Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -236

Accepted - Volume 4

Comment Record
Commentor Mrs. Phyllis Ames Date/Time 2002-07-28 10:06:30
Organization Mannatech distributor
Category Individual

Comments for FDA General
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? They should have to have the proof that it does work and know the side effects. People have gotten very leary about the FDA regulations, especially since they pass things like aspartame.
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 think a lot of people know that all drugs are toxic and I think they need to be warned about this. I also think that prescription drugs shouldn't be able to be advertised. It's all about money.
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? Proof that it works and be able to show it. People figure that as long as something says natural it's good for you. I think on things such as vitamins people need to know that the body doesn't even absorb a lot of them. Theyu need to know which ones work and which ones don't just by reading the label. Also it should have to say it works on people, not animals or what it does for animals, because our bodies are different.
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? Same
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? Plain simple warnings that ANYONE can understand instead of making things complicated. If it's plain and simple people will take the time to read it. If it's hard, they just ignore it and pick something out.
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 think many advertisements are very misleading and sometimes an outright lie so people can make money. A lot of companies don't care how they do it, as long as they make money. Mannaatech makes sure we tell peoople that our products don't heal anything, they just give YOUR body what it needs to fight its battles.
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? If it can be prooven that it works. I think a lot of times the FDA has too much power. I understand why we need it, but I think they let a lot of things go through that shouldn't and some things that should go through are put aside.
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? Mannatech has the clinical proof that it works and I think that things like that should be able to be put in print. We should be able to say Mannatech and not just glyconutrients
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think we should be able to name products in our public meetings and company names if we have the clinical and scientific that it's true.

EC -236