Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -341

Accepted - Volume 4

Comment Record
Commentor Mr. Hank Jost Date/Time 2002-09-05 19:33:04
Organization Mr. Hank Jost
Category Individual

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 don't feel that commercial speech of any kind deserves constitutional protection. The constitution should protect individuals, not powerful corporate entities.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? All products injested by humans should have the same regulation.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Same size
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? This kind of speech probably would undermine FDA because this speech would seem to carry with it the appearance of approval.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Remember who the constitution is written for; the individual.




EC -341