What does a foreign food brand need before its first US shipment?
The table below is the whole checklist. Everything on it is required by law or by the trade before a pallet moves, and each line has an owner. The brand owns the facility side. The importer owns the entry side. When a distributor buys the product, it usually takes the entry side and part of the label work, which is why most brands enter with a distributor rather than alone.
| Requirement | Rule | Who owns it | When |
|---|---|---|---|
| FDA food facility registration | 21 CFR Part 1, Subpart H | The manufacturing facility | Before the first shipment; renewed October 1 to December 31 of every even-numbered year |
| US agent for FDA | 21 CFR 1.227 and 1.232 | The foreign facility designates one | At registration |
| DUNS number (unique facility identifier) | 21 CFR 1.232(a)(2) | The facility, and the FSVP importer at entry | Before registration |
| FCE registration and SID process filing | 21 CFR Parts 108, 113, 114 | The facility, if the product is acidified or low-acid canned | Before the first shipment of that product |
| Prior Notice | 21 CFR 1.279 | The importer or its broker | Before every shipment arrives |
| FSVP importer | 21 CFR Part 1, Subpart L | The US owner or consignee at entry | Before the first import, then ongoing |
| US-compliant label | 21 CFR Part 101 | The brand, verified by the importer | Before the first shipment |
| Importer of record, customs bond, HTS classification | US Customs and Border Protection | The importer | Before the first entry |
| USMCA certification of origin | US Customs and Border Protection | The exporter or producer | With each qualifying shipment |
| Barcodes, insurance, retailer ingredient standard | Trade requirements | The brand, with its distributor | Before the first buyer meeting |
How does FDA facility registration work, and who is the US agent?
Any facility outside the United States that manufactures, processes, packs, or holds food for US consumption must register with FDA before it ships. Registration has no FDA fee. It must be renewed between October 1 and December 31 of every even-numbered year, and any change to the information on file must be updated within 60 days. A registration that is not renewed in the window is treated as expired, and shipments from that facility are refused until it is registered again.
Every foreign facility must designate a US agent: a person or company physically located in the United States that FDA can reach about the facility. The agent is a point of contact, not the importer; the two roles are often confused and they are not the same. The registration also requires a unique facility identifier, and under 21 CFR 1.232(a)(2) the identifier FDA accepts is a DUNS number. Get the DUNS before you start the registration; it is the step brands most often discover late.
Does my product need FCE registration and a scheduled process?
If your product is a low-acid canned food or an acidified food in a hermetically sealed container, yes, and this applies to foreign processors. The facility must obtain a Food Canning Establishment (FCE) registration and file a scheduled process for each product, container, and process combination, which FDA identifies with a Submission Identifier (SID). The rules are in 21 CFR Part 108, Part 113 for low-acid canned foods, and Part 114 for acidified foods, and FDA explains the filings on its acidified and low-acid canned foods registration page.
This is where salsas, pickled products, and jarred sauces get caught. A salsa acidified to a pH of 4.6 or below and sold shelf-stable in a jar is an acidified food. The scheduled process must be established by a process authority, and the FCE and SID must exist before the product ships. A shipment of acidified food from a facility with no FCE or no SID is refused. Dried products, spices, seasonings, and snacks that are shelf-stable because of low moisture do not need process filing; they still need registration, Prior Notice, FSVP, and a compliant label.
What is Prior Notice and when is it filed?
Prior Notice is the electronic notice FDA must receive and confirm before a food shipment arrives at its first US port. Under 21 CFR 1.279, it must be confirmed no less than 2 hours before arrival by road, 4 hours by rail, 4 hours by air, and 8 hours by water, and it cannot be filed more than 30 calendar days ahead through the customs broker's system or 15 days ahead through FDA's own interface. It carries the manufacturer's registration number, the product codes, the shipper, and the importer. Late filing and data that does not match the facility registration are among the most common reasons a compliant product sits at the border. FDA's Prior Notice guidance is the reference.
Who is the FSVP importer and what must they do?
The Foreign Supplier Verification Program puts a US-based party on the hook for verifying that the foreign supplier produces food to US safety standards. That party is the US owner or consignee of the food at the time of entry. If there is no US owner or consignee, the foreign owner must designate a US agent or representative for FSVP in writing. The FSVP importer keeps a hazard analysis, approves the supplier, performs verification activities, and keeps records, and it must provide its own DUNS number at each entry line, as FDA explains in its guidance on the unique facility identifier for FSVP importers.
The foreign facility, for its part, is expected to operate under current good manufacturing practice and preventive controls described in 21 CFR Part 117, which is what the FSVP importer verifies. When a distributor buys the product, it is normally the owner at entry and therefore the FSVP importer.
What has to be on the label?
