Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -345

Accepted - Volume 6

Comment Record
Commentor Mrs. Alice Peters Date/Time 2002-09-06 09:24:24
Organization Mrs. Alice Peters
Category Individual

Comments for FDA General
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? Advertising needs to be restricted. Commercial Speech is intended to manipulate - always for profit. Education, truth, and the health of all really isn't considered by most corporations. Advertising is meant to target a vulnerablility and capitalize on it. That is precisely why children are being targeted more than any other population segment - and it is to their detriment. Advertising in particular, especially television, is intense and the public doesn't have the critical thinking skills necessary to evaluate what is being presented to them - especially being in the passive, hypnotic state that television programmming puts them in - especially children and young adults!!!!
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? A record should contain evidence from a non-related third party test - to support claims. Companies with honest, consistant records of quality, should be rewarded.
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? Yes, especially if there is not an unbiased third party used to evaluate the claims.
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? I would say most people lead very busy lives and don't have the time or energy to evaluate or even read warnings. I would consider a system of symbols, or designs to designate standards of evaluation, health. For example, products that have absolutely no nutritional value (coke and tobacco) should have a mark reflecting that, and another product, like a protein drink, would have a different symbol reflecting health value, but to excercise caution.....etc. Things like fruits and vegetables, with no preservatives etc. would have a symbol relecting a good option, little downside.
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? Money is the barrier to speech in this country. If any individual or group could afford advertising to counter or challenge claims, I would say the FDA could relax on speech related regulation, but unfortunately tha is just not the reality. Free speech, commercial or otherwise, can only be supported if counter arguments can be readily and easily made.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Public health should be the priority of the FDA and protecting those unable to protect themselves. Since Television is the most powerful of all meduims in advertising, I think the focus should remain on banning advertising of tobacco, pharmaceuticals, soft drink products, all alcohol - anything clearly not in the health for all people. These companies can focus their campains on print and radio - where the public has a chance to evaluate and make an informed decisions. Television(including cable) advertising is all seduction and needs regulation!!!

EC -345