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February 28, 2003
The Honorable Mark McClellan, M.D., Ph.D.
Commissioner
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Commissioner McClellan:
On February 17th, 2003, Baltimore
Orioles pitcher Steve Bechler died from heatstroke after running wind sprints
during spring training in Florida. While toxicology reports are not
available as of yet, media reports indicate that Mr. Bechler may have taken a
dietary supplement containing ephedrine the morning of his collapse. He
reportedly purchased a botanical ephedra product in an effort to lose weight.
Moreover, the Broward County Medical Examiner in charge of Mr. Bechler's autopsy
has indicated that the ephedra product may have contributed to his
heatstroke-related death.
Dietary supplements containing botanical sources
of ephedrine alkaloids are generally marketed for weight loss and performance
enhancement. It is estimated that nearly two billion doses of dietary
supplements containing ephedrine alkaloids are sold in this country every year.
The General Accounting Office (GAO) noted in its
July 1999 report to Congress that use of ephedrine alkaloids can affect
individuals' cardiovascular and nervous systems. GAO reviewed the
scientific literature and found evidence suggesting ephedrine alkaloids could
increase blood pressure in persons with normal and high blood pressure;
predispose certain individuals to tachycardia (rapid heart rate); and cause
cardiomyopathy (disease of the heart muscle), stroke, and myocardial necrosis
(death of cells in the heart). In addition, the Food and Drug Administration
(FDA) has received more than a thousand adverse event reports relating to
individuals using botanical ephedrine alkaloids, including numerous deaths.
FDA notes that such reports do not prove
conclusively that botanical ephedrine alkaloids cause death and disease.
To examine this matter further, FDA commissioned the Rand Corporation to examine
the scientific literature to determine whether such a causal nexus exists.
This report is expected to be completed within several months. In the
meantime, and in light of continuing public health concerns about ephedra, the
Committee has initiated an examination of safety issues related to the use of
ephedra products.
Accordingly, pursuant to Rules X and XI of the
U.S. House of Representatives, we request that FDA provide the Committee with
the following information by March 14, 2003:
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Is FDA aware of
instances wherein botanical ephedrine alkaloids are marketed as drugs, i.e.
marketed to diagnose, cure, mitigate, treat or prevent disease in man or
other animals? Is FDA aware of instances wherein botanical ephedrine
alkaloids are marketed in a false or misleading fashion? Is FDA aware
of instances wherein products marketed as dietary supplements actually
contain synthetic ephedrine?
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If FDA is aware
that botanical ephedrine alkaloids are marketed as drugs, does FDA have the
authority to regulate such products as drugs? In the past five years
has FDA taken enforcement action against botanical ephedrine alkaloids
marketed as drugs, marketed in a false or misleading fashion, or containing
synthetic ephedrine? If so, please specify in detail what enforcement
actions were taken.
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All records
relating to FDA's review or analysis of adverse event reports associated
with ephedra products, from January 1, 1998 through the present. For the
purpose of responding to this request, the terms "records" and
"relating to" should be interpreted in accordance with the
attachment to this letter.
Further, because existing evidence suggests that
use or misuse of botanical ephedrine alkaloids may cause serious,
life-threatening conditions, we would urge you to immediately consider requiring
all such products to bear a warning label. FDA had previously contemplated
such action in 1997, though this proposed regulation was never finally
promulgated. From our reading of the Federal Food, Drug, and Cosmetic Act,
we believe FDA has the authority to mandate such a warning label. We urge
FDA to work with all affected stakeholders to swiftly consider requiring all
botanical ephedrine alkaloid products to bear a warning label in order to more
fully protect American consumers.
If you have any questions, please contact Alan
Slobodin, Majority Committee Counsel, at (202) 225-2927 or David Nelson,
Minority Committee Counsel, at (202) 226-3400.
We would appreciate a prompt reply to this
letter.
Sincerely,
W.J. "Billy" Tauzin
Chairman
John D. Dingell
Ranking Member
Michael Bilirakis, Chairman
Subcommittee on Health
Sherrod Brown, Ranking Member
Subcommittee on Health
Cliff Stearns, Chairman
Subcommittee on Commerce, Trade & Consumer Protection
Jan Schakowsky, Ranking Member
Subcommittee on Commerce, Trade & Consumer Protection
James C. Greenwood, Chairman
Subcommittee on Oversight & Investigations
Peter Deutsch, Ranking Member
Subcommittee on Oversight & Investigations
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