Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -196

Accepted - Volume 4

Comment Record
Commentor Mrs. Marielle G. Willett Date/Time 2002-07-25 20:49:43
Organization Family Health Manna
Category Dietary Supplement Industry

Comments for FDA General
Questions
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 distinction is dietary suppliments are naturally provided for us and patents are protecting them against abuse and all people benefit while using them.




EC -196