Cross Border Compliance with Attorney Benjamin L. England

By fdaimportsbenjaminengland

FDA Imports... more

· Society & Culture

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FAQs about Cross Border Compliance with Attorney Benjamin L. England:

How many episodes does Cross Border Compliance with Attorney Benjamin L. England have?

The podcast currently has 16 episodes available.

Cross Border Compliance with Attorney Benjamin L. England episodes:

October 28, 2025 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 medical devices. Benjamin also discusses how companies can manage communication delays with the FDA and Customs, what steps importers should take if their products are detained, and what to expect when the government eventually reopens.
Key Timestamps:
00:55 – How the FDA continues operating during a government shutdown
02:30 – The role of user fees and why most FDA activities remain functional
04:20 – Which inspections and compliance functions are still active
06:10 – Why high-risk imports like seafood and ready-to-eat foods remain top priority
09:00 – How companies should handle delays and communication issues with the FDA
11:15 – The government’s response to health emergencies and contaminated imports
13:40 – How CBP manages inspections, seizures, and enforcement during a shutdown
16:00 – What importers and exporters can expect once the government reopens
Show Description:
Benjamin England provides an inside look at the real-world impact of a federal government shutdown on FDA and Customs operations. Despite the shutdown, he explains that the FDA continues to function at nearly 86% capacity, driven by user fees and essential import enforcement activities.
He highlights how FDA inspectors prioritize higher-risk imports, such as ready-to-eat foods and seafood potentially contaminated with Cesium-137, while lower-risk products like cosmetics and animal food experience fewer inspections. Benjamin also discusses how the FDA’s risk-based matrix determines where limited resources are allocated and how Customs continues to perform mandatory inspections.
For importers and manufacturers, Benjamin offers guidance on managing delays, communicating effectively with regulators, and ensuring compliance while operations are slowed. He warns that once the government reopens, backlogs and staffing shortages will likely extend delays for weeks or months. His advice emphasizes staying proactive, maintaining contact with compliance officers, and seeking experienced regulatory support to navigate the challenges.
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20min
October 13, 2025 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 between one-time detention and detention without physical examination
[00:05:00] Common reasons companies are added to the FDA import alert list
[00:07:00] High-risk industries, products, and countries more frequently flagged
[00:09:30] How companies are placed on import alerts and the lack of formal notice
[00:11:00] Steps businesses must take to be removed from an import alert
[00:13:00] Real case examples of companies removed from FDA alerts
[00:15:00] Proactive strategies to monitor risks and avoid FDA red flags

About the Show:
FDA Imports Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, founder of FDAImports.com. The show helps importers, exporters, and global businesses navigate the complex legal and regulatory landscape at the U.S. border. With expert insights on FDA, Customs, USDA, DEA, and trade compliance, listeners gain practical strategies to protect their products and keep supply chains moving.
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20min
September 29, 2025 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 matter under customs law
[00:04:00] The role of free trade agreements and why origin has always been important for CBP
[00:06:00] Differences in FDA vs. USDA concerns over product origin
[00:09:30] CBP enforcement actions, penalties, and the use of prior disclosures
[00:13:00] Common mistakes companies make in declaring origin and the risks of misclassification
[00:16:00] “Made in the USA” claims and FTC enforcement on misleading labeling
[00:18:00] Best practices for businesses: conducting origin evaluations, HTS classification, and documentation

About the Show:
FDA Imports Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, founder of FDAImports.com. The show helps importers, exporters, and global businesses navigate the complex legal and regulatory landscape at the U.S. border. With expert insights on FDA, Customs, USDA, DEA, and trade compliance, listeners gain practical strategies to protect their products and keep supply chains moving.
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22min
August 28, 2025 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-regulated goods are impacted by tariff changes
08:15 – Increased FDA inspections and reallocation of resources
11:10 – Industries most affected: food, cosmetics, medical devices, pharmaceuticals
14:25 – The evolving relationship between FDA and Customs at U.S. ports
18:20 – Common issues triggering shipment holds: labeling, documentation, and new inspector errors
23:05 – Compliance risks when importing from China, India, and Mexico under USMCA
27:40 – Labeling enforcement as a leading cause of FDA detentions
31:10 – Practical steps importers can take to protect shipments and avoid costly delays
34:55 – Key advice for navigating FDA and Customs scrutiny in 2024 and beyond

About the Show:
FDA Imports Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, founder of FDAImports.com. The show helps importers, exporters, and global businesses navigate the complex legal and regulatory landscape at the U.S. border. With expert insights on FDA, Customs, USDA, DEA, and trade compliance, listeners gain practical strategies to protect their products and keep supply chains moving.
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19min
August 04, 2025 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 compliance officer authority
10:30 – FOIA backlogs and agency resource cuts
11:30 – CBP resources remain strong vs. FDA bottlenecks
12:00 – Operational impacts on importers: shipment delays, labeling scrutiny
13:30 – Ingredient disclosure, red dye regulations, and allergy concerns
14:30 – Consumer protection rationale for FDA involvement
15:00 – Peptides, Canadian drug imports, and upcoming policy shifts
17:00 – How importers can stay agile during regulatory uncertainty
18:00 – Final tips and why to monitor FDA budget and leadership

