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Ruling to FDA in Nutraceutical case

This article was originally published in The Tan Sheet

Executive Summary

U.S. District Judge for the district of Utah, Paul G. Cassell finds FDA's rulemaking banning ephedra dietary supplements was "procedurally and substantially proper" on March 16. However, Jonathan W. Emord of Emord & Associates says in an e-mail "one critical point" in the decision "cuts against the FDA": Cassell found FDA "explicitly limited its rulemaking and the reach of its final rule" to ephedra supplements. Thus, even if this decision stands it ensures the Final Rule "is not precedent for the creation of a supplement-wide risk-benefit adulteration standard," Emord says. Nutraceutical had sought summary judgment that the agency acted in an arbitrary and capricious manner and violated administrative procedure law in issuing the 2004 ban of ephedrine-alkaloid dietary supplements (1"The Tan Sheet" Feb. 19, 2007, p. 13). Emord says the law firm will file a notice of appeal to the Tenth Circuit on March 19...

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