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EPHEDRA'S SAFETY AND BENEFITS CONFIRMED

Overwhelming Evidence Continues to Demonstrate No Association Between Reported Adverse Events and Ephedra When Consumed as Directed

Washington, DC (September 14, 2000) --- Public meetings held recently at the Department of Health and Human Services, and sponsored by the Office of Women's Health (OWH), confirmed the safety and benefits of Ephedra. With overwhelming evidence provided by experts, consumers and patients, the testimony continued to demonstrate the safety of the product. Key testimony was provided by a seven-member panel of medical and scientific experts which concluded that the evidence does not demonstrate an association between reports of adverse events and the product when it is consumed as directed. The expert panel, which has a broad depth of knowledge in every relevant aspect of human physiology, found that the reported events are consistent with events occurring naturally, and that the adverse events reported by the Food and Drug Administration are not consistent with the published literature.

"Conservative estimates suggest no greater risk for adverse events than the risk in the general population," said Dr. Stephen E. Kimmel, panel chair. "The number of reported adverse events are consistent with what would occur in the general population, even after accounting for possible under-reporting of events. Such findings represent the efforts of the panel to step back from the emotional impact that individual adverse reports can have and look objectively at the available scientific information.

"Additional testimony was provided by Arne Astrup, MD/PhD, of Copenhagen, Denmark, whose studies of ephedrine and caffeine found that when the two are combined they are indeed effective as a weight loss product. Dr. Astrup also pointed to an FDA report on the published literature as misrepresenting data in his study on the safety of the two ingredients to instead support FDA's allegations concerning Ephedra. "I think our data and results are mischaracterized and the presentation is flawed and distorted," said Dr. Astrup. "It's giving a very negative picture of the safety profile of the combination of ephedrine/caffeine, which is not supported by our research."

Many consumers and several treating physicians also testified as to their experience and success using Ephedra products for weight loss. The experience related by Ms. Mario Banks, a school teacher from Jasper, Alabama, was typical of the consumer comments. "I am proof that Ephedra-based products are indeed a safe, simple and reliable program for losing and maintaining weight loss. In four months I am thrilled to be 30 pounds lighter. This has just been a wonderful and positive experience," said Ms. Banks.

Dr. Gary Huber, of the Texas Nutrition Institute, testified regarding his randomized, placebo-controlled study of 60 individuals that evaluated the effects of dietary supplements containing Ephedra on weight loss. Although his study is still ongoing, Dr. Huber's testimony indicated that Ephedra products are safe and useful for weight loss.

Consumer statements were backed through research presented by several prominent experts in obesity, including Dr. George Bray, Boyd Professor of Medicine at the Louisiana State University and Executive Director of the Pennington Biomedical Research Center. "I am here today to argue for the continued availability of over-the-counter products containing Ephedra Alkaloids as one tool to help combat obesity," said Dr. Bray. He reported that Ephedra products were, in his view, safe, effective and affordable products for losing weight, and concluded that, "the balance of the risk-benefit fulcrum is clearly on the side of benefit."

Also presented at the meetings was a survey of supplement companies commissioned by the American Herbal Products Association, which found that with an estimated 3 billion servings of Ephedra being consumed each year, only 25 "serious adverse events" were reported during 1999. This is a reporting rate that is consistent with or far below many foods and OTC drugs that are accepted by the public and FDA as safe.

The FDA also had its own personnel and outside consultants testify at the OWH public meetings. However, they failed to establish that Ephedra was not safe and effective when used as directed. Independent researchers and leading academic experts consulting with industry showed that the AER database was not useful from a scientific standpoint, that FDA had seriously mischaracterized the published literature, and that FDA and its consultants had ignored pertinent data on the benefits of these products.

To date the FDA has not assessed whether the adverse event reports it has received are consistent with background risk, but the seven-member expert panel found that, in all cases, reporting rates for persons using Ephedra were within the expected range for the general population. This analysis, the first of its kind, supports what informed experts have long been saying; when ephedra is consumed according to current national standards, ephedra products are safe and useful as dietary supplements.

For more information on testimony by the expert panel, an executive summary of the meetings, and other related information, logon to www.EphedraFacts.com.

The Ephedra Education Council 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.

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