Nutraceutical Sues FDA Over Ephedra Ban

SALT LAKE CITY--Nutraceutical Corp. filed suit in U.S. District Court for the District of Utah against the Food and Drug Administration (FDA), alleging the agencys ban on ephedra-containing dietary supplements is not substantiated and violates federal law. FDA did not prove by a preponderance of the evidence that all dietary supplements containing ephedrine alkaloids, regardless of dose, are adulterated in violation of the [Federal Food, Drug and Cosmetic Act (FDCA)], the complaint read.

Park City, Utah-based Nutraceutical Corp. is the parent company of Solaray Inc., which manufactures an ephedra dietary supplement with only naturally occurring ephedrine alkaloids, and no more than 10 mg of such alkaloids per serving. The complaint noted Nutraceutical filed comments after FDAs proposed ephedra rule in 1997, asking for an exemption due to its low dose; further comments were filed in April 2003 after FDA requested input on health risks associated with ephedra intake.

The lawsuit was filed May 3 by Emord & Associates and Berman, Tomsic & Savage. Among the suits causes of action are:

*FDA failed to prove ephedra presents a significant or unreasonable risk of illness or injury at every dose level and as labeled.

*Congress did not intend a risk-benefit analysis ratio to be used in reviewing whether dietary ingredients are adulterated.

*Because foods containing ephedra may still be sold, the ban on dietary supplements is arbitrary and capricious, in violation of the Administrative Procedure Act.

*FDAs decision to articulate a standard of unreasonable risk by weighing the risk/benefit ratio for the first time in this ban is in violation of comment requirements for rulemaking.

Nutraceuticals suit seeks a declaration that the ban violates several federal laws and procedure requirements, and an allowance to continue selling the Solaray ephedra product. It also offers an alternative; if the rule stands, Nutraceutical requests compensation for the lost value of the products.

Marc Ullman, a partner in the New York firm Ullman, Shapiro & Ullman, said the filing does have valid points, particularly in the risk/benefit area. This suit was filed by someone who knows what hes doing with a track record of defeating the FDA, Ullman said. I wouldnt be surprised if he gets all or part of the ruling overturned.