Cross Border Compliance with Attorney Benjamin L. England

FDA’s ‘No Artificial Colors’ Shift: When Enforcement Changes but the Law Doesn’t

Episode Summary: In this episode of FDA Imports: Cross Border Compliance with Attorney Benjamin England sheds light on the FDA's recent enforcement discretion around color additives, impacting labeling regulations and creating confusion for importers. He clarifies the distinction between natural and synthetic colors, discusses the FDA's changing approach to artificial colors claims, and outlines the compliance challenges importers may face in light of this guidance. Key Timestamps: 00:00 – Introduction 02:15 – Differentiating between natural and synthetic colors 04:30 – FDA's enforcement discretion on artificial colors claims 07:45 – Compliance implications for importers 11:20 – Potential risks and considerations for companies 15:00 – Navigating FDA's evolving enforcement expectations About the Show: *FDA Imports: Cross Border Compliance with Attorney Benjamin England* is the go-to podcast for insights into cross-border compliance issues, hosted by industry expert Benjamin England. Join as the show unravel the complexities of FDA regulations and provide valuable guidance for businesses dealing with import compliance challenges.

Customs Brokers vs. FDA Compliance: Where Importers Get Bad Information

Episode Summary: In this episode, Benjamin England delves into the complexities of FDA compliance for importers and customs brokers. He highlights the common misunderstandings that lead to compliance breakdowns and emphasizes the crucial role importers play in ensuring regulatory adherence. From the responsibilities of customs brokers to the challenges faced at the border, this episode offers valuable insights for companies navigating FDA regulations in international trade. Key Timestamps: 00:00 – Introduction to FDA Compliance & Broker Responsibilities 01:20 – Importer vs. Customs Broker Roles Explained 03:00 – Where the Assumption Breaks Down 04:30 – Broker Limitations & Experience Gaps 06:00 – Common Communication Failures Before Shipment 07:30 – What Happens at the Border When Compliance Fails 09:00 – Missing Data, Approvals & Entry Errors 10:30 – Who Bears the Risk: Importer vs Manufacturer 12:00 – Consequences: Refusal, Export, or Destruction 13:30 – Broker Liability & Contract Limitations 14:50 – Managing Risk & Verifying Broker Accuracy 16:00 – Structuring Responsibilities & Contracts About the Show: *FDA Imports* is a podcast series hosted by Benjamin England, focusing on the intricate landscape of FDA compliance in cross-border trade. With expert insights and practical guidance, the show equips businesses with the knowledge needed to navigate regulatory challenges effectively.

FDA Corrective Action Plans: Why Most CAPAs Fail and What Actually Works

Episode Summary: Benjamin England delves into the intricate world of FDA corrective action plans, shedding light on why many plans fail to meet FDA standards despite companies' efforts. From understanding the root cause to the importance of documentation, Ben provides invaluable insights into creating effective action plans that satisfy FDA requirements. Key Timestamps: 00:00 – Introduction to FDA Imports & Corrective Action Plans 01:20 – What is a CAPA & When FDA Requires It 03:10 – Import Alerts, Root Cause Analysis & CAPA Process 05:00 – Why CAPAs Fail: Root Cause Challenges 06:40 – Investigations & Common Mistakes in CAPAs 08:20 – Importance of Documentation & Evidence 10:00 – Implementation Records & Proving Compliance 11:40 – Systemic Fix vs Temporary Fix 13:10 – Supplier Risks & Real-World Examples 14:40 – Timing of CAPA & Impact on Import Status 16:00 – Ongoing Imports & Strategic Timing Considerations 17:00 – FSVP, Verification & FDA Expectations About the Show: *FDA Imports* is your go-to resource for navigating the complex world of FDA compliance in international trade. Join us as we unravel the nuances of FDA regulations, offering expert guidance to ensure your company stays in line with FDA requirements.

Tariffs Update: Navigating the Latest Legal Landscape

Episode Summary: In this episode, attorney Benjamin England discusses the recent Supreme Court ruling on IEEPA tariffs and the implications for companies navigating the complex world of international trade and FDA oversight. From constitutional issues to refund mechanisms, Benjamin provides valuable insights into the evolving tariff landscape. Key Timestamps: 00:00 – Introduction 01:30 – IEEPA Tariffs Ruling 05:45 – Constitutional Implications 08:20 – Refund Mechanisms 11:10 – Legal Landscape Analysis ...continues with detailed insights About the Show: *FDA Imports* is a podcast hosted by attorney Benjamin England, focusing on cross-border compliance issues related to FDA regulations and international trade. Join us for expert insights and discussions on navigating complex legal challenges in the import industry.

Supreme Court Strikes Down Trump Part 4

This is just a quick update at the end of the week about what I think clients should be doing regarding #refunds of #IEEPA #tariffs post #SCOTUS ruling. We generally advise a belt-and-suspenders approach meaning a “me too” lawsuit in the #CIT sooner rather than later and protests. The lawsuit should be sooner because if there’s gonna be a roll up into a #consolidation, you want to be in that first group that’s consolidated. It increases chances of an earlier refund. And you can also sue later, but you will have to probably be consolidated in a later group which will cause delays. Also there’s the #protest option, which we are recommending as a back up plan. Remember you have unforgiving time frames on protests: 180 days after #liquidation. #CBP is advancing liquidation to try to cut off your rights on refunds. Watch the video for more. contact@fdaimports.com -- don't hesitate and please send this to anybody that you know needs this general (not legal) advice.