Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -91

Accepted - Volume 298

Comment Record
Commentor Mr. Steven Schmidt Date/Time 2003-03-07 14:26:25
Organization Applitech Inc
Category Individual

Comments for FDA General
Questions
1. General Comments It appears the media has magnified the issue of dietary supplements containing Ephedrine Alkaloids. As a direct result the general public is alarmed and confused about a substance they had believed was safe. My wife uses a product called BioLean that contains Ephedra. She is a primary care physician and well acquained with Ephedra. I know for a fact that she has had difficulty losing weight and that her current usage of BioLean has resulted in a 15 pound weight loss. I remember her telling me that the amount of Ephedra in Biolean is well below that of a common cold remedy called Sudafed. She has had no adverse reactions for taking it about six months and in fact is so pleased to be wearing clothing she had not worn for quite some time. I also know for a fact that BioLean is currently undergoing clinical trials at Johns Hopkins University. Why not ask them what their experience has been. There also is a RAND report that has reviewed ephedra products. I believe their report confirms the the safety of ephedra products. If legislation is required let it not respond to hysteria. If that were the case simple asprin would have been banned as a dangerous agent long ago due to misuse. Please look at the products on the market and determine if their primary ingrediant is ephedra. If that is the case perhaps it would be possible to abuse the agent simply by taking too many. However blanket regulation of all products containing ephedra would be a mistake. The expression comes to mind of ...throwing out the baby with the bathwater.... If that be the case then the common pain relief formula know as acetaminophen should be reviewed. The results show 15,000 emergency room visits each year. Let's see if the makers of Tylenol want their product elevated to a prescription drug. In closing I request a balanced responsible review of the facts, and an admonition of the media to look before they leap. Respectfully, Steven Schmidt




EC -91