Docket Management
Docket: 03N-0069 - FDA Task Force on Consumer Health Information for Better Nutrition
Comment Number: EC -9

Accepted - Volume 1

Comment Record
Commentor Mrs. Ans Los Date/Time 2003-03-21 04:35:02
Organization Wellness Int. Network
Category Consumer Group

Comments for FDA General
Questions
1. General Comments Dietary Supplements Containing Ephedrine Alkaloids. Dear sirs/madame, I' am a woman of 47 jears old , I 'am and health user of nutritional supplements (Biolean)whith ephedra for 3,5 jears now. I am a daily user. I feel better, I have more energy, I have lost 5 pounds weight, My allergic rections dissapeared, my concentration improved. I have never had any serious adverse reaction. More than 30 individuals -- family members, friends, etc. also use ephedra.They have not had any serious or adverse reactions to. The product I am taking are currently undergoing clinical trials at Johns Hopkins University. The RAND report confirms the safety of ephedra products. I will support responsible legislation, not a blanket response of banning all ephedra products. In stead of other products that 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. This product(Biolean)is healthy and save to use. 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. 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 fysical ailments are present. * Health policy should be based on the science and the presumption that educated consumers will act responsibly in matters involving their own health. They have the right to make their own choices, and to consume products that are proven safe by science, and to decide based on the science, what products they should be taking. Thank you verry much paing attention to my words. Best regards, Ans Los The Netherlands




EC -9