Eleventh Circuit Affirms That FDA’s Ephedra Final Rule Complied With the APA and that Seizure of Ephedra Supplements Was Proper

On October 7, 2008, the U.S. Court of Appeals for the Eleventh Circuit, in Hi-Tech Pharmaceuticals v. Lester M. Crawford, affirmed a district court decision finding that: (1) FDA complied with the Administrative Procedure Act (“APA”) in promulgating its final rule banning dietary supplements that contain ephedrine alkaloids; and (2) the government’s seizure of Hi-Tech Pharmaceuticals’ dietary supplements was proper because those supplements were adulterated.  (Hi-Tech Pharmaceuticals is not to be confused with Hi-Tech Pharmacal Co. Inc.)  Under FDC Act § 402(f)(1), a dietary supplement is adulterated if it presents a significant or unreasonable risk of illness or injury.  In any proceeding under that section, the government bears the burden of proof, and a court must decide the issues on a de novo basis.  Focusing on use of the term “de novo” in § 402(f)(1), Hi-Tech Pharmaceuticals argued that the FDC Act “requires a district court to hear original evidence on the question of adulteration, even where the FDA has conducted an administrative rulemaking process and promulgated a valid rule declaring the product adulterated.”  Noting that the issue was one of first impression, the appellate court disagreed, and held that “it is sufficient for the Government to present evidence that: (1) the regulation exists and (2) it applies to the product that is the subject of the enforcement action.”  The appellate court dismissed as meritless Hi-Tech Pharmaceuticals’ other arguments challenging the validity of FDA’s ephedra final rule.

By Ricardo Carvajal