About the Show:
FDA Imports: Cross-Border Compliance with Benjamin L. England is your front-line podcast for real-world insights into FDA, CBP, and international trade regulations. Hosted by veteran FDA attorney and strategist Benjamin L. England, each episode offers critical guidance for companies navigating border compliance, import law, and global supply chain risks.
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19min
July 07, 2025 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 and the topic
01:00 – Difference between an FDA refusal and a CBP seizure
02:30 – What triggers each enforcement action
04:00 – Deadlines and warning signs in detention notices
05:30 – First steps to take after receiving a notice
06:30 – Destruction vs. export procedures (including FDA supervision)
07:30 – Legal remedies: rescission, petition, or forfeiture
09:00 – Criteria for reversing FDA refusals
10:30 – When litigation is appropriate (or not)
12:30 – Why CBP is more litigation-friendly than FDA
13:30 – Most common mistakes importers make
15:00 – How CBP redelivery demands work after refusal
16:00 – When to hire an attorney for seizures or rescissions
17:00 – Compliance systems to avoid enforcement actions
About the Show:
FDA Imports: Cross-Border Compliance with Benjamin L. England is your go-to source for practical legal guidance on FDA, CBP, and global trade compliance. Hosted by attorney and regulatory strategist Benjamin L. England, each episode offers actionable insight for importers, manufacturers, and international companies facing regulatory enforcement.
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19min
April 28, 2025 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 on pharmaceutical development and import/export
15:24 - Future predictions for international trade relations

About the Show:
FDA Imports Cross-Border Compliance with Attorney Benjamin L. England is a podcast that explores legal challenges, compliance issues, and regulations affecting global trade. The show provides expert insights into FDA-related products including foods, drugs, cosmetics, and medical devices.
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19min
April 09, 2025What’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 of the previous episode on food labeling basics
00:27 – Common mistakes in food labeling
01:09 – Technical misbranding risks: Front and side panel requirements
02:24 – Artificial flavoring, food colorings, and compliance issues
04:35 – Understanding nutrient content claims (e.g., "good source of vitamin D")
07:02 – The legal risks of false or misleading claims in food labeling
09:34 – Health claims: FDA regulation and enforcement
12:00 – What does "natural" mean? FDA policies vs. legal risks
13:58 – Organic labeling and USDA vs. FDA jurisdiction
14:09 – FDA’s enforcement at the border and compliance strategies
15:25 – How Benjamin L. England & Associates helps companies navigate compliance
16:03 – Avoiding violations and managing disputes with FDA
About the Show:
FDA Imports – Cross-Border Compliance is a podcast dedicated to helping businesses navigate U.S. regulatory compliance for imported foods, drugs, medical devices, and cosmetics. Hosted by industry experts, each episode provides practical insights on FDA, USDA, and CBP regulations, helping manufacturers, importers, and exporters stay compliant and competitive in the U.S. market.
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18min
March 15, 2025 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 experts to understand evolving regulations and compliance challenges. In a world of ever-changing trade policies, knowledge is the key to staying ahead.
About the Show: FDA Imports: Cross-Border Compliance is a podcast dedicated to helping businesses navigate the complexities of U.S. food, drug, and medical device imports. Hosted by industry experts, the show provides in-depth discussions on regulatory compliance, enforcement trends, and best practices to ensure seamless cross-border trade.
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26min
March 10, 2025Behind 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: Cross-Border Compliance
00:06 – Overview of U.S. food import regulations
00:31 – Key FDA regulations for imported food
00:41 – The roles of FDA and USDA in food regulation
02:00 – USDA’s permit requirements and import restrictions
03:30 – FDA’s focus on adulteration and misbranding
05:00 – The pre-approval process for canned and shelf-stable foods
06:17 – Breaking down food adulteration risks
07:53 – What happens when the FDA detects a violation?
08:01 – FDA’s sampling and detention process
10:27 – How FDA selects shipments for inspection
12:59 – FDA’s targeted approach to food safety enforcement
14:20 – Labeling violations: The most common import issue
16:08 – Understanding food labeling requirements
About the Show:
FDA Imports: Cross-Border Compliance is a podcast dedicated to helping businesses navigate the complexities of U.S. food, drug, and medical device imports. Hosted by industry experts, the show provides in-depth discussions on regulatory compliance, enforcement trends, and best practices to ensure seamless cross-border trade.
...more
20min

FAQs about Cross Border Compliance with Attorney Benjamin L. England:

How many episodes does Cross Border Compliance with Attorney Benjamin L. England have?

The podcast currently has 16 episodes available.