EXPERTS REVIEW MOST RECENT FDA REPORTS ON EPHEDRA

When Taken According to Current Standards, Latest FDA Reports Consistent with Previous Findings, No Association Between Ephedra Consumption and Serious Adverse Events

Washington, DC (June 5, 2001) � Experts who reviewed the most recent Food and Drug Administration (FDA) reports on Ephedra confirmed their conclusion, based on the totality of evidence, that these reports do not demonstrate an association between Ephedra consumption and serious adverse events (AERs). This conclusion is consistent with recent clinical data showing that Ephedra is safe and beneficial for weight loss, and with the previous findings of Cantox Health Sciences International's quantitative risk analysis, and of a multidisciplinary expert panel sponsored by the Ephedra Education Council (EEC).

As part of an ongoing effort to work with the FDA and other federal and state agencies to establish responsible standards for dietary supplements containing Ephedra, the dietary supplement industry has obtained from FDA the most recent AERs for Ephedra products. AERs cannot be viewed as scientific "data," and it is not possible to use AERs to establish whether an event is attributable to Ephedra or whether Ephedra increases the risk of adverse events. Nonetheless, industry has agreed to review all new AERs that FDA receives for Ephedra products in an effort to help monitor whether the current national standard for these products is working, and in order to foster a more cooperative approach with FDA concerning the regulation of these products.

"The review of the most recent AERs is consistent with the written comments of the Expert Panel of the Ephedra Education Council submitted to FDA in October 2000, which stated that 'available information does not demonstrate an association between the use of dietary supplements containing ephedrine alkaloids and serious adverse events' when consumed according to the national standard," said Dr. Stephen Kimmel, Chairman of the EEC's Expert Panel.

"These conclusions are also consistent with a quantitative risk study submitted to FDA in December 2000 by Cantox Health Sciences International, and with data from clinical studies on ephedrine and Ephedra products, including the recently published abstract of the Harvard and Columbia study," Dr. Kimmel added.

Researchers at the prestigious Harvard and Columbia Universities, who recently published data in abstract form in the FASEB Journal and Obesity Research, found that herbal Ephedra, when combined with caffeine, lowered body weight, fat and body mass index. There were no significant adverse events in this 6-month study, and rigorous testing of cardiac function showed little or no effect on heart rate or blood pressure. In addition, data published last month in The International Journal of Obesity also showed that the combination of Ephedra and Guarana in healthy, overweight subjects produced significant weight and fat loss.

As with past reports, the most recent batch of AERs shows why frequent media reporting of the raw number of AERs is meaningless and only confuses consumers. The new AERs include many that bear no relationship to Ephedra consumption. This includes reports on products that did not contain Ephedra, reports where no adverse event is listed, and cases where the event occurred well prior to any Ephedra consumption. Also included were cases medically unrelated to Ephedra, such as gallstones, small bowel obstruction and fat feet, as well as ludicrous reports such as that of a married woman who had an affair with a student, for which she has been criminally prosecuted. The only experts who have reviewed the entire FDA collection of AERs have consistently found that the AERs, when considered in the context of scientific data from clinical studies, do not represent a public health concern when Ephedra products are consumed according to current standards - a total dose of 100mg per day at 25mg four times a day.

Most important, the enormous potential benefits of Ephedra products for millions of consumers must be considered. According to the Centers for Disease Control, more than 60% of Americans are obese or overweight, and obesity results in 300,000 preventable deaths each year in the United States. Because of the clinical data showing safety and efficacy, leading experts in obesity have urged FDA to permit continued access to Ephedra products, one of the few useful tools that consumers have to help them lose weight.

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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