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Ruling stokes ephedra controversy; FDA ban in question

The decision has prompted calls for a change in the law that classifies dietary supplements as food.

By Mike Norbut, amednews staff. May 2, 2005.

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Physicians are concerned that a federal judge's decision to strike down a U.S. Food and Drug Administration ban on herbal supplements containing ephedra ultimately will mean the return of what they see as a life-threatening substance.

The April 13 ruling by Judge Tena Campbell of the U.S. District Court in Utah threatens the FDA's ability to enforce its year-old ephedra prohibition nationally and raises questions about the strength of its regulatory authority over dietary supplements. These products currently fall under food guidelines and are not subject to the same premarket restrictions as prescription drugs.

The decision "puts America's patients back in harm's way and will no doubt cause confusion," said AMA Trustee Ronald M. Davis, MD.

In response to the ruling, some federal lawmakers and physicians called for a legislative remedy that would toughen the agency's power to stop the sale of products known to have damaging effects on their users.

The decision underscores the need to revisit how supplements are regulated, said Gary Wadler, MD, an internist and sports medicine specialist in Manhasset, N.Y., and a former trustee with the American College of Sports Medicine. "It's an issue of premarket safety assurances vs. postmarket surveillance," he said.

Supplements are governed by the Dietary Supplement Health and Education Act of 1994, under which the products are assumed to be safe until proven harmful by the FDA. Thus, it is the agency's duty to determine a safe dosage level for the product, Campbell ruled. But the FDA did not sufficiently prove that ephedra was unsafe for consumers in low doses, she concluded.