Understanding Voluntary Disclosures in FDA and Customs

Episode Summary: In this episode, Attorney Benjamin England sheds light on the nuances of voluntary disclosures in FDA and Customs enforcement. He explains the differences between mandatory disclosures in FDA for safety-related issues and the need for prior disclosures in Customs for duty-related matters. The discussion covers scenarios where voluntary disclosures can mitigate risks and instances where they could potentially lead to increased exposure. Key Timestamps: 00:00 – Introduction: Voluntary Disclosures in FDA and Customs Compliance 00:40 – Key Differences: FDA vs. Customs Disclosure 01:30 – FDA: Importers' Obligation to Report Safety Issues 03:00 – Compliance Responsibility: Importers vs. Manufacturers 04:30 – Increased Compliance for Direct-to-Consumer Imports 05:00 – No Formal Voluntary Disclosure System at FDA 06:00 – Customs: Prior Disclosure for Duty-Related Errors 07:30 – Proactive Reporting Reduces Penalties and Risk 09:00 – Strategic Disclosure Decisions in FDA Cases 10:00 – Customs Disclosure Limits Financial Penalties vs. Duties 11:30 – IRS Analogy: Comparing Customs to Tax Audits 12:30 – When Disclosure May Not Be Necessary 13:30 – Resolving Import Alerts and FDA Detentions 15:00 – High-Risk Customs Issues: Duties and FTAs 16:30 – Customs Investigations: Up to Seven Years of Exposure 17:30 – Factors in Disclosure Decisions: Risk, Exposure, History 18:30 – Global Variations in Compliance Risk Tolerance 19:20 – Conclusion and Key Takeaways About the Show: *FDA Imports: Cross-Border compliance with Attorney Benjamin L. England* is a podcast series hosted by Attorney Benjamin England, focusing on cross-border compliance issues in FDA and Customs regulations. The show provides expert insights and guidance for companies navigating the complexities of international trade and regulatory oversight.