CSMS # 65581188 - Section 321 (De Minimis) Shipments of Products Regulated by the U.S. Food and Drug Administration (FDA)

CSMS # 65581188 - Section 321 (De Minimis) Shipments of Products Regulated by the U.S. Food and Drug Administration (FDA)
U.S. Customs and Border Protection sent this bulletin at 07/09/2025 10:37 AM EDT
CSMS # 65581188 - Section 321 (De Minimis) Shipments of Products Regulated by the U.S. Food and Drug Administration (FDA)
This message provides updated information for claiming a duty exemption under 19 U.S.C. § 1321(a)(2)(C) (de minimis) for low-value shipments subject to U.S. Food and Drug Administration (FDA) requirements. The FDA is updating its previously issued guidance regarding such shipments, and hereby rescinds CSMS #94-001260,
CSMS # 17-000388
,
CSMS # 52257745
, and
CSMS # 53697179
.
All shipments of FDA-regulated products, regardless of quantity and value are subject to the same regulatory requirements and may pose risks to health, safety, and security. Effective immediately, all FDA-regulated products must be submitted to the FDA for review. All prior communications exempting certain low-value FDA-regulated products are rescinded.
CSMS #94-001260 and CSMS #17-000388 stated that certain FDA-regulated products, if eligible for the de minimis exemption, could be released by CBP without FDA review. However, technological capabilities of both the trade and the FDA have advanced significantly. This allows FDA to review all electronically transmitted FDA-regulated products offered for import, regardless of shipment quantity and value, to facilitate legitimate trade and prevent the importation of violative products.
As a reminder, Prior Notice (PN) requirements must still be met on all food and feed shipments, regardless of value or quantity; unless otherwise exempt from PN requirements under
21 CFR 1.277(b)
.
Resources:
FDA Supplemental Guide for ACE:
FDA Supplemental Guide
Information on importing FDA-regulated products and entry types:
Import Basics
Common Entry Types
Information on de minimis shipments:
TFTEA-De Minimis Value Increases to $800
19 CFR Section 10.151 Importations not over $800
Entry Type 86 Frequently Asked Questions
Contact Information:
For general import operations questions:
Imports@fda.hhs.gov
FDA is issuing this message as part of its continued outreach efforts to assist the import community; please make this information available to importers of record, consignees, manufacturers, shippers, and other stakeholders.
Related messages:
CSMS # 17-000388
,
CSMS # 52257745
, and
CSMS # 53697179
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