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Denver, CO -- In a per curiam decision (without a written opinion) issued on October 18, 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.

In a pertinent part the petition faults the panel for imposing "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved by statute for pre-market review of drugs," explaining that the "decision's impact extends far beyond a ban on EDS" by granting "FDA authority to declare any dietary ingredient adulterated on FDA's subjective assessment of the adequacy of the ingredient's health benefits if FDA finds even so much as an infinitesimal risk of illness or injury from ingestion of the ingredient (a ubiquitous condition because all ingredients pose some risk at some dose)." The petition faults the panel for interpreting the Food Adulteration provision of the Act to be internally inconsistent and irrational: "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."

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 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 FDA violated the APA prohibition on arbitrary and capricious decisionmaking by banning ephedrine alkaloids from supplements but allowing their use in foods and traditional chinese medicines.