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Federal appeals court upholds ban on ephedra; ruling reverses Utah judge
This is an archived article that was published on sltrib.com in 2006, and information in the article may be outdated. It is provided only for personal research purposes and may not be reprinted.

Posted: 3:42 PM- A federal appeals court upheld a ban on products containing the dietary weight loss supplement ephedra Thursday, reversing a Utah judge who stopped enforcement of the prohibition against a Park City company.

The 10th U.S. Circuit Court of Appeals in Denver ruled the U.S. Food and Drug Administration correctly followed a mandate from Congress to analyze the risks and benefits of a product. The agency decided there is no acceptable dosage level of ephedrine-alkaloid dietary supplements.

The FDA had banned ephedrine-based supplements as of April 12, 2004, after finding that more than 150 deaths may have been linked to the herb.

That ban was challenged in a lawsuit filed in May 2004 by Park City-based Nutraceutical Corp. and subsidiary Solaray Inc., which said dried whole-herb ephedra sinica - the type of supplement used in their products - had been safely used for thousands of years. The suit asked for a repeal of the nationwide ban or compensation for financial losses.

Nutraceutical attorney Jonathan Emord said Thursday the company will seek a rehearing in front of the entire 10th circuit.

"We will continue to pursue this action for as long as it takes to ensure a just result is achieved," he said.

In April 2005, U.S. District Judge Tena Campbell in Salt Lake City blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose. The judge said the FDA's process in banning ephedra improperly shifted the burden of proving product safety from the government to supplement manufacturers.

Unlike drug manufacturers, supplement makers do not have to prove their products are safe before marketing them.

In arguments last year before the 10th Circuit, FDA attorney Christine Kohl said the ban was based on about 19,000 reports of "adverse incidents" involving ephedra supplements such as heart failure, high blood pressure and death. She acknowledged that there are no clinical studies showing low doses of ephedra pose an unreasonable risk of illness or injury but said that is only because the law does not require supplements to be proven safe.

Emord countered that the agency lacked the scientific evidence to show ephedra is dangerous at any dose. In addition, he said the FDA was wrong to weigh the risks and benefits before deciding that the supplements pose an unreasonable risk.

The 10th Circuit decision sends the case back to Campbell with an order that she enter judgment is favor of the FDA.

Ephedra, or ma huang, also has been used by some as an energy booster.

- Tribune correspondent Robert Boczkiewicz contributed to this story.

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