Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -364

Accepted - Volume 307

Comment Record
Commentor Ms. Debra Markel Date/Time 2003-03-19 19:27:10
Organization Apothecarian Herbals, LLC
Category Health Professional

Comments for FDA General
Questions
1. General Comments March 5, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Sir/Madam, I own/work for a health food store/dietary supplement company in Anytown, U SA, and have been in the natural products industry for several years. Both my customers and I apprec iate the significance of the Dietary Supplement Health and Education Act of 1994 with regard to prot ecting our right to choose how we care for ourselves. I am concerned that FDA has only just begun to implement key sections of DS HEA. 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 donít overlook that DSHEA actually increased FDA's enforcement powers. FDA can seize a dietary supplement if it presents an unreasonable or significant risk of il lness or injury. In addition, the government can stop the sale of an entire class of dietary su pplements if they pose an imminent public health hazard. In sum, I agree with the former FDA commissi oner, Dr. Jane Henney, that DSHEA provides FDA with the necessary legal authority to protect publi c health. DSHEA improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and misleading claims . I strongly support DSHEA and do not think any additional legislative authority is necessary fo r FDA to regulate ephedra or any other dietary supplement. Sincerely, Debra M. Markel Powhatan, VA 23139




EC -364