Episode Summary:
In this episode of FDA Imports: Cross Border Compliance, Benjamin England breaks down how the ongoing federal government shutdown is affecting the FDA and U.S. Customs and Border Protection. Drawing on his experience as a former FDA regulatory counsel, Benjamin explains how much of the FDA’s operations continue due to user fees and why import enforcement remains active even during a shutdown.

He outlines which inspections are still taking place, which types of products are being prioritized, and how the shutdown impacts imported goods ranging from foods and drugs to cosmetics and medical devices. Benjamin also discusses how companies can manage communication delays with the FDA and Customs, what steps importers should take if their products are detained, and what to expect when the government eventually reopens.

Key Timestamps:
00:55 – How the FDA continues operating during a government shutdown
02:30 – The role of user fees and why most FDA activities remain functional
04:20 – Which inspections and compliance functions are still active
06:10 – Why high-risk imports like seafood and ready-to-eat foods remain top priority
09:00 – How companies should handle delays and communication issues with the FDA
11:15 – The government’s response to health emergencies and contaminated imports
13:40 – How CBP manages inspections, seizures, and enforcement during a shutdown
16:00 – What importers and exporters can expect once the government reopens

Show Description:
Benjamin England provides an inside look at the real-world impact of a federal government shutdown on FDA and Customs operations. Despite the shutdown, he explains that the FDA continues to function at nearly 86% capacity, driven by user fees and essential import enforcement activities.

He highlights how FDA inspectors prioritize higher-risk imports, such as ready-to-eat foods and seafood potentially contaminated with Cesium-137, while lower-risk products like cosmetics and animal food experience fewer inspections. Benjamin also discusses how the FDA’s risk-based matrix determines where limited resources are allocated and how Customs continues to perform mandatory inspections.

For importers and manufacturers, Benjamin offers guidance on managing delays, communicating effectively with regulators, and ensuring compliance while operations are slowed. He warns that once the government reopens, backlogs and staffing shortages will likely extend delays for weeks or months. His advice emphasizes staying proactive, maintaining contact with compliance officers, and seeking experienced regulatory support to navigate the challenges.