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FDA Announces Plans to Prohibit
Sales of Dietary Supplements Containing Ephedra

Consumers Advised to Stop Using Ephedra Immediately

On Dec. 30, 2003, FDA issued a consumer alert on the safety of dietary supplements containing ephedra. The alert advised consumers to immediately stop buying and using ephedra products.

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.

Also on Dec. 30, FDA notified manufacturers that it intends to publish a final rule stating that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury. The rule would have the effect of banning the sale of these products as soon as it becomes effective, 60 days after publication.

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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