FDA Updating Import Operations

The Food and Drug Administration has announced that it will “revolutionize” its import operations effective Aug. 4 when it launches the Nationalized Entry Review Program, which will transition the agency from port-by-port reviews to a nationwide system that utilizes staff across multiple time zones, explores automation opportunities, and optimizes resources to focus on higher-risk products. Further changes are expected in early 2026.

For most shipments, the first step in the importation process is the submission of entry information to U.S. Customs and Border Protection. If the shipment contains FDA-regulated products, CBP sends data about those products to the FDA for review. Products transmitted with complete, accurate, and valid data may receive a lower risk score and may be eligible for a release without further review. Any electronic entry that does not receive a release by the FDA’s system (e.g., items identified as higher risk or included on an FDA import alert) is routed to agency staff, who determine the product’s admissibility and subsequently release the product into U.S. commerce, request additional information, or request detention.

The FDA states that NER will improve this process by centralizing agency reviews. Key features of this system include the following.

– Coordinated national response: Instead of each port handling the manual review of certain entries separately, expert teams will coordinate efforts across the country to identify and interdict dangerous products more quickly.

– Harmonized real-time alert system: When the FDA discovers a high-risk product at one port, all other ports are immediately alerted to watch for similar dangerous products. 

– Enhanced efficiency: NER is based on a 2022 pilot program that resulted in 70 percent faster processing times and identified 36 percent more high-risk products for further testing. 

– Increased reviewer availability: The program allows for more FDA reviewer availability and collaboration across the national network. 

In addition, the FDA plans to replace its import review platform with the System for Entry Review and Import Operations in March 2026. The FDA states that this system will streamline its import review process by integrating multiple tools and databases into one comprehensive system, allowing FDA inspectors to access comprehensive information more quickly, preserving critical connectivity with CBP’s systems, and enabling FDA staff to update information and re-screen products more efficiently.