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FDA Fact Sheet

February 28, 2003

HHS Acts to Reduce Safety Concerns
Associated with Dietary Supplements Containing Ephedra

TODAY'S ACTION:

The Department of Health and Human Services (HHS) today reported on new evidence, including a study by the RAND Corporation, suggesting that dietary supplements containing ephedra may present significant or unreasonable risks as currently marketed, and announced a series of actions designed to protect Americans from these risks. Announced actions by the Food and Drug Administration (FDA) included:

• Seeking rapid public comment on the new evidence on health risks associated with ephedra, to establish an up-to-date public record as quickly as possible to support any appropriate new restrictions on ephedra-containing products.
• Seeking rapid public comment on whether the currently available evidence and medical literature present a "significant or unreasonable risk of illness or injury" from dietary supplements containing ephedra. This is the standard that must be met under the Dietary Supplement Health and Education Act for the government to take regulatory action on ephedra.
• Seeking rapid comment on a strong new warning label on any ephedra products that continue to be marketed. The proposed label warns about reports of serious adverse events after use of ephedra, including heart attack, seizure, stroke, and death; cautions that the risk can increase with the dose, with strenuous exercise, and with other stimulants such as caffeine; specifies certain groups (such as women who are pregnant or breast feeding and persons under 18) who should not use these products; and lists other diseases, such as heart disease and high blood pressure, that should rule out the use of ephedrine alkaloids.
• Issuing a set of warning letters against ephedra products making unsubstantiated claims about sports performance enhancement. The RAND study found only minimal scientific evidence in support of such health claims.

NEW RAND CORPORATION STUDY

The RAND study, commissioned by the National Institutes of Health and released today, reviewed recent evidence on the risks and benefits of ephedra and ephedrine. The study found limited evidence of an effect of ephedra on short-term weight loss, and minimal evidence of an effect on performance enhancement in certain physical activities. It also concluded that ephedra is associated with higher risks of mild to moderate side effects such as heart palpitations, psychiatric and upper gastrointestinal effects, and symptoms of autonomic hyperactivity such as tremor and insomnia, especially when it is taken with other stimulants. The study reviewed over 16,000 adverse events reported after ephedra use and found about 20 "sentinel events" including heart attack, stroke, and death that occurred in the absence of other contributing factors. In conjunction with other recent studies of serious adverse events involving persons taking ephedra, the RAND study adds significantly to the evidence suggesting that ephedra as currently marketed may be associated with unreasonable safety risks.

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Additional materials:

• Press Release
• White Paper
• Sample Warning Letter
• List of Warning Letters
• Federal Register
• "Ephedra and Ephedrine for Weight Loss and Athletic Performance Enhancement: Clinical Efficacy and Side Effects" (Rand Report)
• Summary of the Rand Report on Ephedra
• FTC Charges Direct Marketers of Ephedra Weight Loss Products With Making Deceptive Efficacy and Safety Claims (July 1, 2003)
  

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