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10th Circuit Refuses to Rehear Ephedra Case Nutraceutical Appeals to Supreme Court
By Emord & Associates
October 19, 2006
Denver-In a per curiam decision (without a written opinion) issued on October 18th, the U.S. Court of Appeals for the Tenth Circuit denied Nutraceutical Corporation's petition asking the court to rehear its decision to overturn the decision of Judge Tena Campbell (U.S. District Court, Utah) striking FDA's Final Rule banning all ephedrine-alkaloid containing dietary supplements, regardless of dose.
Nutraceutical will file on or before January 8, 2007, a petition seeking U.S. Supreme Court review of the case. If the Supreme Court denies review, the case will continue on remand before District Court Judge Campbell on two remaining causes of action under the Administrative Procedure Act that have not yet been tried. In those causes of action raised in the original complaint, Nutraceutical argues that FDA's Final Rule is invalid because the FDA never gave notice in the Federal Register of its risk-benefit test for dietary supplement adulteration, thus denying the regulated class its statutory right to comment on the test before adoption of the rule. In another yet to be tried cause of action in the original complaint, Nutraceutical argues that the FDA violated the APA prohibition on arbitrary and capricious decision making by banning ephedrine-alkaloids from supplements but allowing their use in foods and traditional Chinese medicines.
