Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -330

Accepted - Volume 307

Comment Record
Commentor Mrs. Karen London Date/Time 2003-03-18 15:33:31
Organization Nature's Pantry
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments Dear Sir/Madam I work for a health food store in Bellevue, WA and I have been in the natural products industry for 5 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 advertising. I am concerned that FDA has only begun to initiate aggressive enforcement actions under DSHEA, yet 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? Simple put, I believe the agency can regulate ephedra without dismantling DSHEA. It is also my understanding that DSHEA increased FDA's enforcemnt powers and that FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. Futhermore, 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 necessry 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, Karen London 10201 NE 10th St Bellevue, Wa 98004




EC -330