Quick Key Takeaways

• As of today, October 1, 2025, the U.S. government is officially shut down.

• FDA will continue import processing, but at reduced capacity—leading to delays.

• The new National Entry Review (NER) system is already creating backlogs; combined with the shutdown, expect slower clearances.

• Importers should prepare for delays, especially with time-sensitive and perishable goods.

• Accurate documentation and proactive steps are critical.

A Shutdown on Top of NER Challenges

The U.S. government officially shut down today, October 1, 2025—and importers should prepare for added challenges with FDA-regulated shipments.

While the Food and Drug Administration (FDA) will continue to process imports, the agency will be operating with limited staff and resources. That means slower processing times, reduced responsiveness, and potential clearance delays across the board.

Even before the shutdown, FDA’s new National Entry Review (NER) system had already been a source of frustration. Importers and brokers have reported backlogs, unclear communication, and slow responses since NER’s rollout.

With the shutdown overlapping NER’s ongoing issues, FDA clearance could become even more complicated. This is not business as usual.

What Importers Can Expect

• Longer clearance times for FDA-regulated shipments.

• Added hurdles for time-sensitive or perishable goods.

• Increased importance of accurate, detailed entry submissions.

Best Practices to Help Minimize Delays

At J.O. Alvarez, Inc., we encourage clients to take extra care with FDA shipments during this period. Here are two key steps that can make a difference:

• ITACS Submissions: If you don’t receive an automatic “May Proceed,” proactively upload supporting documents through ITACS.

• Border Crossings: For trucks without a “May Proceed,” ensure crossings occur during FDA’s operational hours and stop at FDA—even if the shipment has not been flagged.

Our Commitment to You

We understand these developments may cause uncertainty and disruptions for your business. Our compliance team is monitoring the situation closely and will provide updates as conditions evolve.

In the meantime, we recommend planning ahead for perishable and time-sensitive shipments and keeping close communication with our team so we can support you through any challenges.

If you have questions about how the shutdown and NER may affect your shipments, please reach out to our Compliance Team at:

📧 [email protected]