Cross Border Compliance with Attorney Benjamin L. England

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 importer...

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 dec...

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...

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-NA...

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 implementatio...

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 t...

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 th...

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,...

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 importation of pharmaceuticals, offerin...

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 ...

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 navigat...

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 Act...

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 &ndas...

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&rsquo...

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 clients post-Supreme Court ru...

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 Court's ruling on i...

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 bill that actually makes ...

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 continue to the midterms and suddenly al...

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 tariffs then #Russian-oil tariffs,...