Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1242

Accepted - Volume 326

Comment Record
Commentor Ms. Emily Oliveira Date/Time 2003-04-02 19:46:01
Organization WIN
Category Individual

Comments for FDA General
Questions
1. General Comments I have been taking ephedra products for over a year now. I have never been healthier. I have lost a couple dress sizes, about 15 pounds, and I have more energy and motivation than ever. I have never had an adverse reaction. I follow the dosage on the label.My family members and friends also take ephedra products and they too have never had adverse reactions. Our ephedra product(BIOLEAN)is currently undergoing clinical trials at John Hopkins University. The RAND report confirms the safety of ephedra products. I support responsible legislation not a blanket response of banning all ephedra products. Other products such as pain relievers, alcohol, cigarettes,aspirin have been misused by some. The key to any product is proper dosage. 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 Biolean product comes in well below the recommended daily amount for ehedra alkaloids, advising a morning dose of 25 mg, followed by an afternoon dose of 12.5 mg. 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. Thank you.




EC -1242