and to be more
successful in achieving a smoke free status. GSK has played a small but
important part in the overall effort to help adult smokers become
tobacco free, and our primary mission remains to reduce the mortality
and morbidity associated with smoking by offering smokers proven
methods of quitting completely--the ultimate way to reduce risk.
new challenges to recent progress in helping smokers quit
It is well established that overcoming an addiction to tobacco is
one of the most daunting and enduring medical challenges an individual
can face. In fact, it usually takes multiple attempts for most smokers
to become abstinent, and each effort takes a high degree of motivation
and personal courage to overcome the psychological and physiological
effects of withdrawal from the highly addictive and often socially
rewarding use of a cigarette.
To overcome this powerful addiction, smokers need encouragement and
support to promote quit attempts and to convert these attempts into
positive health outcomes. This includes making effective use of
available treatments. Smokers receive this encouragement in a number of
ways--from their friends, their health care professional, and also from
their government and other public institutions. The decision to quit is
easily influenced by smokers' beliefs in their own ability to quit and
by their understanding of the alternatives they have to mitigate the
risks of smoking. Our research with smokers suggests that the
unregulated availability of so-called reduced risk products could lead
millions of smokers to delay or reconsider quitting. A perception that
novel tobacco products have the endorsement of our public institutions
would discourage smokers' commitment to quitting and introduce the
confounding and potentially very deceptive notion that smokers can now
reduce their risk or even ``quit'' by continuing to smoke with these
novel tobacco products, a so-called ``harm reduction'' approach. While
the health benefits of a harm reduction approach have yet to be proven
and remain largely theoretical, the risks of unregulated access to
novel tobacco products are clear and present dangers that could undo
years of progress by Congress, the FDA and the public health community
of which we are a part.
As you no doubt have heard, the great fear held by many public
health experts is that these new tobacco products may be nothing more
than a scientifically sophisticated version of the ``light'' cigarette.
The introduction of ``light'' and ``ultra light'' cigarettes is an
object lesson in how policy decisions can unwittingly mislead the
public and undermine cessation. Public health officials now believe,
many decades too late to be of any help to the health-concerned smoker
who switched to lights over the last thirty years, that lights appear
to have been deliberately designed so as not to reduce tar and nicotine
deliveries when smoked by human beings.
As the National Cancer Institute recently stated, in the definitive
study from the federal government on the deception linked with
``lights,'' ``Marketing this illusion of risk reduction would have been
of concern even if the target for these brands had been confined to
continuing smokers. Instead, these brands were targeted at those
smokers who were thinking of quitting in an effort to intercept the
smokers and keep them smoking cigarettes.'' (USDHHS, 2001, page 5)
Due in large part to the deliberate design of ``lights,'' there was
no reduction in the death and disease burden from tobacco as a result
of the marketing of ``light'' cigarettes. NCI concluded that ``The
absence of meaningful differences in smoke exposure when different
brands of cigarettes are smoked and the resultant absence of meaningful
differences in risk make the marketing of these cigarettes as lower-
delivery and lower-risk products deceptive for the smoker. The reality
that many smokers chose these products as an alternative to cessation--
a change that would produce real reductions in disease risks--makes
this deception an urgent public health issue.'' (USDHHS, 2001, page 1)
Thirty years ago, well-intentioned public health officials
encouraged health-concerned smokers who could not quit smoking to
switch to ``lights.'' At all costs, we must avoid repeating the
mistakes with today's products that were made thirty years ago with
``lights.''
consumer understanding of risk of and interest in novel tobacco
products
At the outset, one critical fact must be recognized. Complete
abstinence is the only method that reduces the future health risk of
smoking to almost zero, and allows for an ex-smoker to achieve a long-
term prognosis essentially equivalent to a never smoker after 10-15
years of abstinence (USDHHS, 1990). The emergence of novel tobacco
products does not change this fact. Novel tobacco products have not
been studied with the same rigor of smoking cessation medicines and
methods. Nor have the studies that have been conducted on these
products been submitted to FDA for evaluation. There is only one proven
way to reduce the harm from tobacco, and that is to quit.
On the other hand, consumers are all too willing to grasp at the
belief that novel tobacco products are indeed safe and effective
alternatives to smoking their current cigarettes. As an example, we
fielded a large consumer survey that exposed the Eclipse concept (a
novel cigarette design that is claimed to primarily heat rather than
burn tobacco) to 1000 smokers and 499 ex-smokers. In the survey, after
hearing a brief account of claims for Eclipse, almost all current
smokers (91.4%) thought Eclipse was safer than Regular cigarettes.
Moreover, almost a quarter (23.9%) considered Eclipse to be completely
safe. On average, participants expected that Eclipse would reduce
smoking risk by 62.1% compared to Regular cigarettes, with three
quarters (75.9%) expecting that Eclipse would reduce health risks by at
least 50%. Eclipse was also regarded as significantly safer than
current Light or Ultra Light cigarettes. Compared to the 23.9% who
regarded Eclipse as completely safe, only 9.4% and 11.3% regarded
Lights and Ultra Lights, respectively, as completely safe. The fact
that consumers perceive novel tobacco products to carry less health
risk than smoking even light or ultra light cigarettes should be
troubling to those who are concerned with the death and disease caused
by tobacco products.
We know that approximately 70% of smokers are interested in
quitting (CDC, 2002c). GSK's mission is to reduce death and disease by
inspiring more smokers to become tobacco, and ultimately, nicotine
free. The scientific data behind our treatments, such as Nicorette gum,
NicoDerm CQ patch, the Commit lozenge, and the prescription smoking
cessation drug Zyban, has been evaluated and approved by the Food and
Drug Administration. These products have been approved as being both
safe and effective for use in trying to quit. With the help of our
products and those of other treatment providers, millions of smokers in
this country have successfully stopped smoking and eliminated all of
the risk of continued tobacco use.
unintended consequences of novel tobacco products--consumer perspective
From a public health perspective, we should be concerned about the
new crop of tobacco products bearing unproven claims to reduce exposure
and risk. The greatest danger is that these products may pose a
significant threat to cessation efforts--regardless of whether a smoker
would have used one of our products in a quit attempt or chosen another
quit method. Smokers who see the claims for products like Eclipse may
now think that a safer cigarette genuinely exists. This may make them
less interested or inclined to try to quit smoking entirely.
There is the added concern that ex-smokers may start smoking again,
thinking that they can now safely consume tobacco products. Likewise,
those who never smoked, particularly adolescents, may take up smoking
for the first time, using one of these new products under the
assumption that a safe cigarette exists.
The consumer survey data commissioned by GSK on smoker and ex-
smoker attitudes towards Eclipse, one of the new generations of tobacco
products sold by R. J. Reynolds, confirms these concerns (Shiffman,
Pillitteri, Burton, et al, unpublished manuscript). Reynolds makes
explicit health claims about reductions in disease risks for Eclipse,
including ``less risk of cancer,'' and ``a lower risk of chronic
bronchitis, possibly even emphysema'' (www.eclipse.rjrt.com, December
2002).
The survey found that 57.4% of smokers said they were ``somewhat
likely'' or ``very likely'' to purchase Eclipse within the next six
months. Most importantly, after hearing about Eclipse, there was a net
decrease of 19% in smokers who were contemplating quitting within 6
months. Furthermore, 15% of the young adults who had recently quit
smoking were interested in buying Eclipse.
In a second study focusing on a novel smokeless tobacco product
among smokers interested in quitting, similarly high levels of purchase
interest were reported. Around 41% of the sample were very or somewhat
likely to want to use the novel smokeless product. Purchase intent
(46%) was higher in consumers with an interest in using nicotine
replacement therapy to quit, a surrogate for smokers more likely to
actually commit to a serious quit attempt. When asked how they would
use these smokeless products, 15% of the sample reported they would use
the smokeless tobacco product as a substitute for cigarettes at times
when they could not smoke, 29% as a way to reduce their smoking rate,
and another 36% as a way to cut back on their smoking in preparation
for quitting.
These results suggest that Eclipse, and its new brethren of
tobacco-based products that have not been proven to reduce the risk of
smoking in any meaningful way, are a threat to cessation and risk
converting ex-smokers back to their deadly addiction.
Do these products genuinely reduce exposure and risk? We do not
know because exposure and risk are determined by the overall pattern
and years of use by smokers in real world conditions, not just by
physical makeup of the product. Nor do we know how these products
perform in the laboratory. But here are a few observations that should
be of profound concern to the public health community of which you are
a part. Eclipse advertising declares that exposure to carbon monoxide
may be higher than traditional cigarettes. Eclipse has been shown to
contain filaments of glass particles not found in traditional
cigarettes that would be inhaled deeply into the lungs (IOM 2001). The
new Quest cigarette offers a program claiming to reduce levels of
nicotine consumption while keeping the level of cancer-causing tar
unchanged--and the tar levels are higher than the majority of low tar
brands consumed today. Many experts would argue that, as was the case
with ``light'' cigarettes, smokers of Quest would consume a greater
number of the reduced nicotine cigarettes in order to avoid withdrawal
and maintain the reinforcing effects of their nicotine addiction. These
smokers could end up consuming more tar with the reduced nicotine
cigarette than their traditional brand of cigarette.
scientific perspective--the risk/benefit equation for novel tobacco
products
I expect the scientific community and tobacco control experts to
provide their view on the potential risks and benefits of expanded use
of novel tobacco products. They believe the tobacco industry's
motivation is to perpetuate the use of tobacco-based products by
introducing a new generation of tobacco products. By offering promises
of reduced exposure to toxins in tobacco smoke, and even making claims
to reduce the risk of cancer and other diseases, these products raise
profound and troubling public health policy questions for our partners
in the tobacco control community.
We should consider carefully the recent findings published in the
American Journal of Epidemiology, that reductions in cigarette use, as
measured by daily smoking rates, had no impact on health risks from
smoking among a large population of heavy smokers (Godtfredsen et al,
2002). Smokers who attempt to reduce the harm of smoking by cutting
down on the number of cigarettes they smoke compensate in the same way
that smokers of so-called light cigarettes compensated by smoking each
cigarette more deeply. Smokers who attempt to reduce their smoking
rates without the support of pharmacotherapy experienced the same
degree of harm as smokers who did not reduce their smoking rates.
The novel tobacco products take various forms. Some burn tobacco or
employ novel technologies to burn or heat tobacco. Others are tobacco-
based but do not burn. The combusting products include Omni and
Advance, and promise to reduce or eliminate exposure to a subset of
toxins in tobacco smoke. The novel products include Eclipse and Accord,
and claim to reduce toxin levels or secondhand smoke. The non-
combusting (i.e. smokeless) products include Ariva, Revel, and Exalt,
promise tobacco satisfaction in situations (e.g. at work or on a plane)
where smoking is not possible or permitted.
Whether they combust or not, all of these products are aimed
squarely at the health-concerned smoker. They have entered the
marketplace in the absence of any independent scientific evaluation of
their claims, and without any governmental scrutiny of the products or
their claims.
Equally troubling are the claims for the smokeless products, like
the Ariva tobacco lozenge. In isolation, one could argue that a
tobacco-based product that does not burn tobacco leaf has a lower risk
profile than one that does. But this could be a short-sighted view to
take given the historical behavior of the smokeless tobacco industry
operating outside of a credible regulated environment. Reviews of past
marketing practices report that this industry deliberately targeted
young males, particularly athletes, in the 1970s and revived lagging
sales by promoting use of smokeless among teenage boys who had not
previously used tobacco. Further, these same reports note that this
industry specifically designed and promoted products with varying
levels of nicotine delivery, perceived strength and a range of flavors
(including ``candy-like'' flavors) so as to facilitate early use by
adolescents and their progression to more addicting, higher nicotine
products (FDA Proposed and Final Rule, 1995 and 1996; Bonnie and Lynch,
1994).
Furthermore, the health benefits of products like Ariva presumably
result in part from the assumption that Ariva would be used to
completely replace all cigarette use and thus overall exposure to
toxins would decrease. It is equally plausible that smokeless tobacco
products would be used in addition to a smoker's typical level of
cigarette consumption, and this is precisely the type of real world
consumer behavior that must be assessed prior to market entry, not
years after this unfortunate consequence has been documented
retrospectively.
Smokers who might have otherwise been inclined to try to quit, may
latch on to a smokeless product bearing an ``Anytime. Anywhere.'' or a
``WHEN YOU CAN'T SMOKE'' claim, and use it to perpetuate their smoking
through the dual use of combusting and non-combusting tobacco. In fact,
the United States Smokeless Tobacco Company expressed the view in their
2000 annual report that the dual use of cigarettes and smokeless
tobacco ``represents great potential for future expansion of the
business'' (UST, Inc, Annual Report, 2000, page 9).
