Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -156

Accepted - Volume 4

Comment Record
Commentor Mr. Ray Gebauer Date/Time 2002-07-25 02:30:14
Organization Mr. Ray Gebauer
Category Individual

Comments for FDA General
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers for supplements should be allowed to be in smaller type.
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Warnings are normally unnecessary for supplements, unless there is clear evidence that there is a present danger.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? No.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? The FDA's speech-related regulations regarding supplements do not advance the public health concerns they are designed to address.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? People should have the right to claim that a supplement may prevent a disease if there is evidence for that.

EC -156