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  5. Importing Food Products into the United States
  6. Import Certification
  1. Importing Food Products into the United States

Import Certification

Import certification is a targeted tool that the FDA can use to address a variety of food safety problems associated with imported foods, including to address systemic and recurring food safety problems in a particular region and in response to food safety risks arising from natural disasters or other contamination events, while maintaining trade flow for compliant products. Based on a determination of risk of an imported food, the FDA can require industry to demonstrate that the food safety risk has been addressed before a food is imported into the U.S.

When the FDA makes this risk determination, the food must be accompanied by an import certification or other assurance (shipment or facility specific) that the food meets applicable FDA requirements as a condition of admission. Import certification maintains market access for compliant products accompanied by the appropriate certification or assurance.

Relationship to Other FDA Programs

Import certification works in conjunction with the FDA's comprehensive imported foods oversight framework, including other import alerts for violative products, facility inspections, examination and sampling programs, Foreign Supplier Verification Programs, and the Voluntary Qualified Importer Program. Import certification enables the FDA to address recurring food safety risks while maintaining efficient trade flow for compliant foods and is a tool the FDA uses judiciously.

How Import Certification Differs from Other Import Tools

Import certification is a complementary tool that works alongside the FDA's existing import authorities in the Import Process.

  • Import Alerts: Employs "detention without physical examination" (DWPE) for products that appear adulterated or violative. Products are detained until compliance is demonstrated through testing at the border or until the firm has addressed the conditions that gave rise to the appearance of a violation.
  • Import Certification: Offers additional assurance to enable continued trade for products with a certification or assurance specified by the FDA, which may include audits of foreign firms or facility certification, or pre-shipment testing by designated entities, while allowing compliant products to move efficiently through the import process.

Authority

Congress granted the FDA import certification authority under section 801(q) of the Federal Food, Drug, and Cosmetic Act through the Food Safety Modernization Act. To exercise import certification authority, the FDA must make a risk-based determination considering several statutory factors, including:

  • Known safety risks associated with the food,
  • Known food safety risks associated with the country, territory, or region of origin of the food, and
  • The adequacy of food safety programs, systems, and standards in the country, territory, or region of origin.

When making a determination on whether import certification is appropriate, FDA considers the statutory factors in light of the specific circumstances involved and evaluates all relevant available information and evidence.  

How Import Certification Works

Certifying Entities - FDA designates which entities may provide import certification, which may include:

Certification Forms - Import certification may take various forms, including:

  • Shipment-specific certificates
  • Listings of certified facilities
  • Other forms as FDA specifies, such as testing records, audit reports, or certificates of analysis

Effective October 31, 2025, the agency will require import certification for shrimp and spices from certain regions of Indonesia, based on the risk of potential contamination of the food with Cesium-137. This represents the first use of this Congressional authority to address ongoing food safety problems while keeping trade flowing for safe products.

For more information, visit Food Imports and Exports page, Import Alerts page and FDA Response to Imported Foods Potentially Contaminated with Cesium-137.

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