FDA food facility registration is required for any facility, in the US or abroad, that manufactures, processes, packs or holds food meant for US consumption, unless an exemption applies. Foreign facilities must also name a US agent, and every registration must be renewed between October 1 and December 31 of each even-numbered year, which means a renewal window runs from October 1 to December 31, 2026.
This piece is written for the marketing lead at a foreign food or beverage brand, not for a regulatory team. We cover who has to register, what the US agent does, prior notice for shipments, the Foreign Supplier Verification Program, US labeling, and the marketing claims that trigger scrutiny. We are a growth firm, not a regulatory consultant or law firm, so treat this as orientation and confirm every decision with current FDA guidance and a food regulatory consultant or attorney. People searching in Mexico and Latin America often call it FDA registro; it is the same process.
What FDA Food Facility Registration Actually Is.
Food facility registration is a listing obligation under the Federal Food, Drug, and Cosmetic Act, strengthened after 2002 and again by the Food Safety Modernization Act. It tells FDA who is making or storing food for the US market, where they are, and who to contact in an emergency. It is filed online through FDA's Unified Registration and Listing System, and FDA does not charge a fee for it.
Two points confuse foreign brands more than any other. First, registration is not approval. FDA does not approve food products, review your label, or certify your facility when you register. Second, FDA does not issue registration certificates. Private companies sell certificates that look official; they are not FDA documents, and printing "FDA approved" or "FDA certified" on the back of that paper in your marketing is a claim that can get you into real trouble.
Who Must Register, and the Common Exemptions.
The rule attaches to facilities, not brands. If your company owns a factory abroad, that factory registers. If a co-packer makes your product, the co-packer's facility registers, and so does any warehouse that holds the food before export. A foreign facility generally does not need to register if the food goes to another foreign facility for further manufacturing or processing before export, unless that later step is minor, such as adding a label.
- Manufacturers and processors of food, beverages, dietary supplements, and ingredients for the US market must register.
- Packers and warehouses that hold food before it ships to the US generally register too.
- Farms, restaurants, retail food establishments and certain nonprofit food establishments are exempt in most cases.
- Facilities handling only meat, poultry and certain egg products regulated exclusively by USDA fall outside FDA registration and follow USDA rules instead.
FDA also requires a unique facility identifier with each registration, and at the time of writing it accepts a DUNS number for that purpose. Getting a DUNS number for a foreign plant can take longer than the registration itself, so start there.
The US Agent and the 2026 Renewal Window.
Every foreign facility must designate a US agent who lives in or maintains a place of business in the United States and is physically present there. The agent is FDA's point of contact for routine and emergency communications, and FDA can treat a message sent to the agent as sent to the facility. The agent must confirm the designation, so the registration is not complete until they do.
Renewal is the deadline brands miss. Registrations must be renewed between October 1 and December 31 of every even-numbered year, and FDA treats a registration that is not renewed as expired. The next window opens October 1, 2026 and closes December 31, 2026. Food from a facility without a valid registration can be held at the border, often in the middle of fourth quarter retail.
Prior Notice and FSVP: The Import Side.
Registration covers the facility. Every shipment needs its own filing, called prior notice, submitted to FDA before the food arrives. It is usually filed by the customs broker through the US customs system or directly through FDA's prior notice interface. The notice identifies the product, the manufacturer and its registration number, the shipper, and the arrival details. Deadlines depend on how the food travels: shorter lead times for road, longer for air and rail, longest for ocean freight, and before mailing for international mail. Food that arrives without adequate prior notice can be refused and held.
The Foreign Supplier Verification Program sits with the US importer. Under FSVP, the importer must show that the foreign supplier produces food in a way that meets US safety standards: a hazard analysis, an evaluation of the supplier, verification activities such as audits or testing, corrective actions and records. If your US distributor or retail buyer is the importer, the FSVP work usually sits with them, and they will ask you for documents. If you import yourself with no US entity, you may need to designate a US agent or representative to act as the FSVP importer. Ask your customs broker and regulatory consultant which applies before you plan a direct-to-consumer model.
One related change matters for DTC brands: at the time of writing, the US has suspended duty-free de minimis treatment for low-value parcels from all countries, so shipping individual orders from abroad now means duties and a formal or informal customs entry, on top of FDA requirements. Confirm current rules with a licensed customs broker.
Labels and Marketing Claims: A Separate Requirement.
Registration says nothing about your label. US food labels follow their own rules, and a label that is legal in the EU, UK or Mexico usually needs changes. The core elements are a statement of identity, net quantity in both US customary and metric units, an ingredient list, a Nutrition Facts panel in the US format, the name and place of business of the manufacturer, packer or distributor, and an allergen declaration.
