Any company importing IQF fruit into the United States needs a clear picture of FDA requirements. The basic goal is to ensure that foreign produced food is as safe and traceable as domestic food, through a combination of facility registration, preventive controls, prior notice, and verification of foreign suppliers.
This article is an overview for commercial buyers. It is not legal advice, but it will help you ask more targeted questions and design your compliance framework.
FDA food facility registration
Under the Federal Food, Drug, and Cosmetic Act, as amended by the Food Safety Modernization Act, facilities that manufacture, process, pack, or hold food for consumption in the United States must register with FDA and renew that registration every two years in even numbered years.
If a foreign facility fails to register or its registration is suspended, FDA can refuse or hold shipments from that facility at the port.
When you import IQF fruit, you should be able to obtain:
- The FDA registration number of each producing or packing facility
- Confirmation that registration is current
Prior Notice of imported food
FDA must receive Prior Notice for all human and animal food that is imported or offered for import into the United States.
Prior Notice includes details such as:
- Identity of the product
- Manufacturer and shipper
- Country of production
- Port of arrival and estimated time
There are specific time windows for filing Prior Notice depending on the transport mode. If Prior Notice is missing or incorrect, FDA can refuse entry or hold the shipment.
Foreign Supplier Verification Programs for importers
FSMA introduced Foreign Supplier Verification Program requirements for food importers. In simple terms, the US importer is responsible for verifying that the food they bring into the country meets US safety standards.
Standard FSVP requirements include:
- Conducting hazard analyses for the imported food
- Evaluating the foreign supplier’s performance and risk profile
- Determining and performing supplier verification activities, such as audits or testing
- Taking corrective actions where necessary
- Ensuring proper importer identification at entry and maintaining records.
If an importer does not have an adequate FSVP for an IQF product, FDA can refuse admission of that product into the country.
FSMA and traceability
FSMA also includes a Food Traceability Rule that imposes additional recordkeeping requirements for certain high risk foods. While not all frozen fruits fall on the traceability list, many companies choose to apply similar principles across their portfolio to simplify audits.
For IQF fruit, this typically means:
- Lot level traceability from farm to freezer
- Time and temperature records through the cold chain
- Documented corrective action procedures in case of deviations
Practical steps for IQF fruit importers
To align with FDA requirements when importing IQF fruit into the United States:
- Confirm that all manufacturing and packing facilities are properly registered
- Design and maintain a risk based FSVP program for each product and supplier
- Build internal processes for accurate and timely Prior Notice filings
- Keep robust records of COAs, audits, corrective actions, and shipping documents
When you work with suppliers that understand these obligations and have systems built around them, your imports are smoother, and your risk profile is lower.