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 — Posted 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.

In her decision, Campbell ordered the FDA to revisit its rules regarding ephedra and prohibited the agency from taking action against Nutraceutical Corp., the Park City, Utah-based company that filed the lawsuit at the heart of the case. The company's challenge of the ban was specific to the sale of "a dietary supplement containing 10 mg or less of ephedrine alkaloids per daily dose."

It remains unclear how the judge's ruling will affect the distribution and manufacturing of ephedra products in the short term. Jonathan Emord, an attorney based in Reston, Va., who represents Nutraceutical, said the decision strikes down the entire FDA ban. But FDA spokeswoman Kimberly Rawlings said the agency plans to look at the judge's decision literally.

"From the FDA's perspective, the order remains in effect for higher doses," Rawlings said. The agency is evaluating its options, including an appeal, she added.

Health food chains General Nutrition Centers, based in Pittsburgh, and Wild Oats Markets, based in Boulder, Colo., said they had removed all ephedra products from their shelves before the FDA ban and had no immediate plans to change their stance. But ephedra-containing products were available for sale on various Internet sites soon after the decision.

"Unnecessary deaths"

Physicians said dosage levels are irrelevant when talking about the return to market of a supplement that has been linked to stroke, heart attack and death in extreme cases and has generated more than 18,000 consumer complaints.

Renewed sales "would mean the unnecessary deaths of children and adults," said Eric Small, MD, a pediatric sports medicine specialist in New York and chair of the American Academy of Pediatrics' Committee on Sports Medicine and Fitness.

"There are a lot of young athletes who take supplements to quickly lose weight," Dr. Small said. "If they want to make a certain weight in a sport, like wrestling, they may resort to taking something like this."

The AMA's Dr. Davis said, "Findings from independent researchers and the government support the scientific basis for a ban on ephedra."

But the judge ruled that the FDA had overstepped its bounds.

"Simply stated, to declare all [ephedrine-alkaloid dietary supplements] adulterated, as it has done, the FDA must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury," she wrote.

Nutraceutical filed the lawsuit to challenge the FDA's regulatory practices, not its specific action with ephedra, company President Bruce Hough said. The company does not have immediate plans to renew sales of its whole-herb ephedra product.

Supplements an odd fit for regulation

Even with dosage instructions, however, ephedra products could still be misused, doctors said.

The American Academy of Pediatrics recently published a new policy statement condemning performance-enhancing substances, and it includes dietary supplements in that category. Very little information is available on the safety and efficacy of these products in children and adolescents, according to the policy statement.

Because of the way dietary supplements are regulated, however, there doesn't need to be much data available before a product like ephedra reaches the market. While prescription and over-the-counter drugs undergo a rigorous process to prove safety and efficacy before gaining FDA approval, supplements are monitored based on complaints from consumers and health professionals once they're already available.

The regulatory framework is challenging because dietary supplements are neither foods nor drugs, said Adriane Fugh-Berman, MD, an associate professor in Georgetown University Medical Center's Depts. of Physiology and Biophysics. Herbs are not patentable, so it would not be profitable for manufacturers of dietary supplements to undergo clinical trials, only to have another company copy its formula, she said.

On the other hand, many supplements have pharmacologically active ingredients, rendering them an odd fit in the food category, she said.

"It makes sense to have them regulated separately," Dr. Fugh-Berman said. But the dietary supplement law "is problematic because it's very confusing to consumers and very difficult for the FDA to regulate."

It often takes a long record of adverse events to put any sort of regulatory action in motion, including some high-profile cases. The ephedra issue took center stage in 2003 when it was cited as a factor in the death of Baltimore Orioles pitcher Steve Bechler. Major League Baseball later banned the substance, joining the National Football League and the International Olympic Committee.

"How soon we tend to forget," Dr. Wadler said.

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Case at a glance

Nutraceutical Corp. and Solaray Inc. v. Lester Crawford, DVM, Acting Commissioner, U.S. Food and Drug Administration, et al.

Venue: U.S. District Court in Utah
At issue: Whether the FDA overstepped its bounds under the Dietary Supplement Health and Education Act of 1994 by banning ephedra-containing products at all dosage levels.
Potential impact: A federal judge ruled the FDA did not sufficiently prove ephedra was unsafe to consumers in low doses, remanding the issue back to the agency for further rule-making. Physicians worry that if ephedra products return to store shelves, the supplements could once again harm patients, especially children and adolescents.

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External links

U.S. District Court for the District of Utah ruling in Nutraceutical Corp. and Solaray Inc. v. Lester Crawford, DVM, et al., in pdf (link)

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