FDA Bans Ephedra Products

In late December, the U.S. Food and Drug Administration announced it will ban dietary supplements containing ephedra because it poses an “unreasonable health risk.”

Ephedra products, usually marketed as dietary aids or “energy” enhancers, are widely used as stimulants. They are often found at the checkout counters of truckstops and other retail outlets.

On Dec. 30, the FDA issued a consumer alert on the product. The agency has notified manufacturers of dietary supplements that contain a source of ephedrine alkaloids, such as ephedra, Ma huang, Sida cordifolia and pinellia.

The FDA will publish a rule that will ban ephedra in dietary supplements, which will become final 60 days after publication.

California, Illinois and New York already have similar bans in place.

The FDA first proposed regulating ephedra in 1997. Tommy Thompson, U.S. Health and Human Services secretary, had announced in July that the FDA was considering a ban.

“FDA will publish a final rule as soon as possible that will formalize its conclusions that dietary supplements containing ephedrine alkaloids present unreasonable risks to those who take them for any reason,” Thompson said. “Today’s action puts companies on notice of our intentions, and it tells consumers that the time to stop using ephedra products is now.”

Ephedra, also called Ma huang, comes from botanicals, and its main active ingredient is ephedrine. Manufacturers have promoted it as an aid to weight loss, sports performance and increased energy.

But the FDA said it found ephedra was only effective for short-term weight loss. It said ephedra is an adrenaline-like stimulant that has been linked to heart problems and strokes. Other studies have found it raises blood pressure and creates stress on circulation, the FDA said.

The American Medical Association “strongly supports” the ban, said Dr. Ron Davis, AMA spokesman.

“Over 18,000 people have reported adverse events from ephedra use to the FDA, and a long list of sports associations have already banned dietary supplements containing ephedra, including minor league baseball, the International Olympic Committee and the National Football League,” Davis said.

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Metabolife, one of the 62 companies that received FDA notification, said in a statement that it disagreed with the ban.

“Millions of consumers throughout the United States have used ephedra dietary supplements as a safe, inexpensive and effective means by which to support weight loss,” the California company said in a prepared statement.

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