Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -208

Accepted - Volume 4

Comment Record
Commentor Ms. Jo Cooper Date/Time 2002-07-26 09:39:31
Organization Ms. Jo Cooper
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? Please don't block the right of the American people to learn about the potential benefits of non-toxic dietary supplements. People are perfectly capable of educating themselves and making decisions about what is appropriate for them to try, given information; indeed, it is their responsibility to do so. As a former Hepatitis C patient who was bedridden despite the best efforts of a number of physicians, and who was completely restored to a normal life thanks to a non-toxic dietary supplement, I want you to make it as easy as possible for people to get helpful information about the perfectly safe options they might consider; dispense with potentially frightening labels (these ingredients have not been evaluated by the FDA, etc.); and allow for free speech regarding the potential health benefits of dietary supplements. People should have a right to chose natural, non-toxic, nutritional approaches to healing over toxic pharmaceuticals, and we should not prejudice the process by obscuring potentially beneficial information.

EC -208