Top Doc Journal: Regulate Supplements

March 10, 2003 -- Regulate dietary supplements, say the editors of TheJournal of the American Medical Association. They point to the ephedra controversy as the latest example of the need for new laws to protect the public.

Public attention has focused on dietary-supplements safety following the recent death of 23-year-old Baltimore Orioles pitcher Steve Bechler. A Florida medical examiner blamed ephedra -- a dietary supplement -- for the death.

Phil B. Fontanarosa, MD, JAMA executive deputy editor, is lead author of the editorial.

"The current system for regulation of dietary supplements is inadequate," the editors write. "Major changes in the system used to regulate these products are required."

JAMA is also publishing a version of the RAND Corp. report on ephedra prepared for the U.S. Department of Health and Human Services. The report is the basis for the recent call by HHS Secretary Tommy Thompson -- and subsequent FDA action -- to limit access to ephedra.

That study, by Paul G. Shekelle, MD, PhD, director of a RAND task force, finds ephedra is linked to relatively rare but catastrophic injuries. People taking ephedra have 2.2 to 3.6 times greater risk of heart palpitations, increased sweating and blood pressure, and psychiatric or gastrointestinal symptoms. And while the study finds that ephedra use can result in short-term weight loss, there's no evidence it helps athletic performance.

"The results of this analysis cast doubt on any claims that use of dietary supplements containing ephedra or ephedrine can help achieve long-term weight loss or weight maintenance or can enhance athletic performance," the JAMA editorial notes. "The findings also strongly suggest increased risk of serious adverse effects associated with these products. ... It is hard not to be impressed by the number of serious cardiovascular complications in young adults."

Ephedra may be only the tip of the iceberg, Fontanarosa and colleagues suggest. They note that dietary supplements are less regulated than "virtually any other products available for public consumption." A 1994 law exempts dietary supplements from FDA regulation over their safety and effectiveness.

Current law forbids manufacturers to make "disease claims" for supplements. But it allows "structure/function claims." That is, the product label can't say the drug helps Alzheimer's disease. It can say that the product improves mild age-associated memory loss. The JAMA editors say that if a supplement has biological activity, it should be treated as a drug. If it does not have biological activity, it should not be allowed to make any health claims.

"Manufacturers of dietary supplements are trying to have it both ways," Fontanarosa and colleagues write. "They claim their products are powerfully beneficial, on the one hand, but harmless on the other. To claim both makes no sense, and to claim either without trials demonstrating efficacy and safety is deceptive."

The editorial calls for specific actions:

• Laws and/or regulations should group dietary supplements. Products within groups should be reviewed and classified according to possible biological action, benefit, and risk.
• FDA should more strongly regulate dietary supplements. This would include review of efficacy and toxicity, as well as quality control and manufacturing processes.
• Manufacturers of dietary supplements should be responsible for tracking and reporting adverse events associated with use of the products.
• The Federal Trade Commission should work with the FDA to make sure advertising for dietary supplements is not misleading.