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Fdaimportsbenjaminengland
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Cross Border Compliance with Attorney Benjamin L. England
Supreme Court Just Shut Down Trump's Tariff Strategy - Part 3
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 #Customs do anything much less refund IEEPA tariffs in 90 days. Watch the video to see why. In this video, I also discussed: The 10-15% #sect...
2026-02-28
07 min
Cross Border Compliance with Attorney Benjamin L. England
Supreme Court Just Shut Down Trump's Tariff Strategy - Part 2
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 all the discussion will be about the economy -- not ICE, not rivers and seas, not the biology of men and women. The WH didn't back...
2026-02-25
06 min
Cross Border Compliance with Attorney Benjamin L. England
Supreme Court Just Shut Down Trump's Tariff Strategy - Part 1
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, #fentanyl tariffs all sorts of tariffs. So if you haven’t been listening to me before and didn’t already start, then now it’s time to act...
2026-02-25
02 min
Cross Border Compliance with Attorney Benjamin L. England
Navigating FDA Imports and Compliance Risks
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 the evolving enforcement strategies affecting import cargo. Key Timestamps: 00:00 – Introduction to FDA Imports and Compliance 03:15 – FDA's Authority Over Imports and Exports 06:45 – Intersection of State and Federal Laws in Import Regulation 10:30 – Relevance of Federal Law in State Regulati...
2026-02-16
20 min
Cross Border Compliance with Attorney Benjamin L. England
Post-Market Problems: When FDA Comes Knocking After Your Product Is Already on Shelves
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 and regulatory adherence. Key Timestamps: 00:00 – Introduction 01:30 – Understanding Customs and FDA Attention at the Border 05:15 – Post-Customs Questions and Investigations 09:45 – FDA's Broader Jurisdiction Beyond the Border 13:20 – The Importance of Compliance Post-Importation 17:05 –...
2026-02-02
21 min
Cross Border Compliance with Attorney Benjamin L. England
Supreme Court IEEPA Tariff Challenge: How Importers Can Preserve Refund Claims (180 Day Protest Rule)
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 – Introduction 02:45 – Overview of IEEPA and its implications 06:20 – Filing a protest with customs for tariff refunds 10:15 – Importance of filing a lawsuit for expedited refund process 14:30 – Acting before vs. after the Supreme Court ruli...
2026-01-20
19 min
Cross Border Compliance with Attorney Benjamin L. England
Supply-Chain Transparency 2.0: Tracing Every Ingredient from Source to Shelf
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, offering essential insights for importers. Key Timestamps: 00:00 – Introduction 03:45 – Supply Chain Transparency 2.0 06:10 – FSMA-204 Traceability Requirements 09:25 – Future Expansion of Traceability Demands 12:15 – CBP's UF LPA and Forced Labor Documentation 15:40 – Maintaining...
2025-12-19
22 min
Cross Border Compliance with Attorney Benjamin L. England
Data-Driven Enforcement: How FDA’s New Screening Systems Are Changing Border Compliance
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 identify high-risk shipments and streamline inspections. He also discusses the role of machine learning in modern compliance systems, the critical importance of data accuracy for importers, and how technology continues to evolve the relationship between FDA, Customs, and other regulatory agencies.
2025-11-28
19 min
Cross Border Compliance with Attorney Benjamin L. England
Private Label Pitfalls: Customs and FDA Risks You Didn’t See Coming
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 owners often overlook. From contract structures to regulatory oversight, he provides a roadmap for U.S. brands sourcing overseas and highlights the pitfalls that can trigger costly FDA and Customs issues. Key Timestamps [00:01:00] What private labeling looks like in FDA-regulated industries
2025-11-10
19 min
Cross Border Compliance with Attorney Benjamin L. England
Government Shutdown Impact: How FDA and Customs Operations Are Affected
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 a shutdown. He outlines which inspections are still taking place, which types of products are being prioritized, and how the shutdown impacts imported goods ranging from foods and drugs to cosmetics and me...
2025-10-28
19 min
Cross Border Compliance with Attorney Benjamin L. England
Import Alerts & Red Flags: How to Stay Off FDA’s Watchlist
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 compliance. He also shares real-world case examples, highlights industries most at risk, and provides practical strategies to reduce exposure to FDA enforcement. Key Timestamps [00:01:00] What FDA import alerts are and the industries they impact [00:03:00] The difference...
