FDA recently implemented the Nationalized Entry Review Program (NER), which centralizes how the agency reviews imports nationwide. The program is effective as of August 4, 2025. Key changes include:
- Coordinated National Response: Rather than each port conducting manual reviews of certain entries on its own, specialized teams now coordinate their efforts across the country to more quickly identify and stop dangerous products.
- Harmonized Real-Time Alert System: If the FDA detects a high-risk product at one port, such as contaminated infant formula or counterfeit drugs, alerts are immediately shared across all ports so they can watch for the same threats.
- Improved Efficiency: Built on a successful 2022 pilot, the NER program has sped up processing by 70% and increased detection of high-risk products by 36%.
- Expanded Reviewer Capacity: The program allows for more FDA reviewer availability and collaboration across the national network.
The FDA's current evaluative standards, regulatory requirements, and admissibility thresholds remain the same.
The FDA has also published a communications guide that includes general contact protocols, hot shipments handling, email formatting requirements, and FAQs.
Diaz Trade Law provides assistance with FDA pre-compliance as well as assistance in successfully navigating FDA enforcement actions.
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