Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -132

Accepted - Volume 2

Comment Record
Commentor Mr. Thomas Waldenfels Date/Time 2002-06-18 00:03:23
Organization na
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? Yes. Drugs are deadly. Supplements are not. All regulation on speech is illegitimate nevertheless.
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 FDA has no right to limit speech regarding food or supplements in any way. The only authority you have is that which you've arrogated unto yourselves. It's illegitimate. You think we're idiots. Indeed, some of us are, but the Constitution of the United states, an unpopular and incovenient document for the FDA, guarantees our right to freedom of speech WITHOUT QUALIFICATION. It doesn't say, ...except when necessary to protect idiots from their own foolish actions. Get out of our lives. Get real jobs doing something productive and let the buyer beware.
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 only label I would countenance at all is one that informs the consumer, in neutral terms, that the FDA has not evaluated the safety or efficacy of the drug or supplement in question. Caveat emptor.
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? NO. You can state, in neutral terms, that the FDA has not evaluated the safety or efficacy of the product in question and make it clear that consumers are responsible for doing their own due diligence.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Stop persecuting the natural foods and supplement industries. Stop ignoring, fighting, and subverting the directives of the courts. Obey the law and get a conscience. To wit...Your refusal to allow the modest and well supported health claims on labels of folic acid supplements, which were proposed by your arch enemies at the Life Extension Foundation, would have saved tens of thousands of lives and prevented countless birth defects. Do you care? I doubt it. It's all about money and power. You regulate. We suffer and die.

EC -132