Nutraceutical Corp. has filed a motion for rehearing and for rehearing en banc of the decision of the United States Court of Appeals for the Tenth Circuit in Neutraceutical Corp. v. Von Eschenbach, No. 05-4151 (Aug. 17, 2006).
The Tenth Circuit’s decision reversed the Utah District Court and held that the FDA’s ban on low dose ephedra was not arbitrary or capricious.
According to counsel for Nutraceutical, Emord & Associates, P.C.,
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.”
The petition explains that, in context, the statutory term “unreasonable risk” is defined as that dose level that causes illness or injury and above. The statutory term “significant,” by contrast, “describes the degree of illness or injury incurred (e.g., a tumor as opposed to a headache).”
To read the petition for rehearing, click here.