Court reopens door to ephedrine alkaloids

A U.S. district court has reopened the door to the use of ephedrine alkaloids. On April 13, U.S. district judge for Utah, Tena Campbell, ruled that the Food and Drug Administration failed to prove that 10 milligrams or less of ephedrine alkaloids presents a risk. She remanded to the FDA for further rulemaking consistent with her court order and barred the FDA from taking enforcement action against the plaintiffs for the sale of their dietary supplement containing 10 milligrams or less of ephedrine alkaloids per daily dose.

The plaintiffs in this case were Nutraceutical Corp. and Solaray, Inc.

The ruling has no effect on FDA’s ban on products that contain a higher dose of ephedrine.

This case is Nutraceutical Corporation and Solaray, Inc., Plaintiffs, vs. Lester Crawford, D.V.M., Acting Commissioner, U.S. Food and Drug Administration, et al., Defendants, and can be downloaded at www.utd.uscourts.gov/documents/crawford.html.

Source: United States District Court for the District of Utah, http://www.utd.uscourts.gov/

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