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Judge Overturns Ephedra Ban

April 15, 2005

Ephedra • FDA Wants Ephedra Ban Restored • Feds Seize Supplements Containing Ephedra • Judge Overturns Ephedra Ban • Metabolife Indicted • Ephedra Banned • Feeling the Heat -- • Nutrition Info

After mounting complaints and health concerns, the government banned the diet supplement ephedra in late 2003. Now a federal judge has ruled the Food and Drug Administration overstepped its bounds when it took the substance off the market.

U.S. District Judge Tena Campbell of Salt Lake City ruled the FDA's ban was too broad, and that the agency had failed to prove its case that low doses of ephedra pose a significant or unreasonable health risk. But at the time of the banning, ephedra had been linked to more than 150 deaths and the FDA was under intense pressure from consumer health groups to act.

The judge's ruling is not likely to bring all ephedra products back on the market, since it specifically focused on low-ephedra supplements. The case was brought by Nutraceutical International of Park City, Utah, the maker of a low-ephedra product.

Nutraceutical took the FDA to court on the grounds that it had not proven that low-ephedra products were dangerous. The company has made a dietary supplement with a daily dose of ephedra of less than 10 milligrams, while some ephedra products marketed for rapid weight loss and bodybuilding have had more than 100 milligrams.

Ephedra was increasingly denounced as a health menace throughout 2003, especially after Baltimore Orioles pitcher Steve Bechler keeled over from heatstroke after taking the herbal stimulant during spring training that year.

Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted for use to aid weight loss, enhance sports performance, and increase energy.

Under the Dietary Supplement Health and Education Act of 1994, the FDA bears the burden of proof to show that a dietary supplement presents a significant or unreasonable risk to prevent it from being marketed; in contrast, for drugs that have similar pharmacologic properties to ephedra, manufacturers bear the burden of proof of showing that the drug is safe and effective before it can be marketed.

FDA's concerns about dietary supplements containing ephedra arise in part from ephedra's mechanism of action in the body. Ephedra is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. FDA's evaluation also reflects the available studies of the health effects of ephedra. This includes many studies reviewed by the RAND Corporation, which found little evidence for effectiveness other than for short-term weight loss, as well as evidence suggesting safety risks.

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