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The Food and Drug Administration (FDA) has released updated guidance on July 9, 2025, regarding Section 321 de minimis shipments that require FDA approval.
Prior to this update, certain goods that qualified for the de minimis treatment could be cleared by Customs and Border Protection without needing FDA approval. With this update, all goods that are of interest to the FDA, regardless of quantity or value, are now subject to review.
This change is attributed to an improvement in technology, both within the FDA and in the industry at large.
Notably, Prior Notice (PN) requirements must still be met on ALL food and feed shipments, regardless of value or quantity, unless exempt under a different regulation.
For more information on this new regulation, please read the full regulation update here.
