Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -157

Accepted - Volume 4

Comment Record
Commentor Mr. RON STEPHENS Date/Time 2002-07-25 08:53:25
Organization Mr. RON STEPHENS
Category Individual

Comments for FDA General
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The public health is harmed when consumers are driven away from the positive healthy effects of hundreds of supplements that are proven to be effective, because of the FDA's requirement for a disclaimer on dietary supplements. Consumers have the responsibility to be diligent about educating themselves when they choose any pharmaceutical or dietary supplement. The FDA, I believe, has long overstepped its regulatory bounds by enforcing their misguided disclaimer (...has not been evaluated by the FDA). If anyone is charged with protecting consumers from false claims, it's the Federal Trade Commission. The FDA's mandate is to evaluate the safety and effectiveness of pharmaceuticals, foods, cosmetics, etc. So who does it protect when it takes the unnecessary step of requiring labels to carry this disclaimer? Not the health of the taxpayers. It protects the giant drug companies who stand to lose millions if more and more consumers choose to improve their health with supplements and reduce their need for high priced pharmaceuticals.

EC -157