The FDA’s ImportShield Program centralizes entry reviews across all U.S. ports, improving consistency, speed, and risk targeting as import volumes rise.
President Trump stated Jan. 24 that he would seek to impose a 100% tariff on Canadian goods if Canada enters into a trade agreement with China.
The FDA recently reported early results from its ImportShield Program, an effort to strengthen oversight amid rising imports driven by e-commerce, trade, and complex global supply chains.
Instead of reviewing FDA-regulated entries port-by-port, ImportShield consolidates multiple regional inspection teams into a single centralized, nationwide review system. The goal is to improve efficiency and consistency across all U.S. ports of entry while allowing FDA teams to focus resources on higher-risk shipments.
What Changed
Under ImportShield, the FDA is shifting to a national-based model that will:
- Conduct entry admissibility reviews nationally rather than at individual ports.
- Leverage staff across multiple time zones to expand coverage.
- Explore automation opportunities to simplify processes.
- Optimize resources to focus on higher-risk products.
What’s Not Changing
The FDA emphasized that this is an internal operational enhancement—meaning:
- Review standards and criteria remain the same.
- Entry submission processes are not changing.
- Public health protection remains the top priority.
How the Review Process Works
Once the FDA receives entry data, the ImportShield team reviews it first. If additional examination is needed, the entry may then be forwarded to the appropriate local FDA Import Office for follow-up.
Trade should continue using ITACS to check shipment status, upload entry documents, and provide exam locations.
New Communication Protocols (Effective August 4, 2025)
ImportShield now requires industry users to follow specific contact protocols, including subject line formatting requirements (such as entry numbers, commodity types, and port codes). The FDA also advises using only one communication method to avoid duplicate requests and delays.
For detailed instructions—including urgent shipment procedures—refer to the FDA ImportShield Trade Communications Guide available on the FDA’s Entry Review page.
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Sources: https://www.fda.gov/news-events/press-announcements/fda-importshield-program-delivers-impressive-results-strengthening-fda-oversight-us-ports-entry
https://www.fda.gov/media/187855/download?attachment=&utm_medium=email&utm_source=govdelivery
