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FIRMS SEEK TO INVALIDATE EPHEDRA BAN, PREVENT ENFORCEMENT ACTION
By FDAnews Drug Daily Bulletin
September 03, 2004
The manufacturers of the dietary supplement ephedra have asked a U.S. District Court to invalidate the FDA rule banning the substance and to enjoin the FDA from enforcement action against the plaintiffs for the continued sale of ephedra in low doses.
A motion for summary judgment filed in the U.S. District Court for the District of Utah's central division argues that the FDA violated sound scientific procedures and several statutory laws in arriving at its conclusion that the substance should be banned. The ban took effect in April of this year.
Two firms, Nutraceutical and Solaray, initially filed suit against the FDA in May, shortly after the ban took effect. The firms have marketed whole-herb ephedra as a dietary supplement since at least 1988. Though only Nutraceutical and Solaray are plaintiffs in the litigation, when the FDA was proceeding against the supplement it sent warning letters to more than 60 dietary supplement firms.
The rule banning ephedra marked the first time the FDA used its authority under the 1994 Dietary Supplement Health and Education Act (DSHEA) to ban dietary supplements. The agency said it had received 16,000 ephedra-related adverse events reports leading up to the ban.
