Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -161

Accepted - Volume 4

Comment Record
Commentor Mrs. Carol Rempel Date/Time 2002-07-25 10:59:52
Organization Mrs. Carol Rempel
Category Dietary Supplement Industry

Comments for FDA General
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? The FDA should NOT be involved in steering people away from products through product labeling unless there has been SOLID SCIENTIFIC VALIDATION to their comments. The public has a right to do their own research and make their own decisions! Dietary Supplements are just that - food for the body.
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? DIETARY SUPPLEMENTS: Everyone has the right to choose which foods to put into their body, whether it's from the grocery store or the health food store shelves. If something claims to have an effect on a disease, then the public should have a right to evaluate those claims on their own.
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? If certain drugs are known to have side-effects, it's good to let the public know about it. However, the FDA should stay out of the food industry unless a certain product or substance is PROVEN to be harmful.
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? There should be no difference.
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? Such speech would not undermine anything if off-label uses of the product have basis in scientific studies and validations that are available to the public.
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 FDA's speech-related regulations actually PREVENT people new to the food-supplement industry from addressing their health concerns by unneccessarily warning them off products that have been proven BY SCIENTIFIC VALIDATION to be good for them. Unless the FDA is going to evaluate food supplements by scientific research standards, they need to stay out of the game!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Take warning labels off food supplements unless the substance has PROVEN to be harmful.

EC -161