- The Washington Times - Thursday, April 14, 2005

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

The judge ruled in favor of a Utah company, Nutraceutical Corp., that challenged the Food and Drug Administration’s ban. The company asserted in its lawsuit that ephedra ?has been safely consumed? for hundreds of years.

Supplements that included ephedra were once widely used for weight loss and bodybuilding, with industry groups claiming at least 12 million users. The amphetaminelike 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 FDA ordered the substance taken off the market in April 2004.

Park City, Utah-based Nutraceutical and its subsidiary, Solaray, challenged the FDA’s April 2004 ban in U.S. District Court in Salt Lake City, saying 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 do.

?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,? Judge Campbell wrote.

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

FDA spokeswoman Kimberly Rawlings said the agency was reviewing the decision.

Nutraceutical President Bruce Hough called the ruling ?a great affirmation for the system, that the court goes back and says, ?This is Congress’ intent’ and follow it,? he said.

Mr. Hough said it was too soon to say whether the company would resume selling products containing ephedra.

Judge Campbell’s ruling, written Wednesday and released yesterday sends the matter back to the FDA ?for further rule making consistent with the court’s opinion? and keeps the agency from enforcement action against the companies.

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