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INDUSTRY SUPPORTS EPHEDRA SCIENCE-BASED INITIATIVE SEEKS POLICY BASED ON SCIENCE NOT SPECULATION

STATEMENT FROM THE EPHEDRA EDUCATION COUNCIL

WASHINGTON (June 14, 2002) ‚ In response to the announcement issued by the U.S. Department of Health and Human Services' on June 14, 2002 regarding its new science-based initiative to study Ephedra dietary supplements, the Ephedra Education Council issued the following statement:

"Secretary Thompson's call for a science-based initiative to study Ephedra is a common-sense regulatory approach that will lead to a policy ultimately based on science rather than speculation. Recent clinical research and long-term usage supports the safety of Ephedra, but the industry is as interested as HHS in having more definitive data. The Secretary's message to consumers is exactly right: Be responsible, read the label, review the science, and make a decision that is right for you.

"The recent landmark Harvard/Columbia study, which found that Ephedra dietary supplements are safe and effective for healthy overweight individuals when used as directed, is a perfect example of the kind of in depth scientific research that will be evaluated under the Secretary's initiative, and will bring balance and rigor to the Ephedra safety policy discussion. Secretary Thompson's statement is also commendable for moving the policy discussion on Ephedra's safety to a more advanced level. For too long this important public safety issue has been stuck in first gear, and has looked only at the collected adverse event reports (AERs).

"The Secretary has been advised by FDA that "adverse event reports alone regarding dietary supplements containing ephedrine alkaloids do not provide a scientific basis for assessing the safety of these products and that there is need for further scientific research." While useful as signals that further study might be indicated, these reports are scientifically unreliable and do not provide the basis for sound regulation.

"Responsible Ephedra manufacturers and distributors of Ephedra industry also support Secretary Thompson's and FDA's enforcement initiative to aggressively pursue and remove illegal dietary supplement products. We have long advocated for the removal of synthetic ephedrine and illegal products promoted to children as street drug alternatives, such as those marketed as herbal ecstasy, magic mushroom, and primal rush. The Federal Food, Drug and Cosmetic (FDC) Act and Dietary Supplement Health and Education Act (DSHEA) of 1994 provide FDA with the necessary power to close down these companies and criminally prosecute those who break the law. Stepped up enforcement by FDA against individuals, manufacturers and distributors of these illegal Ephedra products safeguards the reputations of the responsible dietary supplement industry and restores consumer confidence in legal Ephedra products.

"Since millions of Americans have used the product safely to lose weight, Ephedra offers both personal and public benefits. Each individual's loss of weight with Ephedra dietary supplements is another victory in the battle against obesity."

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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