Overview

Warnings and Safety Information

Adverse Reaction Reporting

Announcements & Meetings

General Information

Industry Information & Regulations

Questions & Answers

Other Sources of Information

Alerts and Related Information

• FDA Press Release: FDA Issues Regulation Prohibiting Sale of Dietary Supplements Containing Ephedrine Alkaloids and Reiterates Its Advice That Consumers Stop Using These Products February 6, 2004
  • Questions and Answers about FDA's Actions on Dietary Supplements Containing Ephedrine Alkaloids February 6, 2004
  • Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk Federal Register, February 11, 2004
  • Final Rule Summary February 6, 2004
• FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra December 30, 2003
  • Press Release December 30, 2003
  • Consumer Alert December 30, 2003
  • Questions and Answers about FDA's Actions on Ephedra Dietary Supplements December 30, 2003
  • FDA Letter to Firms Marketing Ephedra Dietary Supplements December 30, 2003
  • Companies Marketing Ephedra Dietary Supplements that Received FDA's Letter Dec. 30, 2003. December 30, 2003
• FTC Charges Direct Marketers of Ephedra Weight Loss Products With Making Deceptive Efficacy and Safety Claims July 1, 2003
• HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra February 28, 2003
  • Evidence On The Safety And Effectiveness Of Ephedra: Implications For Regulation February 28, 2003
  • Fact Sheet February 28, 2003
  • Sample Warning Letter February 28, 2003
  • Summary of the Rand Report on Ephedra February 28, 2003
  • Rand Report: Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects. February 2003
• FDA Announces The Availability Of New Ephedrine And "Street Drug Alternative" Documents March 31, 2000
  • Adverse Event Reports Associated with the Use of Dietary Supplements Containing Ephedrine Alkaloids
• FDA Proposes Safety Measures for Ephedrine Dietary Supplements Press release June 2, 1997
• FDA Statement on Street Drugs Containing Botanical Ephedrine Press Release, April 10, 1996
• FDA Warns Consumers Against Nature's Formula One February 22, 1995
• Adverse Events with Ephedra and Other Botanical Dietary Supplements FDA Medical Bulletin, September 1994

Testing Methodology

• FDA's Analytical Methods for Testing of Products Believed to Contain Ephedrine Alkaloids March 2005

Public Meetings

• Letter About Public Meeting on August 8, 2000, Concerning the Safety of Dietary Supplements Containing Ephedrine Alkaloids
  • Transcripts of the Meeting August 8-9, 2000
  • Meeting summary
• Food Advisory Committee Meeting on Dietary Supplements Containing Ephedrine Alkaloids. August 27-28, 1996
  • Transcripts and Minutes of the Meeting August 27-28, 1996
• Minutes of the Special Working Group on Food Products Containing Ephedrine Alkaloids FDA Food Advisory Committee, Oct 11-12, 1995

Proposed and Final Regulations

• Final Rule Declaring Dietary Supplements Containing Ephedrine Alkaloids Adulterated Because They Present an Unreasonable Risk Federal Register, February 11, 2004
• Reopening of the Comment Period: Dietary Supplements Containing Ephedrine Alkaloids; February 28, 2003
• Reopening of Comment Period: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, July 31, 2000 (also available in PDF)
• Notice: Public Meeting on the Safety of Dietary Supplements Containing Ephedrine Alkaloids August 8, 2000 Federal Register, July 12, 2000
• Notice of Availability; Extension of Comment Period: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, May 22, 2000 (also available in PDF)
• Notice of Availability: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, April 3, 2000 (also available in PDF)
• Administrative Docket Update; Availability: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, April 3, 2000 (also available in PDF)
• Proposed Rule; Withdrawal in Part: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, April 3, 2000 (also available in PDF)
• Proposed Rule: Dietary Supplements Containing Ephedrine Alkaloids Federal Register, June 4, 1997