Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -118

Accepted - Volume 2

Comment Record
Commentor Ms. Tamara Andreas Date/Time 2002-06-05 17:46:49
Organization Ms. Tamara Andreas
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? The FDA has no right to interfere with freedom of speech. A company has the right to state or print truthful information, and this right should not be interfered with. It doesn't matter to whom the speech is made.
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? Food and dietary supplement companies should be allowed to make any truthful claim about their product. No additional disclaimer should be mandated. For example, they should not be required to state that their claim has not been approved by the FDA. In the absence of such a disclaimer, there is no reason for the average consumer to assume that the claim was approved by the FDA.
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? Disclaimers should not be required at all. All that should be required is truthfulness.
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? The government should only protect consumers from untruthful (fraudulent) claims, both in advertisements and on labels.
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? If the FDA's speech-related regulations were designed to advance the public health of medicine companies, then they do a good job. However, they harm the general public health in that they prevent people from having the relevent information to select alternative or natural medicines.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I've been told that the Supreme Court has already made it clear that the FDA policies are in violation of the First Amendment, and should thus be changed. The government should only require truthfulness in advertising and labeling.




EC -118