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Sales of Supplements Containing Ephedrine Alkaloids (Ephedra) Prohibited

Dietary supplements that contain ephedra have been banned in the United States since April 2004. FDA banned the products after it determined that ephedra posed an unreasonable risk to those who used it.

Ephedra, also called Ma huang, is a plant or herb that contains ephedrine, a substance that is regulated by FDA as a drug when created chemically in the lab. As such, it is subject to strict federal standards for safety and effectiveness. However, ephedra has generally been marketed as an ingredient in dietary supplements, which are not bound by the same strict standards as drugs. Nevertheless, under a 1994 law, FDA can remove a dietary supplement from the market if it creates an unreasonable risk of illness or injury.

FDA has long regarded ephedra-based dietary supplements as potential health hazards. Substantial evidence of harm emerged in 2003, when a major study reported more than 16,000 adverse events associated with the use of ephedra-containing dietary supplements, including heart palpitations, tremors and insomnia. The study also found little evidence that ephedra is effective in boosting physical activities and weight loss -- as claimed by its promoters. FDA subsequently determined that ephedra presents an unreasonable risk of illness or injury. On April 12, 2004, the agency's final rule prohibiting the sale of dietary supplements containing ephedra went into effect.

Update: On May 14, 2007, the Supreme Court denied certiorari in the case of Nutraceutical Corp vs. von Eschenbach. The denial of certiorari means that the Supreme Court declines to review the Aug. 17, 2006, decision by the U.S. Court of Appeals for the Tenth Circuit that upheld FDA's 2004 regulation banning dietary supplements containing ephedrine alkaloids. Accordingly, the Tenth Circuit's decision stands and the regulation is in full force.

The documents below provide background on FDA's actions:

FDA Statement on Tenth Circuit’s Ruling to Uphold FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids (Aug. 21, 2006)

Dietary Supplements With Banned Ephedrine Alkaloids Seized (Feb. 24, 2006)

FDA Requests Seizure of More Dietary Supplements Containing Ephedrine Alkaloids (Jan. 12, 2006)

FDA Final Rule Banning Dietary Supplements With Ephedrine Alkaloids Becomes Effective (April 12, 2004)

FDA Issues Regulation to Prohibit Sale of Dietary Supplements Containing Ephedrine Alkaloid (Feb. 6, 2004)

Federal Register - Final Rule (Feb. 11, 2004)

Final Rule Summary

Questions and Answers

How FDA Tests Products Believed to Contain Ephedrine Alkaloids

Documents About FDA's December 2003 Ephedra Consumer Alert

• FDA Plans Regulation Prohibiting Sale of Ephedra-Containing Dietary Supplements
• FDA Letter Alerts Firms Marketing Ephedra Dietary Supplements
• List of Firms that Received FDA's Letter
• FDA Plans to Prohibit Sales of Dietary Supplements Containing Ephedra (Spanish version)

Documents About FDA's February 2003 Actions on Ephedra

• HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra (Feb. 28, 2003)
• Fact Sheet: HHS Acts to Reduce Safety Concerns Associated with Dietary Supplements Containing Ephedra (Feb. 28, 2003)
• White Paper: Evidence on the Safety And Effectiveness Of Ephedra: Implications For Regulation (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 Marketers of Ephedra Weight Loss Products With Making Deceptive Claims (July 1, 2003)

Additional Background

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