Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -7

Accepted - Volume 1

Comment Record
Commentor Mr. Robert Linden Date/Time 2002-05-26 19:25:01
Organization Peak Management Consulting and Training
Category Dietary Supplement Industry

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? The primary argument is that drugs are toxic by virtue of the fact that they are drugs. Dietary supplements that are food based are not toxic. While some people have allergic reactions to some food(s), that does not automatically mean that there should be a curtailing of free speech concerning what a fod based supplement can or cannot do. I request that you do nothing that will curtail what freedom of speech there is included in the Dietary Supplement Health Education Act.
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? Yes, the FDA may distinguish claims concerning conventional foods from those relating to dietary supplements. In cases with which I am familiar, all of the supplements are made from vine ripened foods which contain all the nutrients that foods that are picked prior to ripening don't
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 is an old adage that says that The devil is in the fine print. I always read the fine print.
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? There should be very few warnings written on supplement labels unless there is overwhelming scientific evidence that shows it to be necessary.
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? Unaware of any SS evidence. In reference to your second question, I don't believe the FDA should have greater latitude over labels and frankly, the First Amendment and SS evidence would, if anything, mitigate against such control.
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? Don't know.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? To some extent they do, but I find they produce more alarm than public health.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Reduce your regulations concerning dietary supplements.




EC -7