Ephedra Decision Overturned

Nutraceutical Corp. v. Eschenbach, August 17, 2006

In this case, the 10th Circuit overturned an order entered in favor of manufacturers of dietary supplements containing ephedra. The 10th Circuit held that the FDA properly carried out its statutory function by determining that there was no safe level of ephedra. What is particularly interesting is that the 10th Circuit commented that the FDA’s own expert “exaggerated margins of error in order to come to a conservative conclusion that the cardiovascular effects produced by a dose of 9 mg of EDS daily may be dangerous.” The Court then went on to note that the FDA relied on other work to support its conclusion.