Date:   4/14/2005 2:59:29 PM ( 19 y ago)
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Judge Strikes Down FDA Ban on Ephedra
46 minutes ago Health - AP

By MARK THIESSEN, Associated Press Writer

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.


The judge ruled in favor of a Utah company that challenged the Food and Drug Administration's ban. Utah-based Nutraceutical claimed in its lawsuit that ephedra "has been safely consumed" for hundreds of years.


Supplements that included ephedra have been widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitching prospect Steve Bechler. The FDA ordered the substance off the market in April 2004.


Judge Tena 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.


FDA officials did not immediately return a call seeking comment.


Company president Bruce Hough said the decision is about "protecting the public's access to safe and effective dietary supplements."



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Court Rules in Favor of Nutraceutical


Park City, Utah (April 14, 2005) — Nutraceutical International Corporation (NASDAQ: NUTR) today announced an important court decision that it believes will benefit its retail customers and the public. On April 13, 2005, the United States District Court for the District of Utah, Central Division, granted Nutraceutical’s motion for summary judgment against FDA in Nutraceutical’s lawsuit involving FDA’s Final Rule on Ephedra.

Mr. Bruce Hough, President of Nutraceutical, commented that yesterday’s decision “is, in our view, about protecting the public’s access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court’s ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements.”

Mr. Hough continued, “The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are 'presumed to be safe.'”

Nutraceutical and its subsidiary Solaray, Inc. marketed whole-herb ephedra as a dietary supplement from 1988 until April of 2004. At the time the Final Rule on Ephedra was issued, Nutraceutical and Solaray’s product contained directions limiting dosage to 10 mg. or less of naturally occurring ephedrine alkaloids per daily serving. Under the Court’s Order, FDA’s Final Rule on Ephedra has been remanded to FDA for further rulemaking consistent with the Order, and FDA has been enjoined from taking enforcement action against Nutraceutical or Solaray for the sale of dietary supplements containing 10 mg. or less of ephedrine alkaloids per daily dose. FDA has the right to appeal the Court’s decision.

A complete copy of the Court’s decision may be found at http://www.nutraceutical.com/courtruling/.

 

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