Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -241

Accepted - Volume 298

Comment Record
Commentor Mr. Nicholas Carone Date/Time 2003-03-12 14:18:15
Organization Healthy Nutrition, Inc
Category Company

Comments for FDA General
1. General Comments Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 March 12, 2003 Dear Sir/Madam, I own a nutritional product supplements company in Bethesda, MD, USA, and have been in the natural products industry for 2 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? 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. 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. Simply put, I believe the agency can regulate ephedra or any other dietary supplement without dismantling DSHEA. Sincerely, Nicholas Carone President Healthy Nutrition, Inc PO Box 30872 Bethesda, MD 20824-0872 301.654.7770

EC -241