Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -146

Accepted - Volume 2

Comment Record
Commentor Mr. John_J Herda Date/Time 2002-07-08 11:02:50
Organization Mr. John_J Herda
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? Regarding speech about drugs and dietary supplements, they should mention how much of the money profits from the product are given to medical schools or otherwise to influence health care professionals. It may comply with FDA requirements and still be misleading. The speech should be worded such that it says the same thing to learned intermediaries or to consumers.
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? Let the advertizers make their claims but then say that the FDA has not tested the product or does not support these claims etc.
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? The word WARNING followed by bulleted specifics would be the easiest to scan quickly. If possible they should contain percentages of the population that may be adversly affected. Each bulleted item could start off in larger type then have the details in smaller a font.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, let advertizers claim more but include counter claims if there are any.




EC -146