Beyond The Border: What's Happening in FDA & Customs

Episode Summary:

In this episode of FDA Imports – Cross-Border Compliance, host Kevin Rosenquist speaks with attorney Benjamin L. England about the latest regulatory updates affecting FDA and USDA-regulated industries from mid-January to mid-February 2025. They discuss the impact of new tariffs on imported goods from China, potential increases to pharmaceutical tariffs, and the consequences for the food, drug, and medical device industries.

Additionally, they examine significant layoffs at the FDA following leadership changes in the Department of Health and Human Services (HHS) and how these staffing reductions may impact regulatory oversight, product approvals, and food safety enforcement. If you're an importer, manufacturer, or stakeholder in the FDA-regulated space, this episode provides critical insights into evolving policies and compliance challenges.

Timestamps:

• 00:00 – Introduction to the episode and guest Benjamin L. England
• 00:06 – Overview of recent regulatory developments (mid-January to mid-February 2025)
• 00:27 – Benjamin’s update from El Salvador; Kevin reports on freezing temperatures in Colorado
• 00:49 – Background on Benjamin L. England and FDAImports.com
• 01:52 – Discussion on new tariffs affecting FDA and USDA-regulated imports
• 02:07 – Breakdown of China tariffs: seafood, pharmaceuticals, medical devices, and consumer goods
• 04:35 – Why pharmaceuticals are particularly vulnerable to tariff increases
• 07:02 – Possible escalation of tariffs to 25–35% and what it means for industry costs
• 08:22 – Predictions on future U.S.-China trade policies under the Trump administration
• 09:28 – FDA layoffs and restructuring under new HHS Secretary Robert F. Kennedy Jr.
• 09:48 – Impact of mass firings on medical device and pharmaceutical approvals
• 12:00 – FDA’s approach to regulating food additives and recent leadership resignations
• 14:09 – Compliance concerns for importers as FDA resources shift
• 15:10 – Closing thoughts on key issues to monitor in the coming months

About the Show:

FDA Imports – Cross-Border Compliance is a podcast designed to help businesses navigate the complex world of U.S. regulatory compliance for imported foods, drugs, medical devices, and cosmetics. Each episode provides expert analysis on FDA, USDA, and CBP regulations, helping manufacturers, importers, and exporters stay informed, compliant, and competitive in the U.S. market.