Letter to Tommy G. Thompson - Secretary of U.S. Department of Health and Human Services

March 20, 2003

The Honorable Tommy G. Thompson, Secretary
U.S. Department of Health and Human Services
200 Independence Avenue, S.W.
Washington, D.C. 20201

Dear Secretary Thompson:

We are writing regarding the potential health risks posed by ephedra and certain other dietary supplements. We are concerned that your review of solely ephedra may stop short of what is necessary to ensure that consumers are informed and protected adequately from the adverse consequences that may be associated with various other supplements.

As you know, ephedra products, like many dietary supplements presumed to be harmless under the Dietary Supplement Health and Education Act (DSHEA) of 1994, remain widely available and consumed. This, despite the fact that ephedra has been linked to more than 50 deaths and thousands of reports of adverse health effects, including high blood pressure, seizures, heart attacks, and strokes. And as you know, ephedra was recently listed as a contributing cause of the death of Baltimore Orioles pitcher Steve Bechler. Your agency's ongoing effort to assess the potential health risks of ephedra and to help educate the American public about the product is clearly necessary and overdue.

However, concern with dietary supplements extends well beyond ephedra. The Senate Committee on Commerce, Science, and Transportation has received testimony and correspondence from doping and health experts who believe that many dietary supplements pose potentially-serious health risks. Some experts warn, for example, that steroid precursors often found in dietary supplements may interfere with normal growth and bone development, cause hormonal imbalances, liver and kidney damage, and an increased risk of certain types of cancer. These warnings are of particular concern given recent reports that adolescent boys are among the heaviest users of steroid precursors, such as androstenedione.

In his recent correspondence with the Committee, the Chairman of the United States Anti-Doping Agency (USADA), Frank Shorter, observed that "[w]e have strict control over steroids, but a nine year-old can walk into a store and buy what is essentially steroids. And the problem is that, in children, the effects of this stuff are worse. They stop growing, or their muscles get too big for their bodies." Dr. Raymond Woosley of the University of Arizona, a noted pharmacologist with a special interest in the safe use of medications, has opined that dietary supplements that are being used to treat diseases or enhance personal performance should be viewed, and regulated, as drugs. Because only a small fraction of serious health events are reported by consumers to the FDA, Dr. Woolsey has warned that, "hundreds, if not thousands, of people have suffered strokes, heart attacks and other serious injury because of these products."

Based on the concerns voiced by these experts and many others, we encourage you to expand your ongoing review of ephedra to include other potentially-dangerous dietary supplements.

Thank you for your interest in this area, and we look forward to your further efforts to address possible risks posed by these products.

Sincerely,

John S. McCain
Chairman

Ernest F. Hollings
Ranking Member

cc: Commissioner Mark B. McClellan, M.D., Ph.D, Food and Drug Administration