FDA issues alert on safety of dietary supplements containing ephedra – Newsletter – Brief Article
The U.S. Food and Drug Administration (FDA) recently issued a consumer alert that dietary supplements containing ephedra present an unreasonable risk of illness or injury, and should not be consumed. The agency also notified manufacturers and marketers of these products of its intent to publish a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids. The final rule will become effective 60 days after its publication. The FDA took this action after conducting a comprehensive evaluation of the pharmacology, safety, effectiveness, and adverse effects of dietary supplements containing ephedra. This process is required under the Dietary Supplement Health and Education Act of 1994 for banning a dietary supplement that presents a significant and unreasonable risk to human health. Ephedra, a naturally occurring substance derived from botanicals, is an adrenaline-like stimulant that can have potentially dangerous effects on the heart. Its principal active ingredient is ephedrine which, when chemically synthesized, is regulated as a drug. Products containing ephedra have been promoted to aid weight loss, enhance sports performance, and increase energy. For more information and links to related documents, go online to http://www.hhs.gov/news/press/2003pres/20031230.html.
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