Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1333

Accepted - Volume 326

Comment Record
Commentor Mrs. Christina van de Weerd Date/Time 2003-04-04 09:04:44
Organization Crossroads
Category Health Professional

Comments for FDA General
1. General Comments I have used ephedra products for almost two years and I have benefited enormously from it; I feel great ; I have more energy and I lost 10 kilo,s. I never had any adverse reaction.Many of my family and clients have used these product and have not had any serious or adverse reactions. The products I am taken are currently undergoing clinical trials at Johns Hopkin University. The RAND report confirms the safety of ephedra products and I support responsible legislation, not a blanket response of banning all ephedra products. Look at the other products that can be abused or misused, such as acetaminophen, pain relievers and not to mention alcohol and cigarettes. The product that 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/caffeine mix. Biolean has no direct caffeine source (less than 10 mgr is present from the Green Tea) and the ephedra accounts for a small fraction of the total formula. The product Biolean, that my family uses, 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 contains warnings far above those reqiured 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. I am very content with this product.

EC -1333