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 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.

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.

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: 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.
 

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 you're an importer, manufacturer, or stakeholder in the FDA-regulated space, this episode provides critical insights into evolving policies and compliance challenges.
Timestamps:
00:00 – Introduction to the episode and guest Benjamin L. England
00:06 – Overview of recent regulatory developments (mid-January to mid-February 2025)
00:27 – Benjamin’s update from El Salvador; Kevin reports on freezing temperatures in Colorado
00:49 – Background on Benjamin L. England and FDAImports.com
01:52 – Discussion on new tariffs affecting FDA and USDA-regulated imports
02:07 – Breakdown of China tariffs: seafood, pharmaceuticals, medical devices, and consumer goods
04:35 – Why pharmaceuticals are particularly vulnerable to tariff increases
07:02 – Possible escalation of tariffs to 25–35% and what it means for industry costs
08:22 – Predictions on future U.S.-China trade policies under the Trump administration
09:28 – FDA layoffs and restructuring under new HHS Secretary Robert F. Kennedy Jr.
09:48 – Impact of mass firings on medical device and pharmaceutical approvals
12:00 – FDA’s approach to regulating food additives and recent leadership resignations
14:09 – Compliance concerns for importers as FDA resources shift
15:10 – Closing thoughts on key issues to monitor in the coming months
About the Show:
FDA Imports – Cross-Border Compliance is a podcast designed to help businesses navigate the complex world of U.S. regulatory compliance for imported foods, drugs, medical devices, and cosmetics. Each episode provides expert analysis on FDA, USDA, and CBP regulations, helping manufacturers, importers, and exporters stay informed, compliant, and competitive in the U.S. market.
 

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 of FDA’s regulatory authority at the border.
[02:51-04:30] Importance of having a system in place to monitor suppliers and ensure compliance.
[04:31-06:00] The process of detaining and refusing shipments based on the appearance of violations.
[06:01-08:00] FDA's approach to handling violations and the consequences of detentions, including the impact on future shipments.
[08:01-10:00] Recidivism and how FDA can take more severe enforcement actions, like issuing import alerts.
[10:01-12:00] Detailed discussion on the bond system used for importing goods and Customs' role in enforcing compliance.
[12:01-14:00] Consequences of failure to export or destroy goods after FDA refusal, including bond claims.
[14:01-16:00] Civil penalties and Customs' ability to seize goods versus FDA’s role in enforcement.
[16:01-18:00] Explanation of FDA detention vs. refusal, and how importers can navigate these situations.
[18:01-20:00] Strategies for resolving issues with detained or refused shipments, including correcting the violation or removing the product from FDA jurisdiction.
[20:01-22:00] Detailed explanation of the bond system and the financial risks involved for importers.
[22:01-24:00] Consequences of not handling FDA’s refusal properly and how Customs enforces compliance through bond claims.
[24:01-25:00] Conclusion and contact information for further guidance on FDA import regulations.
 
About The ShowThe "FDA Imports" podcast offers expert insights into navigating the complexities of FDA import regulations for businesses involved in importing FDA-regulated products. Hosted by Kendall Trosky and featuring FDA regulatory expert Benjamin England, the show covers essential topics such as FDA enforcement actions, compliance strategies, and the legal landscape surrounding imports. Each episode provides practical advice and real-world examples to help manufacturers, importers, and distributors avoid costly mistakes and ensure smooth operations when crossing U.S. borders. Whether you're a seasoned professional or new to the industry, the podcast delivers valuable guidance on managing FDA import requirements.

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 practical challenges importers face navigating these updates.
 
Timestamp Highlights:
00:00 – Introduction to the podcast and Benjamin L. England
00:39 – What changes to expect in FDA and customs regulations with Trump back in office
02:41 – Reduction of regulations and the impact on FDA compliance
04:30 – Changes in the loophole for goods valued at less than $800 for personal use
05:23 – FDA's increased regulatory requirements and challenges with government communication
06:21 – Impact of tariffs and the enforcement of regulations, including the $800 import rule
08:46 – Tariffs on Chinese goods, Canada, and Mexico, and the effect on FDA-regulated products
10:56 – Potential impact of tariffs on fresh produce imports from Mexico and Canada
12:39 – Focus on tariffs affecting imports from China, Canada, and Mexico
13:23 – How tariffs affect the availability and cost of goods, especially fresh produce
15:44 – FDA's future regulatory changes under the Trump administration's appointees
16:44 – The Trump administration’s strategy with political appointees in the FDA and other departments
 
About the Show:
FDA Imports Cross-Border Compliance with attorney Benjamin L. England is a podcast that delves deep into the complexities of customs and FDA-regulated imports. Each episode provides expert advice on navigating the intricate world of international trade, import regulations, and compliance, helping businesses stay informed and compliant as regulations evolve. Hosted by Benjamin L. England, a seasoned attorney with extensive experience in the field, this show brings clarity to the often confusing world of imports, food and drug regulations, medical devices, and more.

