Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1270

Accepted - Volume 326

Comment Record
Commentor Mr. Howard Chasser Date/Time 2003-04-03 11:20:55
Organization Jandi's Nature Way
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments Dear sir/Madam, I own a health food and dietary supplement store in Oceanside, NY and have been in the natural products industry for almost 27 years. My 7000+ customer base 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 just begun to initiate aggressive enforcement actions under DSHEA, yet is calling for suggestions about increased legislative authority in order to better regulate the supplement industry. DSHEA should be fully implemented including the enforcement of GMP's (preliminarily issued a few weeks ago - mandated in 1994) before calling for new laws. I believe the agency has the authority to regulate ephedra or any dietary supplement deemed unsafe without changes to DSHEA. It is 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. Further, FDA can stop the sale of an entire class of dietary supplements if they determine they pose an imminent public health hazard. The former FDA commisioner, Dr. Jane Henney, has stated before Congress that she beleives that DSHEA provides FDA with 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, -Howard Chasser

EC -1270