FDA Compliance for Imported Food Products

FDA Compliance Checklist for Importers

Use this checklist to ensure your imported food product meets all FDA requirements before shipping:

• FDA facility registration — Your manufacturing facility is registered with the FDA and registration is current (renewed in even-numbered years). See FDA food facility registration requirements.
• U.S. Agent appointed — A U.S.-based agent is designated to receive FDA communications on behalf of your foreign facility. See U.S. agent for FDA food facility.
• Prior Notice submitted — Your U.S. importer or customs broker has submitted Prior Notice to the FDA before the shipment arrives at the U.S. border.
• FDA-compliant label — Your product label meets all FDA requirements: Nutrition Facts, ingredient list, allergen declaration, net weight in dual units, English language, and U.S. responsible party address. See FDA label requirements for imported food.
• Importer of Record designated — A licensed U.S. customs broker or U.S. distributor is named as the Importer of Record (IOR) and is responsible for CBP entry.
• FSMA Foreign Supplier Verification (FSVP) — Your U.S. importer has an FSVP program in place for your product, as required by the Food Safety Modernization Act for most imported foods.

FSMA and Foreign Suppliers

The Food Safety Modernization Act (FSMA) introduced the Foreign Supplier Verification Program (FSVP), which requires U.S. importers to verify that the foreign food they import meets U.S. food safety standards. This is the U.S. importer's responsibility, not the foreign manufacturer's — but as the exporter, you should be prepared to provide documentation.

Your U.S. importer may ask you for food safety records, certifications, audit reports, or other documentation as part of their FSVP obligations. Having these ready in advance speeds up the import process.

Labeling Is the #1 Cause of Import Refusals

The FDA's import refusal database shows that mislabeling is consistently among the top reasons imported food shipments are refused entry into the U.S. Common labeling violations include:

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  Non-FDA Nutrition Facts panel format (EU, Canadian, or other formats)
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  Label entirely in a foreign language
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  Missing allergen declaration, especially sesame (required since January 2023)
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  Net weight in metric only — both U.S. customary and metric required
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  No U.S. importer or distributor address on the label
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  Ingredient list not in descending order by weight or using non-English names

Related Guides

• Export food to USA requirements
• FDA food facility registration requirements
• U.S. agent for FDA food facility
• How to sell food in the U.S. as a foreign company