Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -130

Accepted - Volume 298

Comment Record
Commentor Ms. Carol Killeen Date/Time 2003-03-08 00:14:24
Organization Wellness Opportunities Group
Category Individual

Comments for FDA General
Questions
1. General Comments This letter is regarding Docket #95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids. I have been using BioLean which contains ephedra for 3 years. Over the years I have lost 12 lbs. and 6 inches. Recently, I started using the product again and have lost 10 lbs. and 6 inches in the past 5 weeks. I have never had any serious adverse reaction to this product. As a matter of fact, it has helped to curb my appetite and maintain a healthy level of energy while dieting. Five of my sisters, one brother as well as many of my friends have also used BioLean which contains ephedra and have lost weight and inches without any serious or adverse reactions. The BioLean product I am taking is currently undergoing clinical trials at Johns Hopkins University. The RAND report confirms the safety of ephedra products. I support responsible legislation, but not a blanket response to ban all ephedra products. Taking products like BioLean off the market is like taking acetaminophen that can be abused or misused off the market. Acetaminophen accounts for about 15,000 emergency room visits each year, pain relievers for about 16,000 deaths each year, not to mention alcohol and cigarettes. The BioLean product should not be confused with the multitude of diet or energy products that have been on the market. Many of these controversial products have contained somewhere between 75% to 95% ephedra or ephedra/caffeine mix. BioLean has no direct caffeine source (less than 10 mg is present from the Green Tea) and the ephedra accounts for a small fraction of the total formula. BioLean comes packaged for daily consumption in well below the recommended daily amount for ephedra alkaloids, advising a morning dose of 25 mg, followed by an afternoon dose of 12.5 mg. The BioLean contains 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. For these reasons, I think it would be a crime to take this product off the market just because some people chose to misuse or abuse other products that contain ephedra. There is a need for products like BioLean because the obesity and weight problems in the country and other health related cost as a result of obesity far out weigh the risk of deprieving people with products that can safely help them lose weight.




EC -130