Nutraceutical Files Motion in Ephedra Fight

SALT LAKE CITYOn Feb. 9, Nutraceutical Corp. filed a responsive motion in U.S. District Court, Utah, in its case against the Food and Drug Administrations (FDA) ephedra ban, rebuffing FDAs contention it complied with the Administrative Procedures Actrelative to Federal Register notification and public comment allowance. Specifically, Nutraceutical told the court: FDA did not offer the public a proposed new standard defining adulteration for all dietary supplements (the very thing it adopted in the 2004 Final Rule). The company contends FDAs method was, instead, pointed exclusively at ephedrine alkaloids shown to cause harm at specific daily serving levels, without even hinting whether a new standard would be adopted for all dietary supplements.

If FDAs contention that ephedrine alkaloids present an unreasonable risk at every dose levels is given credence, how can FDA fulfill its pubic health mission by exempting those same alkaloids in foods and Traditional Asian medicines, the company wrote. [FDA] has adopted a convoluted, irrational and capricious regulatory scheme, one that is contrary to its public health mission.