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February 24, 2003
Mark B. McClellan, M.D., Ph.D.,
Commissioner of Food and Drugs
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Dear Commissioner McClellan:
The untimely and tragic death of
Baltimore Orioles pitcher, Steven Bechler, should remind all consumers about
the dangers of taking dietary supplements containing ephedrine alkaloids ("ephedra").
It should also serve as a clarion call to the U.S. Food and Drug Administration
to immediately ban dietary supplements containing ephedra from the marketplace.
Serious concerns continue to mount about the health risks and efficacy claims
of weight loss and energy boosting supplements that contain ephedra, an herbal
supplement that acts like an amphetamine. These products have been extremely
popular with athletes. This was apparently the case with Mr. Bechler. While
the toxicology report is still pending on the official cause of Mr. Bechler's
death, the FDA already has compelling data showing that ephedra poses serious
and unreasonable health risks to consumers.
From January 1993 through October 2000, the FDA received almost 1,400 reports of adverse events linked to ephedra use, including heart attacks, strokes, seizures, and at least 81 deaths. This is only the tip of the iceberg, because the vast majority of serious adverse events related to ephedra are never reported to the FDA or, indeed, any health professional or agency.
According to an analysis released by the Annals of Internal Medicine in February, products containing ephedra accounted for 64% of all adverse reactions to herbal products reported to the American Association of Poison Control Centers in 2001. The researchers calculated relative risks for an adverse reaction to ephedra compared with other herbs in the database and found huge (100-fold or more) increases in risk for those taking ephedra.
The American Medical Association has called for ephedra's removal from the marketplace. In addition, a host of other organizations representing athletes, including the International Olympic Committee, the National Football League, and the National Collegiate Athletic Association, have already banned ephedra's use among their members and players.
Recognizing the risks posed by these products, companies in the private sector have removed these unsafe products from store shelves. Twinlab Corporation, a major herbal supplement manufacturer based in Hauppauge, N.Y., plans to cease all sales of products containing ephedra as of March 2003, because of "escalating insurance costs and regulatory uncertainties." In addition, recently, 7-Eleven, Inc. announced it would no longer carry dietary supplements containing ephedra in its 5,300 retail convenience stores.
States and localities also have acted to protect residents from these dangerous products. On the state level, last session, California passed legislation prohibiting the sale of such products to minors, and requiring clear and conspicuous warning labels including a toll free number to report adverse events. On the local level, governments such as in Suffolk County, New York, voted to ban the sale of ephedra-containing products to both children and adults.
Finally, Consumers Union supports these efforts, and renews its request that the FDA act expeditiously to protect consumers from the dangers of ephedra-containing dietary supplement products. While we understand that the Agency may wish to wait for the results of a RAND Corporation study of ephedra, we believe sufficient evidence exists for more immediate action. For your reference, attached is a November 15, 2002 letter signed by Jim Guest, president of Consumers Union, and Dr. Marvin Lipman, Chief Medical Adviser for Consumers Union, to Secretary Tommy Thompson outlining in greater detail the reasons we believe FDA should immediately ban ephedra-containing dietary supplements from the marketplace.
Thank you for your attention to this request.
Sincerely,
| Janell
Mayo Duncan Legislative and Regulatory Counsel Washington Office Consumers Union |
Elisa
Odabashian Senior Policy Analyst West Coast Office Consumers Union |
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