Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -72

Accepted - Volume 1

Comment Record
Commentor Mrs. Judith Mathat Date/Time 2002-05-30 00:39:40
Organization Independent USANA 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? Evidence establishing those supplements produced by the Good Manufacturing Practices for Nutritional Supplements should be noted on all packaging as to the purity and potency by the FDA and any warnings to what would comprise supplement abuse by an unwitting comsumer. All supplements should be noted as to their EXACT content and if not available, noted as not meeting any claims to purity and potency and content.
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? The most important function of educating consumers to prescription use does not always come from the doctors due to their busy schedules. The best paractices have come from the pharamacology interaction at the time of dispensing prescriptions and should be enhanced and supported by the FDA, particularily with regards to interaction of different types of drugs prescribed and others being taken. A drug data base co-mingling alert if you will.
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? Definately foods and dietary supplements are worlds apart in their preparation and content resulting from that preparation. Something such as 7 bowls of cooked spinach would equal the amount of Vitamin ??? and whatever. Also the calcium contained in this gallon of milk equals ??? of pills with ??? mgs. of (a certain type of calicum, i.e calcium citrate, etc.).
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 noted in larger type than contents on label, but the same type should note any medical advantages found from using the product.
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? Amounts of certain supplements, drugs can have certain effects if taken over the prescribed dosage. Keep responsibility on the consumer but use larger print for alerts or have brightly colored labels for the most dangerous drugs.
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? Let the consumer decide, let the FDA set up the information scientifically and use consistent labeling and coding to assist in that process, not directive responsibility.
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? Allow supplement manfacturers to provide double blind study information and AMA and other scientific studies information along with the products. Also all prescription and over the counter drugs and all product warnings.
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 danger of any product should be revealed by a: 3 in 150,000 chance of adverse reaction, etc.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Allow supplement manufacturers to be rated according to their Good Manfacturing Practices and product contents.




EC -72