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Anabolic Steroids Experiences

Anabolic steroids & bodybuilding experiences

Federal Judge Strikes Down F.D.A.'s Ban on Ephedra

Friday, April 15, 2005

A federal judge in Utah today struck down the federal government's ban on the dietary supplement ephedra, which was pulled from the market last year after it was linked to more than 100 deaths.

The judge, Tena Campbell of the United States District Court in Salt Lake City, said that ephedra was a dietary supplement and that under rules of the Food and Drug Administration it was the government's burden to prove whether the supplement was harmful if taken in dosages recommended by the manufacturer. In this case, the judge said, the government had failed to do so.

Supplements that included ephedra have widely been used for weight loss and bodybuilding, but have been linked to 155 deaths, including that of Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles, in 2003.

The F.D.A. ordered ephedra taken off the market in April 2004. The Nutraceutical Corporation, a Utah company that manufactured the supplement, sued to overturn the ban.

In a ruling dated Wednesday, the judge ordered the matter sent back to the F.D.A. "for further rulemaking consistent with the court's opinion" and said the agency must lift the ban on sales of ephedra until further review.

Judge Campbell said the F.D.A., in its review of the matter, had not provided research showing whether ephedra was harmful if taken at dosages of 10 milligrams per day of ephedra alkaloids recommended by Nutraceutical in its packaging.

In his 19-page ruling, Judge Campbell said that the government had determined that "a dietary supplement shall be deemed a food," and that under those rules governing the safety of food "the government must produce the preponderance of the evidence as to the harmful effects from the dietary supplement when used as recommended and suggested in the labeling."

"The F.D.A. must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury," the judge said. "The proper focus here is on the evidence the F.D.A. presented regarding the risks of low-dose" ephedra supplements.

An F.D.A. spokeswoman, Kimberly Rawlings, told news agencies that the F.D.A. was reviewing the decision.

The president of Nutraceutical, Bruce Hough, said in a statement that "the court's ruling clarifies the steps F.D.A. must take to comply with the law in its regulation of dietary supplements."

You can read the whole sentence at: http://anabolic-steroids.blogspot.com/ephedra.pdf
posted by Frank Mori, Friday, April 15, 2005