Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -320

Accepted - Volume 307

Comment Record
Commentor Mrs. Mary Moore Date/Time 2003-03-18 07:15:47
Organization E'ola International
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Dear Sir/Madam, I work for a health food dietary supplement company in Cypress, CA, and have been in the natural products industry since 1996. Both my customers and I appreciate how the passage of the Dietary Supplement Health and Education Act of 1994 improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and misleading claims. I am concerned that FDA has only just begun to initiate aggressive enforcement actions under DSHEA, yet is calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn't you first give these recent efforts a chance to work, and perhaps even implement good manufacturing practices for supplements, before calling for new laws? Simply put, I believe the agency can regulate ephedra without dismantling DSHEA. So far, no one I have met has had difficulty with Ephedra, by using it in accordance with their personal need & within company directions. For me personally, it has benefitted my health beyond what conventional medicine could. I have been an RN for 24 years & had been on precription medications for allergies since 1988. My lungs had continued to become more congested, with ever increasing asthma & snoring at night--according to my husband. E'ola's products are helping to alleviate & control my asthma and snoring, this may have saved my marriage. Considering the JAMA publication of adverse drug reactions and deaths annually, well I'm afraid of what will happen to my health should you take away this option for me. Why should anyone, using products or medications irresponsibly, be able to take away my opportunity to pursue better health & to share that opportunity with others? It is also my understanding that DSHEA increased FDA's enforcement powers and that FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. Furthermore, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. The former FDA commissioner, Dr. Jane Henney, has even stated before Congress that she believes that DSHEA provides FDA with the necessary legal authority to protect the public health. I agree with Dr. Henney, strongly support DSHEA, and do not think any additional legislative authority is necessary. Sincerely, Mary Moore

EC -320