Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -180

Accepted - Volume 298

Comment Record
Commentor Mr. Jan Wagenaar Date/Time 2003-03-10 03:07:10
Organization Wellness
Category Individual

Comments for FDA General
Questions
1. General Comments I have been using EPhedra in BioLean for more than 2 months and feel in good shape and condition I lost 5 kg with BioLean. I never had any serious adverse reaction. Also my wife and 2 sisters are using ephedra and have not had any serious or adverse reactions. The products I am taking are currently undergoing clinical trials at Johns Hopkins University. The RAND report confirms the safety of ephedra products. I am against banning all ephedra products. Any other product can be abused or misused, such as acetaminophen (15,000 emergency room visits each year), pain relievers (16,000 deaths each year), not to mention alcohol and cigarettes. The product yI have consumed (BioLean) 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. The product I consume comes 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 product I have consumed 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.




EC -180