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FDA Wants Ephedra Ban Restored

May 9, 2006 | Consumer Affairs The Food and Drug Administration went to court this week asking that its ban on the weight loss aid ephedra, lifted by a federal judge, be restored.

In a blunt assessment, the FDA lawyers said the judge who made the ruling misunderstood the law.

The agency banned ephedra two years ago after the dietary supplement was linked to serious side effects and even death. The FDA determined that ephedra, taken in any amount, poses a health risk.

One company that manufacturers ephedra-containing products, Nutraceutical Corp., sued to overturn the ban.

U.S. District Judge Tena Campbell in Salt Lake City ruled in favor of the company, finding that the ban could not be enforced against supplements containing doses of ephedra less than 10 milligrams.

The judge also ruled that the FDA improperly placed the burden of proof on Nutraceutical, requiring it to prove there was some benefit to ephedra use. The judge said the burden of proof instead is on the FDA.

But in arguments before the 10th U.S. Circuit Court of Appeals, the FDA said federal law does in fact give it the authority to act to ban the use of a substance it believes is harmful.

Nutraceutical Corp. told the appeals court that if the interpretation of the law is upheld, then the federal agency could ban virtually any substance on the market if it can be determined that its uses in large doses may be harmful.

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