Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -139

Accepted - Volume 298

Comment Record
Commentor Mr. Robert Wagner Date/Time 2003-03-08 10:04:52
Organization Wagner & Company
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments Dear Sir, I have been a user of ephedra for over 11-years, the product I use is called Biolean and is manufactured by Wellness International in Plano, Texas. This product has been a tremendous help in maintaining my health and weight, I have lost 35-lbs and kept it off for 9-years, I have normal cholesterol levels and my blood work has never been better, I just got my physical and my doctor is very pleased, I am 43-years old. I have also been a distributor of ephedra products for the last 10-years, most of my retailers are physicians and they have helped thousands of their patients lose weight and take better care of their health. I know there are many nutritional companies making ephedra products and there may be some who don't follow recommended industry guidelines, but that is not a good reason in my opinion to ban the substance altogether. I completely agree with regulations and warnings on labels along with your recent announcement that quality and quantities be regulated and checked when companies make claims. A total ban on ephedra would be detrimental to millions of americans and would seriously impact their ability to deal with the epidemic of obesity. I also feel that we as american citizens have the rights to choose how to maintain our weight and we should continue to have that right. There are warnings on tobacco and alcohol and we can still use them, lets get the labels and dosages right on ephedra so we can still choose to use it also. I want you to know that there are many companies that are already doing things the right way and Wellness International is one of them, our product BioLean with ephedra (37.5 mgs per day) and BioLean Free which is free of ephedra are being clinically studied at Johns Hopkins Medical School as we speak. My wife and I have been helping doctors help their patients with our BioLean system for 7-years and after a clinical study was published in the Endocrinology Journal last December the people at Hopkins contacted us. I would be happy to discuss this further and or speak to you in person if you wish. The media has really gone nuts with its recent reporting on ephedra including doing a execution before having a trial when they stated as a fact that ephedra led to Mr. Bechlers death without even having a toxicology report. The recent Rand study shows ephedra is not the dangerous substance that the media claims it is also. I urge you to please listen to the american people and what they want to do and not a few organizations who are on a witch hunt to ban ephedra, the science is very clear, there are over 50-studies backing the safety of ephedra when used as directed on the label. People need to be responsible for there own actions and if they choose not to read the label or follow instructions then who's fault is that? We need to be responsible for our actions and stop blaming others, Mr. Bechler's death is very sad but based on his past medical history , if he did use ephedra he shouldn't have, the bottle clearly stated a person with his medical problems not use it. Did you know that last year alone over 15,000 people visited emergency rooms because of complications to aspirin, did you know that the 6th leading cause of death in this country last year was due to rightfully prescribed drugs, that is over 100,000 deaths due to prescriptions. No one is crying to ban aspirin. Please stop this witch hunt being led by the media. Lets let the people of america keep their rights to use dietary supplements including ephedra. We have all lost enough of our freedoms since the events of 911, we don't need more rights taken away. The american people need to know that this great country still provides freedoms whether you agree with them or not. Thank you for letting me share my opinion. Sincerely, Bob Wagner Bohemia, NY (631)981-1010




EC -139