Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -66

Accepted - Volume 298

Comment Record
Commentor Mr. IVAN CAMP Date/Time 2003-03-06 17:47:05
Organization WIN, LTD
Category Individual

Comments for FDA General
Questions
1. General Comments I understand you are attempting to gather facts about Ephedra so here are a few. 1. I have been using a quality Ephedra product DAILY for almost 11 years now with absolutely no negative side effects whatsoever while having the benefit of weight control and more energy. I am a former Army officer (left as a Captain after serving with the 82nd Airborne Division as well as the 2nd Infantry Division) with over 15 years of service to my country. During those 15 years, I battled a weight problem so as to remain within the limits required by the Army for my height (197 lbs). I left the military in 1992 and it was around that time that I began taking a quality Ephedra product, Biolean. Since then, I have maintained a healthy 192 lbs with about 1/10th exercise that I used to have to put in while on active duty just to stay at 197! 2. I know many people, literally thousands, who take the same product and also are having the same results. Some of these include my wife, my 62 year old father, my 60 year old mother, and the vast majority of the people I know firsthand. 3. By his own admission ( on CCN last week), the director of HHS stated that the Rand report showed, convincingly, that reports of 2.5lbs of weight loss a month were verifiable but he, being the “Ephedra hater” that he is, tried to make this a negative. Sadly, as doctors recommend that a healthy amount of weight loss is from1-2 lbs per month, it seems that Ephedra products have been deemed “ineffective” by the powers that be despite the undisputed facts as reported in the Rand report. Why does my government, to which my wife and I pay massive amounts in taxes to each year (that’s right, MASSIVE!) commission a report if it is just going to blatantly ignore the findings in that report? Why are you wasting my money? 4. The product I am taking is currently undergoing an extensive double-blind placebo study with the acclaimed Johns Hopkins University to lend further support to the fact that Ephedra is safe and works. I would suggest you look into the results of that report before you make any decisions that are NOT the will of the people you swore to serve. 5. I support, and always have, RESPONSIBLE legislation on all consumable products. Proper labeling is key to proper use. Along those lines, I reviewed the proposed labeling you are recommending and I was shocked to see that it exceeds ANYTHING I have ever seen. Even cigarettes and alcohol don’t carry such extensive labeling and they kill 10 of thousands of Americans daily. How about acetaminophen (15,000 emergency room visits each year) and other pain relievers (16,000 deaths each year). Why are you not targeting these products with all of their documented fatalities? The answer is simple-because used as directed, they are typically safe. Why is it that a pack of cigarettes can carry a little warning the size of a postage stamp after it has been documented that millions have died from it but you are going to put such a huge labeling burden on a product that, according to the Rand report, can’t be clinically shown to have killed anyone, ever? In my opinion, this is a back-door attempt by the agency to “ban” the product by requiring such labeling that manufactures will not be able to comply due to the sheer size of the requirements. You would need to put the product in a container the size of a Corn Flakes box in order to comply with all of these proposed labeling requirements. How about a little sign of sanity here? Where is the science? 6. The most respected scientific evidence on Ephedra concludes that this compound is safe in dosages anywhere from 80 mg to 150 mg per day (taken in smaller increments throughout the day). Biolean comes in way under this number, advising a morning dose of 25 mg, followed by an afternoon dose of 12.5 mg. 7. By your own admission, millions of people take Ephedra-containing products on a daily basis. If this is true, which you know it is, and Ephedra is deadly, why aren’t people dropping dead all over the place? Why has the reported “death toll” remained the same mystical “100 deaths linked to Ephedra” since 1996? Has anyone ever shown you the name by name listing of those “100 deaths”? No, because they don’t exist! The RAND report confirms that no serious events have occurred 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 event reports revealed 21 sentinel events, cases involving Ephedra that may indicate a safety problem but do not prove that Ephedra caused the adverse event. 8. In closing, I urge you to review the science, act RESPONSIBLY, and not “jump on the band wagon” just because it is the “popular” thing to do. You have a duty to represent us, the people, not the industries that want to get their hands on this product so they can charge 10 times the going rate for it without any R & D costs. Sincerely, Ivan Camp




EC -66