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Denver, CO -- Today Nutraceutical Corporation filed its Petition for Rehearing or Rehearing en Banc in the United States Court of Appeals for the 10th Circuit. The petition calls on the entire 10th Circuit to rehear the case, explaining that the three judge panel of the court violated the Supreme Court's canons of statutory construction and raised questions of exceptional importance by reversing the U.S. District Court decision (Judge Tena Campbell presiding). Counsel for Nutraceutical on appeal include law professor Richard A. Epstein (University of Chicago), Jonathan W. Emord (Emord & Associates) and Marcy G. Glenn (Holland & Hart).
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."
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)."
A copy of the petition is available upon request.
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