Docket Management
Docket: 95N-0304 - Dietary Supplements Containing Ephedrine Alkaloids
Comment Number: EC -388

Accepted - Volume 307

Comment Record
Commentor Mr. Bob Norman Date/Time 2003-03-20 10:28:24
Organization Vitamer Labs
Category Dietary Supplement Industry

Comments for FDA General
Questions
1. General Comments I believe that the potential harm associated with the abuse of products containing ephedra is serious and needs to be addressed fully. At the same time, I know that 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 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. Thank you.




EC -388