Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -115

Accepted - Volume 298

Comment Record
Commentor Dr. Gameil Fouad Date/Time 2003-03-07 17:57:51
Organization Biotron Laboratories, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Dear Sir/Madam: I am employed by a manufacturer of dietary supplement ingredients. More specifically, I represent a company that has a very conservative view towards supplements, and we adhere to a strict internal Quality Policy which states that we shall ...produce high quality products that are well designed, safe and have consistent and predictable characteristics - all of which ultimately benefit the consumer. To these ends, we voluntarily limit ourselves to dealing primarily in vitamins and minerals with proven benefit. We encourage strong oversight of the dietary supplement industry for two primary reasons: 1) The consumer should have confidence that the products he or she chooses are safe and 2) as an industry, we suffer collectively from the few 'bad apples' that deal in fads, sell products of questionable benefit, lack sufficient technical and scientific expertise, make outlandish claims and have few if any quality control procedures in place. This being said, I have reservations with the current FDA request for increased legislative authority beyond the powers granted FDA under DSHEA. As I understand it, the current ephedra controversy is exactly why DSHEA was written. That is, the FDA has authority to sieze supplements that present an unreasonalbe or significant risk of illness or injury. In addition, I understand that HHS can stop the sale of an entire class of supplements if it is determined they pose an imminnet public health hazard. As I write, FDA has finally released GMP proposals that were suggested years ago as part of DSHEA. Not only are these proposals not in practice, they have not yet been formally published in the Federal Register. Clearly, full implementation of DSHEA has not yet become the reality. As a representative of the supplement industry I applaud the efforts of FDA to protect consumer safety while providing a level playing field for companies who voluntarily follow strict guidlines in terms of saftey and efficacy. I believe FDA has authority under current laws to perform these duties without placing undue burden on reputable firms. Rather than expanding FDA authority under the law, I urge the administration to provide FDA the resources to more fully carry out their current mandate and give DSHEA every chance to prove its value to both industry concerns as well as the protections to citizens for which it was orignially written. Thank you for your attention in this matter. Very Sincerely, Gameil T. Fouad, Ph.D.

EC -115