2025-10-13
19 min
Cross Border Compliance with Attorney Benjamin L. England
Country of Origin Confusion: Customs Declarations That Can Get You in Trouble
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 be diligent in documenting and reviewing their practices. England also explores the overlap of customs law, FDA and USDA oversight, and FTC enforcement when origin claims are made. Key Timestamps [00:01:00] What country of origin declarations are and why they...
2025-09-30
21 min
Cross Border Compliance with Attorney Benjamin L. England
Trump, Tarrifs, and the New FDA Import Inspectors
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 growing role of FDA and Customs collaboration, labeling enforcement trends, and strategies importers can use to mitigate risk in an increasingly volatile regulatory environment. Key Timestamps: 00:01 – Show introduction 02:00 – The return of tariffs and long-term trade implications 05:30 – How FDA-reg...
2025-08-28
18 min
Cross Border Compliance with Attorney Benjamin L. England
How to Reverse an FDA Import Refusal or CBP Seizure
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 Canada, and how businesses can adapt in a volatile regulatory climate. Timestamps: 00:00 – Introduction and episode overview 01:00 – Pharmaceutical tariffs and valuation warnings 02:00 – De minimis abuse and postal surcharge increases 05:30 – FDA leadership shakeups and resulting delays 08:30 – ORA to OII: FDA reorganization and complia...
2025-08-04
18 min
Cross Border Compliance with Attorney Benjamin L. England
FDA, CBP, DJT: What’s News?
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 company, and your import privileges. Whether you're facing a Notice of FDA Action or a CBP Seizure Notice, this episode provides a step-by-step breakdown of how to respond, and when to escalate. Timestamps: 00:00 – Introduction to Benjamin England an...
2025-07-07
18 min
Cross Border Compliance with Attorney Benjamin L. England
Pharmaceutical Imports, Commerce & CBP Tariffs & that dreaded number: “232”
Episode Summary: In this episode, Benjamin L. England discusses recent developments in pharmaceutical imports, commerce, and CBP tariffs, particularly focusing on Section 232 investigations and reciprocal tariffs. The conversation covers the Department of Commerce's role in regulating international trade and its recent investigation into pharmaceutical imports. Key Timestamps: 00:00 - Show Introduction 00:34 - Discussion of reciprocal tariffs and previous predictions 03:53 - China's retaliation and precious metals trade 05:22 - Department of Commerce's role in trade regulation 08:21 - How Commerce investigations are initiated 11:10 - Impact o...
2025-04-28
18 min
Cross Border Compliance with Attorney Benjamin L. England
What’s Next for FDA Imports? Preparing for Policy Shifts in 2025
Episode Summary: In this episode of FDA Imports – Cross-Border Compliance, host Kevin continues the conversation with attorney Benjamin L. England on the complexities of food labeling compliance. They dive into the common mistakes companies make, misbranding risks, and the legal consequences of misleading claims. The discussion covers nutrient content claims, health claims, organic and natural labeling, and how businesses can avoid costly litigation and regulatory issues. Whether you're a food manufacturer, importer, or distributor, this episode provides crucial insights into ensuring label accuracy and compliance with FDA regulations. Timestamps: 00:00 – Introduction to the episode and guest Benjamin L. England 00:06 – Recap...
2025-04-09
17 min
Cross Border Compliance with Attorney Benjamin L. England
Tariff Talk: Navigating Reciprocal Trade Laws
Episode Summary: In this episode of FDA Imports: Cross-Border Compliance, Host Abigail Vaca welcomes attorney Benjamin L. England and customs broker Sergio Lozano to discuss reciprocal tariffs and their impact on international trade. Ben explains that these tariffs respond to how other countries impose tariffs on U.S. exports, differing from standard tariff structures. Sergio notes the lack of a clear legal definition and how true reciprocity is rare. They explore how reciprocal tariffs can be unpredictable, leading to trade disputes and policy shifts. Businesses must stay informed, assess supply chain risks, and work with...
2025-03-15
25 min
Cross Border Compliance with Attorney Benjamin L. England
Behind the Scenes: Customs Brokers and FDA Regulations
Episode Summary: In this episode of FDA Imports: Cross-Border Compliance, attorney Benjamin L. England breaks down the complex regulations governing food imports into the U.S. He explains the distinct roles of the FDA and USDA, focusing on key compliance areas such as adulteration, misbranding, and the pre-import permit process. Listeners will gain insight into how food safety regulations apply to different products, including high-risk categories like seafood, fresh produce, and canned foods. England also discusses the FDA’s sampling and enforcement process, labeling requirements, and the consequences of non-compliance at the border. Timestamps: 00:00 – Introduction to FDA Imports: Cros...
