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Sales of Supplements Containing Ephedrine Alkaloids (Ephedra) Prohibited

On April 12, 2004, a final rule went into effect prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra).

Ephedra, also called Ma huang, is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted to aid weight loss, enhance sports performance, and increase energy.

But FDA has determined that ephedra presents an unreasonable risk of illness or injury. It has been linked to significant adverse health effects, including heart attack and stroke.

Press Release (April 12, 2004)

Press Release (February 6, 2004)

Federal Register - Final Rule

Final Rule Summary

Questions and Answers about FDA's Actions on Dietary Supplements Containing Ephedrine Alkaloids

Documents About FDA's December 2003 Ephedra Consumer Alert

• Consumer Alert
• FDA Letter to Firms Marketing Ephedra Dietary Supplements
• List of Firms that Received FDA’s Letter
• Press Release (Spanish version)

Documents About FDA’s February 2003 Actions on Ephedra

• Press Release (Feb. 28, 2003)
• Fact Sheet (Feb. 28, 2003)
• White Paper (Feb. 28, 2003)
• Rand Report: Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects (February 2003)
• Summary of the Rand Report on Ephedra
• Sample Warning Letter
• List of Firms that Received FDA's Warning Letter

FTC Charges Direct Marketers of Ephedra Weight Loss Products With Making Deceptive Efficacy and Safety Claims (July 1, 2003)

Additional Background

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