Low Dose Ephedra May Be Back on the Market

A U.S. District Court judge in Salt Lake City, Utah, has lifted the year-old Food and Drug Administration (FDA) ban on the herb ephedra and sent the matter back to FDA for further evaluation. The ruling found FDA regulators failed to meet the standard for outlawing low doses of ephedra and had not proved that the agency’s arbitrarily set dosages of 10 mg or less of ephedrine-alkyloid dietary supplements were dangerous. The ban on sales remains in place for all products containing 11 mg or more of the herb. According to FDA spokeswoman Kimberly Rawlings, the ruling applies nationally.

The April 2004 nationwide ban of ephedra was the first in the United States for a dietary supplement. On April 14, 2005, the Salt Lake City court ruled on a challenge to the ban from Nutraceutical International Corp. and Solray Inc. of Park City, Utah, both nutritional supplements manufacturers, stating FDA had failed to show that low doses of ephedra posed a “significant or unreasonable risk.” At press time, FDA officials were evaluating whether to appeal the court’s decision or if more research was necessary.

For more information on ephedra, go to The National Center for Complementary and Alternative Medicine (www.nccam.nih.gov).