Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -245

Accepted - Volume 4

Comment Record
Commentor Ms. S. Stone Date/Time 2002-07-28 20:30:06
Organization Ms. S. Stone
Category Dietary Supplement Industry

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? Speech about drugs should be regulated more comprehensively because drugs are inherently toxic and have side effects while dietary supplements are essentially non toxic. My concern is that the DSHEA act of 1994 be maintained at all costs to be fair to the public so that we may continue to avail ourselves of natural substances which have been shown to bolster our state of health.

EC -245