Importing FDA-Regulated Products: Understanding FDA and Customs Enforcement Actions

Cross Border Compliance with Attorney Benjamin L. England

Episode Summary

In this episode, Benjamin England discusses the complexities of FDA import regulations, enforcement actions, and the risks that businesses face when importing FDA-regulated products into the U.S. He covers the authority FDA has at the border, how FDA detains or refuses shipments, the importance of bonds, and the consequences of non-compliance. Benjamin also provides insight into how importers can navigate FDA enforcement, handle violations, and prevent future issues.

Timestamps:

[00:00-00:30] Introduction to the topic of FDA import regulations and enforcement.

[00:31-02:50] Benjamin England discusses the scope of FDA’s regulatory authority at the border.

[02:51-04:30] Importance of having a system in place to monitor suppliers and ensure compliance.

[04:31-06:00] The process of detaining and refusing shipments based on the appearance of violations.

[06:01-08:00] FDA's approach to handling violations and the consequences of detentions, including the impact on future shipments.

[08:01-10:00] Recidivism and how FDA can take more severe enforcement actions, like issuing import alerts.

[10:01-12:00] Detailed discussion on the bond system used for importing goods and Customs' role in enforcing compliance.

[12:01-14:00] Consequences of failure to export or destroy goods after FDA refusal, including bond claims.

[14:01-16:00] Civil penalties and Customs' ability to seize goods versus FDA’s role in enforcement.

[16:01-18:00] Explanation of FDA detention vs. refusal, and how importers can navigate these situations.

[18:01-20:00] Strategies for resolving issues with detained or refused shipments, including correcting the violation or removing the product from FDA jurisdiction.

[20:01-22:00] Detailed explanation of the bond system and the financial risks involved for importers.

[22:01-24:00] Consequences of not handling FDA’s refusal properly and how Customs enforces compliance through bond claims.

[24:01-25:00] Conclusion and contact information for further guidance on FDA import regulations.

About The Show
The "FDA Imports" podcast offers expert insights into navigating the complexities of FDA import regulations for businesses involved in importing FDA-regulated products. Hosted by Kendall Trosky and featuring FDA regulatory expert Benjamin England, the show covers essential topics such as FDA enforcement actions, compliance strategies, and the legal landscape surrounding imports. Each episode provides practical advice and real-world examples to help manufacturers, importers, and distributors avoid costly mistakes and ensure smooth operations when crossing U.S. borders. Whether you're a seasoned professional or new to the industry, the podcast delivers valuable guidance on managing FDA import requirements.