By Rakesh M. Amin
Over the years, products containing ephedra have been widely publicized for many uses including consumer weight loss and athletic performance enhancement. On December 30, 2003 the United States Food & Drug Administration (FDA) issued a consumer alert on the safety of dietary supplements containing ephedra, specifically advising consumers to stop purchasing and using products containing ephedra.1 Simultaneous to the consumer alert, the FDA notified manufacturers of its intention to publish a final rule stating that dietary supplements containing ephedrine alkaloids create an unreasonable risk of illness or injury for consumers.2
The rule hopes to combat purported escalation in the alleged unreasonable health risks associated with dietary supplements containing ephedra. The FDA reported that studies have found little evidence for effectiveness other than short term weight loss, but suggests safety risks including potentially dangerous effects on the heart.3
The FDA first proposed a rule in 1997 requiring a warning label be placed on dietary supplements containing ephedra and proposing various limitations in dosage (e.g., 8 mg ephedra alkaloids per dose, 24 mg total intake per day; banning the combination of ephedra with caffeine-containing herbs, etc.).4 In 2000 the FDA modified its proposal, and followed up in February 2003 announcing a series of comprehensive actions designed to protect Americans from what the agency considered the potentially serious risks of using dietary supplements containing ephedra.5 The rule will have the effect of banning the sale of dietary supplements containing ephedrine alkaloids and would become effective sixty (60) days after publication.
The FDA’s proposed ban follows the current trend of state legislation restricting the sale and use of dietary supplements containing ephedrine alkaloids. Currently three states, Illinois, New York and California, have developed and placed into effect legislation outlawing the retail sale of dietary supplements containing ephedra and/or any of its alkaloids.6, 7, 8 States do allow a narrow exception to an otherwise ban on the sale of products containing ephedra. State legislation currently permits conventional health professionals to prescribe products containing ephedra alkaloid-containing products (i.e., prescription and nonprescription drugs) within the scope of their practice as explicitly approved by the FDA.
The FDA has regulated ephedra products according to standards of the Dietary Supplement Health and Education Act of 1994 (DSHEA), placing the burden of proof on the government to show that the supplement presents a significant or unreasonable risk of illness or injury under the conditions recommended or suggested in labeling.9
For more information on the FDA ban on the sale of dietary supplements containing ephedra, visit http://www.fda.gov/oc/initiatives/ephedra/december2003/. Also, an extensive monograph on ephedra from ABC’s new book The ABC Clinical Guide to Herbs, and various related articles on ephedra research and regulation from previous issues of HerbalGram and HerbClip are available on ABC’s website, at www.herbalgram.org. Further inquiries or comments can be directed to Rakesh M. Amin at Amin Law, LLC, by telephone (312) 327-3382 or send an email to Rakesh@amin-law.com.
1 See Consumer Alert: FDA Plans Regulation of Prohibiting the Sale of Ephedra-Containing Dietary Supplements and Advises Consumers to Stop Using These Products, (December 30, 2003), available at <http://www.fda.gov/oc/initiatives/ephedra/december2003/advisory.html>.
2 Baca, J., Representative Letter Sent by the FDA to Companies Marketing Ephedra Dietary Supplements, (December 30, 2003) available at <http://www.fda.gov/oc/initiatives/ephedra/december2003/warningltr.html>.
3 Shekelle, Paul, M.D. PhD., et al., Evidence Report/Technology Assessment Number 76, Ephedra and Ephedrine for Weight Loss and Athletic Performance: Clinical Efficacy and Side Effects, RAND Report (February 2003), available at <http://www.fda.gov/bbs/topics/NEWS/ephedra/summary.html>.
4 21 C.F.R. Part 111, Dietary Supplements Containing Ephedrine Alkaloids, (June 4, 1997), available at <http://www.cfsan.fda.gov/~lrd/fr97064a.html>.
5 HHS Acts to Reduce Potential Risks of Dietary Supplements Containing Ephedra, FDA News, February 28, 2003), available at <http://www.fda.gov/bbs/topics/NEWS/2003/NEW00875.html>.
6 720 ILCS 602, Ephedra Prohibition Act, Illinois General Assembly, (May 28, 2003), available at <http://www.legis.state.il.us/legislation/ilcs/ilcs2.asp?ChapterID=53>.
7 Laws of New York: Chapter 385, Bans the sale of dietary supplements containing ephedra; provides exemptions for non-prescription over the counter drugs approved or regulated by the FDA; further provides for criminal penalties, (August 19, 2003), available at <http://public.leginfo.state.ny.us/menugetf.cgi>.
8 California Senate Bill 582, Ephedrine Group Alkaloids, (effective January 1, 2004), available at <http://info.sen.ca.gov/pub/bill/sen/sb_0551-0600/sb_582_bill_20030911_enrolled.html>.
9 Dietary Supplement Health and Education Act of 1994, Public Law 103-417, 103rd Congress, (October 25, 1994), available at <http://www.fda.gov/opacom/laws/dshea.html>.
EDITOR’S NOTE: This article had not been peer-reviewed at the time this newsletter was sent. An edited and peer-reviewed version, including the FDA’s final ruling, will be published in an upcoming issue of HerbalGram.