Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -254

Accepted - Volume 4

Comment Record
Commentor Mr. Nicholas Eltgroth Date/Time 2002-07-29 10:44:05
Organization Nick's Sales and Service
Category Health Professional

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? I believe that the restrictions concerning statements that there are definite health benefits from certain scientifically proven glyconutritional and phytonutritional products, should be lifted. FDA should allow the proven health benefits of these products to be advertised as such for the promotion of better health. Do not negate the benefits of the DSHEA act.
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? I believe that statements that a group of nutritional supplements has not been approved by the FDA makes it look to some people like a warning that the products are dangerous and should not be taken. I do not think that this warning is necessary or useful.




EC -254