In the absence of public health-based regulation of these products,
and well controlled studies of actual patterns of consumer use
completed prior to market entry, we have no way of knowing whether this
new generation of products will reduce exposure and risk in any
meaningful way when used by smokers under normal or typical conditions
of use. Nor do we understand the impact on quitting behavior amongst
those smokers who otherwise would have achieved complete abstinence
when they are exposed to the unsubstantiated claims of these novel
tobacco products. Even more of a concern, we will not know what effect
this marketing will have on the possibility of young people initiating
tobacco use. The unfettered access to the marketplace for these
products has created a massive, uncontrolled clinical trial, with
commercialization and hefty promotion and advertising preceding a
scientifically credible demonstration that there is adequate proof to
support the marketing claims and expected public health outcomes of
these products.
regulatory approaches for novel tobacco products: recommendations
The most appropriate way to assess the potential risks and benefits
of these products is through a regulatory system that assures the
public of comprehensive regulation of all tobacco products; a system
where a public health-based regulatory agency evaluates products and
claims before they enter the marketplace. As this Subcommittee goes
forward with its consideration of the role of tobacco-based products in
a harm reduction framework, we need to ensure that an appropriate
degree of scientific and regulatory accountability is brought to bear
on any tobacco products that purport to reduce exposure or risk. One
way to achieve this accountability is by insisting that no product or
claim should appear in the marketplace until it has been evaluated by
an independent, public health-based regulatory authority. Such an
agency, and we believe it should be FDA, should decide whether there is
an adequate scientific basis to support whatever claims the
manufacturer seeks to make.
Whereas the tobacco-based products are carefully designed to
perpetuate tobacco use, or at least could have that real world effect,
in contrast GSK and other providers of treatment interventions offer
quitting programs rigorously studied and evaluated for their safety and
efficacy by FDA prior to appearing in the marketplace. We are proud of
the collaboration we entered into with Congress, the FDA and the public
health community in the mid-1990s to expand access and utilization of
nicotine replacement therapies by marketing them as over-the-counter
medications starting in 1996. , , , . We have been encouraged by the
evidence that offering treatments directly to consumers can
significantly increase utilization of these products to support quit
attempts.
Yet, we have not exhausted our opportunities to innovate in the
area of tobacco dependence treatment through the use of pharmaceuticals
and other public health interventions that expand utilization while
also improving outcomes, as recent success in the area of quit lines
have shown. We believe it should be the policy of our government to
encourage sponsors to develop new indications and uses for current
products, and to work with sponsors to accelerate development of a
range of novel treatment products. GSK has a number of new products
that offer the promise of more consumer acceptable formulations and
regimens and a range of experimental drugs are in development within
industry and academia. For instance, over-the-counter nicotine
replacement therapy products are limited to up to 12 weeks of use as
compared to six months or more under their former prescription status.
Addiction experts have argued that the appeal and effectiveness of
currently marketed treatments could be enhanced dramatically should we
consider new uses and indications such as combination therapy, use of
intensive behavioral interventions alongside pharmacotherapy, reduction
of cigarettes alongside a gradual increase in medicinal nicotine
administration, and use of NRT for relapse prevention and long term
maintenance of cessation. Promising drugs and interventions like these
should be fast tracked when judged by the FDA to qualify for such
status.
Finally, GSK welcomes scientifically validated and regulated claims
for tobacco-based products. It is not our position that novel tobacco
products cannot be marketed today under existing tobacco regulations or
that it is unconceivable that such products might make a public health
contribution. Our position is that any health claim, expressed or
implied, should be scientifically demonstrated and reviewed by FDA
before such claims are exposed to the most vulnerable within our
society--those who have recently quit, are highly motivated to quit, or
are tempted to begin smoking. For a marketplace flooded with unproven
and unregulated health claims for novel tobacco products will not only
undo years of progress in the tobacco control effort but also damage
our capacity to bring even more effective and consumer accepted
treatments to the millions of consumers who want and deserve meaningful
improvements in their health status.
Today half of ever smokers have become former smokers. Our
challenge and yours is to ensure that successful quitters are not lured
back to smoking and the vast majority of smokers who can and will
eventually quit completely are not discouraged from reducing the harm
of smoking to zero. As to the remainder of smokers who may not be able
to quit, and we would argue that we have many opportunities yet before
us to reduce this number further, we need to find interim and credible
solutions to reducing harm to their health. The current cadre of novel
tobacco products, if allowed to remain in the market absent scientific
evidence of a positive health impact within the population, should
nonetheless be prohibited from making implied or expressed claims of
health improvement until such time as adequate proof and public health
regulatory approval has been obtained.
At GSK, we stand ready to assist the Subcommittee in any way that
we can on these critically important and challenging questions of how
to reduce the extraordinary death and disease toll caused by the use of
tobacco products.
Thank you for the opportunity to appear before you today. I would
be happy to answer any questions that the subcommittee might have.
References
Centers for Disease Control and Prevention. (1997). Impact of
promotion of the Great American Smokeout and availability of over-the-
counter nicotine medications, 1996. Morbidity and Mortality Weekly
Report, 46, 868-871.
Centers of Disease Control and Prevention. (2000). Use of FDA-
approved pharmacologic treatments for tobacco dependence. Morbidity and
Mortality Weekly Report, 49, 665-668.
Centers for Disease Control and Prevention. (2002a). Annual
smoking-attributable mortality, years of potential life lost, and
economic costs--United States 1995-1999. Morbidity and Mortality Weekly
Report, 51, 300-3.
Centers for Disease Control and Prevention. (2002b). Tobacco
control state highlights 2002: Impact and opportunity. Atlanta, GA:
Department of Health and Human Services, Centers for Disease Control
and Prevention, National Center for Chronic Disease Prevention and
Health Promotion, Office on Smoking and Health.
Centers for Disease Control and Prevention. (2002c). Cigarette
smoking among adults--United States, 2000. Morbidity and Mortality
Weekly Reports, 49, 642-5.
Food and Drug Administration. (1995). 21 CFR Part 801, et al.
Regulations restricting the sale and distribution of cigarettes and
smokeless tobacco products to protect children and adolescents;
proposed rule analysis regarding FDA's jurisdiction over nicotine-
containing cigarettes and smokeless tobacco products; notice. Federal
Register, 60 (155), 41314-41792.
Food and Drug Administration. (1996). 21 CFR Part 801, et al.
Regulations restricting the sale and distribution of cigarettes and
smokeless tobacco to protect children and adolescents; final rule.
Federal Register, 61 (168), 44396-45318.
Godtfredsen NS, Holst C, Prescott E, Vestbo J, Osler M. (2002).
Smoking reduction, smoking cessation, and mortality: a 16-year follow-
up of 19,732 men and women from The Copenhagen Centre for Prospective
Population Studies. American Journal of Epidemiology, 156 (11), 994-
1001.
Institute of Medicine. (2001). Clearing the smoke: Assessing the
science base for tobacco harm reduction. Stratton K, Shetty P, Wallace
R, Bondurant S (eds). Institute of Medicine.
Keeler TE, Hu TW, Keith A, Manning R, Marciniak MD, Ong M, & Sung
HY. (2002). The benefits of switching smoking cessation drugs to over-
the-counter status. Health Economics, 11, 389-402.
Lynch BS, & Bonnie RJ. (Eds.). (1994). Growing up tobacco free:
preventing nicotine addiction in children and youths. Washington, DC:
National Academy Press.
Shiffman S, Gitchell J, Pinney J M, Burton SL, Kemper KE, & Lara
EA. (1997). Public health benefit of over-the-counter nicotine
medications. Tobacco Control, 6, 306-310.
U.S. Department of Health and Human Services. (2001). Risks
associated with smoking cigarettes with low machine-measured yields of
tar and nicotine. Monograph Number 13. U.S. Department of Health and
Human Services. Public Health Service. National Institutes of Health.
National Cancer Institute.
UST Annual Report, 2000.
U.S. Department of Health and Human Services. (1990) The health
benefits of smoking cessation: A report of the Surgeon General. U.S.
Department of Health and Human Services. Public Health Service. Centers
for Disease Control. Center for Chronic Disease Prevention and Health
Promotion. Office on Smoking and Health. DHHS Publication No. CDC) 90-
8416.
Mr. Stearns. Thank you, Mr. Burton.
And at this time, Mr. Verheij, if you would give your
opening statement.
STATEMENT OF RICHARD VERHEIJ
Mr. Verheij. Good afternoon, Mr. Chairman and members of
the committee. I am Richard Verheij, Executive Vice President,
External Affairs, for U.S. Smokeless Tobacco Company.
I would like to thank this committee for convening this
hearing to examine the issue of tobacco harm reduction. We see
this hearing as a significant step in the country's ongoing
efforts to address the issues raised by the continued use of
tobacco products by millions of Americans.
Indeed, 50 million Americans smoke. The Institute of
Medicine has predicted that a significant proportion of those
individuals will continue to do so despite a multitude of
approaches with the ultimate objective of total tobacco
cessation. This prediction has prompted the public health
community to consider new complementary strategies, including
tobacco harm reduction.
As we proceed today, it is helpful to keep a couple of
things in mind. First, this debate is not about whether
smokeless tobacco is considered to be safe. Rather, it is about
the increasing consensus in the public health community that
smokeless tobacco is significantly less harmful.
Second, this debate is not about whether smoking cessation
is the best public health strategy. Rather, it is about whether
there are complementary strategies which public health
advocates believe will save millions of lives.
We are here today because of the millions of adult smokers
who do not quit and do not use medicinal nicotine products.
Many in the public health community believe that a harm
reduction strategy based on communicating to adult smokers
truthful information about other options can have a significant
impact on both those individual adult smokers and public health
generally. Simply stated, many researchers have expressed the
opinion that use of smokeless tobacco is significantly less
harmful than cigarette smoking. Based on that judgment, these
same researchers advocate that adult smokers who do not quit
and do not use medicinal nicotine products switch completely to
smokeless tobacco.
There is increasing consensus on this crucial issue among
members of the public health community some of whom are
testifying before this committee today. However, despite this
increase in consensus, it is documented that the vast majority
of adult smokers are unaware of this information.
One researcher has stated that ``until smokers are given
enough information to allow them to choose products because of
lower health risks, then the status quo will remain.''
Our company, along with those public health advocates,
believes that it is crucial that this information be made
available to adult smokers. Such communication will help adult
smokers make more informed choices.
We look forward to discussing the real question: how best
to communicate this important information. We know there are a
variety of opinions on this topic. We welcome a serious and
open dialog that brings to the table all relevant parties to
express their viewpoints and concerns.
That is why we urge the Federal Trade Commission to
initiate a forum that would bring together all of these parties
to examine the most appropriate means for communicating this
important information to adult smokers.
Let me state clearly for the record that U.S. Smokeless
Tobacco Company is committed to restricting tobacco use to
adults only. This commitment is not just rhetoric. It is backed
by concrete action.
In 1997, we were the only smokeless tobacco company to
support the proposed tobacco resolution. When that proposal
failed, we became the only smokeless tobacco company to enter
into the smokeless tobacco master settlement agreement with
Attorneys General of 45 states and various territories.
We are providing more than $100 million to the American
Legacy Foundation for programs to reduce youth usage of
tobacco. Our company is committed to proceeding in a
responsible and deliberate manner that reflects the current
state of the science and addresses the concerns of the public
health community.
This debate presents a broad societal question. How should
we collectively communicate information to adult smokers that
many in the public health community believe will prolong and
save lives. this is truly an unprecedented opportunity. Public
health advocates, researchers, tobacco control activists, and
tobacco product manufacturers all agree on the fundamental
principle that a harm reduction strategy could represent an
important component of a comprehensive public health policy on
tobacco.
There may be disagreement on how best to implement this
strategy. Nevertheless, given the stakes, this issue deserves
serious consideration. We believe this hearing represents a
significant step in that process Thank you for holding this
very timely hearing. May I ask that U.S. Smokeless Tobacco
Company's written statement, which was submitted to the
committee on May 30th, be incorporated in its entirety into the
hearing record after my statement today?
Mr. Stearns. By unanimous consent, so ordered.
[The prepared statement of Richard Verheij follows:]
Prepared Statement of Richard H. Verheij, Executive Vice-President,
U.S. Smokeless Tobacco Company
U.S. Smokeless Tobacco Company (``USSTC'') welcomes the opportunity
to participate in this hearing regarding tobacco harm reduction. This
issue is of immense importance to the 50 million adult tobacco
consumers in the United States, to the public health community, to
medical practitioners and to tobacco manufacturers.
