U.S. Supreme Court to Review 10TH Circuit Ephedra Decision?
Denver, CO -- Today Nutraceutical Corporation filed a Petition for a Writ of Certiorari with the U.S. Supreme Court. The petition asks the Court to review a 10th Circuit Court of Appeals decision which reinstated the FDA ban on dietary supplements containing ephedra. The U.S. District Court for the District of Utah struck the ban as unlawful under the Food Drug and Cosmetic Act (FDCA). Counsel for Nutraceutical on the Petition for a Writ of Certiorari are University of Chicago professor of law Richard A. Epstein and Jonathan W. Emord of Emord & Associates.
In its petition, Nutraceutical states:
...[T]he FDA has nullified the bedrock of adulteration law, that dose determines toxicity. It has negated the fundamental requirement that FDA prove a dietary ingredient itself, rather than a surrogate substance, i.e., a drug, a significant risk before banning the ingredient from the market. Without statutory authorization and against the plain and intended meaning of Congress, FDA has superimposed on the Adulterated Food section a drug risk-benefit standard, eliminating the essential divide between foods and drugs created by the FDCA and rendering the critically important Adulterated Food section internally inconsistent and irrational. That rewrite of the law is causing instability in food and supplement markets.
For a copy of Nutraceutical’s, Petition for Writ of Certiorari call Shannon Young at 202-466-6937.