2025-03-10
19 min
Cross Border Compliance with Attorney Benjamin L. England
Beyond The Border: What's Happening in FDA & Customs
Episode Summary: In this episode of FDA Imports – Cross-Border Compliance, host Kevin Rosenquist speaks with attorney Benjamin L. England about the latest regulatory updates affecting FDA and USDA-regulated industries from mid-January to mid-February 2025. They discuss the impact of new tariffs on imported goods from China, potential increases to pharmaceutical tariffs, and the consequences for the food, drug, and medical device industries. Additionally, they examine significant layoffs at the FDA following leadership changes in the Department of Health and Human Services (HHS) and how these staffing reductions may impact regulatory oversight, product approvals, and food safety enforcement. If yo...
2025-02-27
15 min
Cross Border Compliance with Attorney Benjamin L. England
Importing FDA-Regulated Products: Understanding FDA and Customs Enforcement Actions
Episode Summary In this episode, Benjamin England discusses the complexities of FDA import regulations, enforcement actions, and the risks that businesses face when importing FDA-regulated products into the U.S. He covers the authority FDA has at the border, how FDA detains or refuses shipments, the importance of bonds, and the consequences of non-compliance. Benjamin also provides insight into how importers can navigate FDA enforcement, handle violations, and prevent future issues. Timestamps: [00:00-00:30] Introduction to the topic of FDA import regulations and enforcement. [00:31-02:50] Benjamin England discusses the scope o...
2025-02-07
25 min
Cross Border Compliance with Attorney Benjamin L. England
FDA Detentions Unpacked: Navigating Import Regulations
Episode Summary: In this episode of FDA Imports Cross-Border Compliance, attorney Benjamin L. England provides valuable insights into the regulatory shifts under the Trump administration, focusing on FDA, customs, and the potential impacts of new tariffs on the import industry. He discusses how the regulatory landscape is changing with the return of Trump to the White House, including the effects of previous policy reversals and new tariffs on imports from countries like China, Canada, and Mexico. Benjamin explains how the FDA and customs regulations may evolve in response to these changes, and he also touches on the...
2025-01-31
17 min
Cross Border Compliance with Attorney Benjamin L. England
FDA and Customs: The Dynamic Duo Behind Smooth Imports
Episode Summary In this episode, Benjamin England, founder of FDAImports.com, provides an in-depth look at the FDA and customs regulations for importing FDA-regulated products into the U.S. He explains the roles of customs brokers, the FDA, and Customs and Border Protection (CBP), outlining key steps importers need to take for smooth and compliant importation. Benjamin also shares valuable tips on maintaining product safety, meeting regulatory requirements, and ensuring truthful labeling and marketing. Whether you’re importing food, pharmaceuticals, or medical devices, this episode is packed with actionable insights for navigating the complexities of U.S. import la...
2025-01-10
24 min
Cross Border Compliance with Attorney Benjamin L. England
Navigating the Complexities of Importing FDA-Regulated Products
Episode Summary In this episode, Benjamin L. England, founder of FDAImports.com, dives deep into the intricacies of navigating FDA regulations and compliance challenges for cross-border imports. From the complexities of importing foods and medical devices to the responsibilities of foreign suppliers and FSVP importers, Benjamin provides invaluable insights. A special highlight includes a humorous and eye-opening discussion about Santa Claus’ recent run-in with FDA authorities, emphasizing the importance of proper certifications and compliance—even for St. Nick. Timestamps: [00:00-00:30] Welcome and introduction to Benjamin L. England. [00:3...
2024-12-20
19 min
Cross Border Compliance with Attorney Benjamin L. England
At the Crossroads of FDA & Customs Law
Episode Summary In this episode, Benjamin L. England shares his extensive experience working at the intersection of FDA and customs regulations. The discussion covers key compliance issues for imported goods, including the importance of understanding labeling laws, common mistakes businesses make, and how changing administrations may impact enforcement trends. Benjamin also provides actionable advice for small businesses navigating regulatory challenges and emphasizes the value of consulting experts for guidance. Timestamps: [00:30-01:27] Benjamin’s background: from microbiologist at the FDA to regulatory consultant and attorney [01:27-02:44] How FDA and customs regulations int...
2024-12-17
17 min