Ephedra: It's Back! Sort of

Tuesday, December 13, 2005

It's not your imagination: A few products containing ephedra are back on the market again, after the supplement was banned by the Food and Drug Administration (FDA) in 2004. Whether these products are being sold legally is under debate.

At the FDA's behest, U.S. marshals in Texas and Oregon last week seized nearly 3,000 bottles of the ephedra-containing dietary supplement Nature's Treat Energy Plus #1.

"We will do all we can to protect Americans from potentially dangerous dietary supplements," said Acting FDA Commissioner Andrew Eschenbach in announcing the seizure.

To bring you up to speed: Since the FDA banned ephedra after it was linked to a number of deaths, most dietary supplement makers have either withdrawn their ephedra products or reformulated them to eliminate ephedra.

But supplement maker Nutraceutical Corp., some of whose products contained ephedra, sued then-FDA Commissioner Lester Crawford over the ban. In April, a federal District Court judge in Utah ruled that Nutraceutical could sell products that contain 10 milligrams or less of ephedra. (Nutraceutical is not the maker of the supplement seized by federal officials last week.)

"The suit is not about the safety of ephedra but about FDA setting new standards for putting safe products on the market," Nutraceutical President Bruce Hough told the publication FDA Week when the ruling was released. "You can't wholesale ban a supplement unless you have good scientific facts behind it."

Even so, dietary supplement trade associations urged their members not to jump back into the market with ephedra products.

"We supported FDA's ban on the product and following the Utah federal court decision publicly advised the industry that the ruling should not be misinterpreted as a complete overturn of the ephedra ban," said Steven Mister, CEO and President of the Council for Responsible Nutrition, which represents dietary supplement makers.

"Until such time that the lawsuit is resolved, companies should not be marketing ephedra, and we encourage FDA to continue to take these kinds of regulatory actions that are available to the agency under the Dietary Supplement Health and Education Act."

That's a sentiment also shared by the American Herbal Products Association (AHPA), another trade group. "We say to the industry, 'Sell your products in conformity with the law,' " said AHPA President Michael McGuffin.

Besides, as McGuffin notes, there's a question of whether low doses of ephedra are even effective for weight loss. "All the evidence is based on taking 90 to 100 milligrams per day," McGuffin said. "Why would anybody think that 10 milligrams has any effectiveness in weight loss? You wouldn't take a tenth of an aspirin if your head is pounding, would you?"

-- Sally Squires

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