Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -281

Accepted - Volume 4

Comment Record
Commentor Mr. James Moore Date/Time 2002-07-30 05:13:36
Organization Mr. James Moore
Category Dietary Supplement Industry

Comments for FDA General
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 are too restrictive in that they curb opportunities to herald proven benefits of dietary supplements. While the FDA should ease restrictions, it should continue to disallow the representation of guarantees related to preventing, curing, or ameliorating disease conditions.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Essentially forbidding the mention - in writing or orally - of a natural substance that has proven to be effective in improving or correcting a disease process or abnormal condition should be changed. Such restrictions should be removed.

EC -281