On July 28, 2025, the U.S. Food and Drug Administration (FDA) sent a notice regarding FDA's Office of Inspections and Investigations (OII) Office of Import Operations (OIO) implementing changes to the import entry review process that will impact engagement with FDA import operations. Effective Aug. 4, 2025, OIO will implement the Nationalized Entry Review (NER) program to address the increasing volume of imported FDA-regulated commodities driven by e-commerce growth, expanded trade volume and supply chain complexities.

OIO is transitioning from the current geographic location model to a national-based review system that will:

• Conduct entry admissibility reviews on a national basis versus the current port-by-port entry review approach
• Utilize staff across multiple time zones for expanded coverage
• Explore automation opportunities to streamline processes
• Optimize resource allocation to focus on higher-risk products

For detailed procedures regarding urgent shipments and additional contact protocols, please refer to the FDA National Entry Review (NER) Trade Communications Guide.