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Admissibility Entry Filing For De Minimis Shipments (Section 321) Products Regulated By The US Food & Drug Administration

June 1, 2023

Recently CBP in conjunction with the US Food & Drug Administration (FDA) has announced a reminder that shipments of a de minimis value (under $800USD), qualifying to be cleared under a Section 321, are still subject to either all or some of the FDA regulations for reporting.

What We Know:

CBP and FDA are reminding the trade that goods subject to FDA requirements that also qualify for clearance under the de minimis provision (shipments valued under $800.00USD) aka Section 321 may be cleared without an entry as long as both the 10 digit tariff number and the applicable FDA product code for any FDA items are on the invoice.

What You Need To Know About The Section 321 De Minimis Value Entry

Affected Commodities: 


•Dinnerware (including eating and/or cooking utensils);

•Radiation emitting, non-medical devices (e.g. microwaves, televisions, CD players, etc.);

•Biological samples for laboratory testing; and,

•Food, excluding: ackees, puffer fish, raw clams, raw oysters, raw mussels, and foods packed in airtight containers intended to be stored at room temperature (low acid canned foods (LACF)).

Special Note for Food Items:  Shipments of Food for consumption by either humans or animals are still required to file a prior notice for shipments clearing as a section 321.  There is no exemption for these regulations regardless of value.

FAQ Section 321 Entry Type 86

What You Need To Do:

If you have a shipment(s) that qualify under the de minimis provision (section 321) you have a few options for entry.  

  • Option 1 - For non-food entries only - ensure that both the HS tariff number and the product code are on the invoice and request clearance under Section 321.
  • Option 2 - For food entries - ensure that the HS tariff number is present on the invoice and file a prior notice through the FDA Prior Notice Web Portal.  Provide the invoice and the prior notice number to the carrier for entry under Section 321.
  • Option 3 - For any commodity ensure the 10 digit tariff number is on the invoice and request your broker enter the goods under an entry type 86, reporting the applicable FDA information with the transmission of the entry

Please see the CBP News Release: CSMS #52257745 with reference to CSMS 17-000388 for complete details.