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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.

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