For decades, the public health community in the United States has
asserted that cigarette smoking is the most deadly epidemic of modern
times. For almost as long, the message of the public health community
to cigarette smokers has been monolithic: stop all use of tobacco. Over
the past several years, however, an increasing number of public health
advocates have voiced doubts about what some have called the ``quit or
die'' approach to smoking cessation.
Rather than rely entirely on programs intended to achieve total
cessation of tobacco use, this segment of the public health community
is urging that a more pragmatic goal be adopted--that of tobacco ``harm
reduction.'' One method of achieving tobacco harm reduction, according
to a growing number of researchers, is to encourage those cigarette
smokers who do not quit and do not use medicinal nicotine products to
switch completely to smokeless tobacco products. This strategy,
however, is complicated by the fact that the vast majority of adult
cigarette smokers in the United States--despite the generally accepted
scientific view to the contrary--believe that cigarette smoking and
smokeless tobacco use involve the same risk of adverse health effects.
The issue of tobacco harm reduction and the potential role of
smokeless tobacco products in that effort is at a crossroads. The
debate is no longer about whether smokeless tobacco is considered by
the scientific community to be a significantly reduced risk alternative
compared to cigarette smoking. The question now is whether that
information should be communicated to adult cigarette smokers or
whether it should be suppressed.
Set forth below is a brief description of USSTC and its smokeless
tobacco products, followed by a review of some of the more significant
issues relating to smokeless tobacco in the context of tobacco harm
reduction.
i. usstc
USSTC is the leading U.S. producer and marketer of moist smokeless
tobacco or moist snuff. Copenhagen and Skoal--two of USSTC's brands--
are America's best-selling moist snuff products. Two other brands--
Rooster and Red Seal--were introduced within the last five years, and
hold established positions in the marketplace. A new pouch product--
Revel--has been test marketed. USSTC maintains manufacturing and
processing facilities in Franklin Park, Illinois; Hopkinsville,
Kentucky; and Nashville, Tennessee.
In 1997, USSTC was the only smokeless tobacco company to support
the proposed tobacco resolution. When the proposal failed to pass the
Congress, USSTC became the only smokeless tobacco company to enter into
the Smokeless Tobacco Master Settlement Agreement (``STMSA'') with
Attorneys General of various states and U.S. territories. Pursuant to
the STMSA, USSTC is providing up to $100 million (plus an inflation
adjustment), over a 10-year period, to the American Legacy Foundation
for programs to reduce youth usage of tobacco and combat youth
substance abuse, and for enforcement purposes.<SUP>1</SUP> Moreover,
USSTC agreed to limitations on its advertising and marketing efforts,
even though this put USSTC at a competitive disadvantage with other
smokeless tobacco manufacturers.<SUP>2</SUP>
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\1\ Youth usage of smokeless tobacco, as reported in surveys
conducted by various federal government agencies and by the University
of Michigan, has declined substantially in recent years. For example,
in 2001 the authors of the report on the University of Michigan's
Monitoring the Future national survey noted that ``[t]he use of
smokeless tobacco by teens has been decreasing gradually from recent
peak levels in the mid-'90s, and the overall declines have been
substantial.'' Johnston LD, O'Malley PM, Bachman JG. (2001) Monitoring
the Future national results on adolescent drug use: Overview of key
findings 2000. (NIH Publication No. 01-4923). Bethesda, MD: National
Institute of Drug Abuse, at p. 34. More recently, these same authors
reaffirmed their earlier findings, noting that the overall declines in
teen use of smokeless tobacco have been ``substantial'' and that ``teen
use of smokeless tobacco is down by about one-half from the peak levels
reached in the mid-1990s.'' Johnston LD, O'Malley PM, Bachman JG.
(2003). Monitoring the Future national results on adolescent drug use:
Overview of key findings, 2002. (NIH Publication No. 03-5374).
Bethesda, MD: National Institute on Drug Abuse, at p. 34.
\2\ These restrictions include, among other things, eliminating
outdoor advertising of smokeless tobacco products, such as billboards
and signs in arenas, stadiums, shopping malls, video-game arcades, and
on public transit. In addition, USSTC voluntarily limited itself to one
brand-name sponsorship in any 12-month period, and agreed to
discontinue distribution to the public of non-tobacco merchandise, such
as caps and T-shirts, bearing the brand name, logo, or trademark of any
smokeless tobacco product.
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As these facts and the remainder of this statement will make clear,
USSTC is truly a ``distinctly different'' tobacco company. Annexed as
Attachment A to this statement are copies of excerpts from UST Inc.'s
(USSTC's parent company) annual reports for 2000, 2001 and 2002 that
discuss the ways in which USSTC is a ``distinctly different'' tobacco
company.
ii. smokeless tobacco in the context of tobacco harm reduction
A. Introduction
Since the Surgeon General's Report in 1964,<SUP>3</SUP> there has
been substantial public health discussion about the potential health
effects of tobacco use. Various public health organizations have
identified the risks of cigarette smoking as including cancer (e.g.,
lung, oral cavity, esophagus, larynx, pancreas, bladder, kidney),
chronic obstructive pulmonary disease, myocardial infarction, and
stroke.<SUP>4</SUP> The Centers for Disease Control and Prevention
(``CDC'') estimates that cigarette smoking caused approximately 442,000
premature deaths in the United States in 1999.<SUP>5</SUP> The Surgeon
General has indicated that the ideal way to avoid such health risks is
to abstain from cigarette smoking.<SUP>6</SUP> Nonetheless, 47 to 50
million adults in the U.S. continue to smoke cigarettes. This number
represents approximately 25 percent of all U.S. adults.<SUP>7</SUP>
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\3\ U.S. Department of Health, Education and Welfare. Smoking and
Health. Report of the Advisory Committee to the Surgeon General of the
Public Health Service. 1964.
\4\ Stratton K, Sherry P, Wallace R, Bondurant S (eds.). Clearing
the smoke. Assessing the science base for tobacco harm reduction.
Institute of Medicine. National Academy Press, Washington, D.C., 2001,
at pp. 367-68.
\5\ Centers for Disease Control and Prevention. Annual Smoking-
Attributable Mortality, Years of Potential Life Lost, and Economic
Costs--United States, 1995-1999. MMWR 2002; 51: 300-303.
\6\ U.S. Department of Health & Human Services, Preventing Tobacco
Use Among Young People: A Report of the Surgeon General (1994); see
also Smoking As A Health Hazard, American College of Cardiology
Position Statement, available at http://www.acc.org/clinical/position/
72565.pdf.
\7\ The National Center For Chronic Disease Prevention and Health
Promotion estimates that 47 million adults in the United States smoke
cigarettes. Targeting Tobacco Use: The Nation's Leading Cause of Death,
Tobacco Information and Prevention Source (2001). The U.S. Department
of Health and Human Services estimates that more than 57 million
Americans currently smoke cigarettes. Preventing Death and Disease From
Tobacco Use, Fact Sheet (Jan. 8, 2001). Other reports suggest that the
number of smokers in the United States is between 46.5 and 50 million.
Cigarette Smoking Among Adults-United States, 1999, MMWR Highlights
(Oct. 12, 2001) Vol. 50, No. 40; Treating Tobacco Use and Dependence,
U.S. Public Health Service, Fact Sheet (June 2000).
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The Surgeon General reached a judgment in 1986 that use of
smokeless tobacco products ``can cause cancer.'' <SUP>8</SUP>
Federally-mandated rotating warnings on smokeless tobacco product
packaging and advertising state:
---------------------------------------------------------------------------
\8\ U.S. Department of Health & Human Services, The Health
Consequences of Using Smokeless Tobacco: A Report of the Advisory
Committee to the Surgeon General (1986).
---------------------------------------------------------------------------
WARNING: THIS PRODUCT MAY CAUSE MOUTH CANCER
WARNING: THIS PRODUCT MAY CAUSE GUM DISEASE AND TOOTH LOSS
WARNING: THIS PRODUCT IS NOT A SAFE ALTERNATIVE TO
CIGARETTES.<SUP>9</SUP>
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\9\ Comprehensive Smokeless Tobacco Health Education Act of 1986,
15 U.S.C. Sec. Sec. 4401-4408.
Numerous methods have been suggested by public health advocates for
achieving tobacco harm reduction, including urging cigarette smokers to
smoke fewer cigarettes, developing ``less hazardous'' cigarettes and
creating alternative sources of nicotine, such as nicotine inhalers. A
growing number of tobacco harm reduction proponents, however, are
arguing for an additional method for achieving their goal. Based on the
generally accepted view in the scientific community that smokeless
tobacco use involves significantly less risk of adverse health effects
than cigarette smoking, they would encourage those cigarette smokers
who do not quit and do not use medicinal nicotine products to switch
completely to smokeless tobacco products.
B. The IOM Report
A logical starting point for discussion of smokeless tobacco in the
context of tobacco harm reduction is the 600 page report issued in 2001
by the Institute of Medicine (``IOM'') entitled: Clearing the Smoke.
Assessing the Science Base for Tobacco Harm Reduction (``IOM Report'').
The IOM was established in 1970 by the National Academy of Sciences to
examine policy matters pertaining to public health, and acts under the
Academy's congressional charter to be an advisor to the federal
government and to assess issues relating to medical care, research and
education. The IOM tobacco harm reduction project was undertaken at the
request of, and was supported by, the U.S. Food and Drug
Administration. The IOM Report explains the need for a tobacco harm
reduction strategy as follows:
Despite overwhelming evidence and widespread recognition that
tobacco use poses a serious risk to health, some tobacco users
cannot or will not quit. For those addicted tobacco users who
do not quit, reducing the health risks of tobacco products
themselves may be a sensible response. This is why many public
health leaders believe that what has come to be called ``harm
reduction'' must be included as a subsidiary component of a
comprehensive public health policy toward tobacco.<SUP>10</SUP>
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\10\ Stratton K, et al. (2001) at p. 201.
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Tobacco ``harm reduction'' is defined in the IOM Report as follows:
For the purposes of this report, a product is harm-reducing if
it lowers total tobacco-related mortality and morbidity even
though use of that product may involve continued exposure to
tobacco related toxicants. Many different policy strategies may
contribute to harm reduction. However, this report focuses on
tobacco products that may be less harmful or on pharmaceutical
preparations that may be used alone or concomitantly with
decreased use of conventional tobacco. (Original emphasis).
<SUP>11</SUP>
---------------------------------------------------------------------------
\11\ Id. at p. 2.
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It is clear from this definition of ``harm reduction'' that, in the
view of the IOM, it is not necessary to demonstrate that a product is
``safe'' or ``harmless'' in order for that product to play a role in
tobacco harm reduction.
The IOM Report had the following to say with respect to smokeless
tobacco products:
Smokeless tobacco products are associated with oral cavity
cancers, and a dose-response relationship exists. However, the
overall risk is lower than for cigarette smoking, and some
products such as Swedish snus may have no increased risk. It
may be considered that such products could be used as a PREP
[Potential Reduced-Exposure Product] for persons addicted to
nicotine, but these products must undergo testing as PREPs
using the guidelines and research agenda contained
herein.<SUP>12</SUP>
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\12\ Id. at. p. 434.
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There has been criticism of the IOM Report's recommendation that
all products proposed for use in the context of a tobacco harm
reduction strategy require substantial and elaborate scientific testing
to demonstrate their harm reduction benefits. For example, Clive Bates,
former Director of the United Kingdom's Action on Smoking and Health,
has made the following comments:
The report places very substantial evidential requirement on
those seeking to bring PREPs to the market with a health
related claim. The easiest approach for the public health and
regulatory community is to demand near complete certainty
before approving the marketing of any PREPs. At first sight
this appears prudent, but it is actually a transfer of risk
from the regulator to the smoker. With insurmountable
evidential hurdles in place, the regulator may sleep easy in a
cocoon of professional skepticism.<SUP>13</SUP>
---------------------------------------------------------------------------
\13\ Bates C. Clearing the smoke or muddying the water? (Editorial)
Tobacco Control 2001; 10: 87-88.
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The IOM Report's focus on the need for further research and
demonstration of harm reduction benefits may be understandable in the
context of new or novel tobacco products or so-called ``safer''
cigarettes. When it comes to smokeless tobacco, however, there is
considerable agreement in the scientific community that the use of
smokeless tobacco involves significantly less risk of adverse health
effects than cigarette smoking.
As Professor Lynn Kozlowski, Head of the Pennsylvania State
University Department of Biobehavioral Health, has stated in a
commentary published last year in the journal Nicotine and Tobacco
Research:
The failure of governments to establish any effective
regulation of tobacco products can be seen as arguably the
greatest failure of public health policy for the past 100
years. I have recently been in a meeting with several
distinguished scientists and opinion leaders interested in
smoking-related public policy and regulation. The majority of
these individuals expressed an unwillingness to express any
public opinion about would-be harm reduction products for
tobacco, until such time as proper regulatory/evaluation
systems were in place to unequivocally judge the degree of harm
reduction afforded by the products as used by society. (This
might be viewed as in keeping with the position of the
Institute of Medicine report.) Clearly the best of all possible
research has not yet been done on snus or medicinal nicotine,
but, equally clearly, it is wrong to assume that we lack
practical scientific bases for estimating that there will be
harm reduction to individual smokers from these products.
Though it is important to attain proper regulation over tobacco
and harm reduction products, this goal is logically and
ethically independent of the need to provide smokers today with
what information we do have about the risks of various
products. (Emphasis supplied).<SUP>14</SUP>
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\14\ Kozlowski LT. Harm reduction, public health, and human rights:
Smokers have a right to be informed of significant harm reduction
options. Nicotine and Tobacco Res 2002; 4 Suppl 2: 55-60 at p. 58.
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C. There is General Agreement in the Scientific Community Regarding the
Comparative Health Risks of Cigarette Smoking and Smokeless
Tobacco Use
USSTC's February 5, 2002 Request to the Federal Trade Commission
(``FTC'') for an advisory opinion <SUP>15</SUP>15, which is discussed
below, contains excerpts from 50 scientific publications, many of which
were peer-reviewed, that assert or support the proposition that the use
of smokeless tobacco involves significantly less risk of adverse health
effects than cigarette smoking. Additional scientific information and
publications that became available subsequent to February 5, 2002 is
reviewed in USSTC's May 9, 2003 submission to the FTC, which is also
discussed below. Two of the publications referenced in that
supplemental submission reflect the generally held view in the public
health community regarding the comparative health risks of cigarette
smoking and smokeless tobacco use. Those publications can be expected
to have a significant impact on the tobacco harm reduction debate, and
therefore merit some discussion.
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\15\ Throughout this statement reference will be made to USSTC's
February 5, 2002 and May 9, 2003 submissions to the Federal Trade
Commission and attachments thereto. Those documents and their
attachments can be found at: http://www.ftc.gov/os/
otherpubliccomments.htm and http://www.ussmokeless.com. Hereafter,
documents that are part of these submissions will be indicated as
follows: ``See Website.''
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i. Royal College of Physicians Report
In December 2002, the Royal College of Physicians (``RCP'') issued
a landmark report entitled Protecting Smokers, Saving
Lives,<SUP>16</SUP> which assessed various issues relating to future
tobacco regulation in the United Kingdom. The RCP is England's oldest
medical institution; among its main functions is to advise the
government, the public and the medical profession on health care
issues.
---------------------------------------------------------------------------
\16\ Tobacco Advisory Group of the Royal College of Physicians.
Protecting smokers, saving lives. Royal College of Physicians of
London, 2002. See Website.
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The 2002 RCP Report recognized that tobacco harm reduction must be
an essential element of any tobacco regulation program:
A tobacco and nicotine regulatory authority should have a clear
objective:
. . . to reduce the overall burden of tobacco-related disease
by contributing to a reduction in smoking prevalence and by
regulating to reduce the harm caused to continuing nicotine
users.'' (Original emphasis) <SUP>17</SUP>
---------------------------------------------------------------------------
\17\ Id. at p. 24.
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The 2002 RCP Report also recognized that smokeless tobacco would be
a key component of any tobacco harm reduction strategy:
Smokeless Tobacco:
As a way of using nicotine, the consumption of non-combustible
tobacco is of the order of 10-1,000 times less hazardous than
smoking, depending on the product. Some manufacturers want to
market smokeless tobacco as a `harm reduction' option for
nicotine users, and they may find support for that in the
public health community.<SUP>18</SUP>
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\18\ Id. at p. 5
---------------------------------------------------------------------------
The issuance of the RCP's 2002 Report is not the first time that
the RCP has led the way on tobacco and health issues. In March 1962,
the RCP issued a report on smoking and health which concluded that
cigarette smoking caused lung cancer. Shortly after the issuance of
that report, the U.S. Surgeon General, Dr. Luther L. Terry, established
the Surgeon General's Advisory Committee on Smoking and Health to
produce a similar report for the United States. That report was
released in January 1964 and is generally referred to as the 1964
Surgeon General's Report. Its conclusions were similar to those of the
1962 RCP Report.
ii. White Paper on European Union Smokeless Tobacco Policy
In February 2003, a group of tobacco and health researchers and
public health advocates from the United Kingdom, Sweden and Austria
published a white paper entitled European Union policy on smokeless
tobacco. A statement in favour of evidence-based regulation for public
health.<SUP>19</SUP> The authors recommend that the current European
Union ban of smokeless tobacco be replaced with a regulatory program
based on the recognition that smokeless tobacco is substantially less
harmful than cigarette smoking and could play a significant role in
tobacco harm reduction. The group summarized the ``public health case''
favoring smokeless tobacco as follows:
---------------------------------------------------------------------------
\19\ Bates C, Fagerstrom K, Jarvis M, Kunze M, McNeill A, Ramstrom
L. European Union policy on smokeless tobacco. A statement in favour of
evidence-based regulation for public health. February 2003. See
Website.
---------------------------------------------------------------------------
We believe that the partial ban applied to some forms of
smokeless tobacco in the European Union should be replaced by
regulation of the toxicity of all smokeless tobacco. We hold
this view for public health reasons: smokeless tobacco is
substantially less harmful than smoking and evidence from
Sweden suggests it is used as a substitute for smoking and for
smoking cessation. To the extent there is a ``gateway'' it
appears not to lead to smoking, but away from it and is an
important reason why Sweden has the lowest rates of tobacco-
related disease in Europe. We think it is wrong to deny other
Europeans this option for risk-reduction and that the current
ban violates rights of smokers to control their own risks. For
smokers that are addicted to nicotine and cannot or will not
stop, it is important that they can take advantage of much less
hazardous forms of nicotine and tobacco--the alternative being
to `quit or die' . . . and many die. (Original emphasis)
<SUP>20</SUP>
---------------------------------------------------------------------------
\20\ Id. at p. 2.
---------------------------------------------------------------------------
Among other points made in the white paper are the following:
[F]or oral tobacco to play a role in harm reduction it is not
necessary to show that it does not cause cancer--it just needs
to be substantially less hazardous than smoking. Even allowing
for cautious assumptions about the health impact, snus--and
other oral tobaccos--are a very substantially less dangerous
way to use tobacco than cigarettes. Smokeless tobaccos are not
associated with major lung diseases, including COPD and lung
cancer, which account for more than half of smoking-related
deaths in Europe. If there is a CVD risk, which is not yet
clear, it appears to be a substantially lower CVD risk than for
smoking. Smokeless tobacco also produces no environmental
tobacco smoke (ETS) and therefore eliminates an important
source of disease in non-smokers and children. These are very
substantial benefits in reduced risk to anyone that switches
from smoking to smokeless tobacco and we believe the public
health community has a moral obligation to explore this
strategy. It is likewise ethically wrong to actively deny users
the option to reduce their risk in this way.<SUP>21</SUP>
---------------------------------------------------------------------------
\21\ Id. at p. 3.
---------------------------------------------------------------------------
* * *
The risk to the user arising from use of a smokeless tobacco
product varies by product and is to some extent uncertain--
notably in the area of heart disease (though at worst the heart
disease impact appears to be substantially less than smoking).
However, we are confident that the evidence base suggests that
it is reasonable to formulate the overall relative risk as
follows: on average Scandinavian or American smokeless tobaccos
are at least 90% less hazardous than cigarette smoking. In a
spectrum of risk, snus is much closer to NRT [nicotine
replacement therapy] than it is to cigarette smoking. (Original
emphasis) <SUP>22</SUP>
---------------------------------------------------------------------------
\22\ Id. at pp. 3-4.
---------------------------------------------------------------------------
D. Individual Risk Versus Population Risk
One concern raised by some in the public health community with
respect to ``reduced risk'' tobacco products is that, while a product
might reduce the health risk to an individual, the aggregate public
health impact on the population might be negative. Thus, for example,
it is argued that if a ``safer'' cigarette reduced the health risks
associated with cigarette smoking by 10 percent, but resulted in a 20
percent increase in cigarette use (either through new smokers or by
causing some smokers who otherwise would have quit to continue
smoking), the aggregate public health impact would be negative.
Professor Kenneth E. Warner of the University of Michigan gives the
following example:
[C]onsider the implications of Star Enterprise's advertising
that its new cigarette, Advance, yields fewer nitrosamines than
conventional cigarettes. Informed that most cigarette smoke
contains nitrosamines and that nitrosamines are carcinogenic,
would smokers preparing to quit flock to the new cigarette
instead, believing that it would greatly reduce their risk of
smoking-induced lung cancer? The net health consequences are
unclear: for those smokers who would have continued smoking
anyway, switching to Advance might well reduce risk. For
smokers who would have quit, or former smokers induced to start
smoking again by the availability of this purportedly ``safer''
product, the active marketing of a low-nitrosamine cigarette
clearly would increase risk. The net impact would depend on the
unpredictable balance between such effects.<SUP>23</SUP>
---------------------------------------------------------------------------
\23\ Warner KE. Reducing harm to smokers: Methods, their
effectiveness and the role of policy. In: Regulating Tobacco. Rabin RL,
Sugarman SD (eds.) Oxford University Press, Oxford. 2001. Chapter 5, at
pp. 133-134.
---------------------------------------------------------------------------
Professor Kozlowski has developed a ``risk/use equilibrium'' chart
<SUP>24</SUP> to assess the issue of individual risk reduction versus
aggregate population impact. The chart compares the ``decrease in
danger (%)'' displayed on the horizontal axis to the ``multiplier to
achieve equal risk'' on the vertical axis.
---------------------------------------------------------------------------
\24\ Kozlowski L, Strasser AA, Giovino GA, Erickson PA, Terza JV.
Applying the risk/use equilibrium: use medicinal nicotine now for harm
reduction. (Editorial). Tobacco Control 2001; 10: 201-203.
---------------------------------------------------------------------------
According to Professor Kozlowski's analysis, a tobacco product that
reduces risk by only 10 percent raises a difficult public health issue
because an 11 percent increase in use of the product would offset the
risk reduction in the population as a whole, and an increase in excess
of 11 percent would result in a negative public health impact on the
population as a whole. On the other hand, a tobacco product that
results in a reduced risk in excess of 90 percent presents a relatively
easy public health issue since the increase in usage necessary to
offset the reduction in risk is so substantial--more that 1,000
percent--that it is highly unlikely to occur.
Given the predominant view in the public health community that the
risk of adverse health effects associated with smokeless tobacco
products is slight compared to that of cigarette smoking, researchers
believe it is highly unlikely the public health benefit of cigarette
smokers switching to smokeless tobacco would ever be offset by
increased usage of smokeless tobacco.
Professor Kozlowski expressed his agreement with this conclusion in
a recent publication entitled Harm Reduction, public health, and human
rights: Smokers have a right to be informed of significant harm
reduction options, in which he applied his ``risk/use equilibrium''
analysis to smokeless tobacco:
When risks from a product are relatively small, the level of
increased use needed to maintain a public health equilibrium
(no changes in population-level problems) becomes very high
(Kozlowski, Strasser, Giovino, et al., 2001) . . . For a
product like snus, if the risk is even 1% that of cigarettes,
use would have to increase 100 times to equal the problems from
cigarettes. If the risk from snus were as much as 5% that of
cigarettes, use would still have to increase an unlikely 20
times for the public health problems to equal those from
cigarettes.<SUP>25</SUP>
---------------------------------------------------------------------------
\25\ Kozlowski LT (2002) at p. 58.
---------------------------------------------------------------------------
E. The Swedish Experience
Proponents of encouraging ``inveterate'' cigarette smokers to
switch to smokeless tobacco products point to the history of cigarette
smoking and smokeless tobacco use in Sweden as support for their view.
Swedish males have the highest rate of smokeless tobacco use and the
lowest rate of cigarette smoking of any Western country, and the daily
use of smokeless tobacco by Swedish males now exceeds that of
cigarettes (18.2 percent daily smokeless tobacco users versus 17.1
percent daily cigarette smokers).<SUP>26</SUP> The following chart
illustrates the changing pattern of tobacco use in Sweden during most
of the past century, including the fact that smokeless tobacco use has
overtaken cigarette smoking in recent years for the first time since
World War II.<SUP>27</SUP>
---------------------------------------------------------------------------
\26\ Henningfield JE, Fagerstrom KO. Swedish Match Company, Swedish
snus and public health: a harm reduction experiment in progress?
