Ephedra: A step backwards
■ A recent judicial ruling struck a blow at the Food and Drug Administration's ban on the food supplement, renewing very real safety concerns about its availability.
Posted May 23, 2005.
Just a little over a year ago, the Food and Drug Administration wisely banned the sale of products that contain the dietary supplement ephedra, an amphetamine-like herb used for weight loss.
This prohibition came in the wake of reports to the FDA of more than 18,000 adverse events and an estimated 100 deaths tied to ephedra. When the agency's action became official, it was widely heralded as a big consumer-protection victory.
But just days after the ban's first anniversary, a U.S. District Court judge in Utah overturned it. That April 13 ruling has created concern among physicians and other health professionals that what they see as a life-threatening substance ultimately will return to the marketplace.
These worries are well-founded. The AMA, which has policy in strong support of the complete ban on ephedra alkaloids in dietary supplements, was deeply disappointed by the decision. The Association believes it will put America's patients back in harm's way.
Bottom line: Dietary supplements containing ephedra carry serious -- even fatal -- health risks, including seizure, stroke, psychiatric problems and heart attack. The 2003 death of 23-year-old Baltimore Orioles pitcher Steve Belcher, for instance, became a focal point in the ephedra debate. A range of scientific evidence underscores these hazards, and they apply even to very healthy people.
Supplements are governed by the Dietary Supplement Health and Education Act of 1994, under which these products are regulated like food and assumed to be safe until the FDA proves them harmful.
The legal challenge on the ban, filed by Nutraceutical, a manufacturer of ephedra products, was specific to the sale of dietary supplements containing 10 mg or less of ephedrine alkaloids per daily dose. Judge Tena Campbell ruled that the FDA, in order to impose a complete ephedra ban, had to show that any dose, no matter how small, presented a significant or unreasonable consumer risk. In her view, the agency failed to do so.
It was an unfortunate legal decision but one rooted in the DSHEA law that is, itself, fundamentally flawed.
In response, some federal lawmakers and physicians have begun calling for legislation that would toughen the FDA's power to stop the sale of such products known to have damaging effects on their users. Some also say these recent events underscore the need for a uniform reporting system to better track the adverse events associated with certain dietary supplements.
The FDA is contemplating an appeal of the ruling. Meanwhile, it is unclear exactly what the immediate impact of the judge's decision may be.
Those in the anti-ephedra camp say it falls short of an outright reversal of the ban because it applies only to doses of 10 mg or less. Moreover, for now, it applies directly only to this specific federal district, which includes Nutraceutical's Utah headquarters. But it could threaten the FDA's ability to enforce the ephedra prohibition nationally.
Prescription and over-the-counter drugs undergo a rigorous process to prove safety and efficacy before gaining FDA approval, but supplements are monitored based on complaints from consumers and health professionals after they are widely available.
This is a contradiction -- ephedra is the concrete example -- that can put Americans at risk. Clearly, thoughtful action is needed -- the sooner the better.