Importing Vietnamese Food into the USA: FDA Registration, Prior Notice and FSVP

What does FDA actually approve?

Nothing, at shipment level. FDA’s own wording is that it is not authorised to approve, certify, license or otherwise sanction individual food importers, products, labels or shipments. Imported food has to meet the same requirements as food produced in the United States, and FDA can examine, sample and detain it at the port of entry.

In practice this means a US purchase from Vietnam rests on three separate obligations whose responsible parties must be identified; one party may fulfil more than one role:

On top of these sit the customs filings every ocean shipment needs, and the labelling rules the product must meet when it is sold.

Facility registration: which facility, and whose number?

A foreign facility that manufactures, processes, packs or holds food for US consumption registers with FDA and names a US agent. Registrations are renewed in the fourth quarter of every even-numbered year, so a registration number from an older document may no longer be valid.

For a buyer, the useful question is not “are you FDA registered?” but “which facility produces my product, and is that facility’s registration current?” A trading or coordination company and a production facility are different entities. We confirm the producing facility and its registration status for the specific product and order. On our quality and certifications page FDA registration is listed as registration, not as a certification, because that is what it is: FDA does not certify facilities through registration.

Prior Notice: how far ahead?

Prior Notice tells FDA what is arriving before it arrives. Under 21 CFR 1.279 it must be received and confirmed:

• no more than 15 calendar days before arrival when filed through FDA’s PNSI web system, or 30 days when filed through the customs ACE system;
• no less than 8 hours before arrival for food arriving by water, 4 hours by air or rail, and 2 hours by road.

For sea freight from Vietnam, the 8-hour minimum is rarely the constraint; the practical risk is a Prior Notice filed with a product description, manufacturer or shipper that does not match the commercial documents. Give your broker the producing facility’s name, address and registration number from the same document set that travels with the goods.

FSVP: who is the importer, and what must they do?

The FSVP importer is the US owner or consignee of the food at the time of entry. If there is no US owner or consignee, it is the US agent or representative of the foreign owner or consignee. That agent or representative must confirm its consent to serve as the FSVP importer in a signed statement. The FSVP importer must be identified at entry by name, email address and a unique facility identifier, for which FDA accepts a DUNS number.

The FSVP importer’s job is to verify that the foreign supplier produces food with the level of public health protection US rules require:

1. analyse the hazards of the food (biological, chemical, physical);
2. evaluate the food and the supplier’s performance, including its compliance history;
3. approve the supplier on the basis of that evaluation;
4. carry out verification activities, such as an onsite audit, sampling and testing, or a review of the supplier’s food-safety records;
5. take corrective action when a problem appears, and keep written records of all of it.

This is where supplier documents do real work. A current food-safety certificate with the right scope, an approved specification, and lot COAs that report the parameters in that specification are the evidence an FSVP importer files. Our supplier qualification guide covers how to request and read them.

Are juice concentrates treated differently?

Yes. FDA’s Juice HACCP rule (21 CFR Part 120) defines juice to include concentrates, and applies to juice sold as such or used as an ingredient in beverages. Juice and juice concentrates produced under that HACCP rule are exempt from FSVP; instead, the importer takes the “affirmative steps” the juice rule sets out for imports and keeps the supplier’s HACCP evidence on file. If you import tropical fruit concentrate for beverage production, tell us the intended use so the processing documents match the rule that applies.

Shelf-stable drinks can fall under a further set of rules. Depending on formulation and pH, a canned or bottled beverage may be regulated as an acidified or low-acid canned food under 21 CFR Parts 108, 113 and 114, which requires a registered processing establishment and a filed scheduled process. Our aloe vera drink guide explains how that affects a private label drink.

Which customs filings sit next to the FDA requirements?

For containerised food imported into the United States, security data generally must also be filed before loading. Under 19 CFR 149.2, the first eight importer data elements of the Importer Security Filing (ISF, often called “10+2”) must be submitted no later than 24 hours before the cargo is laden aboard the vessel at the foreign port, by the ISF importer or its agent. The two additional importer elements — container stuffing location and consolidator — are due as early as possible, no later than 24 hours before arrival at a US port for the voyage from Vietnam. The carrier or NVOCC files its manifest data separately.

Late or inaccurate ISF data can lead to penalties and holds, and the filing depends on supplier data that often arrives late. Our US DDP-oriented supply page describes how we organise shipper, manufacturer and container data for the broker ahead of these deadlines.

What should be settled before the first order?

Write the US roles into the purchase contract, next to the Incoterm:

• FSVP importer: name, address, DUNS number and contact email;
• customs broker and ISF filer: who files, and when the supplier must deliver its data;
• producing facility: name, address and current FDA registration number for each product;
• label: name and address of the manufacturer, packer or distributor on the pack, with appropriate wording explaining its role if it is not the manufacturer, English label text, Nutrition Facts, ingredient and allergen declarations, plus sulphite declaration at 10 ppm or more;
• documents per lot: specification reference, COA parameters, and any certificate your FSVP evaluation relies on;
• duty and landed-cost basis: the tariff code assumed and who bears a change in duty between order and entry.

Labelling deserves early attention: FDA does not approve labels in advance, but it can detain a shipment at entry when the label does not comply. The buyer and the supplier check the label before printing; a problem found at the port means detention, relabelling or refusal.

If you are choosing between a port price and delivered terms, our Incoterms guide compares FOB, CIF and DDP. For the paperwork that travels with each product type, see export documents by product.