Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -196

Accepted - Volume 298

Comment Record
Commentor Mr. David L. Bergsma Date/Time 2003-03-10 15:59:30
Organization Quantum Research, Inc.
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments March 10, 2003 Dockets Management Brand (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 I am President of Quantum Research, Inc.; a dietary supplement research company based in Scottsdale, AZ with affiliates Tucson, AZ, Iowa, California, and Montreal, Canada. We have been in business since 1994. The Dietary Supplement Health and Education Act of 1994 made the existence of our organization possible. Improved consumer access to dietary supplements and information about supplements and increased consumer protection against unsafe products and false and misleading claims has been a great blessing to the consumer. Future operation under the Act will lead to more refinement and even better consumer experience. My reason for writing rests in the following issue. FDA has only just begun to initiate aggressive enforcement actions under DSHEA. Simultaneously FDA is calling for suggestions for increased legislative authority in order to better regulate the supplement industry. I believe you should give these recent efforts a chance to work before calling for new law or regulations. If asked to condense my comments I would respond that the agency can regulate ephedra without dismantling DSHEA. The ability exists already exists. The former FDA commissioner, Dr. Jane Henney, has stated before Congress that she believes DSHEA provides FDA with the necessary legal authority to protect the public health. I agree with Dr. Henney, strongly support DSHEA, and not think additional legislative authority is necessary. Thank you. Yours truly, David L. Bergsma, President Quantum Research, Inc. 7975 North Hayden Road, Suite D-333 Scottsdale, AZ 85258

EC -196