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FDA Food Safety Modernization Act (FSMA) requires importers to verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety standards.

Unless exempt, all importers of human and animal food must develop, maintain, and follow an FSVP for each food and foreign supplier.

The FSVP Importer may or not be the same entity that serves as the “Importer of Record” for purposes of U.S. Customs and Border Protection requirements

In most cases, the FSVP Importer is the

  •  U.S. Owner or Consignee of an article of food that is being offered for import into the United States
  •  U.S. Agent or representative of the foreign owner or consignee at the time of entry

Because of the travel restrictions, social distancing, and other advisories associated with the COVID-19 outbreak, the FDA has determined that most routine onsite inspections are temporarily impractical to conduct at this time. Therefore, the Agency will shift to temporarily conducting FSVP inspections remotely, electronically or by other prompt means, until further notice.




When food is offered for entry into the U.S., the Customs and Border Patrol (CBP) Automated Commercial Environment (ACE) system will require the filer to enter at least one additional code as part of the required data elements.

FSVP Importers should use the entity role code “FSV,” indicating the entry is subject to the FSVP regulation. This will then prompt the ACE system to ask for the importer’s name, email address, and unique facility identifier (UFI) or DUNS Number.


Under modified requirements, importers do not have to conduct hazard analyses or evaluate the food and foreign supplier.

For the modified requirements to apply, the importer will need to annually document its “very small importer” status or obtain assurance that its foreign supplier meets the criteria as “small” foreign supplier.

Importers of dietary supplements and dietary supplement components, as well as importers of certain food from foreign suppliers in countries whose food safety systems FDA has officially recognized as comparable or equivalent, can take advantage of the modified requirements.

The written assurance must include either

  • A brief description of the preventive controls that the supplier is implementing to control the applicable hazard in the food
  • A statement that the supplier is in compliance with State, local, county, tribal, or other applicable non-Federal food safety law, including relevant laws and regulations of foreign countries

FSVP does not apply to these foods:

  • Fish and fishery products, or certain ingredients for use in fish and fishery products
  • Juice, or certain ingredients for use in juice products
  • Food for research or evaluation
  • Certain alcoholic beverages, or certain ingredients for use in alcoholic beverages
  • Certain meat, poultry, and egg products regulated by USDA
  • Food imported for personal consumption
  • Food that is transshipped
  • Food that is imported for processing and export
  • U.S. food that is exported and returned without further manufacturing/processing in a foreign country

Very Small Importers would not have to conduct hazard analyses and would be able to verify their foreign suppliers by obtaining written assurances of compliance.

Remember that, unlike traditional facility inspections, FSVP inspections are based on the review of records submitted electronically, rather than observations of food production or products at a warehouse.

Therefore, we expect you to provide all related documentation, upon request.