August 2006

Appeals court rules for FDA in ephedra ban

A three-judge panel of the 10th Circuit U.S. Court of Appeals ruled in favor of the U.S. Food and Drug Administration (FDA) in a case that had challenged the agency’s 2004 prohibition of any level of ephedrine in dietary supplements.

A legal challenge to FDA’s final rule on ephedrine in dietary supplements was brought by Nutraceutical Corporation and its brand, Solaray, in May 2004. Nutraceutical challenged both FDA’s use of a risk/benefit analysis in making an “unreasonable risk” determination, and the regulation’s ban on even low-dose ephedrine products.

Solaray had sold an ephedra dietary supplement that was formulated and labeled to deliver less than 10 mg per day of ephedrine alkaloids. The U.S. District Court for the District of Utah found in April 2005 in Nutraceutical’s favor on both of these causes of action, findings that have now been reversed by the Court of Appeals.

Jonathan Emord, as counsel to Nutraceutical Corp., has indicated that the company will appeal this decision to the full 10th Circuit Court of Appeals.

The ruling can be found at www.ck10.uscourts.gov/opinions/05/05-4151.pdf.

Source: American Herbal Products Association, www.ahpa.org

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