Importing frozen fruit into the US: FDA registration, Prior Notice, FSVP

When you import frozen fruit, USA FDA rules put three obligations on three different parties. The Vietnamese plant that freezes the fruit holds the food facility registration. A Prior Notice is filed for each shipment on the US side before arrival. The US importer holds the Foreign Supplier Verification Program duty under 21 CFR Part 1 Subpart L, and that duty stays on the importer’s desk.

Which FDA obligation sits with whom?

Registration sits with the plant, Prior Notice is a US-side filing for the shipment, and FSVP sits with the US importer. None of the three sits with a trading brand by default. If your seller is a brand owner producing at a partner plant, the purchase order has to name the plant, or the paperwork points at the wrong party.

Processed fruit does not need a government market-access protocol. IQF, canned, dried, purée and juice lines skip the quarantine gate that fresh fruit faces: no irradiation, no vapour heat treatment, no Radura label. The barrier moves to the plant instead. Base HACCP, a GFSI scheme such as BRCGS or FSSC 22000 where the buyer requires it, and for the US the FDA registration and the importer’s FSVP file.

What does a plant’s FDA registration prove, and how do you check it?

A registration proves that the facility has told FDA it exists and who its US agent is. It says nothing about whether the plant controls the hazards in your product. Treat a registration claim on a Vietnamese plant’s website as unverified until you have the number and the US agent’s name in writing, and your broker has confirmed it works at entry.

Two practical points follow. First, the registrant has to be the plant that does the freezing, not a trading office. Second, registration is a precondition, not a credential. A supplier page that says “FDA approved” is describing something FDA does not do for a food facility. The phrase “FSMA certified” is the same error in a different form. FSMA is a statute, so no plant holds it. What a plant can hold is an FDA registration, a written food safety plan, and a third-party audit report against a named scheme. Ask for whichever document sits behind the claim, with the certifying body, the certificate number, the SKUs in scope and the expiry date.

Who files Prior Notice, and what has to be on it?

In practice the US customs broker files Prior Notice for the importer, and the seller supplies the data. The filing identifies the shipment before it lands, and it carries the manufacturing facility’s identity, which under contract manufacturing means the partner plant, not the brand on the carton.

The failure mode here is administrative before it is legal. Each side assumes the other is filing. The broker needs the plant’s name, address and registration number, the product description and the arrival details. If the commercial invoice names only the trading company, the broker either has to chase the plant’s details by email in the days before arrival or files against the wrong entity. Write into the contract who files Prior Notice and who delivers each data item to the filer, with a deadline measured from the vessel’s departure from Cat Lai or Cai Mep.

Before the first container, check the data against a certificate of analysis and a packing list from the same lot, and confirm that the lot code on each document matches the code printed on the cartons.

What does FSVP actually require of the US importer?

FSVP requires the US importer to show, in its own records, that its foreign supplier produces the food to the US level of public-health protection. In practice that duty turns into a document request on the supplier. US buyers ask for the plant’s hazard analysis, its GFSI certificate and laboratory results, and they usually set their own testing requirements on top.

Many importers also want laboratory results of their own, not only the plant’s. A seller cannot “become FSVP compliant” on the buyer’s behalf. What a seller can do is make the file easy to build by delivering the documents the importer’s activities need: the plant’s hazard analysis for this product, its sanitation and worker-health programme, audit reports, certificates, and lot-level test results. A sampling plan agreed in advance makes the importer’s own testing comparable from lot to lot; the method is covered in the guide to pre-shipment sampling for frozen fruit.

Whether a given hazard calls for an onsite audit of the plant is decided in the importer’s hazard analysis. No FDA text this article relies on names frozen tropical fruit specifically, so that determination stays with the importer and its qualified individual.

What changes when the brand owner is not the plant?

Under contract manufacturing, the US buyer is verifying a facility it has never contracted with directly. The FSVP evaluation and verification have to point at the plant that controls the hazard, and the Prior Notice has to carry that plant’s details. The trading brand is a party to the sale, but it is not the party FDA looks at.

Certificates belong to the plant that holds them. Under contract manufacturing they are, in effect, rented through the processing contract, which is why the scope line on each certificate matters: a plant certified for canned lines may not have IQF in scope. VinFruits Global asks each partner plant for its registration details and the name of the FSVP importer before an order for the United States is specified, because the registration belongs to the plant and the verification belongs to the buyer, and a contract that names neither leaves both unassigned.

The same question belongs in your own supplier approval. Ask who the FSVP importer is for US-bound goods, and who is named on the entry. If the answer is unclear before the first sample ships, it will be unclear at the port.

Why can’t a frozen-fruit FSVP file rest on lot testing?

Hepatitis A and norovirus in frozen tropical fruit are controlled at the plant or not at all. An IQF fruit line has no kill step: the fruit is not blanched or pasteurised, and freezing stops micro-organisms without destroying them, so a virus carried onto diced mango or jackfruit by a worker’s hands is still present when the carton is opened in the United States. FDA, in its strategy for reducing norovirus and hepatitis A in fresh and frozen berries, names the root causes as poor worker hygiene, inadequate toilets, cross-contamination in field and plant, and infected workers, and it encourages hepatitis A vaccination programmes for workers. No finished-product test is cheap and sensitive enough to clear these viruses lot by lot, so a certificate of analysis showing Salmonella negative in 25 g says nothing about them. A US importer’s supplier verification for frozen tropical fruit therefore has to rest on the plant’s worker-health and hygiene programme, confirmed by audit and by records.

The recall record supports this ordering. Frozen fruit recalls from 2020 to 2026 are dominated by Listeria and by hepatitis A and norovirus, with almost none for foreign bodies. A 2023 hepatitis A event linked to frozen strawberries reached 32 US states and led to an FDA and CDC investigation and several recalls; SunOpta and Sunrise Growers recalled about 162,000 cases in June 2023. The same FDA berry strategy records no enteric viral outbreak linked to US-grown berries in 35 years, while the 2022 to 2023 outbreaks traced to imports.

