Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -98

Accepted - Volume 298

Comment Record
Commentor Ms. Janice Sindler Date/Time 2003-03-07 14:38:21
Organization Wellness International Network, Ltd.
Category Individual

Comments for FDA General
Questions
1. General Comments I have been using ephedra products for over 10 years now and have had tremendous results with absolutely no side effects. I use the supplement, Bio-lean, which has been in the marketplace for over 10 years. I have lost weight, have not put it back on, and have felt better than I have ever felt being on this product. I have many friends,family members, and associates who have used and continue to use this product without any side effects. The Bio-lean is so effective that Johns Hopkins Hospital is now doing clinicial trials because so many people have had such great results. The RAND report confirms the safety of these products and I wholeheartedly agree with this report. I definitely support responsible legislation but not legislation that bans the use of products because there are people out there who are not responsible in making sure that they use products of quality and also not overdose on those products that are not safe to begin with. More people die each year from the use of aspirin and/or tylenol, but they are not being considered for removal from the marketplace. There are over 15,000 visits each year to the emergency room because of acetaminophen misuse as well as 16,000 deaths each year due to pain relievers. What about the deaths due to alcohol and cigarettes? I don't see these products being removed from the store shelves. Bio-lean has no direct caffeine source (less than 10mg is from Green Tea) and the ephedra accounts for a small fraction of the total formula. This can't be said about the products out there that have resulted in these deaths. Bio-lean comes in well below the recommended daily amount of ephedra - total daily dosage of 37.5mg. The warnings on the box are well above those required by the FDA and has always advised the consumer not to take it unless advised by a doctor when any concerns are there. Therefore, I am totally opposed to the removal of ephedra products from the marketplace. I feel the consumer needs to take on the repsonsibility of knowing exactly what they are using and this would cut down on so many problems out there. BIO-LEAN is SAFE, EFFECTIVE and has given many, many people the results they have wanted where no other product has been able to do before.




EC -98