U.S. District Court Rules on FDA Ephedra Rulemaking

April 4, 2007

On March 16, 2007, the U.S. District Court for the District of Utah ruled that FDA’s 2004 rulemaking banning ephedrine alkaloid dietary supplements [EDS] was “procedurally and substantively proper.”  Nutraceutical and Solaray brought the suit against FDA to prevent the Agency from enforcing its 2004 final rule banning EDSs of any dosage from the U.S. market.  The bases of the plaintiffs’ challenge were that FDA gave insufficient statutory notice and opportunity for comment on its use of a risk-benefit analysis to determine that EDS are adulterated, and that by banning EDS but not other products containing ephedrine alkaloids FDA’s action was arbitrary and capricious.  In April 2005, the District Court granted summary judgment in favor of the plaintiffs on their separate claim that the risk-benefit analysis used by FDA in the final rule did not conform to its statutory mandate.  However, in August 2006, the Tenth Circuit overturned the lower court’s decision, and the District Court has since granted summary judgment for the defendants on this point.

With regard to the plaintiffs’ notice and comment challenge, the court found that FDA had given adequate opportunity for notice and comment.  Judge Cassell noted that “[t]he [Administrative Procedure Act] requires only limited opportunity to participate – no more.”  Judge Cassell went on to state that the risk-benefit analysis FDA used in determining EDS were adulterated was specifically limited to EDS and had not been established for other dietary supplements.  However, it should be noted that nothing in the decision bars FDA from employing this same risk-benefit analysis in later rulemaking regarding the adulteration of other dietary supplements.  Furthermore, the EDS ban precedent would be useful to FDA if the Agency were sued with regard to its application of the risk-benefit analysis to another dietary supplement.  The court similarly found for the defendants on the plaintiffs’ arbitrary and capricious challenge.  Judge Cassell wrote “[t]he [Dietary Supplement Health and Education Act] requires the FDA to regulate dietary supplements differently than conventional foods –conventional foods and other drug products are subject to their own statutory and regulatory requirements. . . .”


By Bryon F. Powell