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August 28, 2025 18 mins

Episode Summary: In this episode of FDA Imports Cross-Border Compliance, regulatory attorney Benjamin L. England breaks down the evolving challenges importers face under shifting U.S. trade policies. With the return of Trump-era tariffs, FDA-regulated companies are encountering unexpected costs, heightened inspection activity, and more frequent supply chain disruptions. Ben shares insights on the growing role of FDA and Customs collaboration, labeling enforcement trends, and strategies importers can use to mitigate risk in an increasingly volatile regulatory environment.

 

Key Timestamps: 00:01 – Show introduction 02:00 – The return of tariffs and long-term trade implications 05:30 – How FDA-regulated goods are impacted by tariff changes 08:15 – Increased FDA inspections and reallocation of resources 11:10 – Industries most affected: food, cosmetics, medical devices, pharmaceuticals 14:25 – The evolving relationship between FDA and Customs at U.S. ports 18:20 – Common issues triggering shipment holds: labeling, documentation, and new inspector errors 23:05 – Compliance risks when importing from China, India, and Mexico under USMCA 27:40 – Labeling enforcement as a leading cause of FDA detentions 31:10 – Practical steps importers can take to protect shipments and avoid costly delays 34:55 – Key advice for navigating FDA and Customs scrutiny in 2024 and beyond

 

About the Show: FDA Imports Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, founder of FDAImports.com. The show helps importers, exporters, and global businesses navigate the complex legal and regulatory landscape at the U.S. border. With expert insights on FDA, Customs, USDA, DEA, and trade compliance, listeners gain practical strategies to protect their products and keep supply chains moving.

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