Cross Border Compliance with Attorney Benjamin L. England

The Legal Podcast Network
The Legal Podcast Network
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FDA Imports: Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, offering expert insights into the complex intersection of FDA and customs regulations. With decades of experience as a former FDA microbiologist and compliance officer, Benjamin shares practical advice and real-world strategies to help businesses navigate regulatory challenges. Each episode breaks down critical topics, from labeling and import compliance to emerging enforcement trends, making it an essential resource for companies in FDA-regulated industries.

  1. Sep 25

    Trump's Customs Enforcement Executive Order: Importers Need to Know

    Episode Summary: In this episode of FDA Imports: Cross-Border compliance with Attorney Benjamin L. England, host Sean O'Connor speaks with Attorney Benjamin L. England, a former FDA attorney with over 40 years of experience in FDA, customs, and federal regulatory enforcement. They delve into the implications of the new executive order on customs enforcement signed by the president, which introduces significant changes for importers. The discussion covers new importer eligibility rules, the importance of maintaining good standing, and the increased scrutiny on issues like transshipments, undervaluation, and forced labor imports. Benjamin provides insights into how these changes will affect importers, the potential penalties for non-compliance, and offers practical advice for companies to prepare and adapt. This episode is essential for anyone involved in importing goods into the United States, as it provides crucial information on compliance and risk management in light of the new regulations. Key Timestamps: 00:01 – Introduction 00:21 – Overview of the Executive Order 00:54 – Key Changes for Importers 01:56 – Significance of Importer Eligibility Rules 03:18 – Good Standing Requirements 04:48 – Impact of Fentanyl Importation on Eligibility 06:46 – Focus on Transshipments and Undervaluation 07:36 – Customs Enforcement on Quotas and Duties 08:12 – Forced Labor and Withhold Release Orders 09:26 – Penalty Standards and Mitigation 11:31 – Compliance Program Importance 12:59 – Real-World Example of Compliance Challenges 14:36 – Liquidated Damages and Mitigation 16:14 – Advice for Importers on New Regulations About the Show: FDA Imports: Cross-Border compliance with Attorney Benjamin L. England is a podcast dedicated to providing valuable insights into the complex world of FDA and customs regulations. Hosted by experienced professionals, the show offers in-depth discussions on compliance, enforcement, and regulatory changes affecting importers and exporters. Listeners can expect expert analysis, practical advice, and real-world examples to help navigate the challenges of cross-border trade. Whether you're a seasoned importer or new to the industry, this podcast is your go-to resource for staying informed and compliant in an ever-evolving regulatory landscape. For more information, visit our website: http://www.fdaimports.com/

    Trump's Customs Enforcement Executive Order: Importers Need to Know

  2. Sep 11

    IEEPA Refunds: Who Actually Gets Paid And What Happens Next?

    Episode Summary: In this episode of FDA Imports: Cross-Border compliance with Attorney Benjamin L. England, host Sean O'Connor and former FDA attorney Benjamin L. England dive into the complexities surrounding Judge Eaton's recent IEPA refund orders. They explore the implications of the Supreme Court ruling on IEPA tariffs, the challenges importers face with customs, and the potential pushback from customs against Judge Eaton's decisions. Ben explains the intricacies of the litigation process, the importance of understanding liquidation dates, and the strategic considerations for importers contemplating lawsuits to secure refunds. This episode is crucial for importers seeking to navigate the evolving landscape of federal regulatory enforcement and maximize their chances of successful refunds. Key Timestamps: 00:01 – Introduction 00:24 – Judge Eaton's IEPA Refund Orders 01:13 – Supreme Court Ruling on IEPA Tariffs 02:08 – Litigation Posture and Class Action Misconceptions 03:18 – Customs' Response to Judge Eaton's Rulings 04:08 – Challenges with Refund Claims and ACE System 05:28 – Customs' Pushback and Jurisdiction Issues 06:36 – Judge Eaton's Letter to the Department of Justice 08:05 – The Role of Lawsuits in Securing Refunds 09:00 – Unusual Judicial Orders and Pressure Tactics 10:57 – Potential for Settlement and Customs' Responsibilities 12:11 – Complexities in Valuation and Refund Calculations 14:07 – Misunderstandings About Lawsuits and Administrative Processes 16:08 – Importance of Monitoring Protest Deadlines About the Show: FDA Imports: Cross-Border compliance with Attorney Benjamin L. England is a podcast dedicated to helping importers and trade professionals navigate the complex world of FDA regulations, customs, and federal compliance. Hosted by Sean O'Connor and featuring insights from experienced attorney Benjamin L. England, the show offers practical advice, legal analysis, and updates on the latest regulatory changes. Whether you're dealing with tariffs, import/export issues, or compliance challenges, this podcast provides the knowledge and tools needed to succeed in the global marketplace. For more information, visit our website: http://www.fdaimports.com/

