Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1320

Accepted - Volume 326

Comment Record
Commentor Mr. Perry Cain Date/Time 2003-04-03 19:57:33
Organization Orange County Medical Association
Category Association

Comments for FDA General
1. General Comments On behalf of the Board of Directors of the Orange County Medical Association (California), I wanted to express our support of the proposed regulations contained in FDA Docket 95N-0304 relating to dietary supplements containing ephedra. We have reviewed the RAND study and concur with the findings contained in the report and share the concern that ...ephedra as currently marketed may be associated with unreasonable safety risks. In addition we share the view of the American Medical Association (AMA) which states that the risks contained in taking dietary supplements containing ephedra clearly outweigh any benefits and are unreasonable for a product considered merely a food product. As a result, in our opinion the FDA is proper in its view to require strong warning labels placed on products containing ephedrine alkaloids that warn of the possible health consequences. Thank you for the opportunity to share our views on this matter.

EC -1320