On February 6, 2004, the US Food and Drug Administration banned dietary supplements containing ephedrine alkaloids(ephedra) pending Congressional review. The ban culminates a 7-year regulatory process, the first of its kind under the Dietary Supplement Health and Education Act (DSHEA). This paper reviews that process, and the governing rules of DSHEA, within the contexts of modern science and the history of food and drug legislation. The example of ephedra reflects a longstanding conflict between trade and safety and suggests inherent weaknesses within DSHEA that place the public at risk.
(C) 2004 American College of Sports Medicine