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

Accepted - Volume 298

Comment Record
Commentor Ms. Liba Jacobs Date/Time 2003-03-07 14:35:46
Organization The Ventures Group
Category Health Professional

Comments for FDA General
1. General Comments I have been practicing as a clinical RN for over 25 yrs. The statistics cannot be ignored regarding over-weight individuals and obesity reaching epedemic proportion in this country. Western medicine has failed in providing a safe and effective weight loss product. I have effectively and with great confidence recommended the use of Wellness International Network, Ltd products for weight loss and management - specifically the product named BIOLEAN which contains 37.5 mg of ephedra. In the 10 yr history of this company and it's marketing of the BIOLEAN system, there has been no associated liability or harm caused to the consumer base. I personally have used the products for 5 yrs. My 83 yr old father consumes the product as well and has decreased his weight by 20 lbs in conjunction with a lowered LDL cholesterol level eliminating the need for dangerous pharmaceutical agent consumption. Excess use or abuse of Ephedra is no different then abusing caffeine, nicotin, aspirin, tylenol, milk or anything for that matter, as excess in any fashion can be detrimental over time. I refuse to allow the pharmaceutical company's and their economic interest to dictate my personal use of natural herbs that have been used all over the world for thousands of years. Pediatric Sudafed and Sudafed, just to mention a few pharmaceutical synthetic drugs, have large amounts of Ephedrine and have never been mentioned as a threat to our health or our childrens. Each individual has the responsibility to determine safe and effective usage of any consumable and it is ludicrous for the regulatory agencies to attempt to regulate the use of Ephedra.

EC -95