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FDA to Ban Sales of Dietary Supplements Containing Ephedra

Published online by Cambridge University Press:  01 January 2021

Extract

On December 30, 2003, the FDA announced that it will publish a rule banning sales of ephedra - a dietary supplement often utilized for weight loss, increased energy, and enhanced athletic performance - because it poses an unreasonable health risk.The ban will be issued under the auspices of the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA), in response to a process that began in June of 1997, when the FDA first proposed a mandatory warning statement on dietary supplements containing ephedra. FDAs analysis of the scientific evidence has led it to conclude that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act?

Type
Recent Developments in Health Law
Copyright
Copyright © American Society of Law, Medicine and Ethics 2004

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References

U.S. Dept. of Health and Human Services, “FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra,” December 30, 2003.Google Scholar
U.S. Department of Health and Human Services, “FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” June 2, 1997.Google Scholar
21 U.S.C. § 342(f)(1)(a).Google Scholar
See “Questions and Answers About FDA’s Actions on Ephedra,” at <http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html> (last visited January 24, 2004).+(last+visited+January+24,+2004).>Google Scholar
“Government Announces Ban on Ephedra,” at <http://www.cnn.com/2003/HEALTH/12/30/ephedra> (last visited January 25, 2004).+(last+visited+January+25,+2004).>Google Scholar
“FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra,” supra note 1.Google Scholar
U.S. Food and Drug Administration, “Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” available at <http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html> (last visited February 20, 2004).+(last+visited+February+20,+2004).>Google Scholar
U.S. Department of Health and Human Services “FDA Statement On Street Drugs Containing Botanical Ephedrine,” April 10, 1996.Google Scholar
“Government Announces Ban on Ephedra,” supra note 5.Google Scholar
Kaufman, M., “U.S. to Stop Ephedra Sales: Diet Aid Called Unsafe,” Washington Post, December 31, 2003, at A01.Google Scholar
“FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” supra note 2.Google Scholar
“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.Google Scholar
“FDA Statement on Street Drugs Containing Botanical Ephedrine,” supra note 8.Google Scholar
“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.Google Scholar
“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.Google Scholar
5 U.S.C. §§ 801808.Google Scholar
“Questions and Answers about FDA’s Actions on Ephedra,” supra note 4.Google Scholar
U.S. Food and Drug Administration, “FDA Warns Against Drug Promotion of ‘Herbal Fen-Phen,” November 6, 1997.Google Scholar
Bechler v. Cytodyne Technologies, Plaintiffs Complaint at 1, available at <http://news.findlaw.com/hdocs/docs/ephedra/bechlercyto7l603cmp.pdf> (last visited February 20, 2004.+(last+visited+February+20,+2004.>Google Scholar
“FDA Warns Against Drug Promotion of ‘Herbal Fen-Phen,” supra note 18.Google Scholar
FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” supra note 2.Google Scholar
“Government Announces Ban on Ephedra”, supra note 5, quoting Annals of Internal Medicine.Google Scholar
“Questions and Answers About FDA’s Actions on Ephedra,” supra note 4.Google Scholar