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FDA Updates Guidance on Section 321

Certain shipments with a value of less than $800 can be released from U.S. Customs without an entry. However, not all shipments that contain FDA regulated goods are eligible for this type of release.

Per CSMS message 17-000388, the following five (5) categories of FDA regulated goods may be released without FDA notification:

Please note that FDA Prior Notice must still be submitted for food regardless of value or quantity.

Questions related to the FDA reporting requirements for de minimis shipments may be submitted to FDA’s Division of Import Operations at (301) 796.0356 or