To: AWMA Members
From: Scott Ramminger
Re: FDA Ban on Ephedra Products
Date: January 12, 2004

FDA ACTION

On December 30, 2003, the US Department of Health and Human Services Secretary Tommy Thompson announced that the Food & Drug Administration (FDA) had issued a consumer alert regarding the risks of dietary supplements containing ephedra. Specifically, Secretary Thompson outlined the FDA’s plans to ban the sale of these ephedra products that he indicated posed an "unreasonable risk" to human health.

Although the ban does not go into effect yet, the FDA has already notified those companies manufacturing and marketing these products that it intends to issue a final rule prohibiting their sale. According to the FDA, a final rule should be forthcoming in the next few weeks and the ban would take effect 60 days after its publication.

BACKGROUND

The FDA believes a ban is necessary because of concerns about ephedra’s adrenaline-like stimulant properties that can have potentially dangerous effects on the heart. The FDA contends that studies conducted recently confirm that ephedra use raises blood pressure and stresses the circulatory system leading to significant adverse health effects like heart problems and stroke.

Media attention given to cases involving celebrity deaths linked to ephedra use, such as Baltimore Orioles pitching prospect Steve Bechler, have further heightened concerns regarding these products. In 2002, two notable deaths – Korey Stringer, a Minnesota Vikings offensive tackle and Sean Riggins, a high school star athlete – were attributed to use of ephedra products.

OUTLOOK

This ban would mark the first time that the FDA has ordered a dietary supplement off the market and leaders in the dietary supplement industry are already considering bringing a lawsuit against the agency in response to the pending ban. According to the FDA, any company that does not comply with the ban once it is in place could face a variety of enforcement mechanisms such as seizure of the product, injunction against the manufacturers and distributors of such products, and criminal prosecution of violators.

By notifying companies of their intention to ban ephedra products, the FDA hopes to send a strong signal that retailers and others should stop selling these products as soon as possible. According to the FDA, firms that receive such notification should "take steps to ensure they will be in compliance with the law once it becomes effective," the agency further asserts that, "we hope many responsible firms will stop marketing dietary supplements containing ephedra right away, but we want to be clear that all firms will have to comply with the new regulation. Firms failing to cease distribution of their products by the effective date of the rule will face the possibility of FDA enforcement action without further notice."

AWMA is also hosting a conference call with our state association executive directors this month to review this recent FDA action. A representative from the FDA is expected to join on the call to provide an overview of this ban and the impact on our industry.

Additional information on this recent FDA action may be obtained through the FDA website at www.fda.gov or you may call Anne Holloway at AWMA (703) 208 1643 if you have any questions. Be assured that AWMA will notify our members just as soon as the FDA issues the final rule.