Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -256

Accepted - Volume 4

Comment Record
Commentor Mr. Don Davis Date/Time 2002-07-29 11:51:42
Organization Mannatech
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrictive and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
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? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Dear Sir, I wish to express my desire to have access to more information on dietary supplements and the beneficial effect they may have on my health. I feel the FDA's current approach is to restrective and does not allow the puplic enough freedom to determine what is available and how it could help me with my long term health. Thank You for this oppertunity to express my wishes.




EC -256