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EPHEDRA INDUSTRY ADDRESSES RELEASE OF NEW ADVERSE EVENT REPORTS

STATEMENT FROM THE EPHEDRA EDUCATION COUNCIL

WASHINGTON (August 19, 2002) In response to recent media coverage concerning the release of new adverse event reports, the Ephedra Education Council today issued the following statement:

"With the release of new adverse event reports (AERs) on Ephedra dietary supplements, it is important to emphasize that the database from clinical research has scientific and probative value, while the AERs do not, and that the clinical database supports the safety and benefits of ephedra when used as directed. The Food and Drug Administration (FDA) agrees that AERs cannot be used to assess the safety of ephedra. In fact, in June 2002, FDA advised Secretary Tommy Thompson of the Department of Health and Human Services (HHS) that adverse event reports 'alone do not provide a scientific basis for assessing the safety of ephedrine alkaloids or establish a link between the reported adverse events and the ingestion of ephedrine alkaloids.'

"A panel of nationally recognized scientific and medical experts reviewed AERs collected by FDA and came to a similar conclusion. As the panel noted, AERs are only useful as a signal to look at the available clinical data, and nothing more. These experts reported to FDA that the clinical data do not show an association between Ephedra consumption and serious adverse events.

"AERs do not provide the basis for any regulatory action beyond that fully supported by the responsible manufacturers and distributors of Ephedra dietary supplements and no number of additional reports will change this conclusion. Industry fully supports the continued focus of FDA and HHS to pursue a science-based path to appropriate regulatory actions. The best course of action now is for FDA to immediately require the type of comprehensive warning labels that already appear on all Ephedra products marketed by responsible manufacturers and distributors."

The Ephedra Education Council (EEC) is supported primarily by members of the Ephedra Committee of the American Herbal Products Association, a recognized leader in promoting the safe and responsible marketing of dietary supplements. The Council provides factual information to the media and public about dietary supplements containing Ephedra. For more information, logon to www.EphedraFacts.com.

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