FDA and Customs: The Dynamic Duo Behind Smooth Imports

Cross Border Compliance with Attorney Benjamin L. England

Episode Summary
In this episode, Benjamin England, founder of FDAImports.com, provides an in-depth look at the FDA and customs regulations for importing FDA-regulated products into the U.S. He explains the roles of customs brokers, the FDA, and Customs and Border Protection (CBP), outlining key steps importers need to take for smooth and compliant importation. Benjamin also shares valuable tips on maintaining product safety, meeting regulatory requirements, and ensuring truthful labeling and marketing. Whether you’re importing food, pharmaceuticals, or medical devices, this episode is packed with actionable insights for navigating the complexities of U.S. import laws.

Timestamps:
[00:00–00:45] Introduction and Benjamin’s background.
[00:46–02:30] The importance of a customs broker for FDA-regulated imports.
[02:31–05:30] Data transmission process and FDA screening methods.
[05:31–07:45] Key challenges faced by FDA importers.
[07:46–09:10] Role of attorneys and consultants in resolving FDA detentions.
[09:11–11:10] Examples of FDA import issues and solutions.
[11:50–12:45] What to expect from FDA and CBP when importing products.
[12:46–14:20] Steps in the FDA detention process and outcomes.
[14:21–15:10] Handling relabeling, reprocessing, or product refusals.
[15:11–16:45] Key steps for preparing FDA-regulated imports.
[16:46–18:30] How the FDA collaborates with CBP for compliance.
[18:31–20:25] Differences between FDA and CBP’s responsibilities.
[20:26–22:36] Top three priorities for reducing risks and staying compliant.
[22:37–24:11] How to contact Benjamin England and his team.

About The Show

In this episode of the podcast, Benjamin England, founder of FDAImports.com, breaks down the complexities of importing FDA-regulated products into the U.S. He discusses the critical roles played by customs brokers, the FDA, and U.S. Customs and Border Protection (CBP) in ensuring compliance with import regulations. Benjamin shares essential steps for importers to navigate the regulatory process, including the importance of accurate documentation, understanding tariff codes, and meeting safety and labeling requirements. With practical insights on dealing with FDA detentions and refusals, this episode is a must-listen for businesses involved in importing regulated products.