FDA Publishes Final Rule Related to the Regulation of Food Contact Notifications

The U.S. Food and Drug Administration (FDA) recently published a new final rule that amends the agency’s existing regulations on food contact notifications (FCNs). It specifically addresses substance notifications that are subject to revocation. The purpose of the new rule is to establish additional grounds for the FDA to decide that an FCN is no longer effective, and to allow the manufacturer or supplier of the substance an opportunity to provide the FDA with relevant information before the agency makes a determination regarding the substance’s status.

In essence, the FDA can now determine that a food contact substance (FCS) is not effective for reasons other than safety. Under the new rule, additional reasons for the FDA to conclude that a substance is not effective include where the production, supply or use of the FSC for its intended use has ceased or will cease (”abandonment”), or where an FCN is authorized by a food additive regulation or is the subject of a Threshold of Regulation (TOR). The new rule also allows manufacturers or suppliers that have submitted an FCN to discuss the FDA’s safety concerns and argue why the FCN should continue to be effective.

Finally, the new rule changes the existing confidentiality of information provisions to allow the FDA to disclose certain information related to a determination that an FCN is no longer effective.

Key Insights for FCS Manufacturers and Suppliers

So, what does all of this mean for FCS manufacturers and suppliers? The FDA’s new rule on food contact notifications both expands the agency’s authority and gives manufacturers and suppliers new opportunities to object to the agency’s determinations regarding FCN effectiveness. Crucially, as noted above, these opportunities now arise before the agency makes its determination—which was not previously the case. As the FDA explained in announcing the new rule:

“Before . . . this final rule . . . manufacturers and suppliers could show why an FCN should continue to be effective after the FDA would provide notice of our determination that the FCN is no longer effective. . . . The final rule . . . gives manufacturers or suppliers an opportunity to provide input before the FDA determines that an FCN is no longer effective, which helps provide the FDA all relevant information before making a determination.”

As the FDA also makes clear, the new rule “keeps in place the FDA’s ability to revoke an authorization based on safety concerns” while supplementing the existing grounds for revocation, and manufacturers and suppliers only have a limited amount of time to respond to a proposed revocation. In light of these developments, manufacturers and suppliers should ensure that they promptly review any FCN-related notices they receive from the FDA, and they should work with their regulatory counsel to challenge proposed FCN revocations as necessary.

Contact Us for More Information

Our attorneys advise manufacturers and suppliers on all aspects of FDA regulatory compliance, including FCN compliance. If you would like to speak with one of our attorneys, please contact Gardner Law us to arrange an initial consultation.