Ephedra Ban

Buy Metabadrine with Ephedra While Ban is Appealed

DENVER--Nutraceutical Corp. filed a Petition for Rehearing (or Rehearing en Banc) Sept. 28 in the 10th Circuit U.S. Court of Appeals, challenging the Aug. 17 decision by a three-judge panel that the Food and Drug Administration (FDA), in its ephedra ban, adhered to Congressional mandate in conducting a risk-benefit analysis to determine whether ephedra presents an “unreasonable risk of illness or injury.”

In its appeal, Nutraceutical is requesting the entire 10th Circuit court rehear the case, contending the three-judge panel from the court violated the Supreme Court's canons of statutory construction and raised questions of exceptional importance by reversing U.S. District Court Judge Tena Campbell's April 2005 ruling against FDA's risk-benefit analysis method.

Specifically, the appeal faults the three-judge panel for using "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved for pre-market review of drugs." It further claims the decision's impact extends farther than the ban on ephedra products, giving FDA open license to declare any dietary ingredient adulterated if the agency's subjective assessment finds no health benefits but finds even the slightest risk of illness or injury--any ingredient poses some risk. The appeal notes the definitions of the terms "unreasonable risk"--the dose level that causes illness or injury--and "significant"--which describes the degree of illness or injury incurred.

The company also challenges the court's interpretation of food adulteration. "FDA's rule produces the absurd result of causing raw, crushed Ephedra sinica herb to be unlawful when placed in a gelatin capsule, but legal when placed in a tea bag," it wrote in its appeal.

For more information on the appeal or for a copy of the petition, contact Nutraceutical's counsel, Emord & Associates, at (202) 466-6937.

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