Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -567

Accepted - Volume 307

Comment Record
Commentor Mr. David McGill Date/Time 2003-03-24 10:22:15
Organization Wellness Business Group
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments It is with grave concern that I am writing to the FDA about my ability to use and market formulas with ephedra alkaloids. As most responsible ephedra product marketers believe, properly labeled, properly marketed ephedra products can certainly be used by the general public safely, when used as directed with proper cautions and warnings heeded. I have been using and marketing BioLean a formula with Ephedra Alkaloids for the past ten and a half years. Total consumption daily is 37 1/2 MG with no serving exceeding 25MG. In the past ten and one-half years, with literally thousands of consumers I have not had any client complain of any serious side effects. In fact, I have been using the formula, BioLean from Wellness International Network, Ltd. for this entire period, cycling off the product periodically for best health results. Using the BioLean formulation, my desire for sweets and fatty foods is curbed, I feel more alert and also have seen an improvemnt in my bloodwork over this several year period, with no other significant alteration to my diet or exercise program. I have also had the benefit of reducing my need for various over the counter medications for allergies. My 20 year old daughter using this formula saw a 14 pound weight loss over a three month period, with a cholesterol reduction from 298 to 198. The only thing she did with her diet was add this supplement to her daily regimen. My 74 year old father-in-law, with an obesity issue that was not controlled by any pharnmaceutical formula, under a doctor's supervision, experienced a 25 pound fat loss. In addition to the fat loss his doctor had him reduce his Blood pressure medications and cholesterol meds by 50% using BioLean. I can provide literally hundreds of these types of anecdotal reports, with virtually no negative side effects. In fact, the formulation I market is manufactured in FDA licensed pharmaceutical labs to ensure product quality and consistency. A study on our formulas, published in Endocrine Practice magazine, documented through a retrospective analysis, fat loss results of over 80 patients and comments on the related health benefits derived from the fat loss. Based on the preliminary results from this study, Johns Hopkins Medical contacted our company to determine if the company had interest in supporting a longer-term scientific study on the effectiveness and safety of this formula which contains 37 1/2 mg of ephedra alkaloids in a daily serving. Johns Hopkins is currently about two-thirds of the way through a 1-year double-blind, placebo based study using this formulation. We feel strongly that serious review of a responsibly developed formula can only further clear the air about the ephedra ingredient. The FDA's statement about the RAND report and my own reading of the report came to very different conclusions. In fact the report indicated that in all the studies provided there was not a risk identified with ephedra products when they were used properly by the proper audience. They did indicate additional longer-term studies needed to be done to determine product safety and efficacy over longer-term useage, which the Hopkins study, when published, should help clarify. I support responsible manufacturing practices be followed, ensuring quality and consistency of products. I support responsible labeling with appropriate warnings with product active ingredient amounts that do not exceed 25 mg of alkaloids per serving. In fact our company met the labeling guidelines before the FDA instituted its rulings on the issue. It IS crucial that the product be labeled or restricted so that the product is NOT delivered to the underage youth group. I think the FDA's banning of the Yellow Jacket formula and fining the manufacturer is right-minded and proper. I think banning the ephedra alkaloid summarily, however, would be irresponsible...a case of throwing the baby out with the bath water. Too many people have experienced extremely positive results using our formulation without incident to disregard their wants and needs. Speaking of AER' anaylysis, the RAND study did point to the weakness of the science behind the whole AER issue. Goodness, Acetametophen has been identified with more than 15000 emergency room visits A YEAR....are you going to ban that over the counter formula. Regarding alcohol consumption there are many interesting studies indicating a glass of red wine a day provides many salutary benefits...but it doesn't give license to drink an entire bottle. I won't even go into the excess consumption of alcohol in general. Do what you must to ensure quality and labeling standards are met, that the product be marketed to adults but DO NOT ban outright and ingredient that has been so healthful for so many people. Get the science straight! please. Thank you for you attention to my statement David R. McGill




EC -567