Burden, burden, who's got the burden?

On April 13, 2005, the U.S. District Court for the District of Utah invalidated FDA's final rule banning all dietary supplements containing ephedrine-alkaloids. The Utah federal court entered an injunction stopping FDA from taking any enforcement action to block manufacturers from selling supplements containing 10 mg or less of ephedrine-alkaloids per daily dose. The FDA's final rule - issued in February 2004 - had required dietary supplement manufacturers to prove an ephedrine-alkaloid dietary supplement created a significant benefit; otherwise, if FDA subsequently found any evidence of health risk associated with the supplement, the product would be considered by FDA to be an adulterated dietary supplement for which an agency enforcement action would follow. The Utah federal court, however, rejected the FDA's interpretation of the dietary supplement adulteration provision in the Food Drug and Cosmetic Act. The court held that federal law does not impose the burden on a dietary supplement manufacturer to prove a product's benefit to be lawfully saleable. Rather, the court held that federal law imposes the burden on FDA to determine the precise dose at which a dietary supplement produces toxicity and only then impose a ban at that level and above. In other words, the burden is on FDA to prove a dietary supplement is unsafe, not on a dietary supplement manufacturer to prove a dietary supplement is safe. The court's ruling - the case is Nutraceutical Corporation v. Crawford - declared FDA's ephedra ban unlawful, required FDA to reopen its ephedra rulemaking to perform a dose-dependent toxicity analysis, and enjoined FDA from taking any enforcement action to block manufacturers from selling dietary supplements containing 10 mg or less ephedrine-alkaloids per daily dose.