Nutraceutical Continues Fight Against Ephedra Ban

By William Murphy

Published on October 04, 2006

Nutraceutical's September 28 filing is the latest in a back-and-forth fight that began when Utah federal judge Tena Campbell ruled in April 2005 that the FDA had not proven that a 10 milligram daily dose of ephedra posed an unreasonable risk to consumers. Campbell's decision allowed ephedra to be sold in 10 milligram or smaller dosages, although few retailers resumed sales pending the ultimate outcome of litigation.

The FDA appealed Campbell's decision, and on August 17, 2006, a three-judge panel of the 10th U.S. Circuit Court of Appeals reversed the Utah judge's ruling, effectively banning the sale of ephedra in any amount. Nutraceutical argues in its current petition that the appeals panel erred when it used the same standards for post-market review of ephedra that are reserved for pre-market review of drugs.

Under the federal Dietary Supplement Health and Education Act, the FDA must prove that a supplement poses an unreasonable risk to consumers before it can be banned. Pharmaceuticals, however, must go through a strict pre-market FDA approvals process before drug companies can make them available to the public.

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