    IEEPA Refunds: Who Actually Gets Paid And What Happens Next?

  3. Aug 28

    State EPR Packaging Laws: Who’s Actually the Producer, and Are You Already Liable?

    Episode Summary: In this episode of FDA Imports: Cross-Border compliance with Attorney Benjamin L. England, host Sean O'Connor sits down with Benjamin L. England, a former FDA attorney with over 40 years of experience in FDA, customs, and federal regulatory enforcement. They delve into the intricacies of state Extended Producer Responsibility (EPR) packaging laws, which have taken many food and cosmetic companies by surprise due to recent important deadlines. Ben explains how these laws require producers to manage packaging waste and the penalties for non-compliance. The discussion covers how companies can identify their obligations under these laws, the differences in regulations across states, and the implications for brand owners, manufacturers, and distributors. This episode is essential for businesses navigating the complexities of compliance with state-specific packaging regulations and offers valuable insights into mitigating potential fines and liabilities. Key Timestamps: 00:01 – Introduction 00:21 – Overview of EPR Packaging Laws 00:50 – Impact on Food and Cosmetic Companies 01:15 – State Registration Requirements 02:39 – Identifying Obligated Producers 04:27 – Differences Across State EPR Laws 07:01 – Business Agreements and Liability 09:33 – State Enforcement and Compliance 11:01 – Reporting and Tonnage Obligations 12:28 – Consequences of Non-Compliance 14:18 – Future of EPR Laws in Other States 16:26 – European Models and Political Influences 17:58 – Steps for Companies to Review EPR Obligations About the Show: FDA Imports: Cross-Border compliance with Attorney Benjamin L. England is a podcast designed for businesses navigating the complex world of FDA regulations, customs, and federal regulatory enforcement. Hosted by industry experts, the show provides insights into compliance strategies, regulatory updates, and best practices for managing cross-border trade. With a focus on clarity and practical advice, the series aims to empower listeners to make informed decisions and avoid costly compliance pitfalls. Whether you're a seasoned professional or new to the field, FDA Imports: Cross-Border compliance with Attorney Benjamin L. England offers valuable resources and expert perspectives to help you succeed. For more information, visit our website: https://www.fdaimports.com/

    State EPR Packaging Laws: Who’s Actually the Producer, and Are You Already Liable?

