U.S. FDA Issues Updated Import Guidance for Low Value (Section 321) Shipments

The U.S. Food & Drug Administration (FDA) recently updated its guidance around qualifying imports valued at $800 or less (“Section 321” or “de minimis”) containing articles regulated by the agency. It reiterated that only five categories may be released by U.S. Customs without notification to the FDA for the purpose of determining entry admissibility, if…