Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -449

Accepted - Volume 307

Comment Record
Commentor Ms. Lonnie Andersen Date/Time 2003-03-20 17:01:38
Organization Projects Associates
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments I represent several manufacturers that sell their products to health foods stores in the USA, and have been in the natural products industry for several years. Both my customers and I appreciate the significance of the Dietary Supplement Health and Education Act of 1994 with regard to protecting our right to choose how we care for ourselves. I am concerned that the FDA has only just begun to implement key sections of DSHEA. For instance, the agency recently released its proposed good manufacturing practices for the industry, and yet is immediately calling for suggestions for increased legislative authority in order to better regulate the supplement industry. Shouldn't you first give DSHEA a chance to work as it was intended to before calling for new laws? Please, also don't overlook that DSHEA actualy increased FDA's enforcement powers. FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. In addition, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazars. In sum, I agree with the former FDA commissioner, Dr. Jane Henney, that DSHEA provides FDA with the necessary legal authority to protect public health. DSHEA improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and falshe and misleading claims. I strongly support DSHEA and do not think any additional legislative suthority is necessary for FDA to regulate ephedra or any other dietary supplement. Sincerely, Lonnie Andersen dba Projects Associates

EC -449