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INDUSTRY SUPPORTS DEFERRAL OF PUBLIC CITIZEN PETITION TO BAN EPHEDRA

ADVERSE EVENT REPORTS DO NOT PROVIDE SCIENTIFIC SUPPORT

STATEMENT FROM THE EPHEDRA EDUCATION COUNCIL

WASHINGTON (June 19, 2002) ‚ In response to a letter issued by the U.S. Department of Health and Human Services (HHS) on June 14, 2002 to defer a decision on Public Citizen's petition to ban Ephedra, the Ephedra Education Council today issued the following statement:

"Public Citizen's Sid Wolfe issued a written tirade that did not cite a shred of scientific evidence showing that FDA and HHS are wrong, but continued to rely on the emotion of reported deaths without offering evidence of any causal link between the reports and Ephedra. Public Citizen's position on Ephedra adds to its history of crying "wolf" whenever the advocacy group can use the emotion of reports to get attention and create funding opportunities. Calls by Public Citizen to fire everyone involved at HHS and FDA might be good for fund raising but do nothing to get to a rational science based policy on ephedra.

"The fact remains that, for any product like Ephedra that is widely consumed, and millions of Americans consume Ephedra products, scientific data establish that certain percentages of consumers will have health-related problems, not because they take any specific product, but because they are at risk for such events and they would have occurred regardless of what the person did or ate. Following Mr. Wolfe's logic, if someone has a stroke or heart attack while eating cereal or exercising, FDA and HHS should ban breakfast cereal and exercise.

"With overweight Americans being a national epidemic and Americans wanting to have the freedom to make choices on how to deal with their own individual health issues, it is irresponsible to call for a ban on a product that is used successfully by millions of Americans without scientific justification.

"The Ephedra Industry supports the Department of Health and Human Services (HHS) decision to defer action on a request from Public Citizen to ban dietary supplements containing Ephedra. HHS emphasized that Public Citizen's request was based solely on adverse event reports, and that such reports do not provide any "science" to establish that Ephedra caused the reported events.

"HHS Secretary Tommy Thompson and the Food and Drug Administration (FDA) deferred action for reasons that are consistent with accepted scientific principles. According to HHS, "FDA has advised Secretary Thompson that the types of observed outcomes reported in relationship to the ingestion of ephedrine alkaloids are not uncommon in the general population and therefore the 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."

"The HHS letter was issued on the same day that HHS announced a new science-based initiative to add to the already extensive clinical database supporting the safety and benefits of Ephedra. The effect of HHS's decision is that FDA will use its enforcement powers, and finally resolve remaining questions about Ephedra's safety, and lay to rest the speculation and emotion caused by widespread reporting of adverse event reports. HHS's effort will lend further support to studies like the recently released long term clinical study at Harvard/Columbia Universities, the EEC Expert Panel Report which found no connection between ephedra and serious adverse events, as well as the Cantox Report, a comprehensive risk assessment that determined that Ephedra products are safe when taken as directed pursuant to industry standards.

"All of the clinical studies that are relevant to scientifically assessing Ephedra's safety and benefits show that, when consumed as directed, Ephedra products are safe and produce significant weight loss. Today's HHS and FDA statements are consistent with the science. In stark contrast, Mr. Wolfe's comments are made in frustration and are not constructive."

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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