Medicolegal issues and ergogenic aids: trade, tragedy, and public safety, the example of ephedra and the Dietary Supplement Health and Education Act.
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.
Phillips
George C
GC
Department of Pediatrics, University of Iowa Carver College of Medicine, JCP 2557, 200 Hawkins Drive, Iowa City, IA 52242-1083, USA. george-phillips@uiowa.edu
D019587:Dietary Supplements / Q000009:adverse effects; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D029789:Ephedra / Q000009:adverse effects; D006801:Humans; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing; D013177:Sports; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence