Public Citizen | Publications - Letter to American Medical Association urging their support of HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids (HRG Publication #1604)

Letter to American Medical Association urging their support of HRG petition to the FDA to ban dietary supplements containing ephedrine alkaloids (HRG Publication #1604)



January 17, 2002

Michael D. Maves, MD, MBA
Executive Vice President
American Medical Association
515 N. State Street
Chicago, IL 60610
312-464-5000

Dear Dr. Maves,

            On September 28th, 2000 your predecessor, Dr. E. Ratcliffe Anderson, Jr., called upon the Food and Drug Administration (FDA) to initiate proceedings to remove dietary supplements containing ephedrine alkaloids from the United States market. [1] Citing §402 (f)(1)(A)(i) of the Food Drug and Cosmetic Act, the American Medical Association (AMA) sought to have ephedrine alkaloid dietary supplements deemed adulterated due to their significant or unreasonable risk of illness or injury. [2] 

Public Citizen s Health Research Group (HRG) shares the AMA s concern with the continued marketing of ephedrine alkaloid dietary supplements. Therefore HRG and Dr. Raymond Woosley, Vice President for Health Sciences at the University of Arizona, have filed a petition with the Department of Health and Human Services requesting (1) a ban on the sale and production of ephedrine alkaloid dietary supplements, and (2) an immediate FDA advisory to stop the use of ephedrine alkaloid dietary supplements due to the established risks of injury.[3] In addition to the evidence mentioned by Dr. Anderson in his letter, we based our petition on new adverse event data from the American Association of Poison Control Centers and an updated evaluation of adverse event reports to the FDA s Special Nutritional Adverse Event Monitoring System (SNAEMS).

Our analysis of the data shows that ephedrine alkaloid dietary supplements are associated with more reports of death, myocardial infarction, cardiac arrhythmia, hypertension, stroke and seizure than all other dietary supplements combined. SNAEMS reports that in the interval between January 1993 and February 2001 there were:

· 3308 adverse events for all dietary supplements, of which 1398 (42%) are associated with ephedrine alkaloid dietary supplements (EADS)

· 137 reports of death, 81 (59%) associated with EADS

· 38 reports of myocardial infarction/heart attack, 32 (84%) associated with EADS

· 98 reports of cardiac arrhythmias, 62 (63%) associated with EADS

· 144 reports of hypertension, 91 (63%) associated with EADS

· 85 reports of stroke, 69 (81%) associated with EADS

· 121 reports of seizure, 70 (58%) associated with EADS

Ephedrine alkaloid dietary supplements clearly pose a grave danger to their consumers, without providing any scientifically proven benefit. In response to similar data, on January 9th, 2002 the Canadian government called for a recall of all Ephedra/ephedrine products with labeled or implied claims for appetite suppression, weight loss promotion, metabolic enhancement, increased exercise tolerance, body-building effects, euphoria, increased energy or wakefulness, or other stimulant effects. [4] Furthermore, Health Canada advised Canadians to stop using these products in light of the risks mentioned above. Given the AMA s stated position on ephedrine alkaloid dietary supplements, HRG urges the AMA to immediately join us in our recent petition to ban these dangerous products. Correspondence to the FDA in support of our petition may be sent to FDA Docket 01P-0396.  

The AMA has had the foresight to recognize that our current problem with the lax regulation of dietary supplements is a direct result of the inadequacies of the Dietary Supplement Health and Education Act of 1994 (DSHEA).[5] To that end the AMA has officially called on Congress to modify DSHEA, and has developed appropriate draft legislation which would enhance the FDA s ability to protect consumers by mandating that all supplements, including those already on the market, undergo FDA approval for evidence of safety and efficacy.[6] We hope that your commitment to enforcing existing AMA policy will prevail over your previous belief, when president of the Consumer Healthcare Products Association (CHPA), that DSHEA [currently] grants the U.S. Food and Drug Administration and the U.S. Federal Trade Commission the proper enforcement authority over dietary supplements.[7] Though you have previously stated that you do not see much of an opportunity for the opponents of DSHEA to change this law, and have threatened to use the CHPA s broad experience from 120 years in the over-the-counter industry to defend [the CHPA s] interests in this area, we hope the you are capable of adopting more pro-patient rather than pro-industry views on this important issue.[8]

The AMA s existing policies on dietary supplements clearly have the public s health and safety in mind. We urge you to honor these policies by joining our petition and redoubling the AMA s efforts to reform DSHEA.

Sincerely,

Amer K. Ardati
Research Associate
Public Citizen s Health Research Group

Sidney M. Wolfe, MD
Director
Public Citizen s Health Research Group





[1] Anderson, E, Ratcliffe. AMA Letter to the Food & Drug Administration re: Dietary Supplements Containing Ephedrine Alkaloids. September 28, 2000.

[2] 21 USC 331(a), and 342(f)

[3] HRG Petition to the Secretary of Health and Human Services requesting the ban of production and sale of dietary supplements containing ephedrine alkaloids. September 5, 2001. (FDA Docket # 01P-0396)

[4] See Advisory: Health Canada requests recall of certain products containing Ephedra/ephedrine. January 9th, 2002.

[5] Anderson, E. Ratcliffe. AMA Letter to Michael Mangano. The AMA believes that the primary problem is the Dietary Supplement Health and Education Act of 1994, which failed to provide for adequate regulatory oversight of dietary supplement products by the FDA In that regard, the AMA believes the United States Congress needs to modify DSHEA& The AMA has developed draft legislation to this end. April 26, 2001. Also AMA Policy H-150.954 (2)

[6] ibid.

[7] See News Release of the Consumer Healthcare Products Association. September 10, 2001.

[8] See 2001 President s Report of the CHPA Annual Executive Conference. March 9, 2001.