Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -642

Accepted - Volume 322

Comment Record
Commentor Ms. Dora Carl Date/Time 2003-03-26 10:42:47
Organization Lifestyle Therapies
Category Health Professional

Comments for FDA General
1. General Comments I oppose changes to dietary supplement oversight authority which would undermine consumer rights granted under DSHEA. The 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 the 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. The 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. No further changes are needed at this time. Sincerely, Dora Carl, OTR/L

EC -642