FDA and Customs: The Dynamic Duo Behind Smooth Imports

Episode SummaryIn 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 laws.
 
Timestamps:[00:00–00:45] Introduction and Benjamin’s background.[00:46–02:30] The importance of a customs broker for FDA-regulated imports.[02:31–05:30] Data transmission process and FDA screening methods.[05:31–07:45] Key challenges faced by FDA importers.[07:46–09:10] Role of attorneys and consultants in resolving FDA detentions.[09:11–11:10] Examples of FDA import issues and solutions.[11:50–12:45] What to expect from FDA and CBP when importing products.[12:46–14:20] Steps in the FDA detention process and outcomes.[14:21–15:10] Handling relabeling, reprocessing, or product refusals.[15:11–16:45] Key steps for preparing FDA-regulated imports.[16:46–18:30] How the FDA collaborates with CBP for compliance.[18:31–20:25] Differences between FDA and CBP’s responsibilities.[20:26–22:36] Top three priorities for reducing risks and staying compliant.[22:37–24:11] How to contact Benjamin England and his team.
 
About The Show
In this episode of the podcast, Benjamin England, founder of FDAImports.com, breaks down the complexities of importing FDA-regulated products into the U.S. He discusses the critical roles played by customs brokers, the FDA, and U.S. Customs and Border Protection (CBP) in ensuring compliance with import regulations. Benjamin shares essential steps for importers to navigate the regulatory process, including the importance of accurate documentation, understanding tariff codes, and meeting safety and labeling requirements. With practical insights on dealing with FDA detentions and refusals, this episode is a must-listen for businesses involved in importing regulated products.
 

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.
[00:31-02:16] Overview of FDA challenges in importing regulated products.
[02:17-03:23] Santa Claus’ FDA troubles: A humorous twist.
[03:24-05:18] Regulatory complexities for foods and medical devices sold online.
[05:19-07:21] Common mistakes in compliance for importers.
[07:22-11:30] FDA’s expectations and the Foreign Supplier Verification Program.
[11:31-15:15] Complexities in importing medical products for testing and clinical trials.
[15:16-19:01] Santa Claus’ arrest: How it highlights broader FDA regulatory issues.
 
About The Show
 
FDA Imports Cross-Border Compliance with attorney Benjamin L. England offers an insightful look into the complexities of importing FDA-regulated products, focusing on the challenges faced by businesses navigating FDA and Customs regulations. In each episode, Benjamin provides expert guidance on issues like food safety, medical devices, pharmaceuticals, and the intricacies of selling FDA-regulated products through online platforms. The show offers real-world examples, practical advice, and a touch of humor, all while helping companies understand and manage the complex regulatory landscape to ensure smooth importation and compliance with U.S. laws.

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 intersect and why businesses must understand both[02:44-03:53] Common compliance mistakes businesses make when importing FDA-regulated goods[03:53-05:06] High-risk industries and goods: food, cosmetics, drugs, and medical devices[05:06-06:36] Misbranding and labeling violations: how they’re detected and resolved[06:36-08:34] Impact of labeling mistakes at the border and the importance of accuracy[08:34-12:16] Enforcement trends: stricter compliance and the effects of administrative changes[12:16-13:48] Special considerations for imports vs. domestic products[13:48-15:29] Advice for small businesses: understanding risks, regulations, and seeking expert help[15:29-16:31] Importance of reading regulations and finding the right compliance resources
 
About The Show
FDA Imports: Cross-Border Compliance is a podcast hosted by attorney Benjamin L. England, offering expert insights into the complex intersection of FDA and customs regulations. With decades of experience as a former FDA microbiologist and compliance officer, Benjamin shares practical advice and real-world strategies to help businesses navigate regulatory challenges. Each episode breaks down critical topics, from labeling and import compliance to emerging enforcement trends, making it an essential resource for companies in FDA-regulated industries.