In a Cargo Systems Messaging Service (CSMS) bulletin published on July 9, 2025, the U.S. Food and Drug Administration (FDA) announced that Section 321 shipments would now be subject to FDA requirements.

This CSMS rescinds all prior messages from the FDA that exempted de-minimis shipments from FDA reporting requirements and regulations. All shipments of products subject to FDA regulations, regardless of quantity and value must be submitted for review.

FDA wants to remind the trade that prior notice requirements must still be met on “on all food and feed shipments, regardless of value or quantity; unless otherwise exempt from PN requirements under 21 CFR 1.277(b).”

This change in FDA requirements for Section 321 shipments went into effect on the day of publication.

CSMS # 65581188 can be read here:
https://content.govdelivery.com/bulletins/gd/USDHSCBP-3e8b084?wgt_ref=USDHSCBP_WIDGET_2