Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1363

Accepted - Volume 326

Comment Record
Commentor Mr. Jerry Rayman Date/Time 2003-04-04 17:43:13
Organization Pal Laboratories, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments April 4, 2003 Pal Laboratories, Inc. 10655 NW 29th Terrace Miami, FL 33172 Dear Sir/Madam, I work for a dietary supplement company in Miami, FL, USA, and have been in the natural products industry for several 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. Shouldn't you first give these recent efforts a chance to work, and perhaps even issue good manufacturing practices for supplements, before calling for new laws? Simply put, I believe the agency can regulate ephedra without dimantling DSHEA. it is also my understanding the DSHEA increased FDA's enforcement powers and thea 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, stongly support DSHEA, and do not think any additional legislative authority is necessay. Sincerely, Jerry Rayman Pal Laboratories, Inc. 10655 NW 29th Terrace Miami, FL 33172

EC -1363