Ephedra Ban

 

Judge Strikes Down Ephedra Ban

In April a federal judge in SALT LAKE CITY, UT struck down a ban on ephedra, but that doesn't exactly mean you can start stocking your facility's shelves with the supplement just yet.

In a somewhat confusing decision, U.S. District Judge Tena Campbell ruled that the Federal Drug Administration (FDA) had failed to prove that ephedra was dangerous in doses of 10 milligrams or lower. According to the National Nutritional Foods Association, the court decision leaves room for interpretation.

The federal government will fight a Utah judge's decision to toss a ban on the once popular diet aid ephedra earlier this year.
   A notice filed Monday in U.S. District Court on behalf of the Food and Drug Administration and Department of Health and Human Services says the agencies are appealing to the 10th U.S. Circuit Court of Appeals in Denver.
   At issue is U.S. District Judge Tena Campbell's April ruling that the FDA had no evidence to prove supplements with 10 milligrams of ephedra or less per day were too risky. The ruling - made as part of a lawsuit filed last year by Park City-based Nutraceutical Corp. - blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose.
   Ephedra was pulled from the market in 2004 after the FDA found more than 150 deaths may have been linked to the herb.

 
FDA Wants Ephedra Ban Restored

May 9, 2006

Ephedra - 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. Read more on the Ephedra Ban

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