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Correspondence The Committee on Energy and Commerce W.J. "Billy" Tauzin, Chairman Committee Leaders Question National Collegiate Athletic Association Regarding the Use of Ephedra-Containing Supplements April 9, 2003 Dr. Myles Brand Dear. Dr. Brand: The recent death of 23-year old Baltimore Orioles pitcher Steve Bechler,
whose use of an ephedra-containing supplement was a contributing factor in his
tragic death, according to the Broward County Medical Examiner's Office, has
raised questions about whether Federal action should be taken to address safety
concerns related to ephedra-containing supplements. The Committee on Energy and
Commerce has jurisdiction over matters relating to food and drugs, the
regulation of commercial practices, including sports-related matters, and public
health generally. Accordingly, we have initiated a comprehensive review of
safety issues surrounding the use of ephedra-containing supplements. In response to new studies providing additional evidence of safety concerns
that may be associated with ephedra-containing supplements, the Department of
Health and Human Services (HHS) recently announced several regulatory and
enforcement actions intended to protect Americans from potentially serious risks
of ephedra-containing supplements. HHS also issued a public statement cautioning
the public about the use of ephedra-containing supplements, particularly in
combination with strenuous exercise or other stimulants. Moreover, HHS is
seeking expedited public comment on: (1) new evidence on health risks associated
with ephedra to establish an up-to-date record as quickly as possible to support
new restrictions on ephedra-containing products; (2) whether the currently
available evidence and medical literature indicate a "significant or
unreasonable risk of illness or injury" from dietary supplements containing
ephedra; and (3) a new warning label on any ephedra supplements that continue to
be marketed. According to various media accounts, ephedra has been linked to numerous
deaths and 1,400 reports of health-related problems, including strokes, heart
attacks and seizures. A recent study published in the Annals of Internal
Medicine that compared the safety of ephedra supplements to other herbal
supplements concluded that the relative risk for an adverse reaction from
ephedra supplements was more than 100-fold higher compared to any other herb.
The study also notes that 64% of all adverse reactions to herbal supplements in
the U.S. came from supplements containing ephedra, while ephedra-containing
products represented only 0.82% of herbal product sales. The recently released
results of a RAND Corporation study commissioned by the National Institutes of
Health (NIH) provides additional evidence that ephedra-containing supplements
may be associated with increased health risks, while finding only limited
evidence of health benefits resulting from ephedra use. In light of the potential adverse effects of ephedra-containing products, the
National Football League ("NFL"), as well as the International Olympic
Committee ("IOC") and the National Collegiate Athletic Association
("NCAA"), decided to ban the use of ephedra products among their
athletes. It is our understanding that beginning in 1997 ephedrine was included
in the NCAA's list of banned substances; however, it was not until August 2002
that the NCAA added ephedrine testing to its year-round drug testing program.
The Committee is seeking additional information from the NCAA concerning its
decision to ban the use of ephedra products among its players and its policies
adopted to enforce the ban on ephedra use in professional football. Due to recent press reports raising additional questions about the safety of
ephedra products and the NCAA's decision to ban the use of ephedra products
among its players, we are requesting that, pursuant to Rules X and XI of the
U.S. House of Representatives, you provide the Committee with the information
requested below by Wednesday, April 23, 2003. Explain the NCAA's policies and procedures
regarding the use of ephedra products among collegiate athletes and include
in your response whether the NCAA consulted with players, coaches and/or
other individuals in determining these policies and procedures, and if so,
identify all persons who were consulted on this matter. Provide a copy of
all policies and procedures that relate to the use of ephedra by collegiate
athletes. Explain when and why the NCAA decided to
institute drug testing of collegiate athletes for ephedrine and provide all
records that relate to your decision to institute testing among your
players. From 1995 through the present, state whether
the NCAA has procedures relating to reporting or tracking of adverse health
events among collegiate athletes. If so, identify the entities to which
these reports are made, the individual(s) responsible for retaining such
information, and describe the specific procedures and whether they apply to
adverse events relating to dietary supplements (including, but not limited
to, ephedra products). Provide a copy of all procedures described in this
question. Since the NCAA began testing collegiate
athletes for ephedrine use, state how many athletes have been randomly
tested for ephedrine use and, among those players tested, how many players
have tested positive for ephedrine use. Identify who the NCAA consulted with concerning
the decision to ban the use of ephedrine and/or the NCAA's decision to test
its athletes for ephedrine. For each person(s), provide the name of the
organization to which they are affiliated, the date(s) of any meetings, and
provide all records that relate to the consultation. State whether any employee or agent of the NCAA
has reviewed or requested a review of any scientific literature that
concerns the health effects of dietary supplements (including, but not
limited to, ephedra products) on athletes or other persons. If so, provide
the following information: The name of author and title and date of
literature; The identity of the person(s) within the NCAA
(or person acting at its request) that reviewed the literature; The date when the literature was reviewed;
and All records relating to such review. Prior to the ban on ephedra products, state
whether the NCAA received or reviewed any health complaints or notification
of adverse health events relating to ingestion of dietary supplements
(including, but not limited to, ephedra products) by collegiate athletes. If
so, provide the number of complaints, an identifier for each complainant,
the date of each complaint, the person or entity to which each complaint was
referred, and a description of the resolution of each complaint, including
any action taken by NCAA or other entity in response. All records that relate to the NCAA's position
on the banning and/or use of ephedra products and the testing for ephedrine
in collegiate athletes. Please note that, for purposes of responding to this request, the terms
"records" and "relating" should be interpreted in accordance
with the attachment to this letter. The term "you" or "your"
means the National Collegiate Athletic Association or one or more of its
divisions, subsidiaries or affiliates, or related entities. If you have any questions, please contact Alan Slobodin, at (202) 225-2927,
or Kelli Andrews, at (202) 226-2424, of the Committee Staff. Sincerely, W.J. "Billy" Tauzin Michael Bilirakis Cliff Stearns James C. Greenwood ATTACHMENT The term "records" is to be construed in the broadest sense and
shall mean any written or graphic material, however produced or reproduced, of
any kind or description, consisting of the original and any non-identical copy
(whether different from the original because of notes made on or attached to
such copy or otherwise) and drafts and both sides thereof, whether printed or
recorded electronically or magnetically or stored in any type of data bank,
including, but not limited to, the following: correspondence, memoranda,
records, summaries of personal conversations or interviews, minutes or records
of meetings or conferences, opinions or reports of consultants, projections,
statistical statements, drafts, contracts, agreements, purchase orders,
invoices, confirmations, telegraphs, telexes, agendas, books, notes, pamphlets,
periodicals, reports, studies, evaluations, opinions, logs, diaries, desk
calendars, appointment books, tape recordings, video recordings, e-mails, voice
mails, computer tapes, or other computer stored matter, magnetic tapes,
microfilm, microfiche, punch cards, all other records kept by electronic,
photographic, or mechanical means, charts, photographs, notebooks, drawings,
plans, inter-office communications, intra-office and intra-departmental
communications, transcripts, checks and canceled checks, bank statements,
ledgers, books, records or statements of accounts, and papers and things similar
to any of the foregoing, however denominated. The terms "relating," "relate," or
"regarding" as to any given subject means anything that constitutes,
contains, embodies, identifies, deals with, or is in any manner whatsoever
pertinent to that subject, including but not limited to records concerning the
preparation of other records. Related Documents The
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