Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -106

Accepted - Volume 298

Comment Record
Commentor Mrs. Dara McLeod Date/Time 2003-03-07 15:41:03
Organization West Coast Wellness
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments To Whom It May Concern: I want to strongly voice my opionion that is based on fact and protect my rights as a United States Citizen. I have used ephedra based products, BIOLEAN, from Wellness International, since August of 1995 on a daily basis. My husband had is blood tested by Spectra Cell and his anti-oxidant level is at 97%. I have lost 10 lbs and have gone from a size 10 to size 6 and have maintained healthy weight of 130 lbs. I have reduced my fat ratio to lean muscle ratio. More importantly this has been maintained for a period of over 7 years. I have never had any adverse effects of taking the products, nor has any of my family members. My father who is currently 83 years old has been using ephedra based products and dietary supplements and it has helped him get off of prescription based medicine like Lipator and high blood pressure medicine. My sisters, Nieces, nephews have all been using ephedra based products and I have given these products to 1000's of people over the course of 7 years with no adverse reaction. I want to share my numbers. Biolean is a safe and effective product and has been used internationlly and nationally for over 10 years. Where is the problem? The problem is POLITICAL! I even gave it to Susie Lu, who is the VP of Stanford Labs and she has completely removed herself from 3 alergy medications and asthma medication. I have been using Biolean, from Wellness International and these products are undergoing clinical trials at Johns Hopkins University. I know of hundreds of doctors who use Biolean personally and recommend them to their patients, because they have nothing as effective and safe to give their patients that are clinically obese or overweight. The RAND report confirms the safety of ephedra products. The RAND confirms that no serious events have occured in any clinical setting, and that the risk of experiencing any adverse reaction to ephedra, if any is small. Its review of some 16,000 adverse events reports revealed 21 sentinel events, which means cases involving ephedra that may indicate a safety problem but do not PROVE that ephedra caused the adverse event. The study recognized that such case studies are a weak form of scientific evidence. Therefore, the evidence-based review that was released last Friday, firms what weight loss experts have stated all along - that well-designed clinical trials consistently show that ephedra supplements help healthy, overweight people lose more weight than diet and exercise alone. The Cantox report confirms that 90 mgs of ephedra is safe and effective to take daily on the circulatory and nervous system. This was an independent report that was conducted for the FDA and was published on the Council for Responsible Nutritions Web site. I support RESPONSIBLE legislation, not a blanket response of banning all ephedra products. I believe this is nothing more that powerful pharmaceutical companies wanting to control ephedra themselves so that they can control the dollars. I want to know where are the case studies supporting that ephedra is causing what the MEDIA is claiming. Is this committee looking at the 15,000 emergency room visits each year because of acetaminophen or the 16,000 deaths each year from pain relievers. I don't see any banning of alcohol and cigarettes, knowing that the abuse and misuse is clearly there. People like myself want our freedom of choice. The product that I have consumed for 7 years should not be confused with the multitude of diet or energy products that have been on the market. Many of these controversial products have contained somewhere between 75% to 95% ephedra or ephedra/caffeine mix. Biolean has no direct caffeine source (less than 10mg is present from the Green Tea) and the phedra accounts for a small fraction of the total formula. The product I consume comes in well below the recommended daily amount for ephedra alkaloids, advising a morning dose of 25 mg, followed by and afternoon dose of 12.5 mg. The product I have consumed has contained warnings far above those requred by the FDA (ie serving limits, restrictions to minors), and has always advised consumers not to take unless advised by a doctor when certain physical ailments are present. My product biolean is listed in the Physicians Desk Reference for Non-Prescription Drugs and has truth in labeling and is manufactured in FDA approved pharmaceutical grade facilities. I am demanding that my country supports my request that we do have responsible legislation, but a blanket response of banning all ephedra products clearly violating my constitutional rights of free choice. I want to always have the right to legally purchase my product and consume it personally. A blanket ban would be a travisty for all the millions of people who have had such great health benefits. More importantly, the MEDIA and the pharmaceutical industry is scaring the public. Why are they not printing all the statistics on the deaths from prescription drugs. The Consumer has a RIGHT to choose, as long as there is truth in labeling. WE HAVE A RIGHT TO CHOOSE AND LEGISLATURES CAN NOT BE SWAYED BY THE LOBBYIST WHO ARE NOT BASING IT ON FACT. EPHEDRA DOES NOT KILL. EPHEDRA HAS BEEN AROUND FOR THOUSANDS OF YEARS AND I DON'T WANT TO EVER BE TOLD I CANNOT HAVE ACCESS TO IT. I want my voice to be heard and the hundreds of thousands to possibly millions of consumers that have not had any adverse effects from taking Biolean. A legislature banning EPHEDRA is Wrong and the RAND report confirmed it




EC -106