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Tuesday, December 30, 2003

White House will outlaw sale of ephedra products

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The Bush administration announced yesterday that it will outlaw the sale of ephedra, an herbal stimulant used for weight loss that has been linked to 155 deaths and harmful side effects, such as heart attacks and strokes.

"The time to stop taking this product is now," Health and Human Services Secretary Tommy G. Thompson told reporters in announcing the ban on ephedra and on products that contain it. "They are just too risky to use."

Dr. Mark McClellan, the head of the Food and Drug Administration, said his agency will publish the final rule, which will state that dietary supplements containing ephedrine alkaloids "present an unreasonable risk of illness or injury."

This marks the first time that the federal government has banned a dietary supplement. Manufacturers of products containing ephedra are expected to sue, because they deny that ephedra is unsafe, provided it is used properly.

The ban will take effect two months after the new rule is published. FDA spokeswoman Laura Alvey could not provide a firm date for the rule's publication.

"It will be in the coming weeks," she said.

Dr. McClellan said despite the legally necessary delays, "consumers should stop buying and using ephedra products right away, and the FDA will make sure consumers are protected by removing these products from market as soon as the rule becomes effective."

Mr. Thompson said despite the lawsuits, which he expected, the decision to ban ephedra was "based on the best possible scientific evidence."

A General Accounting Office report found that many people who said they had problems with ephedra had followed the label's instructions.

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