Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -55

Accepted - Volume 298

Comment Record
Commentor Mr. Jeffrey Munroe Date/Time 2003-03-06 11:25:09
Organization A Better Herb Shop
Category Health Professional

Comments for FDA General
1. General Comments I own a health food store in Oklahoma City, Oklahoma, and have been in the natural products industry for several years. Both my customers and I appreciate hoe the passage of the Dietary Supplement Health and Education act of 1994 improved cinsumer access to dietary supplements and information about them, while increasing consumer protection againts unsafe products and false and misleading claims. I am concerned that the FDA has only just begun to initiate aggressive enforcement actions under DSHEA, yet is calling for suggestions for increasedlegislative authority in order to better regulate the supplement industry. Shouldn't you first give 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 dismantling DSHEA. It is 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. Futhermore, the government can stop the sale of an entire class of dietary supplements if they pose an imminet public health hazard. The former 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.

EC -55