The U.S. Food and Drug Administration’s (FDA’s) Office of Inspections and Investigations (OII) Office of Import Operations (OIO) is changing its import entry review process for regulated goods from a geographic-based system to a national-based system.

Effective August 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.  

The NER program implements a standardized, efficient, and technology-driven approach to import entry reviews across all ports of entry. FDA is transitioning from its 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.

FDA says it will not change any other import processes or requirements. Industry must be aware of new communication protocols, effective August 4, which affects how industry contacts contact FDA regarding status of shipments under entry review that have not already gone to the field for assigned work. For entry status inquiries regarding:

• Initial review status (e.g., pending review, documents requested, and etc.), contact NERInquiry@fda.hhs.gov
• Field review status (e.g., pending exam/sampling, detained, refused, and etc.), contact the appropriate division at FDA Import Offices and Ports of Entry.

When contacting NERInquiry@fda.hhs.gov, the following guidelines apply:

• Use this mailbox only for checking status of entries under initial review or providing entry documents
• Email only one FDA mailbox at a time (sending out to multiple boxes may delay response)   
• Use proper subject line formatting, including: Entry number (one entry number per email), commodity type [i.e., Animal Foods, Animal Drugs, Dietary Supplements, Food Related Products, Human Foods, Infant Formula, Medicated Feed, Multiple], and port code.

Check Import Trade Auxiliary Communications System (ITACS) for real-time entry status before contacting the NER team, and use ITACS whenever possible for faster processing.