Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -56

Accepted - Volume 298

Comment Record
Commentor Mr. Terry Jackson Date/Time 2003-03-06 11:51:23
Organization Irwin Naturals
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments March 6, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Dear Sir/Madam, I am the Regulatory Affairs Officer for a dietary supplement company in Los Angeles, California, and have worked directly with the Code of Federal Regulations 21 for over 7 years. I believe the Dietary 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 legislation 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? Simply put, I believe the agency can regulate ephedra without dismantling DSHEA. The passage of DSHEA has increased the FDA’s enforcement powers and 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 donot think any additional legislative authority is necessary. Sincerely, Terry Jackson Irwin Naturals 5310 Beethoven St Los Angeles, CA 90066




EC -56