Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -283

Accepted - Volume 4

Comment Record
Commentor Mr. Gregory Cook Date/Time 2002-07-30 07:21:36
Organization None
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? I believe that the only way the FDA could sustain a position that certain promotional speech about drugs is inherently misleading is when the company/product producer uses language that cannot be vertified by scientific proof. If the comsumer does not take the time nor initiative to educate themselves, then that is their problem.
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? I believe that the regulations in the Nutrition Labeling and Education Act have opened the door for the average consumer to have access to the information they need in order to make an informed decision concerning their healthcare. Any restrictions or narrowing of this Act will be to the detriment of the consumer, not the benefit. In fact, the removal of the FDA disclaimer would be beneficial to the average consumer, enabling them to have a more unbaised approach in their research.
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? I do not believe disclaimers are needed and should be removed.
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? Educated consumers disregard the FDA warnings on dietary supplements completely. The warnings are a source of confusion to those consumers who are just beginning their educational process. They interprete the warning, not as a warning to look at this supplement and its scientific basis, but as a warning to avoid looking at this product completely.
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? There is an inherent difference between prescription drugs and dietary supplements. Any efforts by the FDA to regulate the speech for dietary supplements should be confined to unsubstantiated claims.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The FDA should not restict the Act previously mentioned, but should reevaluate the restrictiveness still inherent in that Act. Is the public really being served with a warning that states that the FDA has not evaluated the ingredients in this product? Is that helping the consumer to get information that he/she needs in order to make informed decisions regarding their healthcare? I do not think so. It is confusing the average consumer, who needs to be encouraged to get education, not run from it.

EC -283