Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -78

Accepted - Volume 1

Comment Record
Commentor Ms. Sharon Hamilton Date/Time 2002-05-30 11:57:38
Organization Ms. Sharon Hamilton
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 FDA has long overstepped its regulatory bounds by enforcing their implications that their misguided disclaimer is somehow protecting the public from dietary supplements. Dietary supplements are important to every citizens health and should not be minimized in importance by these implied messages from the FDA. The public health is surely harmed when consumers are driven away from the positive healthy effects of hundreds of supplements that are proven to be effective. The FDA is remiss with their perpetuation of their implications that somehow these products are of questionnable quality and benefit. If anyone is selling snake oil to the public, it's the FDA. I completely agree with the court that the burden of proof of any supplemental product is on the FDA to prove that claims of benefit made by the manufacturers of dietary supplements are false (which in fact they aren't).

EC -78