Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -170

Accepted - Volume 298

Comment Record
Commentor Mrs. Joy Baker Date/Time 2003-03-09 15:01:19
Organization Wellness International Network, Ltd.
Category Individual

Comments for FDA General
1. General Comments My husband and I have been using ephedra based products since August 2002. I have lost 13 pounds and my husband has lost 10 pounds. We both feel great and has more energy than before. We have NOT experienced any negative effects. My mother has lost 55 pounds to date, she is now off her high blood pressure medications, and need very little insulin(she went from taking 27 units per day to taking only 5 units per day) to treat her Diabetes. I have friends who has used these products for 9 plus, years with only positive effects. The product I am referring to is BioLean. This product is currently being studied by Johns Hopkins University. This product is also listed in the PDR for non-prescriptions drugs for all to see. The RAND report confirms the safety of ephedra prducts. 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. Less than 10 mg is present from the Green Tea. Many other controversial products have contained somewhere between 75% to 95% ephedra or ephedra/caffeine mix. There are products that can be misued or abused like acetaminophen (15,000 emergency room visits each year), pain relievers (16,000 deaths each year), not to mention alcohol and cigarettes. BioLean contain 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. In conclusion I would like to say that I do support responsible legislation, but NOT a blanket response of banning ALL ephedra products.

EC -170