Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -38

Accepted - Volume 1

Comment Record
Commentor Mr. Eugene Mouncer Date/Time 2002-05-29 00:12:13
Organization Mr. Eugene Mouncer
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? The FDA should not have any athority to demand labeling to the effect that the statements have not been evaluated by the FDA. I think the consumer has the mentality to do their own evaluation. There is no legality given to the FDA to impose such requirements.
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? The FDA has no athority to require and should not require the labeling of diatary supplements any differently than all conventional foods.
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? There should not be ANY disclaimers required and so should not have any size of type or prominence required.
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? NO, the government should not have greater latitude over labels. The First Amendment should not relinquish greater latitude over labels.

EC -38