Ephedra Diet Pill Ban Challenged
Nutraceutical Corp. challenged the ephedra ban, and U.S. District Judge Tena Campbell in Salt Lake City ruled last year the ban could not be enforced against supplements containing doses of ephedra up to 10 milligrams. Since billions of servings of ephedra were consumed annually before the ban, reason dictates the diet pill is safe when used as directed. Ephedra is much safer than Vioxx, which the FDA said was safe until it was obvious it was not.

A FDA representative told the judges that Federal Judge Campbell did not understand the law or the FDA’s duties in regulating dietary supplements, especially ephedra dietary supplements. She also said Campbell essentially ignored scientific information on ephedra’s effects on the body.

Campbell ruled that the FDA improperly required Nutraceutical to prove there was some benefit to ephedra use. Instead, the judge ruled, and longstanding legal statutes agree that the FDA should have had to prove harm.

Kohl said the risk-benefit analysis the agency used was proper because it would have been “irresponsible” to commission a clinical study to prove harm after the FDA began receiving reports of adverse effects.