Consumer Alert

Pressure on FDA to Ban Ephedra Continues
RAND Study Shows that Science Supports Safety and Benefits
To Keep Ephedra On The Market,
Act NOW!!!

The Situation:

The Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) issued a proposed rule for Ephedra labeling on Friday, February 28th. FDA stated that it is also considering whether Ephedra may pose a health risk that constitutes "an unreasonable risk" to consumers. An FDA determination of "unreasonable risk" would result in a ban on Ephedra.

Consumers of Ephedra dietary supplements have the opportunity to influence this outcome by writing to the FDA.

The Facts:

The pressure on FDA is the result of overreaction to and over-reporting of adverse reactions, not clinical studies. The RAND report and even critics of ephedra acknowledge it is not possible to determine whether these reports are in any way linked to ephedra consumption. Examples of the types of adverse reactions reported to the FDA can be found by clicking here.

RAND has confirmed that not a single serious adverse event has occurred in more than 55 clinical studies that have been published and that provide scientific support for the safety and benefits of Ephedra dietary supplements. A summary of these studies can be found by clicking here. Based on the consistency of the findings in multiple studies, physicians from around the nation have endorsed the use of Ephedra and have written to HHS supporting the safety and benefits of Ephedra.

As a responsible Ephedra consumer, you understand the importance of reading and following the label instructions, and consulting with a health care professional to answer any questions. For your overall weight loss strategy, keeping these products on the market is a priority. It is time for responsible consumers, like you, to speak out on the benefits of Ephedra that you have experienced.

Taking Action:

Consumers need to take action or else the results could be disastrous. FDA will be accepting comments on Ephedra from all interested parties - (the deadline is April 7, 2003). At the end of the comment period, the agencies will gather all the information submitted on Ephedra, analyzed it, and publish its conclusions about Ephedra dietary supplements in the form of a final regulation.

We encourage you to submit stories about the benefits of Ephedra products to FDA, and provide a copy to your elected officials. You can submit comment online to FDA by clicking here.

You may also send written comments on Ephedra by e-mail to the FDA at [email protected] or by regular mail to the following:

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Do not forget to include the Docket Number 95N-0304 in your correspondence.

For additional information about Ephedra, you should check out the following:

Choice in Nutrition, which is one of the nation's foremost advocacy organizations formed to protect the rights of Americans to choose the nutritional supplements that meet their health needs.

Baylor University's Exercise, Nutrition, and Preventive Health Research Laboratories Comments to FDA about Ephedra.

Reason Online article - "What's Wrong With Mahuang? The weak case against ephedra." By Jacob Sullum.

New York Times article - "BackTalk; Ephedra Is Risky, but So Is Lack of Testing for Stressed Players" By Douglas Kalman.

Time magazine article - "A Major League Loss, Baseball may ban ephedra after a pitcher's death. But the move to penalize the herb may be premature." By John Cloud.

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