How to Reverse an FDA Import Refusal or CBP Seizure

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.