Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -260

Accepted - Volume 4

Comment Record
Commentor Mr. craig weible Date/Time 2002-07-29 13:04:46
Organization Mr. craig weible
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? The FTC is responsible for protecting us from false claims not the FDA. The FDA should not put any disclaimers on nutritional supplements, period.
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? there should be no FDA disclaimers on nutritional supplements

EC -260