Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -315

Accepted - Volume 307

Comment Record
Commentor Mr. Robert Dereme Date/Time 2003-03-17 20:20:22
Organization Natural Balance
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments March 17, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Dear Sir or Madam, I work for a dietary supplement company in Castle Rock, Colorado and have been in the natural products industry for several years. Both I and the customers I deal with appreciate how the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA) has 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 while the FDA has only just begun to use its enforcement powers under DSHEA, it is calling for suggestions for increased legislative authority in order to better regulate the supplement industry. The better approach would be for the FDA to use the existing enforcement powers under DSHEA effectively rather than calling for new regulations. It is my understanding that under DSHEA, the FDA can seize a dietary supplement if it presents an unreasonable or significant risk of illness or injury. Furthermore, under DSHEA, the government can stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. It is hard to imagine greater enforcement or regulatory powers than these. Even former FDA Commissioner, Dr. Jane Henney, testified before Congress that DSHEA provides the FDA with the necessary legal and enforcement authority to protect the public health. Whatever the FDA decides to do in regulating ephedra, it is clear that the agency can act without dismantling or modifying DSHEA. A broad attack on DSHEA because of issues surrounding one ingredient is simply a politically motivated over-reaction. I urge the FDA to leave DSHEA alone and let it continue to function to improve the general health and well-being of American citizens as it has done since its passage. Sincerely, Robert Dereme 31 Lama Drive Shirley, NY 11967

EC -315