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Court Boots Ephedra - Once Again Print E-mail
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Court Boots Ephedra - Once AgainFor now, fans of ephedra can kiss the weight-loss supplement goodbye.

An appeals court has sided with the federal government in its all-out ban on dietary supplements containing ephedra, also known as "ephedrine." The U.S. Court of Appeals in Denver Aug. 17 reserved a lower court decision that permitted sale of products with low-dose ephedra.

"The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure," agency officials said, in a news release.

The FDA banned the dietary supplements in 2004 after unearthing evidence linking the chemical to 16,000 adverse side effects, including heart attacks, strokes and deaths.

Winding through courts

In an appeal filed by supplement-maker Nutraceutical International Corp. in Park City, Utah, the lower court in Salt Lake City in 2005 allowed the sale of the low-dose products, and manufacturers began rushing to get their goods back on the shelves.

Now, Nutraceutical's lawyers vow to appeal all the way to the U .S. Supreme Court.

"The worry is that the FDA can say to anyone, 'We don't like you, you're out of here,'" says Jonathan Emord, the company's lead attorney in the case.

Michael McGuffin, president of the American Herbal Products Association, criticized the way the FDA weights the risks of a supplement against the benefits.
 
"The American Herbal Products Association has long had concerns about FDA's ruling on ephedrine and the outcome of this case," McGuffin says. "FDA refused, in its rule-making process, to acknowledge any benefits for ephedra, even for traditional uses. If the benefit side is judged as zero, the outcome of any risk/benefit analysis will necessarily be skewed.

"The industry will need to evaluate the implications of this as precedent."

Source: U.S. Food and Drug Administration

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