Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -238

Accepted - Volume 4

Comment Record
Commentor Mrs. Diane Chapman Date/Time 2002-07-28 16:50:54
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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 don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
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? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I don't understand most of these questions. All I know is we need access to Dietary Supplements and the information on them because our lives depend on them! My body has been able to completely heal itself from several chronic conditions due to these supplements and the information I was able to obtain about them. We deserve the right, in this country, to research information about any natural substance we want! This is the land of the FREE and if you take that right away from us, you condemn masses of us to a corrupt and deadly medical system of HMO's and toxic drugs offering us NO HOPE of recovery or a better life! In fact, properly prescribed prescription drugs are the fourth leading cause of death in this country! Unbelievable! The American public needs natural supplements and we will gladly take the responsibility to research them and find out which are good and which are not. You do not need to protect us by taking away our rights to live and eat as we please! Do what is right! Allow us complete access to all natural supplements and the research on them!




EC -238