Agencies respond to potential risks of supplements containing ephedra – Newsletter – Brief Article
The Department of Health and Human Services (HHS) recently announced a number of actions designed to protect Americans from the potentially serious risks of dietary supplement products containing ephedra. The results of a RAND corporation study commissioned by the National Institutes of Health provided evidence that ephedra may be associated with health risks and found only limited evidence of health benefits resulting from the use of ephedra. The U.S. Food and Drug Administration (FDA) and HHS actions include: (1) seeking rapid public comment on the new evidence on health risks associated with ephedra to establish an up-to-date record to support new restrictions on ephedra-containing products; (2) seeking comment on whether the currently available evidence presents a “significant or unreasonable risk of illness or injury” from dietary supplements containing ephedra; (3) seeking comment on a strong new warning label on any ephedra products that continue to be marketed; and (4) immediate execution of a series of actions against ephedra products making unsubstantiated claims about sports performance enhancement. The FDA also proposed a label for all ephedra-containing dietary supplements that warns about the risks of serious adverse events, including heart attack, seizure, stroke, and death, and cautions that these risks can increase with the dose, strenuous exercise, and with the concomitant use of other stimulants such as caffeine. Ephedra is a naturally occurring substance derived from the Chinese herb ma huang, and its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. Products containing natural ephedrine have been used to promote weight loss, enhance sports performance, and increase energy.
COPYRIGHT 2003 American Academy of Family Physicians
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