Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -170

Accepted - Volume 4

Comment Record
Commentor Mr. Roger Utsler Date/Time 2002-07-25 15:03:12
Organization MANNATECH INDEPENDANT DISTRIBUTOR
Category Dietary Supplement Industry

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? My belief as a UNITED STATES CITIZEN states i have the right to free speech. I am a CERTIFIED ASSOCIATE of the DSHEA LAW DIETARY SUPPLEMENT HEALTH and EDUCATION ACT of 1994 that the UNITED STATES CONGRESS PASSED THAT WE CITIZENS OF THIS GREAT LAND ARE UNTITLED TO EDUCATE AND TO BE EDUCATED BY INDIVIDUALS CERTIFIED UNDER THE ABOVE STATED LAW. THE FDA HAS NO RIGHT TO REGULATE ANYTHING ABOUT THIS LAW.
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? 1. THE FDA HAS NO RIGHT TO INTERFER WITH THE DSHEA LAW. 2. THE ARE REALLY NO POSITIVE EFFECTS THAT I SEE ABOUT THE PROMOTION OF PRESCRIBED DRUGS. 3. THE CURRENT APPROACH TO TO OVER-PRESCRIBED DRUGS TO ANYONE IS OUT OF CONTROL. (I LOST A GRANDDAUGHTER BECAUSE OF THIS. 4. THERE IS DEFFINANTLY INCREASED PHYSICIAN VISITS BECAUSE OF THE MEDICATION REGIMENT. 5. THE FDA APPROACH NEEDS TO BE OVERHAULED AND LET NEW TECHNOLOGY WITH DIETARY SUPPLEMENTATION BE A NEW PARADIGN. 6.NO THERE IS LESS AND LESS COMMUNICATION ASSOCIATED WITH USE OF DRUGS. 7. THE FDA IS LAGGING BEHIND NEW TECHNOLOGY AND NEED TO BE EDUCATED THAT IN 1940S WE DID NOT HAVE THE PROBLEMS WE HAVE TODAY. 8. TODAY CARDIOVASCULARY DESEASE IS THE NUMBER 1 KILLER. CANCER NUBER 2 AND STILL NO CURE.
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? 1. NO 2. ALL INGREDIANTS THAT ARE HARMFUL TO THE HUMAN BODY SHOULD BE ON THE LABEL FOR CONSUMERS TO READ FOR THERE CHOICE TO CONSUME OR NONCONSUMPTION. 3. ONLY SUPPLEMENTS THAT HAVE SCIENTIFIC BACKING MY R&D AND RESEARCH UNIVERSITY SHOULD BE ALLOWED
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 BE REQUIRED TO BE IN LARGER SIZE FOR CLAIMS AND NOT HIDDEN. ?
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? LARGER LABELS ?
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? ALL LABELS SHOULD BE PRINTED IN LARGE TEXT.
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? THE FDA SHOULD NOT BE ALLOWED TO REGULATE ANYTHING ABOUT THE DSHEA LAW
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? THE FDA COULD LOOK AT THE 1940 AND SEE THERE WERE LESS SICKNESS BECAUSE OF LESS TOXINS AND POLLUTENS
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? THERE SHOULD BE A LAW THAT FORBIDS THE CHANGE OF LAW THAT HELPS CONSUMERS WITH THERE HEALTH AND THE COMPANY THAT CAN PROVE ITS ECAFACY WITH SCIENTIFIC STUDY.




EC -170