Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -245

Accepted - Volume 298

Comment Record
Commentor Dr. Melanie Byram Date/Time 2003-03-12 19:29:42
Organization Smoky Hill Family Practice Residency
Category Health Professional

Comments for FDA General
Questions
1. General Comments Thank you for reopening the debate on ephedra containing products. I am associate director of a family practice residency program in Salina, KS. Prior to working here, I spent 11 years in private practice in Council Grove KS, a small town of 2500 people. While I am overall open to alternative and herbal therapies in my patients, I have numerous times seen patients with adverse effects from ephedra containing weight loss supplements. Most of these patients admitted they would not tell most doctors they were taking these, for fear of being put down. Most had been told by salespeople that even if they had heart disease or high blood pressure, these would be safe if they were on medication. Many were told it would get them off diabetes or hypertension medications. Some stopped their diabetes and blood pressure medication. Most were sold by people in the community under pyramid type schemes, many came from local health food stores. Several patients had serious reactions to the medications and these were reported to the FDA. Many of the products disguised caffeine as kola nut or green tea extract. During my time in Salina, I have offered an alternative health elective for residents and medical students. We have found that the number one product sold in our local health food store is ephedra containing weight loss and performance supplements. One of our residents supervises the athletic dormitory at a local college, Kansas Wesleyan. He estimates that at least half of the athletes are taking some type of performance supplement. Recently one of our workers came to me with a diet aid being promoted by GNC containing sida cordifolia and caffeine. She was told by the salesperson at GNC it was safe with her hypertension and did not contain ephedra. When I looked up sida cordifolia, I found that the active ingredient is ephedra. My recommendation would be to control herbal medications as prescription medicines and require quality control to make sure what is being sold and what it is being sold for and the dosing is appropriate. Until this is accomplished, or another class is established for herbal medicaitons, I personally believe all OTC ephedra products should be removed from the shelf pending further study. I believe deceptive advertising should be investigated. I believe the public needs to be better informed about the risk or potential risk of ephedra, especially in combination with other stimulants. I believe package information needs to be clarified to indicate active ingredients in botanicals, doses, maximum daily doses, along with contraindications for use. I don't believe my patients are any stupider than the average person, but, unless they hear otherwise from me or another respected source, I would estimate that 90% of them believe that OTC weight loss supplements are safe. I appreciate the opportunity to express my concerns about ephedra and ephedra containing weight loss supplements. I am not opposed to keeping ephedra available OTC, as I believe it is appropriately monitored. Thanks ever so much. Melanie Byram MD




EC -245