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.

[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.