Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -128

Accepted - Volume 298

Comment Record
Commentor Dr. Tim Berry Date/Time 2003-03-07 23:58:32
Organization Berry Family Care, LLC
Category Health Professional

Comments for FDA General
Questions
1. General Comments I have safely and effectively used ephedra products in my office practice and personally myself for over 10 years. I have effectively lost weight with this product. I am concerned over the bad media hype associated with ephedra. Of course not all ephedra products are created equal. Some products use it as their main ingredient with the product consisting of 75-95% ephedra or ephedra/caffeine mix. The RAND report confirmed the safety of ephedra products. The product I use and recommend has less than the accepted safe dose as recommended by the Harvard and Columbia reviews. Biolean has a 25mg morning dose and a 12.5mg afternoon dose. Biolean has contained warnings far above those required by the FDA (ie: serving limits, restrictions to minors), and has always advised consumers not to take it unless advised by a doctor when certain physical ailments are present. Johns Hopkins had enough confidence in this product to conduct its clinical obesity trials using it. If you have a credible product, such as the Biolean product, then it can be safely and effectively used for America's number one fastest growing health concern. We should be more concerned about getting rid of obesity rather than ephedra. Of course without ephedra based products, we are limiting our arsenal of weapons that are proven to help make a difference. I do support responsible legislation, not a blanket response of banning all ephedra products.




EC -128