Episode Summary: In Episode 12, attorney Benjamin L. England breaks down urgent developments impacting FDA-regulated importers. From rising tariffs on pharmaceuticals and small-package imports to FDA staffing delays, Benjamin offers deep insight into the regulatory trends reshaping international trade. The discussion also covers evolving dietary supplement enforcement, state drug importation from Canada, and how businesses can adapt in a volatile regulatory climate.
Timestamps: 00:00 – Introduction and episode overview 01:00 – Pharmaceutical tariffs and valuation warnings 02:00 – De minimis abuse and postal surcharge increases 05:30 – FDA leadership shakeups and resulting delays 08:30 – ORA to OII: FDA reorganization and compliance officer authority 10:30 – FOIA backlogs and agency resource cuts 11:30 – CBP resources remain strong vs. FDA bottlenecks 12:00 – Operational impacts on importers: shipment delays, labeling scrutiny 13:30 – Ingredient disclosure, red dye regulations, and allergy concerns 14:30 – Consumer protection rationale for FDA involvement 15:00 – Peptides, Canadian drug imports, and upcoming policy shifts 17:00 – How importers can stay agile during regulatory uncertainty 18:00 – Final tips and why to monitor FDA budget and leadership
About the Show: FDA Imports: Cross-Border Compliance with Benjamin L. England is your front-line podcast for real-world insights into FDA, CBP, and international trade regulations. Hosted by veteran FDA attorney and strategist Benjamin L. England, each episode offers critical guidance for companies navigating border compliance, import law, and global supply chain risks.
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