Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -183

Accepted - Volume 4

Comment Record
Commentor Mrs. Barbara Neller Date/Time 2002-07-25 16:58:43
Organization Mrs. Barbara Neller
Category Individual

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? Producers of dietary supplements should have the ability to print appropriate health claims on the labels of their products, if such claims are accurate and documented, as provided for in the DSHEA
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? If the guidelines in DSHEA are followed, no disclaimer about the FDA not evaluating them should be necessary
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? The January 2000 FDA administrative letter in the Congressional Record that states that a supplement or natural substance cannot be mentioned in writing, recording or orally to improve or correct a disease process or abnormal condition. DSHEA gave this right and it should be upheld.

EC -183