Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -169

Accepted - Volume 4

Comment Record
Commentor Mrs. Allison Gilbert Date/Time 2002-07-25 14:30:55
Organization Mrs. Allison Gilbert
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 think that speech about drugs be more regulated than speach about dietary supplements. Obviously, drugs have more of a potential for harming people than non-toxic dietary supplements! Promotional speech about drugs needs to include the fact that properly prescribed medication is the 4th largest killer in the USA today according to the AMA. Most people do not know that. There are no similar statistics for dietary supplements. People should be encouraged to use dietary supplements for both prevention and healing before resorting to toxic pharmaceuticals!
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? Again, if consumers were encouraged, rather than discouraged from getting the best information they can about the best dietary supplements for the prevention and healing of disease, they wouldn't need to resort to toxic pharmaceuticals. The FDA's current approach can make people think that medication is better for them than non-toxic dietary supplements. This approach does impede the ability of doctors to give optimal medical advice since they would also tend to get more education about drugs as opposed to dietary supplements--which does cause them to be neglectful in helping their patients achieve optimal treatment. Hence--the 4th largest killer in our society today: properly prescribed medication.
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? Why be afraid to allow claims to be made about dietary supplements or foods? The consumer should be able to make their own decisions and get themselves educated about the claims made. The tragedy is with drugs: the consumer depends on his/her doctor to have the education and then tends to feel that whatever drugs a doctor may prescribe is safe! Let foods and supplements offer claims. Foods and supplements are non-toxic!!!! Drugs are deadly--they are the ones that should be regulated heavily!
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 don't need to be on foods and supplements. The side effects and dangers of drugs should be given out to consumers and should be in large-sized letters.
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? Let the warnings or disclaimers be instead websites or book titles or magazine articles where the consumer can get more information to validate the food & supplement claims!
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 can't comment on this.
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 be able to find the study that supports the speech on the label.
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? As above, allow labels to refer to the studies that back up the claims. Then the FDA would be able to regulate the claims by the studies that back them up.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow food and food supplements to have the freedom to make claims on labels without the disclaimers. Let people take responsibility to get educated themselves about the claims.




EC -169