Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -189

Accepted - Volume 298

Comment Record
Commentor Mr. joseph Christy Date/Time 2003-03-10 11:20:36
Organization Trimedica Inc.
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments Dear Sir/Madam, I work for a dietary supplement company in Tempe, AZ, and have been in the industry for over 20 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, better health care and healing with natural medicine practioners at a substantially lower cost than and with great healing results than allopathic doctors, while increasing consumer protection against unsafe products and false and misleading claims. I am very concerned that the FDA has just begun to intiate aggressive enforcement actions under DSHEA, yet is calling for suggestions for increased legislative authority in order to better regulate the supplemnt industry. Shouln't you first give these recent efforts a chance to work, and perhaps even issue good manufactruing practices for supplemnt, before calling for new laws? Simply put, I believe tha agency can regulate ephedra without dimantling DHSEA. 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. Furthemore, the govenment can stop the sale of an entire class of dietary supplemnts if they pose an imminient 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 in strongly supporting DSHEA and do not think any additional legislative authority is necessary. Regards, Joseph Christy




EC -189