Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -120

Accepted - Volume 298

Comment Record
Commentor Ms. Annilise Flanagan-Frankl Date/Time 2003-03-07 20:03:25
Organization Healthy Living Choices
Category Individual

Comments for FDA General
Questions
1. General Comments Department of Health and Human Services (HHS) funded the RAND Corporation to conduct a comprehensive review of the existing science on ephedra. RAND confirms that no serious events have occurred in any clinical setting, and that the risk of experiencing any adverse reaction to ephedra, if any, is small. Its review of some 16,000 adverse event reports revealed 21 sentinel events, which means cases involving ephedra that may indicate a safety problem but do not prove that ephedra caused the adverse event. The study recognized that such case studies are a weak form of scientific evidence. I am an independent dsitributor for Wellness International Network, who has always supported regulatory action based on science (and has included warning labels much stronger than FDA's standards for years), on our products. I wish to inform you of the personal benefits I have received from using BioLean and BioLean Free. I have naturally increased my metabolism and have been able to lower the use of synthetic thyroid hormone prescription medication I have been taking since the age of 16! My freedom to chose the supplements appropriate for my health and the health of my family is not something you should think of controlling! I support accurate labeling of products, which WIN has done for many years!




EC -120