Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -80

Accepted - Volume 298

Comment Record
Commentor Dr. LINDA Pacioretty Date/Time 2003-03-07 13:54:03
Organization BIONEXUS LTD
Category Company

Comments for FDA General
Questions
1. General Comments March 7, 2003 Dear Sir/Madam, I own a dietary supplement company in Ithaca, New York 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 regualte ephedra without dismantling DSHEA. It is also my understanding that DSHEA increased FDA's enforcement powers and the 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, Linda M. Pacioretty, Ph.D. President and CEO BIOnexus, Ltd.




EC -80