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P03-106 |
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The Food and Drug Administration (FDA) is alerting the public to its forthcoming determination that dietary supplements containing ephedra present an unreasonable risk of illness or injury, and should not be consumed. The agency has notified firms manufacturing and marketing these products that it intends to issue a final rule prohibiting their sale, which will become effective 60 days after its publication.
The FDA has taken this step after conducting an exhaustive and highly resource-intensive process required under the Dietary Supplement Health and Education Act (DSHEA) of 1994 for banning a dietary supplement that presents a significant and unreasonable risk to human health.
To meet this challenging standard, the FDA gathered and thoroughly reviewed a prodigious amount of evidence about ephedra's pharmacology; clinical studies of ephedra's safety and effectiveness; newly available adverse events reports; the published literature; and a seminal report by the RAND Corporation, an independent scientific institute. The FDA also reviewed tens of thousands of public comments on the agency's request in February, 2003 for information about ephedra-associated health risks.
The totality of the available data showed little evidence of ephedra's effectiveness except for short-term weight loss, while confirming that the substance raises blood pressure and otherwise stresses the circulatory system. These reactions have been conclusively linked to significant adverse health outcomes, including heart ailments and strokes.
By informing more than 60 dietary supplement firms about the upcoming final rule, FDA is sending a strong and unambiguous signal that dietary supplements containing ephedrine alkaloids present an unreasonable risk. Consumers are urged to stop buying and using these products immediately.
Ephedra, also called Ma Huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated under the Federal Food, Drug and Cosmetic Act of 1938 as a drug. In contrast to the DSHEA-regulated dietary supplements that contain natural ephedra, the safety and effectiveness of the synthesized ephedrine has to be proven by the manufacturer, not the FDA. In recent years ephedra products have been extensively promoted for aiding weight control and boosting sports performance and energy.
Today's announcement is a continuation of a process that started in June, 1997 when FDA first proposed to require a statement on dietary supplements with ephedra warning that they are hazardous and should not be used for more than 7 days. FDA modified this proposed rule in 2000, and in February 2003 it announced a series of measures that included strong enforcement actions against firms making unsubstantiated claims for their ephedra-containing products.
These measures have prompted voluntary compliance with FDA rules, voluntary product recalls, FDA warning letters, seizures and injunctions, criminal actions, and joint enforcement actions with the Federal Trade Commission and the Department of Justice. (More detail on these actions can be found at http://www.fda.gov/ola/2003/dietarysupplements 1028.html]). As a result, ephedra-containing dietary supplements advertised for enhanced sport performance have been removed from the market, there has been a significant decline in the demand for ephedra products, and many firms have stopped their marketing.
Additional information relating to today's announcement is available online at www.cfsan.fda.gov/~dms/ds-ephed.html.
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