Because of the Dietary Supplement Health and Education Act of 1994, dietary supplements are not subject to the pre-market scrutiny that is required of new foods or new drugs. However, according to the Act, these dietary supplements can be restricted if their ingredients are shown to pose a health risk (DSHEA synopsis, 1995). After receiving over 800 reports linking adverse physiological effects to ingestion of ephedrine-based dietary supplements between 1993 and 1997, the FDA determined that this was a public health concern, justifying further investigation into the matter. In 1996, the Food Advisory Commitee convened to address the problem. Over half of the committee were of the opinion that ephedrine was unsafe and should be removed from the market entirely, while the rest felt that when present in smaller doses, ephedrine did not constitute a health concern. Overall, the committee concluded that as a dietary supplement, ephedrine confers no benefits (GAO, 1999). As a result, in 1997, the FDA published a proposal for ephedrine regulation in the Fedreral Register, prohibiting any dietary supplements containing greater than 8 milligrams of ephedrine. Furthermore, the FDA also proposed prohibition of combinations of ephedrine with other known stimulants, such as caffeine. This was the first time the FDA had acted on the DSHEA of 1994 (Turk, 1997). Having been asked by the House of Representatives' Committee on Science to analyze the FDA's basis for such a proposal, the United States General Accounting Office published a report criticizing the FDA's basis for its conclusion, stating that FDA's treatment of evidence was unscientific and hasty (GAO, 1999). In response to the GAO's criticism, the FDA withdrew the 8 milligram criteria, along with the proposed restriction on ephedrine/stimulant combinations, from its proposed rule, admitting that the information available in 1997 was not sufficient to justify such a regulation (FDA, 2000). In defense of the FDA, the GAO did maintain that the FDA was justified in its concern raised by the huge number of adverse event reports (GAO, 1999). The FDA is continuing investigation, having requested that independent conduction of review and analysis of the numerous reports be performed (Haller and Benowitz, 2000).

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© Copyright 2001 Department of Biology, Davidson College, Davidson, NC 28036. Send comments, questions, and suggestions to: jokogoy@davidson.edu