Tobacco Control 2001; 10: 253-257, at p. 254.
\27\ Adapted from Swedish Match's Third Quarter Results, October
23, 2001, as posted on Company's web site. The figures cited reflect
reported taxable shipments of snuff and cigarettes, measured in tons.
---------------------------------------------------------------------------
Tobacco and health researchers have linked Sweden's low rate of
``tobacco-related mortality'' to its high prevalence of smokeless
tobacco use and low prevalence of cigarette smoking:
Sweden, with a long tradition of smokeless tobacco use (16% of
adult males use smokeless tobacco daily) and the highest
penetration of NRT [nicotine replacement therapy] use, is the
only European country that has reached (19%) the World Health
Organization's target of 20% smokers in the adult population by
the year 2000; about 35% of all nicotine consumed comes from
nonsmoked deliver[y] forms. The tobacco-related mortality in
Sweden is by far lower than in any other European or North
American country, although nicotine consumption may not be
lower than in other countries.<SUP>28</SUP>
---------------------------------------------------------------------------
\28\ Balfour DJK, Fagerstrom KO. Pharmacology of nicotine and its
therapeutic use in smoking cessation and neurodegenerative disorders.
Pharmacol Ther 1996; 72: 51-81, at p. 71.
---------------------------------------------------------------------------
In 2001, a New Scientist article summarized the Swedish experience
in the context of tobacco harm reduction:
[S]mokers [in Sweden] aren't faced with the quit-or-die
dilemma. Instead of using a nicotine replacement therapy with
the aim of quitting both smoking and ultimately nicotine, they
can continue using tobacco as a recreational drug, safe in the
knowledge that it probably won't kill them. It's all down to a
product called `snus,' a form of moist ground tobacco that you
pop between your lip and gum.<SUP>29</SUP>
---------------------------------------------------------------------------
\29\ Wilson C. My friend nicotine. New Scientist 2001; 10: 28-31,
at p. 29.
---------------------------------------------------------------------------
* * *
The `Swedish experiment,' as it has come to be known, has
inspired some health campaigners to press for a more
enlightened approach to the smoking epidemic. It's a concept
they call `harm reduction.' `If you look at Sweden, we have a
living example of the concept in action,' says Clive Bates,
director of ASH.<SUP>30</SUP>
---------------------------------------------------------------------------
\30\ Id. at p. 30.
---------------------------------------------------------------------------
Also of interest is Swedish survey data regarding the use of
smokeless tobacco as a smoking cessation aid presented at two
scientific conferences in late 2002. At the 3rd International
Conference on Smokeless Tobacco: Advancing Science and Protecting
Public Health, held in Stockholm, Sweden in September 2002, Dr. Lars M.
Ramstrom, Director of Stockholm's Institute for Tobacco Studies,
reported on a recent nationwide survey of a representative sample 6,700
adults in Sweden sponsored by the Swedish National Institute of Public
Health. Dr. Ramstrom reports the following in the press summary of his
presentation:
``Among males snus is the most commonly used and most effective
smoking cessation aid.'' In support of this conclusion, Dr.
Ramstrom cites survey data indicating that ``76% of male Ever
Daily Smokers have made at least one attempt to quit smoking.
Around 40% of the ``triers'' report that at their latest
attempt they have used some kind of smoking cessation aid. 36%
of these males have used nicotine gum, 20% nicotine patch and
55% have used snus as a smoking cessation aid. No other kind of
cessation aid has been used by as much as 10%.<SUP>31</SUP> The
proportion of those who have succeeded to quit smoking
completely is 50% for gum users, 34% for patch users, 65% for
snus users.'' <SUP>32</SUP>
---------------------------------------------------------------------------
\31\ Dr. Ramstrom noted that the total exceeds 100% because some
smokers used more than one aid.
\32\ Ramstrom L. Press summary entitled: Snus as a substitution for
smoking--the Swedish Experience. See Website.
---------------------------------------------------------------------------
At the 4th European Conference of the Society for Research on
Nicotine and Tobacco: Improving Knowledge and Treatments of Nicotine
Addiction, held in Santander, Spain in October 2002, Clive Bates made a
presentation entitled ``Harm Reduction and Smokeless Tobacco.'' One of
the points made was that ``snus is an important factor in the low
smoking prevalence in Sweden. It is used for cessation and as an
alternative to smoking.'' He cited data from a 2001 survey commissioned
by the Swedish Cancer Society reporting that, among 1,000 ex-smokers,
33% used snus as a smoking cessation aid, compared to 17% who used
nicotine replacement therapies.<SUP>33</SUP>
---------------------------------------------------------------------------
\33\ Bates C. Presentation: Harm reduction and smokeless tobacco.
See Website.
---------------------------------------------------------------------------
The European Union white paper also points to smokeless tobacco as
the explanation for Sweden's low rate of tobacco-related mortality:
Evidence from Sweden suggests snus plays a positive public
health role as a substitute for smoking and as an aid to
smoking cessation. It is impossible to be definitive about
this, because it is impossible to run a controlled trial on a
whole nation.
However, consider the following:
<bullet> Sweden has the lowest levels of tobacco-related
mortality in the developed world by some distance--
approximately half the tobacco related mortality of the rest of
the EU.
<bullet> Sweden has the lowest male smoking prevalence in
Europe (16% daily) and low female (c. 22%) prevalence.
<bullet> However, it has comparable male tobacco prevalence and
total consumption to neighbours Norway and Denmark--suggesting
the big difference is in the type of tobacco used, rather than
overall propensity to use tobacco or consume nicotine.
<bullet> About half of tobacco in Sweden is now consumed as
snus--this share has steadily grown since 1970s.
<bullet> 33% of ex-smokers report use of snus--almost twice the
number that report use of a pharmaceutical treatment (17%).
Among males who have used a single aid to stop daily smoking,
and succeeded to do so, some 70% had used snus and some 30% had
used some kind of NRT.
Some have raised a question as to whether the Swedish experience is
applicable to the United States, asserting that Swedish moist snuff
products contain lower levels of so-called tobacco-specific
nitrosamines (some of which have been reported to be laboratory
carcinogens) than U.S. moist snuff products. For example, Professor
Newell Johnson in an article published in 2001 entitled ``Tobacco Use
and Oral Cancer: A Global Perspective'' conceded that ``on present
evidence, snuff habits as they exist in Scandinavia and probably in the
United States carry lower risk of serious health hazards''
<SUP>34</SUP> than cigarette smoking, but also made the following
comment:
---------------------------------------------------------------------------
\34\ Johnson N. Tobacco use and oral cancer: A global perspective.
J Dent Educ 2001; 65: 328-339, at p. 328.
---------------------------------------------------------------------------
In Scandinavia it is clear that local snuff is not a major risk
factor: two recent case-control studies of oral cancer cases in
Sweden have failed to show an association. This is because
Swedish snus is not fermented and contains much lower
nitrosamine levels than fermented tobaccos. The view that
smokeless tobacco use may be associated with a lower risk of
oral cancer in the United States has led to a movement to
advocate the practice as a less dangerous alternative to
smoking and an aid to nicotine withdrawal in those addicted to
smoking.<SUP>35</SUP>
---------------------------------------------------------------------------
\35\ Id., at pp. 332-333.
---------------------------------------------------------------------------
In fact, there is currently no significant difference in tobacco-
specific nitrosamine (TSNA) levels in U.S. moist snuff products
compared to Swedish moist snuff. Data reported in scientific literature
by researchers from the American Health Foundation, together with data
published by Swedish researchers, <SUP>36</SUP> show that the average
levels of TSNAs in the major U.S. the moist snuff products decreased
77% between 1980 and 1994 (the last time that data for both of these
products was reported in the scientific literature), and that currently
there is no significant difference between the levels of TSNAs in those
products compared to Swedish moist snuff products. A chart depicting
this data follows:
---------------------------------------------------------------------------
\36\ Andersson G, Bjornberg G, Curvall M. Oral mucosal changes and
nicotine disposition in users of Swedish smokeless tobacco products: A
comparative study. J Oral Pathol Med 1994; 23: 161-167 (1993 Swedish
data); Djordjevic MV, Brunnemann KD, Hoffmann D. The need for
regulation of carcinogenic N-Nitrosamines in oral snuff. Food Chem
Toxicol 1993; 31: 497-501 (1992 U.S. data and all earlier data);
Hoffmann D, Djordjevic MV, Fan J, Zang E, Glynn T, Connolly GN. Five
leading U.S. commercial brands of moist snuff in 1994: assessment of
carcinogenic N-Nitrosamines. J Natl Cancer Inst 1995; 87: 1862-1869
(1994 U.S. data).
---------------------------------------------------------------------------
This view is supported by a report issued in 1997 by the
Swedish National Board of Health and Welfare, which concluded:
Recent data suggest that the differences [in TSNA levels reported
in American and Swedish moist snuff] have grown smaller, and that it is
now questionable to make a sharp distinction between use of American
and Swedish moist snuff when assessing risks--at least where TSNA
content is concerned.<SUP>37</SUP>
---------------------------------------------------------------------------
\37\ Ahlbom A, Olsson UA, Pershagen G. Health hazards of moist
snuff. SoS Report 1997; 11:3-29, at p. 7.
---------------------------------------------------------------------------
F. The Gateway Issue
One argument relied upon by those who oppose the use of smokeless
tobacco as a component of a tobacco harm reduction strategy is that
smokeless tobacco may be a causal ``gateway'' to cigarette smoking,
that is, smokeless tobacco use may cause consumers to later take up
cigarette smoking.
The authors of the EU white paper reject the notion of a causal
``gateway'' from smokeless tobacco to cigarette smoking based upon
their assessment of empirical data from Sweden and their analysis of
the studies relied upon by those who argue that there is a ``causal''
gateway effect. Indeed, the authors of the EU white paper conclude that
the Swedish data suggest that smokeless tobacco prevents rather than
promotes cigarette smoking:
Gateway effects. There is concern that smokeless tobacco will
function as a lead-in to smoking for people that would not
otherwise smoke. Such `gateway effects' are always contentious,
and they are hard to demonstrate for the simple reason that we
do not know what smokeless users would have done in the absence
of smokeless tobacco--they may have simply moved straight to
smoking. Gateways can act in the opposite direction too--they
can be `exits' rather than `entrances'. Smokers may move to
smokeless tobacco or use smokeless tobacco to quit, where they
would otherwise have continued to smoke. Starters on smokeless
tobacco may continue as smokeless users but otherwise have
started with cigarettes, so that smokeless tobacco is a
diversion from smoking. In both the US and Sweden, most
smokeless tobacco use cannot be a gateway to smoking, either
because smokeless users never started smoking or because they
started smoking first. For the minority who started using
smokeless before cigarettes they may or may not have had their
smoking caused by smokeless use.
Exit or entrance gateway? Understanding the order in which
tobacco users take up different products is an important and
necessary factor in establishing a gateway effect and whether
the gateway is an exit from or entrance to smoking, but it is
not in itself sufficient to establish a gateway from smokeless
to cigarettes. The basic problem is that it is difficult to
know whether those that start with smokeless tobacco would
otherwise have started on cigarettes in the absence of
smokeless tobacco. The data from Sweden suggest that the
gateway is more likely to be an `exit' from smoking than an
`entrance'. Among Swedish males with a primary use of snus no
more than 20% ever started smoking, while 45% of other males
did become smokers. In addition to this compelling evidence
from the pattern of transitions, Sweden has the lowest rate of
male smoking in Europe, combined with high levels of snus use.
There is no other credible explanation for such low male
smoking prevalence than the displacement and cessation of
smoking through smokeless tobacco use. In total therefore, the
Swedish data suggest that uptake of snus use prevents rather
than promotes smoking and therefore contributes a net public
health benefit. There have been studies in the United States
that claim to show a gateway effect from smokeless tobacco use
to smoking for a minority of smokeless users. However, these
studies or related commentary have generally drawn causal
inferences based on observation of transitions between often
poorly defined categories of tobacco use, and sometimes from
groups that are unrepresentative of the general population,
such as the military. Psychosocial predictors of smoking
initiation (school performance, parental smoking, risk taking
etc.) can be used to assess which smokeless tobacco users might
otherwise have been smokers. When these confounding factors are
taken into account, the data do not show that initial smokeless
tobacco use adds to the propensity to become a smoker.
