Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -1213

Accepted - Volume 326

Comment Record
Commentor Ms. Karen Walker Date/Time 2003-04-02 13:01:32
Organization Sunshine Discount Vitamins
Category Dietary Supplement Industry

Comments for FDA General
1. General Comments FDA already has enough legislative authority to regulate supplements. Former FDA commissioner Dr. Jane Henney, in fact, testified before Congress that DSHEA provides FDA with the necessary legal authority to protect the public health. The passage of DSHEA increased FDA's enforcement powers. The FDA can already seize dietary supplements that pose an unreasonable or significant risk of illness or injury. The Department of Health & Human Services can also stop the sale of an entire class of dietary supplements if they pose an imminent public health hazard. FDA has finally started to fully implement the law by taking aggressive action against unsubstantiated dietary supplement claims as well as recently issuing a proposed rule on good manufacturing practices for supplements. Give these efforts a chance to work. Sincerely, Karen A. Walker Owner Sunshine Discount Vitamins

EC -1213