  4. Aug 14

    FDA Compliance Won’t Protect You From CBP Enforcement

    Episode Summary:  In this episode of Cross-Border compliance with Attorney Benjamin L. England, host Sean O'Connor and attorney Benjamin L. England delve into the complexities of FDA and customs compliance for importers. Benjamin, a former FDA attorney with over 40 years of experience, explains why FDA approval alone may not shield importers from customs enforcement issues.  The discussion covers historical shifts post-NAFTA, the evolution of inter-agency cooperation, and the critical differences in how FDA and CBP evaluate imports. Benjamin shares insights into common pitfalls importers face, such as handling FDA and customs compliance separately, and offers practical strategies for integrating these processes to mitigate risks. Listeners will gain valuable knowledge on creating a cohesive compliance strategy that addresses both FDA and CBP requirements, ensuring smoother import operations. Key Timestamps: 00:01 – Introduction 00:38 – Why FDA Approval Isn't Enough 01:47 – Customs and FDA: Different Jurisdictions 03:08 – Pre-NAFTA Compliance Challenges 04:26 – Evolution of FDA and Customs Cooperation 05:06 – Differences in Product Evaluation 07:48 – Shipment Issues Despite FDA Compliance 10:01 – FDA and USDA Regulatory Overlaps 12:10 – Handling FDA and Customs Compliance Separately 14:14 – CBP Discovering Additional Issues 16:24 – Agencies Working Together on Compliance 17:06 – Integrated Compliance Strategy Tips About the Show:   Cross-Border compliance with Attorney Benjamin L. England is a podcast dedicated to helping businesses navigate the intricate world of FDA and customs regulations. Hosted by Sean O'Connor, the show features expert insights from attorney Benjamin L. England and other industry professionals. Each episode breaks down complex regulatory topics, offering practical advice for importers and exporters.  Whether you're a seasoned professional or new to the field, the podcast provides valuable guidance on maintaining compliance and avoiding costly enforcement actions. With a focus on clarity and actionable strategies,  Cross-Border compliance with Attorney Benjamin L. England  is your go-to resource for Cross-Border compliance

    FDA Compliance Won’t Protect You From CBP Enforcement

  5. Jul 31

    Tariff Refunds Are Triggering New Customs Audits

    Episode Summary: In this episode of Cross-Border compliance with Attorney Benjamin L. England, host Sean O'Connor and former FDA attorney Benjamin L. England delve into the complexities of tariff refund claims and the resulting customs scrutiny for importers. They discuss the Supreme Court's decision that struck down certain tariffs, leading to a new electronic system, CAPE, designed to facilitate refunds. Despite its implementation, only a small percentage of refunds have been processed, as customs audits and evaluations slow the process. The conversation highlights the challenges importers face, such as dealing with FDA holds and determining the true party in interest for refunds. England emphasizes the importance of conducting internal audits to ensure compliance and avoid potential penalties. This episode provides valuable insights for importers navigating the intricate landscape of tariff refunds and customs regulations. Key Timestamps: 00:01 – Introduction 00:07 – Overview of Tariff Refund Claims 00:58 – Supreme Court's Impact on Tariffs 02:16 – Introduction of the CAPE System 03:39 – Challenges in Receiving Refunds 04:52 – Customs' Scrutiny on Past Import Activity 06:34 – Impact of Customs Audits on Refunds 07:04 – When Refund Reviews Become Enforcement Issues 09:05 – Balancing Tariff Refunds with FDA Holds 11:00 – Importer of Record and Refund Claims 12:39 – Civil Disputes Over Refunds 14:52 – Role of Couriers in Refund Claims 16:39 – Litigation Around FDA-Regulated Goods 17:11 – Preparing for Refund Claims: Internal Audits About the Show: Cross-Border compliance with Attorney Benjamin L. England is a podcast dedicated to providing importers and trade professionals with crucial insights into cross-border compliance. Hosted by Sean O'Connor and featuring expert guests like Benjamin L. England, the show covers a wide range of topics, including FDA regulations, customs enforcement, and international trade laws. With a focus on clarity and practical advice, Cross-Border compliance with Attorney Benjamin L. England aims to help listeners navigate the complex world of import compliance and stay informed about the latest developments in the industry.

    Tariff Refunds Are Triggering New Customs Audits

  6. Jul 17

    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.

    Understanding Voluntary Disclosures in FDA and Customs

  7. Jul 3

    Customs Post-Entry Audits Explained: CF-28s, CF-29s, and What Happens After Clearance

