Skip to main content

FDA Will Again Reject Pending FCNs in the Event of a Government Shutdown

The U.S. Food and Drug Administration (FDA) will not change how it handles pending Food-Contact Notifications (FCNs) in the event of another government shutdown. Speaking at Keller and Heckman's 15th annual Food Packaging Law Seminar on September 17, Dr. Thomas C. Zebovitz, a Consumer Safety Officer in FDA's Division of Food Contact Notifications (DFCN), discussed the 2013 government shutdown and the Standard Operating Procedures (SOP) currently being developed on how to handle pending FCNs in the event of another government shutdown.

Zebovitz explained why rejection letters were sent to all of the companies with pending food-contact notification (FCN) submissions when the 2013 shutdown began. In particular, he cited Title 21 of the Code of Federal Regulations (C.F.R.), part 17.104(c), "FDA may object to an FCN if any part of FDA's 120-day review occurs during a period when this program is not funded as requires in Section 409(h)(5) of the act," as the legal basis for issuing the rejection letters. Zebovitz explained that the regulation prevents FDA from changing how it handled pending FCNs and would require the DFCN staff to again issue rejection letters for pending FCNs should another government shutdown occur.

During the 2013 shutdown, DFCN staff sent 28 rejection letters to companies with pending FCNs, including letters for two FCNs for which the technical review was completed. The rejection letters were later reversed, but the remaining 26 FCNs had to be refilled once the government shutdown ended.

Please see Dr. Zebovitz's PowerPoint presentation for further information.