From: Teresa Tsalaky [ttsalaky@triplicate.com]
Sent: Thursday, April 03, 2003 5:58 PM
To: fdadockets@oc.fda.gov
Subject: Ephedra warning labels

Dockets Management Branch
Food & Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear Sir or Madam,

In a proposed rule published Feb. 28, the U.S. Department of Health and Human Services asked for public comment regarding the FDA's desire to add warning labels to products containing ephedra. FDA also is seeking additional legislative authority to address this issue.

Any change in FDA's legislative authority would be the result of amending the Dietary Supplement Health and Education Act (DSHEA), and it would apply to the entire supplement category, not just ephedra.

In my book, "The Ephedra Battlefield," co-authored with Clinton Ray Miller, I predicted the FDA would try to use adverse event reports (AERs) for ephedra to limit access to all dietary supplements. This prediction is proving accurate.

The book points out that in 1997, FDA published a proposed rule that would reduce the strength of ephedra to a degree that would render it useless. FDA had to withdraw the proposal after an audit by the General Accounting Office found its reliance on AERs to be scientifically flawed.

Three years earlier, Congress passed the DSHEA unanimously. It had received more letters in support of this act than it had received for any other legislation in history.

Allow me to make another prediction: The public will continue to protect its access to supplements. Any attempt to weaken the DSHEA using ephedra as a scapegoat will only weaken the FDA. History is about to repeat itself.

Cordially,

Teresa Tsalaky, Publisher
The Daily Triplicate