As of August 4, 2025, the FDA’s Office of Import Operations (OIO) has launched the Nationalized Entry Review (NER) program, a new system that aims to standardize and improve the review of imported products.
Revolutionizing how the agency reviews imports of FDA‑regulated products, the NER replaces the old port-by-port processing model with a centralized, technology driven, national approach to allow for better resource allocation, expedited detection of high-risk items via a harmonized alert system, and expert teams to coordinate national response. The change is driven by surging e-commerce volumes and increasingly complex supply chains. We’ll take a look here at what’s changing under NER, what remains the same, and what businesses should know on the new system.
What’s Changing Under NER
- Nationwide Centralization
Reviews that once happened separately at each port are now handled centrally. Casework is triaged and processed across any port in the U.S., expected to increase efficiency and consistency.
- Cross-Time Zone Staffing
The FDA now deploys staff around the country, improving coverage and keeping operations running seamlessly across time zones.
- Automation and Prioritization
Automation tools are under exploration to streamline workflows, allowing FDA to prioritize higher‑risk products more effectively.
- Real-Time Alerts and Coordination
A high‑risk hit at one port triggers alerts across the entire NER network, enabling rapid coordination and response nationwide.
- Resource Optimization
By pooling reviewers and focusing analytical attention on riskier shipments, FDA is aiming to enhance its resource allocation and scrutiny.
What Remains Consistent
- Review Criteria & Standards: FDA’s existing evaluative standards, admissibility thresholds, and public health protections remain unchanged.
- Protocols for Field Operations: Once a shipment is designated for physical examination, the process remains handled by the local field office in the established manner.
What Industry Must Do Differently
- New Communication Channel
For initial review inquiries (status updates, document requests, etc.), stakeholders must now email NERInquiry@fda.hhs.gov. For field-level status (e.g., exams, detentions), continue contacting the local FDA import division.
- Subject Line Format is Critical
Emails to the NER inbox must follow a precise format:
[ENTRY‑NUMBER] [COMMODITY TYPE] [PORT CODE]
Example:
000‑1234567‑8 Food 2704
Commodity types may include: Animal Foods, Human Drugs, Human Foods, Dietary Supplements, Cosmetics, Infant Formula, Medical Devices, Biologics, and others.
- Use ITACS First
The Import Trade Auxiliary Communication System (ITACS) remains the FDA’s preferred channel for real-time entry status and document submission. Always consult ITACS before emailing NER.
Context: Why NER Matters Now
- End of Low-Value Exemptions
As of July 2025, the FDA eliminated the exemption for low-value (≤ $800) regulated product imports (e.g. the “de minimis exemption”)—meaning all FDA-regulated shipments, regardless of its declared value, must now undergo FDA review. There are no longer automatic exemptions based solely on value.
- Past Pilot Successes
A 2022 pilot of the NER model achieved strong results—processing was 70% faster and led to the detection of 36% more high-risk products.
Impacts on Industry Players
Businesses should anticipate more centralized, standardized, and potentially faster review determinations for shipments that are properly documented and fully compliant with FDA requirements. Under the NER program, entries are no longer reviewed solely at the port of arrival but instead processed by a national team using coordinated risk-based screening. This centralized approach is designed to reduce processing delays for low-risk goods while enhancing scrutiny of high-risk or noncompliant shipments.
To navigate this shift effectively, we strongly recommend that companies proactively educate internal teams—including compliance managers, logistics personnel, and customs brokers—on the revised entry procedures, particularly the use of the NERInquiry@fda.hhs.gov email protocol and the formatting requirements for subject lines. Ensuring that all export and entry documentation is complete, accurate, and aligned with NER formatting standards will be critical to avoid unnecessary delays or holds.
At the same time, businesses must remain vigilant for potential escalations involving flagged entries, especially for high-risk products or those with prior compliance concerns. Centralization means that a red flag raised at one location could trigger increased scrutiny nationwide. As such, companies should maintain clear documentation, respond promptly to FDA inquiries via ITACS or the NER inbox, and be prepared to engage legal or regulatory counsel if entries are delayed, detained, or refused.
What Lies Ahead
- 2026 System Upgrade
Early 2026 will see the rollout of the System for Entry Review and Import Operations, a streamlined digital platform integrating multiple tools and databases for improved efficiency and connectivity with U.S. Customs and Border Protection (CBP). - Operational Tweaks Possibly Ahead
As with any significant structural shift, expect refinements in communication protocols and workflow—especially after initial industry feedback. Stay proactive in adapting.
Concluding Note
The NER Program marks a significant advancement in the FDA’s import oversight framework, offering the promise of improved efficiency, enhanced consistency in entry review, and more effective identification of high-risk shipments. For the regulated industry, this shift requires adapting to new communication protocols, submission processes, and system workflows. Companies that align with these updated procedures can benefit from greater visibility into real-time entry status and potentially faster clearance times for compliant, low-risk products. However, realizing these efficiencies will depend on a strong understanding of the NER system and strict adherence to its procedural requirements.
For more information on the NER program, or for questions on FDA import matters, please contact us at info@garg-law.com.
