Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1381

Accepted - Volume 326

Comment Record
Commentor Mr. Samuel Knoll Date/Time 2003-04-05 09:43:49
Organization Healthway Corporation
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments April 5, 2003 Doockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Docket 95N-0304 Dear Sir: I own 9 stores that retail health foods and dietary supplements, and have been in this industry for 20 years. I have had experience in this industry as a consumer and business owner during the days before the Dietary Supplement Health and Education Act of 1994 (DSHEA) and after DSHEA, and I do not believe that FDA needs any expanded authority at this time in order to protect the public health. DSHEA gave FDA plenty of power to police the dietary supplement industry and to protect consumers. Former Chairman Kessler chose not to enforce DSHEA, and the press has adopted the position that FDA is prevented from exercising any strong oversight of the dietary supplement manufacturers and marketers. This is simply not true. FDA should exercise the power it already has before requesting any additional enforcement power. I agree with former FDA commissioner, Dr. Jane Henney, that DSHEA provides FDA with the necessary legal authority to protetct public health (already). There are some unscrupulous marketers in the dietary supplement market, and FDA (and FTC) should use their existing powers to police those marketers making unwarranted or unsupportable claims. However, no additional authority is needed to provide this protection. DSHEA truly did improve consumer access to dietary supplements and information about them, and this was an important milestone. I strongly support DSHEA and do not think any additional legislative authority is necessary for FDA to regulate ephedra or any other dietary supplement. Sincerely, Samuel H. Knoll 465 Goodspeed Rd Virginia Beach, VA 23451 email:

EC -1381