Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -398

Accepted - Volume 307

Comment Record
Commentor Mr. Seth McLaughlin Date/Time 2003-03-20 11:57:57
Organization Mac's Medicine Mart
Category Health Professional

Comments for FDA General
Questions
1. General Comments I am a certified pharmacy technician, certified nutritional consultant, licensed massage therapist,and third generation herbalist in the german folkloric tradition. I am also one of the authors of Complementary and Alternative Medicine Secrets, a book used by medical schools to teach basics of CAM. I have taught residents for the Quillen School of Medicine's Kingport Residency Program for several years. The Dietary Supplement Health and Education Act of 1994 has a direct impact on my daily work and on the lives of my clients. I am concerned that the FDA has only just begun to implement key sections of DSHEA. For instance, the agency recently released its proposed good manufacturing pratices for the industry, and yet is immediately calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn't you first use and enforce the laws on the books before creating more regulations? DSHEA increased the FDA's enforcement powers. FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. IN addition, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. In sum, I agree with former FDA commissioner, Dr. Jane Henney, that DSHEA provides FDA with the nevessary legal authority to protect public health. DSHEA made many improvements to the status of supplements in the United States. It dramatically increased protection against unsafe products and false and misleading claims. I strongly support DSHEA and do not think any additional legislative authority is necessary for FDA to regulate ephedra or any other dietary supplement. Instead of seeking new powers, simple use of existing powers can effectively protect our people from dangerous products. Sincerely, Seth McLaughlin 1425 E Center ST Kingsport, TN 37664-2501 423.245.2181




EC -398