Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1390

Accepted - Volume 326

Comment Record
Commentor Ms. Margaret Wittenberg Date/Time 2003-04-05 15:38:28
Organization Whole Foods Market
Category Company

Comments for FDA General
1. General Comments April 4, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Docket # 95N-0304 Whole Foods Market owns and operates 142 natural and organic supermarkets throughout the United States, which includes the sale of dietary supplements. We appreciate how the passage of the DSHEA improved consumer access to dietary supplements and information about them, while increasing consumer protection against unsafe products and false and misleading claims. In our experience, we feel that DSHEA has been adequate in both educating and protecting our customers. We are confident that with DSHEA, the FDA has sufficient enforcement powers to protect public health, including the ability to seize dietary supplements that pose an unreasonable or significant risk of illness or injury and also to stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. We are glad to see further efforts to regulate the supplement industry, such as the proposed good manufacturing practices, and we feel implementation of these GMPs will further improve the quality of dietary supplements. Accordingly, we believe the FDA can regulate ephedra without dismantling DSHEA. Furthermore, we strongly support DSHEA, and do not think any additional legislative authority is necessary. Sincerely, Margaret Wittenberg Vice President, Governmental & Public Affairs Whole Foods Market, Inc. 601 North Lamar Blvd., Suite 300 Austin, TX 78703

EC -1390