Response to Public Citizen Health Research Group's Call to Ban the Production and Sale of Ephedra Dietary Supplements

Statement from The Ephedra Education Council

Washington, DC (September 6, 2001) � "In response to Public Citizen Health Research Group's call on the Food and Drug Administration (FDA) to ban the production and sale of Ephedra dietary supplements:

Responsible industry stands behind the science regarding the safety and benefits of Ephedra. When properly consumed, Ephedra is safe, according to medical and scientific experts. Although in its petition Public Citizen references alleged adverse event reports (AERs) associated with Ephedra, it is important to remember that 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 to establish product risk. This was further confirmed by a General Accounting Office report that was highly critical of FDA's use of adverse event reports.

Nevertheless, the 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, which includes limits on serving size (25 mg) and daily consumption (100 mg).

In addition, foods and over-the-counter products accepted as safe such as aspirin and the sweetener aspartame result in thousands of reported adverse events each year. Last year, The American Journal of Emergency Medicine provided information on the number of adverse events associated with aspirin finding that more than 13,000 such events are attributed to the product annually. In comparison to aspirin, the number of alleged adverse events associated with Ephedra is minimal.

Public Citizen's petition also references data collected by the American Association of Poison Control Centers, alleging that the number of adverse event reports associated annually with ephedra supplements are on the rise. In fact, it is important to remember that conservative estimates indicate that over three billion servings of Ephedra products are consumed each year. Yet, with consumption on the rise - nearly tripling over the last several years - the number of alleged adverse events has remained very low. Therefore, when the amounts consumed are included, the frequency of reported events has actually declined, despite the growth in media attention and public awareness.

Public Citizen incorrectly seeks support for its position from a New England Journal of Medicine (NEJM) report on ephedra dietary supplements published late last year. Researchers Christine Haller and Neal Benowitz have conceded, in a letter to the NEJM, that 'our report does not prove causation, nor does it provide quantitative information with regard to risk.' The same principle applies to the Public Citizen petition - since the petition is based on anecdotal reports of adverse events rather than clinical data, there is no scientific basis for the action, banning ephedra, that the petition requests.

It is important to remember that industry has pushed the FDA to adopt responsible regulations to guide the manufacture and distribution of these products, but so far the FDA has failed to respond. The industry standards are supported by scientific and medical evidence collected with respect to Ephedra over the last several years. For example, research conducted at the prestigious Harvard and Columbia Universities, and recently published in abstract form in the FASEB Journal and Obesity Research, showed that dietary supplements containing Ephedra are safe and effective as an aid to weight loss. The data from the Harvard and Columbia study also confirm the results of numerous other clinical studies, including a separate, short-term study conducted by some of the same Harvard and Columbia researchers and recently published in the International Journal of Obesity. In addition, a report in December of last year from Cantox Health Sciences International, an internationally known and respected scientific research organization, analyzed over 19 clinical studies and numerous scientific articles about Ephedra and its chemistry. The analysis showed that Ephedra products, when consumed according to voluntary standards set by industry and codified as law in several states, are safe."

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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. For more information, logon to www.EphedraFacts.com.