    Episode Summary: In this episode of FDA Imports: Cross-Border Compliance, host Sean O'Connor and attorney Benjamin L. England delve into the complexities of customs post-entry audits, focusing on CF-28s and CF-29s. Benjamin, founder of FDAImports.com and a former FDA regulatory counsel, explains why importers shouldn't assume their responsibilities end once a shipment clears customs. He highlights the importance of understanding the conditional nature of customs releases and the potential for audits years after entry. The discussion covers the differences between CF-28 and CF-29 forms, the types of issues that can trigger audits, and the implications of failing to comply with customs regulations. Benjamin also offers practical advice on maintaining proper documentation and the significance of a well-drafted purchase order to mitigate risks. This episode is essential for importers looking to navigate the intricate landscape of FDA and customs compliance effectively. Key Timestamps: 00:01 – Introduction 00:07 – Overview of Customs Post-Entry Audits 00:53 – Conditional Release of Goods by Customs 01:58 – Role of FDA in Customs Compliance 03:08 – Customs Examination and Duty Calculation 04:41 – Understanding CF-28 Forms and Compliance 05:48 – Differences Between CF-28 and CF-29 07:42 – Triggers for Post-Entry Audits 10:26 – Record Keeping and Statute of Limitations 12:23 – Importance of Accurate Declarations 14:04 – FDA Involvement in Customs Investigations 16:08 – Systems to Reduce Post-Entry Audit Risks About the Show: FDA Imports: Cross-Border Compliance is a podcast designed for businesses navigating the complex world of FDA regulations and international trade. Hosted by industry experts, the show provides insights into compliance strategies, regulatory updates, and best practices for managing cross-border transactions. With a focus on clarity and practical advice, each episode aims to equip listeners with the knowledge they need to successfully import and export goods while adhering to legal requirements. Whether you're a seasoned importer or new to the field, this podcast offers valuable guidance to help you stay compliant and avoid costly pitfalls.

    Customs Post-Entry Audits Explained: CF-28s, CF-29s, and What Happens After Clearance

  8. Jun 19

    First FDA-Regulated Import? The Mistakes That Get Shipments Stopped

    Episode Summary: In this episode of FDA Imports: Cross-Border Compliance, host Sean O'Connor is joined by Attorney Benjamin England, founder of FDAImports.com and a former FDA regulatory counsel. They delve into the complexities of first-time FDA-regulated imports, highlighting common mistakes that lead to shipment delays, detentions, or refusals. Benjamin emphasizes the importance of understanding FDA requirements from the outset, including proper documentation and compliance checks before goods leave the foreign supplier. They discuss assumptions that new importers make about FDA requirements, the role of timing in import processes, and the impact of labeling and registration details on shipments. The episode provides valuable insights for businesses entering the US market, offering practical strategies to avoid common pitfalls and ensure smooth import operations. Key Timestamps: 00:00 – Introduction 00:26 – Common Mistakes in First-Time Imports 01:12 – Importance of Early Transaction Compliance 02:39 – Assumptions About FDA Requirements 03:47 – Challenges with Proprietary Information 05:03 – Role of Customs Brokers 06:01 – FDA's Authority at the Border 07:07 – Labeling and Product Compliance Issues 08:15 – Differing FDA Expectations by Product Type 10:18 – Timing and Its Impact on Imports 12:33 – Perishable Goods and Timing Challenges 14:17 – Case Study: Dietary Supplements 17:08 – Cosmetic Products with Drug Claims 19:18 – Impact of Initial Non-Compliance on Future Imports About the Show: FDA Imports: Cross-Border Compliance is a podcast dedicated to helping businesses navigate the intricate world of FDA regulations and international trade. Hosted by industry experts, the show provides insightful discussions on compliance strategies, regulatory updates, and best practices for importing FDA-regulated products. Whether you're a seasoned importer or new to the field, this podcast offers valuable knowledge to ensure your business meets regulatory standards and avoids common pitfalls. With a focus on clarity and practical advice, FDA Imports is your go-to resource for staying informed and compliant in the ever-evolving landscape of cross-border trade.

    First FDA-Regulated Import? The Mistakes That Get Shipments Stopped
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FDA Imports: Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, offering expert insights into the complex intersection of FDA and customs regulations. With decades of experience as a former FDA microbiologist and compliance officer, Benjamin shares practical advice and real-world strategies to help businesses navigate regulatory challenges. Each episode breaks down critical topics, from labeling and import compliance to emerging enforcement trends, making it an essential resource for companies in FDA-regulated industries.

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