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Utah Company Files Suit Challenging FDA Ephedra Ban

Utah Company Files Suit Challenging FDA Ephedra Ban

Posted - May 4, 2004 at 9:59 a.m.



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SALT LAKE CITY (AP) -- Nutraceutical Corp. and its subsidiary Solaray have filed a federal court lawsuit challenging the Food and Drug Administration's bad on dietary supplements containing ephedra.

It was the second suit challenging the FDA ban. A New Jersey ephedra manufacturer, NVE Pharmaceuticals Inc., tried to head off the nationwide ban on the herbal stimulant before it took effect April 12, arguing that ephedra, the main ingredient in its diet supplement, is safe if used as directed.

A federal judge denied NVE's request, meaning the ban will stay in place until the two lawsuits can be considered. No trial dates have been set.

A FDA spokeswoman said Tuesday the agency does not comment on pending litigation.

Ephedrine supplements were widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler. The FDA's ban on all dietary supplements containing ephedrine alkaloids went into effect April 12.

Nutraceutical, a dietary supplements company based in Park City, claims in the lawsuit filed Monday in U.S. District Court that ephedra "has been safely consumed for millennia."

The company contends its product is safe because it contains only low doses of the ephedrine alkaloid.

The lawsuit claims that the FDA did not meet its burden of proving that all ephedrine dietary supplements present "a significant or unreasonable risk of illness or injury at every dose level and as labeled."

It also contends that banning dietary supplements but allowing ephedrine-containing conventional foods is "an arbitrary and capricious agency action."

The suit seeks to have the FDA's rule declared illegal. It asks that if the court does not find the rule to be illegal, then it rule that Nutraceutical's loss be considered a "taking," which would require the government to pay compensation.

In a similar case, U.S. District Judge Joel Pisano in Newark, N.J., refused to grant a temporary restraining order that would have prevented the FDA from banning the products.

(Copyright 2004 by The Associated Press. All Rights Reserved.)

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