Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -42

Accepted - Volume 298

Comment Record
Commentor Mrs. Carol Hukari Date/Time 2003-03-05 20:40:18
Organization Annasa, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Dear FDA: I work for a dietary supplement company in Los Angeles and have been in the natural products industry for over 14 years. I, along with our customers, appreciate how the passage of the Dietary Supplement Health and Education Act of 1994 improved consuemr access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and miselading claims. I'm concerned that FDA has only just begun to initiate aggressive enforcement actuions 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 effors a chance to work, and perhaps even issue good manufacturing practices for supplements, before calling for new laws? Said another way, I believe your agency can regulate ephedra without dismantling DSHEA. It's 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 commissioenr, 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. Thank you. Sincerely, Carol Hukari

EC -42