Judge Strikes Down FDA Ban on Ephedra

Judge Strikes Down FDA Ban on Ephedra

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SALT LAKE CITY (AP) -- A federal judge Thursday struck down the FDA ban on supplements containing ephedra, the once-popular weight-loss aid that was yanked from the market after it was linked to dozens of deaths.

Park City-based Nutraceutical Corp. and its subsidiary Solaray challenged the Food and Drug Administration's April 2004 ban in U.S. District Court in Salt Lake City.

The lawsuit claimed ephedra was wrongly being regulated by the FDA as a drug and not a food.

U.S. District Judge Tena Campbell appeared to agree, and said current law presumes that all food -- including dietary supplements -- are presumed to be safe.

The Dietary Supplement Health and Education Act requires the FDA to prove that a dietary supplement is harmful, rather than having the manufacturer prove it is safe, as is required with drugs. The law also does not require supplement makers to report adverse reactions, as drug companies must.

"The FDA's imposition of a risk-benefit analysis places a burden on the producers of (ephedrine supplements) to demonstrate a benefit as a precondition to sale, and that is contrary to Congress' intent," the ruling says.

"Unlike medical device and drugs, dietary supplements are not classified on the basis of a risk-benefit analysis," Campbell said.

Nutraceutical President Bruce Hough said the lawsuit had little to do with ephedra and more to do with forcing the FDA to follow the rules Congress set down for it.

"This is a great affirmation for the system, that the court goes back and says, 'This is Congress' intent,' and follow it," he said.

"At this point, the FDA is evaluating the decision," said spokeswoman Kimberly Rawlings.

Hough said it was too soon to say if the company would again start selling products containing ephedra. "We'll just evaluate it."

Supplements that included ephedra were once widely used for weight loss and bodybuilding, with industry groups claiming at least 12 million users. The amphetamine-like stimulant, which speeds the heart rate and constricts blood vessels, has been linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler. The federal government banned it a year and a day before Campbell's ruling.

Nutraceutical claimed in its lawsuit filed last May that ephedra "has been safely consumed for millennia."

Campbell's ruling, written Wednesday and announced Thursday, declared the ban invalid, sends the matter back to the FDA "for further rulemaking consistent with the court's opinion" and keeps the agency from enforcement action against the companies.

(Copyright 2005 by The Associated Press. All Rights Reserved.)

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