Additional data from Sweden contradicting the theory of a causal
``gateway'' from smokeless tobacco to cigarette smoking was recently
published by Rodu et al. in a paper entitled Evolving patterns of
tobacco use in northern Sweden.<SUP>38</SUP> The researchers report on
their analysis of data from a prospective follow-up study of
approximately 3,400 men and women in northern Sweden, and describe the
evolving patterns of tobacco use in this population over the period
1986 to 1999. While the researchers conclude that ``the use of snus
played a major role in the decline of smoking rates amongst men in
northern Sweden,'' <SUP>39</SUP> some of their data is of particular
relevance to the ``gateway'' issue. They report that among men who used
moist snuff but had never smoked at the beginning of the study, not a
single person switched to cigarette smoking during the follow-up period
of 5 to 13 years, and only 1 percent of these men used both moist snuff
and cigarettes during the follow-up period.
---------------------------------------------------------------------------
\38\ Rodu B, Stegmayr B, Nasic S, Cole P, Asplund K. Evolving
patterns of tobacco use in northern Sweden. J Intern Med 2003; 253:
660-665.
\39\ Id. at p. 660.
---------------------------------------------------------------------------
G. Cigarette Smokers' Misperception that Smokeless Tobacco and
Cigarettes Involve Equal Health Risks and Their Right to
Accurate Information
At the November 2001 meeting of the National Conference on Tobacco
or Health in New Orleans, Louisiana, Dr. K. Michael Cummings of New
York's Roswell Park Cancer Institute, and his colleagues, presented
results of a survey of a nationally representative sample of over 1,000
adult cigarette smokers regarding their beliefs about tobacco products.
Of particular interest was the fact that 82% of adult cigarette smokers
responded that they believed smokeless tobacco was just as likely to
cause cancer as smoking cigarettes.<SUP>40</SUP>
---------------------------------------------------------------------------
\40\ Presentation by Dr. K. Michael Cummings at the National
Conference on Tobacco or Health in November 2001.
---------------------------------------------------------------------------
Given these survey results, it was not surprising that in a 2002
publication, Dr. Cummings made the following comments regarding the
comparative health risks of smokeless tobacco and cigarettes, and the
need to provide adult cigarette smokers sufficient information to
permit them to make informed choices regarding the tobacco products
they choose to use:
Competition to produce more consumer-acceptable medicinal
nicotine products would be helped by educating consumers about
what factors in tobacco products really contribute to disease
risk. Ironically, many smokers do not perceive much difference
in health risk between smokeless tobacco products, nicotine
medications and cigarettes. Yet if all nicotine products were
put on a risk continuum the actual difference between smokeless
and nicotine medications would be seen as fairly minor compared
to the difference in disease risk between smoked and smokeless
products (Stratton et al. 2001). Until smokers are given enough
information to allow them to choose products because of lower
health risks, then the status quo will remain. Capitalism, and
not governmental regulation, has the greatest potential to
alter the world-wide epidemic of tobacco-related disease.
(Emphasis supplied) <SUP>41</SUP>
---------------------------------------------------------------------------
\41\ Cummings KM. Can capitalism advance the goals of tobacco
control? Addiction 2002; 97: 957-958 at p. 957.
---------------------------------------------------------------------------
Professor Kozlowski has also commented recently concerning the
urgent need to provide cigarette smokers with information regarding
risk reduction options and their right to receive such information:
Cigarettes kill about half of those who smoke them . . . It is
urgent to inform smokers about options they have to reduce
risk. This needs to be done in ways that inform smokers as
fully as possible that never starting and complete quitting as
soon as possible are the best choices to promote health, while
also indicating that snus or medicinal nicotine (the latter
more than the former) would be preferable to continued smoking.
Also, complete substitution of these products should be
encouraged over mixing them with continued smoking. The harm
reduction message will be complex. There will be many ways to
give it. Some will misinterpret even the most artfully framed
message. Notwithstanding, public health policy in this instance
lacks compelling justification to override the human rights of
the individual. Individuals have the right to such health
relevant information.<SUP>42</SUP>
---------------------------------------------------------------------------
\42\ Kozlowski LT. (2002) at p. 59.
---------------------------------------------------------------------------
H. USSTC's Request for FTC Guidance
On February 5, 2002, USSTC filed a request with the FTC seeking
issuance of an advisory opinion regarding the acceptability of
communicating in advertising that smokeless tobacco products are
considered to be a significantly reduced risk alternative as compared
to cigarette smoking (See Website). USSTC noted in its request that
issuance of an advisory opinion by the FTC would address an issue of
significant public interest to adult tobacco consumers, USSTC, and
other smokeless tobacco manufacturers. USSTC explained the rationale
behind its request as follows:
USSTC requests that the Commission issue an advisory opinion
supporting the use of statements in advertising that provide
the public with truthful and substantiated information about
the harm reduction that a growing number of public health
advocates believe can result from switching from cigarettes to
smokeless tobacco products. The benefits of making such
information available to consumers would be twofold: it would
provide ready access to scientific opinion that otherwise would
be difficult or costly to obtain, and it would help adult
consumers make better educated choices about the tobacco
products they use. As the federal agency with authority over
tobacco advertising, the FTC should act affirmatively to
provide guidance in this area.
USSTC believes that the types of information it proposes to
communicate in advertising are truthful, non-misleading and
substantiated. At the same time, USSTC recognizes that cross-
category (i.e., smokeless tobacco advertisements directed at
adult smokers) comparative advertising of reduced risk tobacco
products raises issues which currently are the subject of
ongoing public health debate. Providing USSTC with an advisory
opinion would inform USSTC and other smokeless tobacco
manufacturers of the criteria the FTC will apply when
considering such statements. At a minimum, FTC consideration of
these issues would advance the public debate on the issue of
tobacco harm reduction, and increase the amount of information
available to the public regarding reduced risk alternatives to
cigarette smoking. Indeed, as part of its consideration of this
request, the FTC may wish to hold a public workshop or similar
forum to facilitate a full exchange of views on the issues
involved.
USSTC's request made clear that any statement USSTC made would be
truthful and non-deceptive, and gave an example of the type of
statement contemplated:
USSTC proposes to disseminate advertisements with the following
or similar statements:
The Surgeon General in 1986 concluded that smokeless
tobacco ``is not a safe substitute for smoking
cigarettes.'' While not asserting that smokeless
tobacco is ``safe,'' many researchers in the public
health community have expressed the opinion that the
use of smokeless tobacco involves significantly less
risk of adverse health effects than smoking cigarettes.
For those smokers who do not quit, a growing number of
researchers advocate switching to smokeless tobacco
products.
Following the submission of its request to the FTC, USSTC
representatives met with FTC staff representatives on May 21, 2002 in
order to present an overview of various issues relating to its request,
as well as to answer any questions that might be raised by the FTC
staff. Following the presentation and discussion, USSTC provided to the
FTC staff additional information and documentation responsive to their
requests. A similar meeting was held with representatives of Department
of Health and Human Services public health agencies on May 30, 2002.
Copies of the presentation materials relating to these meetings are
annexed as Attachments B and C.
In the spring and summer of 2002, smokeless tobacco and tobacco
harm reduction was the topic of discussion and debate at various
scientific conferences and public policy forums in the United States
and abroad. On May 16, the subject was discussed at a scientific
conference in London entitled Harm Reduction, Smoking and Smokeless
Tobacco; on May 29, the issue was the subject of a forum entitled
Marketing Highly Regulated Products at Northwestern University in
Chicago; on June 20 through 22, the issue was discussed at the Third
European Conference on Tobacco or Health in Warsaw, Poland; on June 26,
the issue was debated at a seminar sponsored by the American Council on
Science and Health in New York City; and on July 16, the issue was the
subject of debate at the CATO Institute in Washington, DC.
In the summer of 2002, USSTC became aware of the scheduling of two
very important scientific conferences that would include a public
debate directly relevant to USSTC's request. On September 22 through
25, 2002, the Centers for Disease Control, the National Cancer
Institute, and the Stockholm Center of Public Health, Center For
Tobacco Prevention, would sponsor the 3rd International Conference on
Smokeless Tobacco: Advancing Science & Protecting Public Health, in
Stockholm, Sweden. The conference would bring together leading experts
on smokeless tobacco, and feature a session on tobacco harm reduction.
Similarly, the 4th European Conference of the Society for Research on
Nicotine and Tobacco was to be held on October 3 through 5, 2002, in
Santander, Spain. This conference would also include discussion and
presentations of research findings on current scientific issues
relating to smokeless tobacco, including harm reduction. In view of the
pendency of these scientific conferences, on August 12, 2002, USSTC
temporarily withdrew its request for an advisory opinion so that it
would have the opportunity to provide for the FTC's consideration
significant new information expected to be presented at these
conferences.
On May 9, 2003, USSTC submitted to the FTC information regarding
smokeless tobacco as a reduced risk alternative to cigarette smoking
that had been presented or published subsequent to the August 2002
temporary withdrawal of its request for FTC guidance. As expected, the
Stockholm and Santander conferences produced important new information
relevant to USSTC's request. More significantly, however, two
publications had appeared in late 2002 or early 2003 that will have a
major impact on the public debate regarding smokeless tobacco in the
context of tobacco harm reduction. Those publications, discussed above,
are a report from London's Royal College of Physicians and a white
paper prepared by a group of European tobacco and health researchers
and public health advocates. In addition, several other scientific
publications or documents had appeared that were relevant to USSTC's
request for FTC guidance.
Significant new information from the above-referenced scientific
conferences and publications was reviewed in USSTC's May 9, 2003
filing, submitted together with copies of the referenced materials (See
Website).USSTC suggested in its submission to the FTC that the
Commission may wish to consider holding a workshop or other forum to
address the appropriateness of conveying tobacco harm reduction
information as part of smokeless tobacco advertising. USSTC continues
to believe that such a workshop would afford all of the participants in
this public health debate an opportunity to present their views in a
constructive and productive manner. It might also help form a consensus
as to how we move forward on this important public health issue and
could provide guidelines to ensure that any comparative risk
communication is directed at adult smokers to avoid any unintended
consequences.
iii. conclusion
Some tobacco control activists have taken the position that USSTC
should be prevented from communicating to adult cigarette smokers the
prevailing view in the scientific community regarding the comparative
health risks of tobacco products. Interestingly, they also believe that
neither the federal government nor the public health community has any
responsibility to undertake that task.
On the other hand, some in the public health community believe that
communication of that vital information could have a significant
positive impact on the lives of adult cigarette smokers. Indeed, some
in the public health community believe that USSTC must confront the
question of whether it has a responsibility to step forward and
communicate this critical information to adult cigarette smokers in
light of the vacuum created by the federal government and the tobacco
control activists.
Mr. Verheij. Thank you.
Mr. Stearns. Mr. Myers.
STATEMENT OF MATTHEW MYERS
Mr. Myers. My name is Matthew Myers. I am the President of
the Campaign for Tobacco Free Kids, and I am here today
representing my organization.
Today this committee has bene given a false choice. It is
not about whether more should be done to reduce the harms of
tobacco but how. This committee and its members do not face the
Hobsean choice, do nothing or choose to use smokeless tobacco.
The choice is not quit or die.
Every one of the major public health organizations in this
nation have an agenda for how we can reduce the death toll of
tobacco. This committee, if it is serious about reducing the
death toll of tobacco, has a prominent role to play.
Let me start out by saying there are constructive things
that we can and should do together. Despite the rhetoric, this
nation has never funded a sustained, national, preventive
public education campaign aimed at tobacco, either at children
or to help people quit. If we want to reduce the number of
people who smoke, States like Massachusetts, California, and
Mississippi have shown we can do a great deal that we are not
doing.
Two, the Department of Health and Human Services
Interagency Council on Smoking and Health have come up with a
comprehensive report on smoking cessation. If we want to help
those smokers quit, the answer is not to throw up our hands, as
Mr. Rodu suggested. We have learned in states that have adopted
aggressive programs with quit lines and access to smoking
cessation programs that we can dramatically reduce the number
of people who smoke.
We all say that there are people out there who cannot quit,
and there are, but there are many people out there who can quit
who we have not helped.
Three, there are proven smoking cessation products out
there that have been shown to be safe and effective. We are
doing far too little to encourage their broader use for harm
reduction, to encourage their development in a manner that will
make a major difference.
And, fourth, our organization and every one of the major
organizations in this nation have come before this committee
before and have urged this committee to grant the Food and Drug
Administration comprehensive regulatory authority over all
tobacco products. If we want to do harm reduction based on
science, not rhetoric; if we want to make the truism that
knowledge if power, then we will insure that there is a
government agency that has regulatory authority over the
product so that we will know and consumers will know what is in
that product; so that we will know and consumers will know
truthfully not just what the manufacturers want us to know but
the truth, the full truth about the relative harmful effects of
those products.
