Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -270

Accepted - Volume 298

Comment Record
Commentor Dr. Barrie Tan Date/Time 2003-03-14 14:37:32
Organization American River Nutrition, Inc.
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments March 14, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Sir/Madam, I own a dietary supplement company in Hadley, Massachusetts, and have been in the natural products industry for more than 15 years. 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. You should give these recent efforts a chance to work, and provide GMPs for supplements, before calling for new laws. I believe the agency should and can regulate ephedra without dismantling DSHEA. It is also my understanding that DSHEA increased FDAs enforcement powers and that FDA can seize a dietary supplement if it presents an unreasonable or significant risk of 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 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, Barrie Tan, Ph.D. President




EC -270