Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -60

Accepted - Volume 1

Comment Record
Commentor Mr. Joshua Virkler Date/Time 2002-05-29 12:41:16
Organization Christian Leadership University
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 argument for regulating claims about drugs more comprehensively than dietary supplements is rooted in the fact that dietary supplements are basically herbs, vitamins and minerals that have been collected from nature and packaged for retail sale; while drugs are inherently more dangerous because the developers have taken bits and pieces of natural compounds and fooled around with them to try and make them more powerful. Over 100,000 people die each year from complications from drug interactions, and another 100,000+ die each year from taking drugs as directed! No one would ever have the audacity to suggest that dietary supplements are even remotely as dangerous as drugs have been proven to be.
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 average person does not believe that whatever they read on a package, be it food or dietary supplements, is the absolute truth. Food packaging often claims the contents are healthy, or delicious, but that doesn't mean people believe it. I am unaware of any basis to believe that people approach claims about conventional foods and dietary supplements differently, as dietary supplements, by definition, are intended to supplement nutritional needs not obtained through 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? This requirement is both ridiculous and unconstitutional. No one expects warnings to be the same size as benefit claims. We have become accustomed, as a society, to look for the fine print in everything. It is unreasonable to expect people to be foolish enough to believe that warnings should and/or would be of equal or similar size to claims. And there is no constitutional basis to allow FDA to require this.
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 is no constitutional, moral, or public protection basis for FDA to require a warning that a dietary supplement, or claims about a dietary supplement, has not been evaluated by FDA. This does nothing to promote public health or safety, and any arguments that it does are fallacious.
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? There is no evidence to suggest that FDA has any more constitutional authority over labels than advertising.
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? FDA's speech-related regulations do not advance public health concerns in any way, shape or form.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA should immediately stop forcing dietary supplement labels to include the statement that FDA has not evaluated the supplement or claims about it. FDA should stay out of the dietary supplement business, as it has no constitutional authority to be there.

EC -60