Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -168

Accepted - Volume 4

Comment Record
Commentor Mrs. Pat Pedersen Date/Time 2002-07-25 14:25:36
Organization Products of Distinction
Category Health Professional

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? we NEED THE FREEDOM TO CHOSE NATURAL PRODUCTS,IF WE WISH. wE NEED FREEDOM TO SAY THAT THEY MAY HELP IMPROVE OUR HEALTH. 106,000 PEOPLE DIE EVERY YEAR FROM PRESCRIPTION DRUGS TAKEN AS DIRECTED,BUT YOU ARE NOT TAKING DRUGS AWAY. we NEED NATURAL PRODUCTS,IF WE SO CHOSE. ISN'T THIS STILL A FREE COUNTRY. WE THINK THE FDA SHOULD KEEP TO THE BUSINESS OF CHECKING ON RX DRUGS. PLEASE LEAVE THIS ALONE. THE DASHA LAW OF 1994 IS OKAY. LEAVE IT ALONE. PAT PEDERSEN OF IOWA
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 THEY DO. BROCOLLI DOESN'T SAY THAT IT COULD PREVENT CANCER,BUT MAYBE IT SHOULD SAY SOMETHNG LIKE THAT. DOCTORS BELIEVE THAT IS TRUE.
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? THERE ISN'T ENOUGH INFO ON SIDE EFFECTS.

EC -168