U.S. Food and Drug Administration (FDA) Guidance

  • Filas: octubre 25, 2022
  • Regiones afectadas: Norteamérica
  • Tipo de aviso: Arancel
Dear Valued Customer, 

The U.S. Food and Drug Administration (FDA) recently issued guidance on food facility registration, refusal of inspection by a foreign food establishment or foreign government and a reminder on admissibility entry filing for de minimis shipment (Section 321) for regulated products.

Firstly, owners, operators, or agents in charge of a domestic or foreign facility engaged in manufacturing/processing, packing, or holding food for consumption by humans or animals in the U.S., are required to register the facility with the FDA.  The registration and renewal period is now open between October 1, and December 31, 2022.  The FDA will consider the registration of a food facility to be expired if a facility’s registration is not renewed by December 31, 2022.  For more information, review the following information:
Online Registration of Food Facilities | FDA 
Food Facility Biennial Registration Fact Sheet (fda.gov) 
Food Facility Registration User Guide: Step-by-Step Instructions for Registration | FDA

On October 20, 2022, the FDA issued guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an FDA inspection.  The FDA Food Safety Modernization Act (FSMA) gives the FDA authority to refuse entry of food offered for importation to the United States if the foreign food establishment or foreign government has refused to permit the FDA to inspect the foreign establishment that produced the food.  For additional information on examples of situations that would cause refusal, review the following information:
Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government | FDA
Federal Register: Refusal of Inspection by a Foreign Food Establishment or Foreign Government; Guidance for Industry; Availability

Finally, on October 20, 2022, the Cargo Systems Messaging Service (CSMS) #53697179 announced a reminder to the importers related to the import of low value shipments subject to FDA regulations.  The CSMS message reminds importer and customs brokers that CBP, FDA, and other government agencies (PGAs) can clear de minimis/section 321 shipments electronically using Entry Type 86, as long as a 10-digit harmonized tariff schedule (HTS) is provided.  When submitting entries, the customs broker must include appropriate FDA product code and information for each FDA line item.  Additionally, when importing food products, the FDA prior notification of food, including animal feed, that are offered for import into the U.S. is required for all modes of transportation including a de minimis entry.

Thank you for being our Valued Customer. If you have any questions, please do not hesitate to contact your C.H. Robinson commercial representative for further information.

C.H. Robinson