Section 321 (De Minimis) Shipments of Products Regulated by the U.S. Food and Drug Administration (FDA)
Published Jul 9, 2025
Summary
CBP/FDA announces that all FDA-regulated products, including Section 321 de minimis shipments, must now be submitted to FDA for review regardless of value or quantity, rescinding prior guidance that exempted certain low-value shipments. Prior Notice requirements for food and feed shipments remain in effect.
Summary is machine-generated at the linking layer for discovery only. Refer to the source bulletin for authoritative guidance.
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