Saw this today. If the challenge to the FDA’s “authority” to ban substances without following all appropriate guidelines were successful, it would set an interesting precedent.
SALT LAKE CITY (AP) - Nutraceutical Corp. and its subsidiary Solaray have filed a federal court lawsuit challenging the Food and Drug Administration’s ban on dietary supplements containing ephedra.
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.
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. Nutraceutical asks that if the court does not find the rule to be illegal that it be paid compensation from the government for its losses.
In a similar case, U.S. District Judge Joel Pisano in Newark, N.J., last month refused to grant a temporary restraining order that would have prevented the FDA from banning the products.
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