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 [00:03:00] Who is legally responsible for compliance at the border [00:05:00] Common documentation and registration problems in private label arrangements [00:07:00] How formula or label changes by manufacturers can create risk for brand owners [00:09:30] What happens if shipments are detained and the brand owner isn’t listed as importer [00:11:00] How contracts can protect brand owners from regulatory risks [00:13:00] Why indemnification clauses don’t shield importers from FDA enforcement [00:15:00] Why many companies fail to draft contracts until after problems arise [00:17:00] Key advice for U.S. brands launching private label products sourced overseas 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.