Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1356

Accepted - Volume 326

Comment Record
Commentor Mr. Jon Cooper Date/Time 2003-04-04 16:18:53
Organization Suffolk County Legislator
Category Other

Comments for FDA General
1. General Comments I am the author of the county law, recently enacted in Suffolk County, NY, that bans the sale of all dietary supplements containing ephedra. This is the first law of its type in the nation. Suffolk’s ephedra ban was approved in the County Legislature with broad bipartisan support, following more than six months of intense legislative debate. We faced a massive lobbying effort against the bill that was organized by the pro-ephedra lobby, primarily two ephedra manufacturers (Twinlab Inc., and NBTY Inc.) and an ephedra distributor (Wagner & Company). Although several dozen people testified in opposition to this legislation, including several local doctors, virtually all of them admitted upon questioning that they were distributors of ephedra supplements and thus had a financial stake in seeing the bill defeated. To counteract this, we heard testimony in support of the bill from numerous medical and health professionals, as well as from Suffolk residents who lost family members due to ephedra. Karen and Tom Schlendorf lost their 20-year-old son, Peter, and Doug Hanson lost his 37-year-old wife, Anne (a mother of two young children). Both died after they ingested dietary supplements containing ephedra. The FDA proposal to require warning labels for dietary supplements containing ephedra does not do enough to protect public health. The enactment of DSHEA in 1994 stripped away important consumer protections by eliminating the requirement for pre-market safety testing of dietary supplements. In addition, the passage of DSHEA meant that dietary supplement manufacturers no longer had to report adverse events to the FDA, which has made it impossible to track ephedra-linked deaths and other adverse side effects. It is clear by now that over-the-counter ephedra supplements do more harm than good. How many more parents must lose a child — and how many more children must lose a parent — before the FDA will act? I urge you to do the right thing and ban the sale of all dietary supplements containing ephedra before more lives are lost. Thank you very much for your consideration. Sincerely, Jon Cooper Suffolk County Legislator 215 East Main Street, Suite 201 Huntington, NY 11743 Tel: 631-854-4500 Fax: 631-854-4503

EC -1356