Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1170

Accepted - Volume 326

Comment Record
Commentor Mrs. Stacey Pady Date/Time 2003-04-01 14:00:58
Organization Wellness International Network
Category Health Professional

Comments for FDA General
Questions
1. General Comments I think that banning all ephedra product's and the selling of all dietary supplements are not necessary and that people are jumping on the bandwagon to ban it because of so much attention brought by the media over professional baseball player Steve Bechler's tragic death, who already had a history of border-line Hypertension (high blood pressure), liver abnormalities and was heavily exerting himself on an empty stomach and dehydrated. Many factors need to be considered and weighed heavily in this debate over its effective use when taken the recommended dosage set forth by the FDA guidelines. It has been proven safe and helpful in weight loss management when taken as directed along with proper warnings on our product bottles/boxes stating risk's and contraindications of ephedra based products. We also recommend consulting a physician for approval to take the product/product's the consumer/client would like to use in order to maximize the benefits of our products. Many persons fighting this debate are un-educated about ephedra when taken as directed, you can read about them at www.ephedrafacts.com. Wes Siegner, general counsel of the Ephedra Education Council in Washington, said in a statement, Suffolk County has ignored the more than 55 clinical studies on ephedra, and the many medical and scientific experts who have concluded that these supplements are safe and have significant health benefits when taken as directed. Their are many more side effects associated with prescription/over-the-counter medications than there are for our product line at Wellness International Network Ltd. Our products have been proven beneficial & to work effectively for people with certain ailments and/or diseases. This freedom gives people the opportunities to purchase products that have no medical insurance or to buy products that work at a cheaper cost than pharmaceutical companies charge with their outrageous prices on prescriptional medications, it doesn't take a genious to know that. Wellness International Network is already a proven company whose products work effectively and safely when taken correctly as listed in the Physician's Desk Reference for over-the-counter medications and dietary supplements, that should say it all!!! All I can say is educate yourself about the facts of ephedra. John Hopkins University in Houston, Texas approached our company and is currently performing clinical studies on both of our weight loss products Biolean (ephedra based product) and Biolean Free (ephedra free product) and having optimal/positive results with both product's. Don't ban the entire nutritional supplement industry based on one incident that have nothing to do with our company and its line of products. We are providing the public with alternatives to prescription medications and they should not have that right taken from them by legislation being backed by the greedy pharmaceutical companies. I recommend you read any medication you are taking in the PDR or Nursing Drug Handbook, you will find many side effects that you probably didn't even know about, something the media keeps failing to mention, like tylenol, advil, claritin, prevacid, zoloft, and the list goes on and on!! Let's make the right decision that is most benificial to the consumer base that needs/wants these products. I am currently taking Biolean as well as most of my family members and friends and have yet to have an adverse reaction reported yet. Everyone who takes it feels great, has energy and are loosing weight and would like to continue to do so!!




EC -1170