The US lists nine major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Sesame was added effective January 1, 2023, and it catches brands whose home market treats it differently.
Claims are where marketing meets the regulator. FDA separates authorized health claims, qualified health claims, nutrient content claims such as "low sodium" or "high in fiber", and structure and function claims. Each has rules, and a disease claim on a food or supplement can turn it into an unapproved drug in FDA's eyes. FDA updated its definition of "healthy" in a rule finalized in late 2024, with a compliance period running several years. "Natural" has no formal FDA definition; FDA's longstanding policy is that nothing artificial or synthetic has been added that would not normally be expected, and it is a frequent target of US consumer class actions. Advertising claims also fall under the FTC, which expects substantiation for what you say in ads, not just on the pack.
“Every claim in a US ad has to be one the label can back up, and the label has to be one the regulator would sign off on. Build the claims list first and write the ads second.”
Step by Step: Registration to Launch-Ready Listing.
| Requirement | What it covers | Usual owner | Marketing dependency |
|---|---|---|---|
| Food facility registration | Each facility that makes, packs or holds US food | Facility owner, with regulatory consultant | Cannot ship; no launch date without it |
| US agent | FDA contact for foreign facilities | Paid agent service or US subsidiary | None directly, but must stay current |
| Biennial renewal | October 1 to December 31, even years | Regulatory owner | Q4 inventory at risk if missed |
| Prior notice | Each shipment before arrival | Customs broker | Launch timing and restock plans |
| FSVP | Importer verifies foreign supplier safety | US importer or designated agent | Retail buyers ask for documents |
| US label and claims | Nutrition Facts, allergens, claims | Brand, reviewed by consultant or attorney | Every listing, ad and influencer brief |
What Usually Goes Wrong.
- The co-packer's registration lapses at renewal and nobody on the brand side checks, so product sits at the border in December.
- The brand buys an unofficial registration certificate and writes "FDA approved" on its website and Amazon listing.
- Ad copy and influencer scripts reuse home-market benefit claims that the US label does not support, including disease language.
- The allergen statement leaves out sesame or uses home-market wording, and a retailer or marketplace flags it after launch.
- Nobody agrees who the FSVP importer is, so a retail buyer's onboarding stalls on a document request.
- Pack photography gets shot before the US label is final, and every listing image has to be redone.
Where the Regulation Stops and the Marketing Work Begins.
Registration, prior notice and FSVP are gates. They decide whether the product can enter, not whether anyone buys it. Once the label and claims are reviewed by the right professional, the marketing work starts from that approved source: product detail pages and Amazon listings that repeat only approved claims, packaging photography of the final US label, search and marketplace ads with copy checked against the claims sheet, and review and influencer programs that follow FTC endorsement rules. We keep a running claims sheet for exactly this reason, and it is the first document we ask for. The wider set of US advertising rules is covered on our US marketing compliance page.
We coordinate with your regulatory consultant, customs broker and attorney rather than replacing them, and building the launch on top of their approved labels and claims is work Theory Road does for food and beverage brands.
Do foreign companies need FDA registration to sell food in the US?
In most cases, yes. Any foreign facility that manufactures, processes, packs or holds food for US consumption must register with FDA unless an exemption applies, and it must name a US agent. The requirement attaches to the facility, so a brand using a co-packer depends on that co-packer's registration. Confirm your specific situation with FDA guidance or a food regulatory consultant.
When is the FDA food facility registration renewal in 2026?
Registrations must be renewed between October 1 and December 31 of every even-numbered year. The current window runs from October 1 to December 31, 2026. A registration that is not renewed is treated as expired, and food from that facility can be held at import. Check each facility in your supply chain, including warehouses and co-packers, not just your own plant.
Does FDA registration mean my product is FDA approved?
No. Registration only tells FDA who makes or holds food for the US market. FDA does not approve conventional foods, does not review your label when you register, and does not issue registration certificates. Saying "FDA approved" or "FDA certified" in marketing because you registered is misleading and can create regulatory and legal exposure.
What is FDA registro for Mexican food companies?
FDA registro is the common Spanish name for FDA food facility registration. Mexican plants that make, pack or hold food for the US register the same way as any foreign facility, name a US agent, renew in even-numbered years, and ship with prior notice. The US label, including Nutrition Facts and allergens, is a separate step that usually needs changes from the Mexican label.
Is prior notice the same as FDA registration?
No. Registration covers the facility and is renewed every two years. Prior notice is filed for each shipment of food before it arrives in the US, usually by your customs broker, and it references the manufacturer's registration number. Food arriving without adequate prior notice can be refused or held, so both must be in place before a launch.