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December 17, 2024 17 mins

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.

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