Utah Company Sues FDA Over Ephedra Ban

A Utah supplement manufacturer and its subsidiary company have filed a federal lawsuit against the Food and Drug Administration that challenges the FDA's ban on dietary supplements containing ephedra. The suit asks that the ban be declared illegal on the grounds that the agency has not proven that ephedra is unsafe, and that even if the court does not find the ban illegal, the manufacturer should be compensated for losses incurred by the FDA's ban.

In its lawsuit, Nutraceutical Corp. and its subsidiary, Solaray, claim that ephedra "has been safely consumed for millennia," and contends that its product is safe because it contains only low doses of ephedrine alkaloids. The FDA's ban on all dietary supplements containing ephedra went into effect on April 12, 2004.

The lawsuit claims that the FDA has failed to meet its burden of proving that all ephedrine-containing dietary supplements present "a significant or unreasonable risk of illness or injury at every dose level and as labeled." It further contends that the process of banning dietary supplements that contain ephedra, yet allowing ephedrine-containing foods to remain on the market, is "an arbitrary and capricious agency action."

As with a similar lawsuit filed by two other supplement makers in April, the Nutraceutical suit asks that the FDA's ban on ephedra be made illegal. In a rather unique step, however, Nutraceutical's suit also asks that if the court does not find the FDA's ban illegal, it should then rule that Nutraceutical's losses resulting from the rule be considered a "taking," which would require the federal government to compensate the company for its financial losses.

The suit was filed in U.S. District Court in Salt Lake City.

Nutraceutical's case marks the third time in a month that a supplement manufacturer has sued the FDA over the ephedra ban. A federal judge in New Jersey refused to block the ban in a similar case brought by two other supplement makers in April.