We will be in a position where we will be able to control
the advertising. So we will not have to have a rhetorical
debate in the abstract about whether marketing of relative
health claims will make a difference in terms of the number of
people who start or stop. We will have the authority of the
agency to accomplish the goal we set out in this case.
So that if this committee is truly serious about reducing
the harms caused by tobacco, let me suggest there are three
things we can do right off the bat. Let me also ask that we
have this debate today about the use of smokeless tobacco in
the real world, and the real world is this.
As Dr. Carmona has said, smokeless tobacco as used in the
United States has been conclusively shown to be a cancer
causing agent. Smokeless tobacco as used in the United States
is different than smokeless tobacco as a produce used in
Sweden. It has far higher levels of nitrosamines, and in my
testimony I have provided you specific studies that have been
done that demonstrate that smokeless tobacco in the United
States has infinitely higher levels of nitrosamine. The two
most popular products, both made by UST fall into that
category.
Second, smokeless tobacco product or snus, as Congressman
Cubin referred to it, in Sweden is controlled for other things.
It is controlled for cadmium, lead, arsenic, nickel, chromium,
benzopyrene. It is controlled for none of those things in the
United States.
If Sweden has a different experience, it is because they
have a different regulatory regime. They have a different
product.
Three, Sweden is different for another reason that we need
to think about seriously. Sweden bans tobacco advertising.
Smokeless tobacco companies in Sweden did not make health
claims on advertisements. That is not what happened. The
scientific community communicated accurate, helpful information
to consumers in the absence of consumers being bombarded by
uncontrolled advertising, and that is what I really want to
talk about here.
In the United States today, in the absence of FDA
regulation over this industry and this product, what are we
really talking about when we are talking about this. Well, let
me show you the reality of where we will see advertisements for
smokeless tobacco products with claims that they are safer.
Off to my left are two ads. The first ad on the far right
is ``Cock-a-Doodle Freakin' Do.'' When we met with U.S.
Smokeless Tobacco and said is this the kind of advertisement
that under current law you would be permitted to make this
claim in, the answer was yes.
When we asked would the FTC have the authority to prohibit
you from making such a claim in that ad if you got what you
wanted, the answer to that was no. They did say, however, that
that ad embarrassed them because of its obvious appeal to kids,
and on February 28, 2002, wrote to us to say that ad would
never appear again.
Well, it did not. The ad on the left did. The reality is in
the absence of meaningful regulation over tobacco marketing, it
is not a guess. It is a virtual guarantee that we will do the
same thing that we did in the 1980's, use this kind of
advertising to expand the number of children who use tobacco
products.
And let me suggest when it is a child who uses smokeless
tobacco, we are not talking about reduction of risk. We are
talking about a cause of cancer.
Now, a second thing that is very important and a very real
concern----
Mr. Stearns. I just need you to sum up.
Mr. Myers. And I will.
The risk of using smokeless tobacco to discourage quitting
of those who cannot is also very real. Two thousand, the
President of UST in describing his marketing strategy
explicitly said the goal is dual use.
For people who might otherwise quit because of clean indoor
air restrictions, we want them to be able to use this product.
For people who switch to dual use, they increase the risk of
disease.
And let me just finish with one critical last point. It is
nice to have this debate in the abstract. We have to have it in
the reality. There may be a place to discuss the role of
smokeless tobacco, but it should take place only after this
committee has worked with the rest of the Congress to grant the
Food and Drug Administration the kind of regulatory authority
to accomplish the goals you have all talked about.
We heard a great deal today about 400,000 people dying.
There is much we can do to solve that problem.
[The prepared statement of Matthew Myers follows:]
Prepared Statement of Matthew Myers, President, Campaign for Tobacco-
Free Kids
Good morning Mr. Chairman, and members of the Committee. My name is
Matthew Myers. I am the President of the National Center for Tobacco-
Free Kids, a national organization created to protect children from
tobacco by raising awareness that tobacco use is a pediatric disease,
by changing public policies and by actively countering the special
interest influence of the tobacco industry.
Mr. Chairman, I want to thank you for inviting me to testify on the
question of whether tobacco, and specifically smokeless tobacco, can
cure smoking. The question seems simple and straightforward enough, and
so deserves a simple and straightforward response. The answer today is
the same as it was almost twenty years ago when the House Energy and
Commerce Committee last held hearings on the health effects of
smokeless tobacco products. In the absence of the kind of meaningful
regulation of both the content and marketing of smokeless tobacco
products that could be provided by the Food and Drug Administration
(FDA), the answer is no.
smokeless tobacco is a cause of serious disease
Let us start with a basic premise: smokeless tobacco products as
sold in the United States have been found to increase the risk of oral
cancer and other serious diseases. The Surgeon General, the National
Cancer Institute, the American Cancer Society, the American Dental
Association, the Scientific Advisory Committee to the World Health
Organization and numerous other scientific bodies have all determined
that there is conclusive evidence that smokeless tobacco products as
sold in the United States increase the risk of serious disease. This
conclusion is no surprise. Scientists have identified twenty-eight
cancer-causing chemicals in these products.
Today we are seeing history repeat itself. Just as we had the last
time this committee met to discuss smokeless tobacco, we have a
smokeless tobacco industry that refuses to acknowledge the health
effects of its products seeking government approval to use health-
related claims in advertising whether or not that advertising's primary
appeal is to children. In 1985 the then President of the Smokeless
Tobacco Counsel testified before this Committee ``it has not been
scientifically established smokeless tobacco is a cause of any human
disease.'' In April 1999, a spokesperson for the United States
Smokeless Tobacco Company, a subsidiary of U.S. Tobacco (UST) was
quoted in the Providence Journal as claiming that it has not been
``scientifically established'' that smokeless tobacco is ``a cause of
oral cancer.'' This statement resulted in the Rhode Island Attorney
General suing UST for violating the multi-state settlement agreement's
prohibition on making false statements about the health effects of its
tobacco products. UST was required to pay $15,000 to the Attorney
General's office to fund efforts to prevent youth tobacco use and to
formally acknowledge that the Surgeon General and other public health
authorities have concluded that smokeless tobacco is addictive and can
cause oral cancer.
Just last year, UST claimed in a letter to the Federal Trade
Commission (FTC) that ``smokeless tobacco has not been shown to be a
cause of any human disease.'' UST would have this committee think that
it is new evidence that has motivated it to seek approval to market its
products as a safer alternative to cigarettes. The unfortunate reality
is that this is a company that has never acknowledged that its products
cause harm. How can you have a meaningful discussion about the
potential to use a cancer-causing product to reduce the harm from
smoking with an industry that won't acknowledge that its products cause
harm and hasn't agreed to meaningful government regulation?
smokeless tobacco advertising has increased youth use
There is a second basic point about which there can be no dispute.
Twenty-five years ago few young people in this country used smokeless
tobacco products. However, in large part in response to a massive
marketing campaign that in part portrayed smokeless tobacco use as
safer than cigarette smoking, the number of people who used these
products and the demographics of who used these products changed in the
early 1980's. Smokeless tobacco usage among young males rose
dramatically. As a nation we experienced a sixty percent upswing in
smokeless tobacco use among young men resulting from a decade of
smokeless advertising. The lesson is clear: in the absence of
meaningful government regulation, our children are vulnerable to
smokeless tobacco marketing that portrays smokeless tobacco use in a
manner that kids find acceptable. Largely because the major smokeless
tobacco manufacturers have fought FDA regulation of both their products
and their marketing, our kids are as vulnerable today as they were 25
years ago.
Was it an accident that smokeless tobacco use rose in the 1980's
even as the leading smokeless tobacco companies argued that they didn't
market to kids? The answer from their own documents is no. According to
internal company documents, UST developed a graduation strategy some
time ago for hooking kids as new smokeless tobacco users. As one
document states:
``New users of smokeless tobacco attracted to the product for a
variety of reasons are most likely to begin with products that
are milder tasting, more flavored, and/or easier to control in
the mouth. After a period of time, there is a natural
progression of product switching to brands that are more full-
bodied, less flavored, have more concentrated `tobacco taste'
than the entry brand.''
UST has also used the addition of flavorings to increase the appeal
of its products to children. In 1993, cherry flavoring was added to
UST's Skoal Long Cut, an entry or starter product. A former UST sales
representative revealed that, ``Cherry Skoal is for somebody who likes
the taste of candy, if you know what I'm saying.''
Many had hoped that when the United States Smokeless Tobacco
Company signed its settlement agreement with the states in 1998 its
marketing practices would change dramatically. It did not happen
because UST has apparently interpreted the broad prohibition against
targeting youth as not requiring it to change the kind of advertising
and youth oriented imagery that it has previously used that has made
its products so appealing to children. A May 2002 study by the
Massachusetts Department of Public Health found that UST's overall
magazine advertising increased 135% from 1997 to 2001. The study also
found that UST's advertising in magazines with high youth readership
increased 161% during the same time period. For the period 1997-2001,
UST's expenditures in youth magazines increased from $3.6 million to
$9.4 million. Thus, smokeless tobacco advertising that appeals to
children has continued unabated. One only has to look at the images
projected by this advertising to understand its appeal to children.
While UST may increase or decrease its advertising in certain magazines
for its own purposes when it chooses, the evidence is that the MSA has
not provided the legal club that was anticipated. In addition, although
the multi-state settlement agreement has limited UST's ability to
continue to do brand name sponsorships of some events and teams, UST
continues to be a promotional sponsor of both professional motor sports
and rodeo and bull riding.
There is a legitimate concern that in the absence of meaningful
government regulation of smokeless tobacco products, and how they are
marketed the disastrous experience of the early 1980's could be
duplicated again today. If that occurred, more lives would be
needlessly lost as the result of an effort that started out seeking to
reduce the harm caused by tobacco products.
not all smokeless products are alike
There is a third fundamental point--not all smokeless tobacco
products are alike. UST has continued to market products far higher in
one cancer-causing class of agents--nitrosamines--than its counterparts
in Sweden, despite the technical ability to produce low nitrosamine
products. Data concerning Swedish snus is often cited by UST in support
of its desire to market its products--all of its products, including
its products with very high nirtrosamine levels--as a way to reduce the
risks of tobacco use because of some data that indicates that it has
not been associated with an increase in cancer in Sweden.
Swedish smokeless products are much lower in cancer-causing
nitrosamines than U.S. products. In 1995 the average Tobacco Specific
Nitrosamines (TSNA) in Swedish Snus was approximately 5 mg/kg. By 2000
that number had been reduced to 2 mg/kg. An independent study conducted
for the State of Massachusetts by the American Health Foundation in
2001 found, in contrast, that while the Swedish snus it tested
contained 2.8 ug/g TSNA's, UST's two largest selling products--Skoal
and Copenhagen contained 64 ug/g and 41.1ug/g TSNA levels,
respectively.
Even more disturbing, a new study just conducted by the American
Health Foundation for the Massachusetts Department of Health that
examined nitrosamine levels in snuff over the last three decades found
that nitrosamine levels actually rose in one of the two most popular
American brands in 2003 after declining in 2002. The American Health
Foundation found that the TSNA levels in these brands this year were
22.0 and 27.9 ug/g respectively--levels far higher than those found in
Sweden at any time in the last thirteen years. These findings are
critical to the Committee's consideration because TSNA's are widely
accepted as the most serious carcinogens in oral snuff made in the
United States.
The American Health Foundation discovered another distinction
between American smokeless tobacco products and Swedish snus. The
nitrosamine levels of U.S. smokeless products increase once they leave
the manufacturing plant and continue to increase the longer they sit on
the shelf, in one case by an amazing 137 percent over six months.
Swedish snus does not. It is clear that American manufacturers like UST
know how to produce low nitrosamine smokeless tobacco products, but
have chosen not to do so in their most popular products.
Nitrosamines are not the only harmful component in smokeless
tobacco products and this is another distinction between American
smokeless tobacco products and those in Sweden. Swedish snus is also
controlled for heavy metals found in smokeless tobacco products, like
cadmium, lead, nickel and chromium, as well as substances such as
arsenic, BaP's, and pesticides. None of those controls apply to
American products. It is for these reasons that organizations like the
Scientific Advisory Council to the World Health Organization in
November 2002 distinguished between the evidence that it found
conclusively linked U.S. smokeless tobacco products and oral cancer and
the evidence that it found that the health effects of Swedish Snus were
more uncertain.