The label must meet 21 CFR Part 101: a Nutrition Facts panel in the US format, an ingredient statement in descending order by weight with sub-ingredients declared, all required elements in English, net quantity in both US customary and metric units, certified color additives declared by name, and declaration of the nine major allergens, including sesame. US Customs also requires imported goods to be marked with their country of origin. FDA's Food Labeling Guide covers the format. The recurring label failures, and what buyers reject beyond the law, are in why US retailers reject imported food products.
What does customs require: importer of record, bond, HTS, and USMCA?
Separately from FDA, every entry needs an importer of record, a customs bond, and a Harmonized Tariff Schedule classification that determines the duty rate. A licensed customs broker normally files the entry and the Prior Notice together. US Customs and Border Protection's basic importing page is the starting point. For products from Mexico or Canada that qualify as originating goods, a USMCA certification of origin from the exporter or producer supports duty-free entry; CBP's USMCA page sets out the requirements, and what that means for seasoning and flavor systems is in USMCA benefits.
Which state rules apply on top of federal law?
Federal compliance does not end the list. California AB 418 prohibits Red 3, brominated vegetable oil, potassium bromate, and propylparaben in food sold in California from January 1, 2027. California's Proposition 65 requires a warning on products that expose consumers to listed chemicals above safe harbor levels, and lead in spices and chile products is a recurring enforcement area for imported brands. Other states have passed dye restrictions for school meals and broader laws that are being tested in court. A brand selling nationally should plan for the strictest state it ships to.
What does the retailer add?
Three things, none of them law. A GS1 barcode on the unit and on the case, product liability insurance at the level the retailer or distributor sets, and an ingredient standard that is usually stricter than federal law. The last one decides more listings than the first two.
In what order should a brand do all this?
- Formula and label review against the retailer standard, before anything else, because reformulation changes the product.
- DUNS number, then FDA facility registration with a US agent.
- FCE registration and SID filing, if the product is acidified or low-acid canned.
- Identify the FSVP importer: your distributor, or a designated US representative.
- Final label, GS1 codes, insurance.
- Customs broker, bond, HTS classification, USMCA documentation.
- Prior Notice for every shipment, filed by the broker with data that matches the registration.
Brands that work with us do steps 4 through 7 with us, and we review steps 1 and 2 before they apply. How those roles are written into a contract is in what an exclusive US distribution agreement covers. What each item costs is in how much it costs to enter the US market with a food brand. See what we look for.
Questions brands ask about US import requirements
Is there an FDA fee for food facility registration?
No. FDA does not charge for registration or renewal. Brands pay only a service provider if they use one for the US agent role or the filing.
Do I need a DUNS number to register with FDA?
Yes. FDA requires a unique facility identifier on every registration, and the identifier it accepts is a DUNS number. The FSVP importer also provides its DUNS at each entry line.
Does my salsa need FCE registration and a scheduled process?
If it is acidified to a pH of 4.6 or below and sold shelf-stable in a sealed container, yes. A process authority establishes the scheduled process, and the FCE and SID must be on file before the product ships, including for foreign facilities.
Can my distributor be my FSVP importer?
Yes, when the distributor is the US owner or consignee of the food at the time of entry. If nobody in the United States owns the food at entry, the foreign owner must designate a US representative in writing.
What happens if the facility registration lapses?
FDA treats the facility as unregistered. Shipments are refused until the facility registers again, and a lapsed registration cannot be renewed; it has to be submitted as new.
Do trade samples need Prior Notice?
Yes. Prior Notice applies to food offered for import, including commercial and quality-control samples. The main exclusion is food carried by an individual for personal use.
Sources
- FDA, Registration of Food Facilities and Other Submissions
- 21 CFR 1.232, Required registration information (eCFR)
- FDA, Guidance for Industry: Compliance with Providing an Acceptable Unique Facility Identifier for FSVP
- FDA, Acidified and Low-Acid Canned Foods (LACF) Registration
- 21 CFR Part 108, Emergency Permit Control (eCFR)
- 21 CFR Part 113, Thermally Processed Low-Acid Foods (eCFR)
- 21 CFR Part 114, Acidified Foods (eCFR)
- 21 CFR 1.279, When must prior notice be submitted to FDA (Cornell LII)
- FDA, Guidance for Industry: What You Need to Know About Prior Notice of Imported Food Shipments
- FDA, FSMA Final Rule on Foreign Supplier Verification Programs
- 21 CFR Part 117, Current Good Manufacturing Practice and Preventive Controls for Human Food (eCFR)
- 21 CFR Part 101, Food Labeling (eCFR)
- FDA, Food Allergies
- FDA, Guidance for Industry: A Food Labeling Guide
- US Customs and Border Protection, Basic Importing and Exporting
- US Customs and Border Protection, USMCA
- California Legislative Information, AB 418
- OEHHA, Proposition 65
- GS1 US
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