Public Interest Group Wants Ephedra Supplements Banned

WASHINGTON--The Public Citizen Health Research Group (www.citizen.org), founded by Ralph Nader, asked the federal government to ban the sale and production of ephedrine alkaloid dietary supplements and send out an immediate advisory concerning the possible health risks associated with these products. Written by Sidney Wolfe, M.D., Amer Ardati (the group's director and research associate, respectively) and Ray Woosley, M.D., Ph.D., from the University of Arizona Medical Center, the letter was sent to Health and Human Services Secretary Tommy Thompson asking him to implement these requests for ephedrine alkaloids, which include ma huang, ephedra, ephedrine, pseudoephedrine and methylephedrine.

The letter reported that FDA's Center for Food Safety and Applied Nutrition's (CFSAN) Special Nutritionals Adverse Event Monitoring System showed that ephedrine alkaloid supplements were associated with more reports of death, myocardial infarctions, cardiac arrhythmias, hypertension, stroke and seizure events than all other dietary supplements combined. It also cited that there was a "sharp" increase in adverse event reporting for ephedra users from 1997 through 1999 at the American Association of Poison Control Centers. However, a spokesperson at the Ephedra Education Council (EEC) (www.ephedrafacts.com) stated that, according to the council's statistics, there was also a large increase in ephedra users during that time period.

The letter detailed that ephedrine alkaloid products may lead to kidney stones and hepatitis. The letter also suggested ephedrine may also initiate or exacerbate autoimmune conditions (such as toxic shock syndrome) because ephedrine may act in a fashion similar to pseudoephedrine, which has been linked to autoimmune function.

The authors also addressed the economic impact of these suggested actions. "The only potential loss of income is to the manufacturers and distributors of ephedrine alkaloid dietary supplements," they wrote. "Potentially, there will be savings on the productivity of citizens who otherwise would have been injured by ephedrine alkaloid dietary supplements."

Wolfe and his associates concluded in the letter to Thompson that, "From the perspective of defending the public health, you must be willing to take on this drug (ephedra)-pushing part of the dietary supplement industry."

"It's important that we acknowledge that ephedra is not a benign substance, and that there is needs to be some government regulatory overview on this substance," said Michael McGuffin, president of the American Herbal Products Association (AHPA) (www.ahpa.org). "We agree with Public Citizen that there needs to be a change in the regulatory approach to this ingredient. Where we disagree is that we wouldn't remove it from the market, we would see to it that it was properly labeled, which we asked FDA to do last October. However, they responded 181 days later that this was 'too complex an issue to provide a response at this time.'"

Both McGuffin and EEC consultant Steven Karch, M.D., believed that the science Public Citizen used to support its letter was off base. "I'm sure the letter was well-intended, but it was based on very bad science," Karch said. "I've read all of the adverse reports that [Public Citizen] has, and the reports don't have the data to support the authors' conclusions. By them condemning ephedra products, they're dismissing reasonably good evidence that this ingredient helps in weight loss. However, with the American Heart Association's Web site saying that 40 percent of Americans are overweight, even a 10-pound weight loss decreases your risk profile."

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