Judge strikes down FDA ban on ephedra

Posted: Friday, April 15, 2005

SALT LAKE CITY — A federal judge Thursday 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 — including that of Baltimore Orioles pitching prospect Steve Bechler.

The judge ruled in favor of a Utah supplement company that challenged the Food and Drug Administration's ban. Nutraceutical claimed that ephedra ''has been safely consumed'' for hundreds of years, and that ephedra was wrongly being regulated by the FDA as a drug and not a food.

Judge Tena Campbell agreed, saying federal law places more restrictive rules on the FDA in determining whether to ban foods as opposed to drugs. The judge said the law 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.

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.

He said Nutraceutical interprets the ruling to mean that the company is allowed to start selling ephedra supplements again, but added that it is too soon to say whether it will put the products back on the market.

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

FDA spokeswoman Kimberly Rawlings said the agency is ''evaluating the decision.''

Bechler was 23 when he died after a spring training workout on Feb. 17, 2003, sent his body temperature to 108 degrees.

The medical examiner who performed the autopsy said the pitcher had a history of borderline high blood pressure and an abnormal liver. The medical examiner also said that ephedrine — the active substance in the plant ephedra — played a major role in the pitcher's death.

In an effort to quickly shed the weight he gained during the offseason, Bechler took over-the-counter diet pills containing ephedra. The drug had been banned by the NCAA, NFL and International Olympic Committee, but not by Major League Baseball.

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. The federal government banned it one year ago.

Campbell's ruling 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.

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On the Net:

Nutraceutical: http://www.nutraceutical.com/

FDA: http://www.fda.gov



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