For a peeled and diced tropical line, the documents that carry weight are the ones describing people: symptom screening and exclusion records, toilet and hand-wash provision at the entrance to the clean zone, glove and hand-wash procedures, and any vaccination programme.

Does the intended use on the specification change the FSVP file?

Yes. Ready-to-eat status is decided by what the label and specification declare, not by the fruit. The same bag declared “for smoothies and toppings” is ready-to-eat. Declared as an ingredient to be heated to at least 75 °C for 30 seconds before eating, it is not.

That choice decides where the hazard is controlled. If the importer’s customer cooks the fruit, control can sit downstream, and the FSVP rule has a route for hazards controlled by the customer. Smoothie, ice-cream and yoghurt buyers will not accept a heat-before-eating declaration, and a B2B sale into those plants puts the fruit into a process with no kill step. A regulator reads the product that way. For most frozen tropical fruit sold into the US, the downstream route is closed in practice, and verification has to happen at the plant.

Which microbiological numbers can a US buyer point to?

There is no single FDA import limit table for frozen fruit. The nearest published federal numbers are the USDA Commodity Specification for Frozen Fruit of June 2017, which governs USDA purchasing, not imports. At least one large EU and Japanese buyer specification asks for 375 g and 125 g sample masses, against the 25 g in law.

The sources behind this table give limits and sample masses, not test methods, so the method column is left to the contract: the buyer names the method for each parameter, and the certificate of analysis for each lot states the method actually used.

Two readings follow. First, these numbers measure process hygiene and bacterial pathogens; none of them addresses hepatitis A or norovirus. Second, the contract with a large buyer, not the law, is what drives testing cost. Quote the USDA figures as a federal purchase specification, not as an FDA requirement.

When does frozen purée move under juice HACCP?

When it is sold as a beverage ingredient. Under 21 CFR 120.1, juice includes purées and concentrates, so a frozen purée bought to go into a drink falls under the juice HACCP regulation in Part 120, not only the general import framework for frozen pieces.

Part 120 brings its own importer duty. 21 CFR 120.14 places a verification obligation on the importer of juice, and 21 CFR 120.24(a)(2) requires a 5-log pathogen reduction, with an exemption for a single thermal step that makes the product shelf-stable or for thermal concentration. One product family can therefore sit under two importer regimes, decided by form and end use: diced frozen mango on FSVP, the same mango as a beverage purée under juice HACCP. Whether juice imported in compliance with Part 120 is also exempt from FSVP is a point to confirm with your broker or FSVP qualified individual before the first order; until it is confirmed, build the file for both regimes on a purée line. Canned acidified fruit is a third regime again, with process filing under 21 CFR 108.25 and Part 114, and 21 CFR 114.3(b) names tropical fruits; frozen lines escape it.

What clauses should go into the purchase order?

The clauses follow directly from the split of responsibility. Each names a party and a document, so that nothing is left for both sides to assume.

1. Manufacturing facility. The seller names the plant that freezes the product, its address, its FDA food facility registration number and its US agent, and notifies the buyer in writing before any change of plant.
2. Prior Notice. The contract names the filer, normally the buyer’s US customs broker, and the seller delivers plant details, product description, lot codes and arrival data to that filer within an agreed number of days after vessel departure.
3. FSVP documents. Before the first shipment, the seller supplies the plant’s hazard analysis for this product, current GFSI certificate with scope and expiry, the most recent audit report, and the plant’s worker-health and hygiene programme.
4. Lot documents. Each shipment carries a certificate of analysis per lot, with test methods and sample masses stated, matching the lot codes on cartons and packing list.
5. Intended use. The specification states the intended use and whether the product is ready-to-eat, and the label follows it.
6. Audit access. The seller arranges access to the plant for an audit by the buyer or its nominated auditor on reasonable notice.

Common questions

Does the Vietnamese supplier need its own FDA registration to export frozen fruit to the US?

The plant that physically freezes the fruit holds the FDA food facility registration. A trading company or brand owner that does not process the fruit is not the registrant for that product. Ask for the plant’s name, address, registration number and US agent in writing, and have your broker confirm the details before the first shipment.

Who is responsible for FSVP when importing frozen fruit from Vietnam?

The US importer. FSVP sits in 21 CFR Part 1 Subpart L and is the importer’s own duty. The seller cannot hold it for you. What the seller can do is supply the documents your file needs: the plant’s hazard analysis, its GFSI certificate, audit reports, its worker-health and hygiene programme, and lot-level laboratory results.

Who files Prior Notice for a frozen fruit container?

In practice the US customs broker files it for the importer, using data supplied by the seller. Under contract manufacturing the filing must carry the partner plant’s details, not only the brand name on the carton. Write into the contract who files and who delivers each data item, so neither side assumes the other has done it.

Can a certificate of analysis prove frozen fruit is free of hepatitis A?

No. No finished-product test is cheap and sensitive enough to clear hepatitis A or norovirus lot by lot, and an IQF line has no kill step. Supplier verification for frozen tropical fruit has to rest on the plant’s worker-health and hygiene programme, confirmed by audit and records, not on a lot result.

Is frozen fruit purée covered by FSVP or by juice HACCP?

It depends on use. Under 21 CFR 120.1, juice includes purées and concentrates, so a frozen purée sold as a beverage ingredient falls under juice HACCP in Part 120, with an importer verification duty in 21 CFR 120.14. Frozen fruit pieces are covered by FSVP. Whether a Part 120 purée is also exempt from FSVP is a point to confirm before the first order.