New Supplement Rule Was Not Previewed in Ephedra Proposal – Nutraceutical
This article was originally published in The Tan Sheet
Executive Summary
FDA's 1997 proposed rule on ephedra did not foreshadow the agency applying a new adulteration standard to all dietary supplements; this renders the 2004 ban a violation of the Administrative Procedures Act, Nutraceutical Corp. argues in the latest filing in its suit against the agency
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Ruling to FDA in Nutraceutical case
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...
Ruling to FDA in Nutraceutical case
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...
Ruling to FDA in Nutraceutical case
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...