Regulatory Status

In 2004, the FDA issued a final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids (ephedra), citing concerns over safety and potential risk of illness or injury.

The FDA reviewed evidence about ephedra's pharmacology: peer-reviewed scientific literature on ephedra's safety and effectiveness, adverse event reports, and a seminal report by the RAND Corporation, an independent scientific institute. Spontaneously reported adverse effects with high-profile sports figures and others raised public awareness and fueled the debate over safety. Subsequent to the ban, various trade groups and supplement companies have criticized the ban, and an appeal of the decision with temporary suspension of sanctions in some jurisdictions, pending further review, has occurred. Regardless of the regulatory outcome, reintroduction of OTC ephedra-containing supplements is not likely to occur.

Although banned in the United States, use of ephedra in other countries is likely to continue.

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