Ban against ephedra supplements at any does upheld.

Darrell Miller

08/22/06

Date: August 22, 2006 11:48 AM
Author: Darrell Miller (dm@vitanetonline.com)
Subject: Ban against ephedra supplements at any does upheld.

A three-judge panel of the 10th U.S. Circuit Court of Appeals in Denver late last week overturned a 2005 ruling by a Utah district court that had allowed the sale of low-dosage ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids.

The appellate decision, which is effective immediately, supports FDA’s original determination that no dosage of ephedra is safe for consumption and means that it is unlawful to manufacture and sell any supplements containing ephedra, even products containing low doses of the herb.

The original ban was challenged in a May 2004 lawsuit by Nutraceutical Corp, and its subsidiary Solaray Inc., which said dried whole-herb ephedra sinica - the type of supplement in their products – had been safely used for thousands of years.

The U.S. district judge in Utah blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose. The Utah District Judge said FDA’s process in banning ephedra improperly shifted the burden of proving product safety from the government to supplement manufacturers.

While noting that the Dietary Supplement Health and Education Act of 1994 (DSHEA) categorized dietary supplements as foods and are not, therefore, subject to premarket approval by FDA, the appellate panel found that the Utah district court had interpreted this basic provision to narrowly.

The panel said that the Food, Drug and Cosmetic Act (FDCA), of which DSHEA is a part, should not be interpreted “too restrictively” but should instead be read in a manner “consistent with the statute’s overwhelming purpose to protect public health.”

Nutraceutical’s attorney has indicated that the company would appeal the ruling to the full appeals court.

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