Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -266

Accepted - Volume 4

Comment Record
Commentor Ms. Jackie Denig Date/Time 2002-07-29 16:06:52
Organization Ms. Jackie Denig
Category Individual

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? FDA could insist that dietary supplements have assays on their products.. to test their validity... I do NOT want doctors to be responsible for dietary supplements... that is like telling us we can't EAT without the doctors permission.. where is our freedom ??
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? Make the nutritional companies provide studies and possible side effects if they advirtise a particular nutrient. I can't believe all of the advirtising that goes on for drugs with ALL he side effects and people still want to take 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? Yes, conventional foods (processed foods) are killing us. SUGAR especially.. it is in everything !! Dietary supplements are a choice that people are allowed to make. I wish GRAS had been out when sugar was created.. it wouldn't pass. Processed foods are hard to regulate
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 the same size
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Let the public choose their own dietary supplements. FDA has a tough job but don't rule that only doctors can handle dietary supplements and vitamins etc.. that is NOT proper.. just make supplement companies provide assays and prove their products DON'T kill you... there is a reason a drug is regulated.,.. drugs KILL at high enough doses...




EC -266