Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -122

Accepted - Volume 298

Comment Record
Commentor Ms. Alison Sahl RN, B.S.N. Date/Time 2003-03-07 20:28:57
Organization Wellness Opportunities Gruop
Category Health Professional

Comments for FDA General
1. General Comments I am an ICU nurse in Dallas. I have been using the product BioLean, an ephedra containing product for the past 4 years. I have lost 30 pounds and kept it off. I have never experienced any unpleasant adverse reactions. I also have over 400 friends and family members who have experienced only beneficial results from this product. As a RN, I have a professional liability to protect and am confident that the 37.5mg of ephedra in Biolean is safe and effective. This should not be confused with other products such as Ripped Fuel that contain 334mg of ephedra per 2 capsules and recommend taking 6 capsules/day. That is equivalent to 1002mg ephedra/day which would be one entire month supply of BioLean. As an ICU nurse, I have seen people take and entire bottle of aspirin or Tylenol resulting in death and I don't see anyone trying to take those products off the market because common sense and an educated opinion would tell you people that abuse like that are the exception, not the rule. Is is rational to put labels on Aspirin bottles saying consuming this entire bottle may result in death? Of course not! The products I am taking are currently under clinical trials at Johns Hopkins University. The Rand report also confirms the safety of Ephedra products. This product, Biolean, has contained warnings far above those required by the FDA and we always advised consumers not to take it unless advised by a doctor when certain physical ailments are present. With the epidemic of obesity in America at an all time high, an Ephedra based product is an empowering tool which allows people to make wiser choices regarding their health. It would be wrong to deny the use of Ephedra containing products to the millions of people who have used it safely and responsibly. Not just wrong, but immoral and unethical. The responsible use of ephedra is something I have a professional, moral, and ethical duty to advocate. I support responsible legislation based on scientific facts, not a reactive, uneducated blanket response of banning all ephedra products. In fact, if this is attempted, I will be forced to say you are killing millions of obese americans by banning responsible use of ephedra based products. An educated, proactive RN Alison Sahl RN,B.S.N.

EC -122