In an article published on April 5, 2019, news provider Chemical Watch informed about an ongoing delay in the U.S. Food and Drug Administration’s (FDA) food contact notification review process. The partial government shutdown that occurred towards the beginning of 2019 restricted the FDAs ability to process new notifications that continued to be submitted over the course of the 35 days that the government was operating at limited capacity. Dennis Keefe is the director of the FDA’s food safety office, and he explained at Chemical Watch’s recent Food Contact Regulations USA conference that they “may not be able to complete [their] review in 120 days,” which is the expected amount of time for the agency to respond to a notification.
Keefe went on to comment that “it may be that some FCNs become effective, and that if we identify safety concerns afterwards, we will have to take some regulatory action to [render them ineffective].” He warned companies submitting new notifications to ensure that their submitted data is thorough and complete. “Please take this seriously, because there are consequences if you don’t. We do not have the capacity at this time to engage in an iterative process with you.” If all goes well, the FDA may be able to catch up with the notification review by mid-summer, but Keefe forecasted this would more likely be the end of September.
Lisa Martine Jenkins (April 5, 2019). “US government shutdown created food contact notification bottleneck.” Chemical Watch