What Importers Need to Know About Importing Food into the United States
Who needs to register with the FDA?
Most facilities that manufacture, process, pack, receive, or hold food must register with the FDA every two years. This includes most foreign manufacturers and some importers. There are exceptions to the registration requirement, so businesses should confirm whether their facility qualifies.
What should businesses know about food labels?
Food offered for import into the United States must comply with FDA food-labeling requirements. Labels and packaging must be informative and truthful, and the labeling information generally must be in English. For most prepared foods like breads, cereals, canned and frozen foods, desserts, etc., food labeling is required. Nutrition labeling for raw fruits and vegetables and fish is voluntary.
Before shipment, importers should review the product label for applicable requirements including:
Product identity
Ingredient information
Nutrition labeling, when required
Allergen declarations, when applicable
Country of origin marking, when applicable
Manufacturer or distributor information
Specific labeling requirements vary by product. Importers should confirm the applicable requirements rather than assume every food uses the same label.
What should importers verify with foreign suppliers?
Importers should confirm that the foreign supplier and product meet applicable FDA requirements before shipment.
At a minimum, verify:
FDA facility registration: Confirm that the foreign facility is registered when registration is required. FDA registration information is confidential, so importers must contact the firm to confirm its status.
Ingredients and formulation: Make sure ingredients and food additives comply with applicable FDA requirements.
Label compliance: Confirm that labeling and packaging are informative, truthful, and meet applicable FDA requirements.
FSVP requirements: Determine whether the importer is subject to the Foreign Supplier Verification Program. Under FSVP, covered importers are responsible for verifying that foreign suppliers have adequate preventive controls to produce safe food.
Applicable certificates or permits: Check whether the specific product has additional requirements, such as requirements for seafood, juice, or low-acid canned and acidified foods.
What is FDA Prior Notice?
Prior Notice is notification that FDA must receive before food is offered for import into the United States. Its purpose is to help FDA target inspections and determine whether an imported food shipment may present a threat or serious risk to public health.
Who is responsible?
The importer is responsible for the prior notice.
What is the FDA Prior Notice Submission Timeline?
Prior Notice must be submitted to FDA and confirmed for review before the food arrives in the United States:
Land by road: At least 2 hours before arrival at the port.
Land by rail: At least 4 hours before arrival.
Air: At least 4 hours before arrival.
Water: At least 8 hours before arrival.
International mail: Prior Notice must be submitted before the food is sent to the United States.
How early can it be submitted?
Through ABI/ACE/ITDS: Up to 30 calendar days before the anticipated arrival.
Through the FDA Prior Notice System Interface (PNSI): Up to 15 calendar days before the anticipated arrival.
The submission is considered complete, and the timing requirement begins, when FDA confirms the Prior Notice for review and provides a Prior Notice (PN) Confirmation Number.
What happens if requirements are not met?
FDA may request additional information or detain a product when submitted information does not match FDA records or applicable requirements. In certain cases, such as required registration or process filing for low-acid canned or acidified foods, a product may be refused. Inaccurate or incomplete entry information can also delay review.
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