FDA Issues Final Rule on Determinations that an FCN Is No Longer Effective

The U.S. Food and Drug Administration (FDA) issued a final rule amending its food additive regulations (21 C.F.R. §170.105 and §170.102) to provide additional reasons that may be the basis for the Agency to determine that a Food Contact Notification (FCN) is no longer effective and to provide the manufacturer or supplier of the substance an opportunity to provide input before it makes such a determination. 

Prior to issuing this final rule, FDA regulations (§ 170.105) set forth the process by which FDA may determine that an FCN is no longer effective. This determination could only be made upon an Agency finding that data or other information demonstrate the intended use of a food contact substance (FCS) is no longer safe. The current regulations do not provide reasons other than safety as the basis for FDA to determine that an FCN is no longer effective. 

Under the new rule, additional reasons that FDA can now use to determine that an FCN is no longer effective are:

• The production, supply, or use of the FCS for its intended has ceased or will cease, or 
• The FCS identified in an FCN is authorized by a food additive regulation or covered by a threshold of regulation (TOR) exemption. 

The new rule also provides manufacturers or suppliers the opportunity to provide input before FDA determines that an FCN is no longer effective.

In a press release announcing the final rule, FDA stated that these changes will allow the Agency “to more effectively respond to new information on the safety and use of food contact substances.” FDA also stated that it intends to update its list of effective FCNs accordingly. The final rule is effective May 21, 2024.