Answer: One feature of an FCN that differs from a Food Additive Petition is the proprietary nature of an FCN. Unlike a patent or trademark, a notifier's proprietary right to an effective FCN is not necessarily exclusive. Another party or competitor can submit an FCN to FDA for the same substance and, provided FDA does not object, obtain its own notification in the normal course.
This process can be repeated by anyone who collects and submits adequate chemistry and toxicology data demonstrating that the substance is safe. A subsequent notifier can obtain and rely on the non-confidential data submitted by previous notifiers -- including migration and toxicology data.
Back to FAQs