Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -302

Accepted - Volume 307

Comment Record
Commentor Ms. Jennifer Hutcheson Date/Time 2003-03-17 15:24:40
Organization Goen Technologies
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments To whom it may concern: Hello, I am a concerned citizen and I’d like to express how I feel about this controversy regarding ephedra. A few years ago, when I was at a party in college, someone broke out a purple bottle of “herbal ecstasy” and started handing them out three to each person. A few minutes later, my friend complained of rapid heartbeat and nausea. The bottle contained ephedra, kola nut, and a few other herbs. Obviously, these people were taking ephedra to get high. Those purple pills my friend took contained about 100 milligrams of ephedra, which is a dangerous amount to take at one time. Her reaction, however, was not severe, but uncomfortable. In January of this year I accepted a job as a medical writer from Goen Technologies, makers of the supplement TrimSpa, which offers both a regular formula, containing ephedra, and an ephedra-free product. Knowing that ephedra made my friend sick that day made me feel cautious about this herb. However, after working here for almost three months, I must say that I am thoroughly convinced that TrimSpa is an ethical, honest company with the highest possible care for their customers. In contrast to the irresponsible marketing and formulation of the “herbal ecstasy,” this product contains only 12 milligrams of active ephedra per pill. In one day, that’s 36 milligrams of active ephedra. This is an extremely low amount, as most weight-loss formulas containing ephedra use double or triple this much. I started taking TrimSpa to lose weight the first week I started work. I consider myself a healthy, active person, and I wanted to lose 10-15 pounds. So far, in three months, I’ve lost 8 pounds solely from taking TrimSpa. It’s been cold, so I have not been exercising in the morning as I usually do. As far as side effects go, I feel what I can compare to the way I feel when I drink a 10-ounce cup of Dunkin Donuts coffee. That’s it. In fact, I feel better, healthier, and more in charge of my own health now that I’m taking this herb. And what about other options for weight loss? What are they? Phen-fen is gone, as it should be, and other drugs, such as Meridia, are for obese people. I only want to lose a few pounds and feel healthier and happier. There is no doubt that we Americans need to confront our weight-loss demons. We are getting fatter and fatter each day. According to the Surgeon General, in NJ where I live less than 10% of people were obese in 1991. In 2000, over 20% of people are obese. And these statistics are self-reported, and everyone knows that people routinely under-estimate their weight. So the actual prevalence is likely higher that 20%. When I was growing up in the 1980s, in school it was drilled into my head to “Just Say No” to drugs and alcohol. The message got through to me; drugs don’t solve problems, they just create new problems to go with the old. After the “Just Say No” lecture, we all marched down to the cafeteria where we ate fried chicken nuggets, french fries, corn, chocolate milk, and ice cream. It seems clear to me now that yes, drugs and alcohol are dangerous, but food can be just as seductive and crippling when children are not given correct information and guidance in their choices. The fact is that those chicken nuggets and ice cream WILL KILL people. In fact, being obese causes early death nearly on the same scale as smoking cigarettes does. Being fat kills 300,000 Americans a year, while smoking kills 400,000. Soon these numbers will be equal! If you do the math, you will see that in 1991, when less than 10% of NJ resident were obese, I was 17 years old. Ten years later, more than 20% in NJ are obese. Could it be that these children, the “Just Say No” generation, kept eating fatty foods after they graduated from school? The answer is obvious. We were never taught to take care of and respect our bodies. Now, by taking a thermogenic weight loss pill containing a low dose of ephedra and caffeine, there is finally some hope for overweight and obese people. People have lost over 100 pounds by using this formula. Billions of doses of this formula are consumed each year, and serious adverse events are RARE, no matter whose standards are employed! The RAND Report, which was published last month, could only link ephedra to 2 deaths in the past 10 or more years! This is the best scientific evidence available to date. I can’t understand why the media is using the RAND Report to criticize ephedra, when in fact, this report actually EXONERATES the herb. I won’t launch into statistics, but you are all aware that aspirin, lightning, drowning, prescription drugs, even dog bites, kill more people each year than have ever died from ephedra! When it is used responsibly, it is safe! It simply is not fair or relevant to demonize all makers of ephedra products based on the lousy concern for safety of a few irresponsible companies. To tell you the truth, I feel anger when I think about the bad rep ephedra has. It is silly, based on ridiculous information, and it seems everyone, including the FDA, has jumped on the “anti-ephedra” bandwagon. I wish someone would step up to the plate and tell the truth. Herbal ecstasy “dealers” should be put out of business! But don’t penalize responsible companies who are doing the right thing. Ask the 300,000 people who will die this year from being fat what is deadly—a weight-loss pill that works or a lifetime of eating fatty food! They’ll tell you the truth. So ban ephedra and caffeine combinations for weight loss, and let us all get as fat as houses. Pass the bologna and butter sandwiches. We’ll all just sit on our couches, watching Emeril, remembering to “Just Say No” to the evils of drugs and alcohol while we gorge ourselves on potato chips and Burger King commercials. Viva la Big Mac! Thank you for allowing me to express my opinion on this matter. Jennifer Hutcheson

EC -302