There is a third distinction between what is described as the
Swedish experience and the likely result in the U.S. The marketing and
advertising of smokeless products in the United States and Sweden is
completely different. Sweden forbids the marketing and advertising of
all tobacco products, and no claims in advertising about relative
safety of these products are permitted. In the United States there are
few restrictions on the advertising and marketing of smokeless tobacco
products, and UST wants to make explicit claims about the relative
safety of its products.
The difference in the laws governing marketing in the two countries
is critical. When our organization met with representatives of UST and
asked if they believed that there was anything to prevent UST from
using ads featuring roosters with what we perceived to be youth
oriented slogans placed in youth oriented magazines to promote their
products as less hazardous than cigarettes, they were quick to say no.
They went further. UST said that if they were given permission to claim
that their products were less hazardous than cigarettes, it was their
belief that the FTC did not have the legal authority to tell them what
kinds of ads or magazines those claims could appear in.
claims of reduced risk could dissuade smokers from quitting
There is a fourth fundamental point. Another potential risk to
permitting smokeless tobacco to be marketed as a harm reduction
mechanism in the absence of meaningful government regulation is that
claims of risk reduction could lead smokers who would otherwise quit
not to do so. The risk is real. In August 2001, UST announced plans to
market a new smokeless tobacco product called Revel. UST is marketing
the new product as a way to consume tobacco in places or situations
when smoking is not allowed or is not socially acceptable. Many smokers
quit after the enactment of restrictions on smoking in the workplace.
There is legitimate concern that in the absence of any regulation of
where and how smokeless tobacco products are marketed, some current
cigarette smokers who would otherwise quit will switch instead to Revel
or other smokeless products. This concern is compounded by studies that
show that claims of reduced risk can lead consumers to falsely
underestimate the relative benefits of quitting versus switching.
there is much the federal government can and should do to reduce the
harm of tobacco products
My fifth point: There is a great deal that can and should be done
to reduce the harm caused by tobacco. It is a misplaced priority to
focus so much attention on smokeless tobacco in the current environment
when there is so much that everyone agrees on that will make a real
difference. Let me highlight some of the actions this Congress and the
executive branch could take that will reduce the harms currently being
caused by tobacco use in our society.
1) The federal government is doing far too little to fund programs
or adopt policies that have been proven effective in reducing tobacco
use. Comprehensive tobacco prevention programs have been proven to work
in every state that has tried them. Yet, the federal government has not
funded a meaningful national sustained public education campaign.
2) The federal government is doing far too little to fund cessation
programs or to promote and make available the cessation tools that have
been proven to help smokers quit. A recent Report conducted at the
request of the Department of Health and Human Services laid out a
comprehensive plan to encourage and assist smokers to quit. It should
be adopted and implemented.
3) The FDA already has authority over FDA approved medicinal
nicotine products. These products have been proven to be safe, at least
for short-term use, but little has been done to encourage their
improvement or to explore their long-term use and potential for harm
reduction. Before we turn to a cancer-causing agent as a tool to reduce
the harms caused by tobacco, shouldn't we first make sure we have done
everything we can to maximize the potential role of safe products that
our government has already reviewed and approved? FDA can initiate a
review of the use of nicotine replacement products without the need for
further legislation, and it should do so.
comprehensive regulation of tobacco products by the fda iis a necessity
My sixth and, perhaps, my most important point: The single most
important action this Congress can take to reduce the harm that current
tobacco products are causing is to provide the FDA with meaningful
authority over all tobacco products. In case we needed further proof, a
study conducted by scientists at the Centers for Disease Control and
Prevention published in the journal Nicotine & Tobacco Research just
last Friday demonstrated once again that without a federal agency that
has oversight over tobacco products consumers are being deprived of
critical information about the risks of individual products and are
being sold products that contain more toxins than are necessary. The
study found that even while tar levels in Marlboros have gone down over
the last several decades, nitrosamine levels in Marlboros have
increased and are higher, in fact, than most locally produced popular
brands in other countries throughout the world.
The high nitrosamine levels may provide at least a partial
explanation for why cancer rates have not declined as expected when tar
levels declined. Don't be confused; the importance of this study is not
that we can save lives if we just reduce nitrosamine levels in
Marlboros. The real importance of this study is that there are dozens
of known carcinogens and toxic substances in current tobacco products
that we are not controlling and about which the public is not being
informed. This study proves that the reduction of any one toxin may
have little impact if you don't control the level of other toxic
substances, and that you cannot count on manufacturers on their own to
provide this information truthfully and completely to consumers. The
lesson is clear--what you don't know will kill you. In the absence of
government regulation tobacco manufacturers--smokeless and cigarette--
will not produce the least hazardous product possible and consumers
will not have the type of complete information needed to make a truly
informed choice.
The latest study reminds us that in the absence of a governmental
agency with the authority to require manufacturers to test and disclose
the toxic substances in their products, claims that any tobacco
products reduce the risk of tobacco-related disease should not be
trusted or permitted. Our experience with both light and low tar
products demonstrates why this is so important. For decades tobacco
manufacturers have advertised light and low tar products in a manner
that they knew led consumers to believe that these products were safer
than traditional cigarettes. The evidence is now conclusive that these
light and low tar products have not in fact reduced the overall risk of
disease. This public health tragedy could have been avoided if tobacco
manufacturers had been required to disclose to the FDA the levels of
different toxins in their products and their knowledge about the actual
levels of tar and other harmful substances that consumers were
receiving.
Mr Chairman, this hearing dramatically underscores the pressing
need for Congress to give the Food and Drug Administration the
authority to regulate tobacco products effectively. A discussion about
harm reduction has to begin with a discussion about providing the FDA
with the kind of authority that is necessary to protect consumers,
verify claims, and require that all reasonable steps are taken to
reduce the harm caused to smokers. Is there a role for smokeless
tobacco in a comprehensive effort to reduce the death toll from tobacco
overseen by the FDA? No one has the information to make that decision
today. The FDA should be open to all strategies that are scientifically
based and that will save lives. The decision about what role smokeless
tobacco plays in that overall scheme is a decision that can only be
made by the FDA after it has all of the relevant information before it.
Why the FDA? The FTC lacks both the authority and the expertise to
do the job by itself. I worked at the Federal Trade Commission and was
responsible for that agency's tobacco-related activities. The job of
the FTC is to stop false, deceptive or misleading advertising. It is
not a science-based agency. It lacks the authority to restrict
smokeless tobacco marketing that appeals to children or to prevent
claims of reduced risk to be used to make these products more
attractive to children. It further lacks the authority to evaluate
different smokeless tobacco products for relative safety, to require
smokeless tobacco manufacturers to disclose to it changes in the
product that could impact its relative harm or to require smokeless
tobacco manufacturers to lower the level of toxic substances in their
products. The FTC is most effective when it is able to work with the
FDA with regard to products over which both have jurisdiction. If FDA
is given this authority over tobacco products, the two agencies working
together could make a very positive difference.
Mr. Chairman, if UST and the other smokeless tobacco companies are
serious about reducing the harm caused by tobacco and about assuring
that the marketing of its products as less hazardous contributes to
public health, they would support giving FDA the strong authority it
needs to regulate tobacco products as outlined by the major public
health groups. I have no doubt that FDA would have had this authority
already but for the opposition of the major cigarette and smokeless
tobacco manufacturers. They should not now be rewarded for their
opposition to meaningful government regulation by being permitted to
make health-related claims that we lack the ability to verify only
because of the lack of such regulation.
Mr. Stearns. And I thank the gentleman.
Mr. Sweanor.
STATEMENT OF DAVID SWEANOR
Mr. Sweanor. Thank you very much, Mr. Chairman.
I am David Sweanor. I am a lawyer based in Canada. I spent
the last 20 years working full time on a broad range of tobacco
control activities both in Canada, where I am very pleased with
a lot of what we have accomplished, including the last 12
months. We appear to have knocked per capita consumption down
by over 12 percent, which is a world precedent setting rate of
decline.
I have also been very involved in activities globally,
although the views I express today are going to be those of
mine and not for any of the organizations I have worked for.
The public policy goal, public health goal of tobacco
control is important to keep in mind. What we are trying to do
is to reduce death and disease, and there is three broad ways
we can do that. We can reduce tobacco onset. We can facilitate
cessation, and we can reduce toxicity for those who use the
product.
This is important because the status quo is truly horrible.
We have got a product that dominates the market that kills half
of its long term users. Among these long term users we have
people who believe that nicotine itself is what causes cancer.
Many people do not want to use medicinal nicotine products
because of the fear of cancer. They are less likely to use
them. They will not use them as long as they should or as much
as they should.
They believe smokeless tobacco causes cancer at least at as
great a rate as smoking. And perhaps most importantly, they
believe light cigarettes are significantly less hazardous.
Well, what do we do with a mess like this? And I think that
a key part of understanding potential solutions is to recognize
that though nicotine is a primary reason people would be
smoking, combustion is a primary reason that they are dying.
So that in theory at least reduced risk products make a
tremendous amount of sense, and I think properly regulated by a
body like FDA, these products have the potential to complement
the other aspects of what we are doing in tobacco control of
supporting what we are doing to prevent onset and to encourage
cessation.
But this is not merely theoretical. We do have examples of
elsewhere in the world where medicinal products are given a
broader range of indicated uses. We have examples of people who
have used medicinal products for years with no apparent ill
effects.
We do have the example from Sweden where there has been a
massive transformation in their market from one dominated by
cigarettes to one dominated by smokeless tobacco, with a
concomitant decline in the rates of disease that follows
smoking. It does not follow tobacco use.
In theory at least, there is a spectrum of risk here, and
there would be the ability to offer products with information
so that consumers get to decide where in that spectrum they
want to be. I think to work though, you do need to have some
form of comprehensive regulation. Without it, you cannot
guarantee public health. You cannot give consumers protection,
and I would argue you cannot effectively allow the operation of
a marketplace because there is a whole lot of questions that
come out, such as how do we know that a product really does
reduce risk on a one for one basis compared to a standard
cigarette.
I would say that is fairly easy. There is no problem
dealing with that dealing with medicinal nicotine. I don't
think there is any problem with that dealing with low
nitrosamine smokeless tobacco. The Surgeon General clearly
does.
How would we know that a product might only reduce some or
what would be the impact if it only reduces some of the
cigarettes somebody might otherwise smoke? Where does the
product fit on that spectrum of risk? How does it impact on
things like cessation and youth uptake, and how do you
communicate a message to the public?
Because one of the problems we have now is that even
totally truthful communications from a tobacco company will
probably not be believed. There has to be some way that people
can get honest communications that are believable so that they
are in a position to do something that their own health.
I think these are very difficult issues, but I think that
there is also a need for prompt action. You have got roughly
1,300 Americans dying every day as a direct result of cigarette
smoking. What do we do?
Well, we do need that broad regulatory framework for all
tobacco products, and in the meantime, we need to look at
things like what should we do with medicinal nicotine. I mean,
one of the clear consensuses that I have been hearing here
today is that everybody seems to think we should have broader
access to these products.
Well, surely there can be some way that your committee can
alert the FDA and the FTC that you want them to do that. You
want them to examine the role of these products in harm
reduction. While they are at it, what can they do to set
something in place that allows the manufacturers of smokeless
products to come forward and say, ``Here is what we have got on
offer as well.''
There ought to be more discussion about this. There needs
to be a way that people can dialog and discuss what is
happening because I do not think it is any longer a question of
will there be alternative products or should we give
information to consumers. It is a question of how are we going
to evaluate those products and how are we going to get truthful
information to consumers in a way that is actually going to
allow them to make more informed decisions about their own
health.
Thank you.
[The prepared statement of David Sweanor follows:]
Prepared Statement of David Sweanor, Counsel, Non-Smokers' Rights
Association
Thank you very much for the opportunity to appear before this
committee to talk about a truly critical issue for global public
health.
My name is David Sweanor, and I am counsel to the Non-Smokers'
Rights Association [NSRA] in Canada, an organization I have worked for
for over 20 years. NSRA has been a primary driver for a very full range
of public health policies aimed at reducing the toll from tobacco.
These include health-oriented tobacco tax policies, restrictions on
tobacco sales, comprehensive restrictions of tobacco advertising and
promotion, detailed package-based heath information--including picture-
based warnings covering 50% of packages and package inserts giving
additional health information, comprehensive disclosure of additives
and sales data, and regulatory authority over tobacco manufacturing
standards. These policies have played a key role in very significant
drops in Canadian tobacco consumption, which have outpaced US declines.
Last year alone, and largely due to very significant cigarette tax
increases, per capita consump |