Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -216

Accepted - Volume 4

Comment Record
Commentor Dr. Ramses Toma Date/Time 2002-07-26 11:55:39
Organization California State Univ.
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? MOST OF THESE SUPPLEMENTS ARE NOT NEEDED ,UNLESS IN CASE OF AILMENT. There must be a tighter regulations to protect the average individual from false advertisinf
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? all supplements must be treated in its regulations as drugs do

EC -216