Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -146

Accepted - Volume 298

Comment Record
Commentor Mr. Raymond Schloss Date/Time 2003-03-08 13:14:07
Organization Schloss Consultancy
Category Individual

Comments for FDA General
Questions
1. General Comments Docket #95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids: I have used Biolean from Wellness International Network containing 25mg ephedra daily. I have lost 15kg in 3 months without any side effects! Biolean is undergoing currently clinical trials at the John Hopkins Institute The RAND report confirms the safety of ephedra products, support responsible legislation which is not not a blanket response of banning all ephedra products! Other products 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 I 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. Biolean 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 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.




EC -146