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.