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.
[00:31-02:16] 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.