Government Actions To Reduce Risks of Ephedra
On December 30, 2003, the U.S. Department of Health and Human Services (DHHS) and the Food and Drug Administration (FDA) notified manufacturers of the FDA's intent to publish a final rule on dietary supplements containing ephedrine alkaloids. The rule will have the effect of banning the sale of these dietary supplements when it becomes effective, 60 days following publication. In addition, FDA issued an alert to consumers advising them to stop using ephedra products immediately.
- Press Release: FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra (HHS; 12/30/2003)
- Consumer Alert: Stop Using Ephedra-Containing Dietary Supplements (FDA; 12/30/2003)
- Additional FDA Materials (FDA; 12/30/2003)
More information about ephedra…
- DHHS Fact sheet (2/28/2003)
- FDA Press release (FDA; 2/28/2003)
- FDA White Paper: Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation (FDA; 2/28/2003)
- RAND Report: Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects (AHRQ; March 2003)
- Report of Ephedra Working Group to the National Advisory Council for Complementary and Alternative Medicine (February 2003)
- FDA Press release (FDA; 3/31/2003)
The FDA announced enforcement actions against firms that are marketing street drug alternative products, some of which contain ephedra or other sources of ephedrine. - Review of Call Records (PDF) (GAO)
The General Accounting Office reviewed health-related call records for users of Metabolife 356.
Note: PDF files requires a viewer such as the free Adobe Reader.
