Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -169

Accepted - Volume 298

Comment Record
Commentor Mrs. Kim Markuly Date/Time 2003-03-09 13:45:52
Organization Living Well Solutions
Category Health Professional

Comments for FDA General
Questions
1. General Comments I am a registered nurse with over 25 years of practice in the emergency department. I have taken BioLean for over 2 years. BioLean is currently in clinical trials at Johns Hopkins University and the first herbal product listed in the PDR for Non prescription drugs. Personally, I have lost over 20 pounds, but more importantly have regained muscle strength in my left arm and left leg and am rebuilding my immune system. As a patient with chronic Lyme disease, I have been able to stop taking the many pharmaceutical drugs and concentrate on building my health. BioLean has been an important factor in my health. I have personally witnessed numerous people loose weight and reverse diabetic conditions with the help of this product. My most recent person has lost over 50 pounds and now has normal glyocohemoglobins. I have never seen anyone use BioLean and had any serious adverse reactions. However, I have seen numerous patients treated for Acetaminophen over dosage. I support responsible legislation and not a blanket response of banning all ephedra products. The RAND report confirms the safety of ephedra products. The fact that a product can be abused is no basis for banning, as was seen with alcohol in the 1930's. As a registered nurse, I was impressed by the high standard that BioLean is manufactured. It is pharmaceutical grade, with warnings, directions and restrictions for responsible consumers. In reviewing the information given about other ephedra products, I find many with large amounts of caffeine as is true with the product Xenadrine. As a nurse, I have cautioned heart patients about the use of caffeine for years. I find it curious that so much emphasis is on the ephedra and no one is concerned about the caffeine. I wonder what the public response would be to banning coffee or cola drinks? Let's let our policies and standards been driven by good science and good sense, rather than scare tactics.




EC -169