FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra

Consumers Advised to Stop Using Ephedra Immediately

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

Press Release

Questions and Answers about FDA's Actions on Dietary Supplements Containing Ephedrine Alkaloids (updated February 6, 2004)

Documents About FDA's February 2003 Actions on Ephedra

• Press Release (Feb. 6, 2004)
• Fact Sheet (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

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

Additional Background