Cross Border Compliance with Attorney Benjamin L. England

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...

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 understandin...

Episode Summary: In this episode of *FDA Imports: Cross-Border Compliance* Benjamin England delves into the significance of TrumpRX.gov in the context of drug pricing policy and pharmaceutical importation. Exploring the complexities of pharmaceutical pricing disparities between the US and Europe, Ben sheds light on the regulatory changes initiated by the Trump administration to facilitate the impo...

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 t...

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 valu...

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...

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 Tar...

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...

Episode Summary: In this episode, Attorney Benjamin England delves into the aftermath of the Supreme Court ruling that struck down Trump's tariffs, leading to a maze of confusion for import-export businesses. He outlines strategies for clients, including filing lawsuits and utilizing the protest process to reclaim overpaid tariffs. Key Timestamps: 00:00 – Introduction 01:30 – Strategies for client...

Episode Summary: In this episode, attorney Benjamin England discusses the recent Supreme Court rulings on tariffs initiated by President Trump and their implications for businesses. From reciprocal tariffs to fentanyl tariffs, learn about the legal intricacies and potential refund processes involved. Key Timestamps: 00:00 – Introduction 01:30 – Overview of Trump's tariff actions 03:45 – Supreme Co...

Still NO ONE has told #CBP to #refund #IEEPAtariffs including none of the Courts that have ruled. The day #SCOTUS knocked down Trump's #IEEPA tariffs, two Congresspersons introduced the #ReliefAct. It’s another example of why all new legislators (and some old ones) should be required to pass at least a high school level civics class before taking their seats. These two don’t know how to write a bi...

SCOTUS did not change anything except the basis for the tariffs. It did not rule against the trump tariffs. It ruled against using IEEPA as a basis for the President to issue tariffs without congressional action. Now, Congress has a problem -- All SCOTUS did was drag Congress into the arena after the tariffs have not had the catastrophic effects all the doomsayers predicted. That debate will conti...

SCOTUS RULES TRUMP ADMIN DROOLS! #scotus just issued a very broad defeat to the #Trump administration respecting the #IEEPA #tariffs ruling in agreement with the #CAFC that IEEPA is not a proper basis for any tariffs not just the ones that were in front of the court that everybody has been talking about. This ruling is so broad that it this extends all of the IEEPA-based tariffs, including #Brazil...

Episode Summary: Attorney Benjamin England delves into the complexities of FDA imports and cross-border compliance. From discussing the FDA's authority over imports to examining labeling enforcement and compliance risks, Ben sheds light on the regulations governing FDA-regulated products. Gain insights into the statutory basis for FDA oversight, the impact of state laws on federal regulations, and...

Episode Summary: In this episode, attorney Benjamin England explores the complexities of postmarket issues that arise after products clear the border. From FDA investigations to recalls, Benjamin breaks down the challenges importers face when FDA scrutiny returns to their doorstep. Gain valuable insights into compliance strategies and the responsibilities importers hold in ensuring product safety...

Episode Summary: In this episode, attorney Benjamin England sheds light on the Supreme Court challenge regarding tariffs under IEEPA and how companies can safeguard themselves amidst the legal uncertainties. Learn about potential refund strategies and crucial steps to take before and after the court ruling, offering actionable insight for importers facing tariff challenges. Key Timestamps: 00:00 –...

Episode Summary: Attorney Benjamin England, founder of FDAImports.com, delves into the intricacies of supply chain transparency in FDA-regulated importing. From FSMA-204 to the UFLPA, he highlights the critical need for importers to document ingredient origins and ensure compliance with FDA oversight. Learn how traceability plays a vital role in safeguarding against food safety events and recalls,...

Episode Summary: In this insightful episode, Benjamin England, founder of FDA Imports and former FDA regulatory counsel, explores how artificial intelligence and predictive analytics are transforming the way the FDA and U.S. Customs evaluate imports. Ben breaks down how the PREDICT system—short for Predictive Risk-Based Evaluation for Dynamic Import Compliance Targeting—uses data-driven scoring to...

Episode Summary In this episode of FDA Imports: Cross Border Compliance, attorney Benjamin L. England, founder of FDAImports.com and former FDA regulatory counsel, unpacks the complex world of private labeling and contract manufacturing. England explains how private label arrangements work in FDA-regulated industries, who holds responsibility at the border, and the hidden compliance risks brand ow...

Episode Summary: In this episode of FDA Imports: Cross Border Compliance, Benjamin England breaks down how the ongoing federal government shutdown is affecting the FDA and U.S. Customs and Border Protection. Drawing on his experience as a former FDA regulatory counsel, Benjamin explains how much of the FDA’s operations continue due to user fees and why import enforcement remains active even during...

Episode Summary In this episode of FDA Imports: Cross Border Compliance, attorney Benjamin L. England, founder of FDAImports.com and former FDA regulatory counsel, breaks down the complexities of FDA import alerts. England explains what import alerts are, how companies get flagged, the risks of detention without physical examination, and what businesses must do to clear their products and restore...

Episode Summary In this episode of FDA Imports: Cross Border Compliance, attorney Benjamin L. England, founder of FDAImports.com and former FDA regulatory counsel, unpacks the critical role of country of origin declarations in international trade. He explains why origin determinations go beyond simple labeling, how they impact tariffs, duty evaluations, and compliance risks, and why companies must...

Episode Summary: In this episode of FDA Imports Cross-Border Compliance, regulatory attorney Benjamin L. England breaks down the evolving challenges importers face under shifting U.S. trade policies. With the return of Trump-era tariffs, FDA-regulated companies are encountering unexpected costs, heightened inspection activity, and more frequent supply chain disruptions. Ben shares insights on the...

Episode Summary: In Episode 12, attorney Benjamin L. England breaks down urgent developments impacting FDA-regulated importers. From rising tariffs on pharmaceuticals and small-package imports to FDA staffing delays, Benjamin offers deep insight into the regulatory trends reshaping international trade. The discussion also covers evolving dietary supplement enforcement, state drug importation from...

Episode Summary: In this tactical episode, FDA regulatory attorney Benjamin L. England explains the critical differences between FDA import refusals and Customs and Border Protection (CBP) seizures, and what businesses can do when their products are detained, refused, or seized. From legal definitions to strategic responses and mistakes to avoid, Ben outlines how to protect your goods, your compan...