US Food Import Requirements: What Foreign Food Brands Must Know
Foreign food brands exporting to the US face FDA registration, FALCPA labelling, and customs requirements. Here is what international food businesses need to know about US food imports.
The US is the world's largest food import market. Thousands of foreign food brands sell their products to US consumers through importers, distributors, or DTC ecommerce. Every foreign food entering the US must comply with US food law.
FDA Prior Notice
All food imported into the US for human or animal consumption must have prior notice submitted to the FDA before or at the time of import. This is done through the FDA's Prior Notice System Interface (PNSI) or through the Customs and Border Protection's Automated Broker Interface.
Foreign Supplier Verification
US importers are required to verify that their foreign food suppliers are producing food that meets US food safety standards under FSMA's Foreign Supplier Verification Program (FSVP). If you are selling through a US importer or distributor, they need your food safety documentation.
FALCPA Labelling for Imported Products
Products imported for retail sale in the US must comply with FALCPA allergen labelling. If your product is labelled for a foreign market (e.g., EU labelling with 14 allergens), you may still need to add or modify the label for US compliance — particularly for the Contains statement format.
DTC Export to US Consumers
UK and European brands selling directly to US consumers via their Shopify store face a different set of requirements. Customs duties, FDA import thresholds, and shipping carrier requirements for food all apply.
Ensure your food products display FALCPA-compliant allergen information on your Shopify store with Allergen Matrix at saltai.app.
Understanding the FDA's Food Facility Registration Requirement
Any facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA under Section 415 of the Federal Food, Drug, and Cosmetic Act. This requirement applies to foreign food facilities as well as domestic ones, and it is a foundational step before any commercial shipments can reach US consumers. Registration must be renewed every two years during the October-to-December window in even-numbered years, and failure to maintain an active registration can result in shipments being refused at the US border.
For many small and mid-sized foreign food brands, FDA facility registration comes as a surprise. If you are operating from a UK or European production kitchen or co-manufacturer, your facility still falls within scope if the food is destined for the US market. The registration process itself is handled through the FDA's Industry Systems portal and requires a US Agent to be appointed — a person or entity physically located in the United States who can act as a point of contact between the FDA and your foreign facility.
Choosing the right US Agent is a practical decision that deserves attention. Your US Agent must be available to the FDA at all times and is responsible for relaying communications, including inspection notices and compliance queries. Many foreign brands appoint a third-party regulatory consultancy or a trusted importer to fulfil this role. Keeping your registration current and your US Agent informed of any changes to your product range or production site is a straightforward but critical compliance habit to build into your annual calendar.
US Nutrition Labelling: The Nutrition Facts Panel
Beyond allergen labelling, food products sold at retail in the United States must carry a Nutrition Facts panel that complies with FDA regulations under 21 CFR 101. This is distinct from the EU's nutrition declaration format, and the differences are significant enough that a label designed for European markets will not meet US requirements without modification. Key differences include the mandatory declaration of added sugars, the use of Daily Value percentages calibrated to US dietary reference values, and the requirement to declare vitamin D and potassium rather than vitamins A and C.
Serving size rules in the US are also more prescriptive than many foreign brands expect. The FDA defines Reference Amounts Customarily Consumed (RACCs) for different food categories, and your declared serving size must align with these benchmarks rather than being set at the brand's discretion. Getting serving sizes wrong cascades into errors across the entire Nutrition Facts panel, including the calorie count, which sits in a larger font and carries significant consumer and regulatory weight. Working with a US-qualified nutritional labelling consultant before printing packaging is strongly recommended.
For brands selling DTC through Shopify, the online product listing does not typically replace the requirement for a compliant physical label on the product itself. However, displaying accurate allergen and nutrition information on your product pages is both a consumer expectation and, in many states, an emerging legal requirement for online food retailers. Tools that help you maintain consistent, accurate allergen information across your digital storefront reduce the risk of consumer complaints and support your broader US compliance posture.
Bioterrorism Act and the Importance of Recordkeeping
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 introduced recordkeeping requirements that affect every link in the food supply chain reaching the US market. Foreign food facilities and US importers must maintain records that allow the FDA to trace food one step forward and one step back in the supply chain. In practical terms, this means your importer or distributor needs to be able to identify where a product came from and where it was sent, within a defined timeframe that varies by business size.
For foreign exporters, this requirement reinforces the importance of maintaining detailed batch records, supplier declarations, and shipment documentation. If the FDA initiates a traceback investigation — which can happen quickly during a foodborne illness outbreak — your ability to provide clean, accurate records can mean the difference between a targeted product recall and a broader enforcement action against your entire product range. Many foreign brands underestimate how quickly FDA investigations move and how thoroughly US importers expect their suppliers to document production and distribution activity.
Building a documentation system that satisfies both your home market requirements and the FDA's traceability expectations is a worthwhile investment. Cloud-based food safety management platforms can help you maintain version-controlled records that are readily accessible and shareable with your US partners. When your importer's FSVP audit comes around, being able to produce a clean documentation pack quickly signals professionalism and reduces the friction that can otherwise delay new product launches or annual supplier re-approvals.
Voluntary Qualified Importer Program and Expedited Entry
The FDA's Voluntary Qualified Importer Program (VQIP) is a fee-based programme that offers expedited review and import entry for food importers who can demonstrate a high level of control over their supply chains and a consistent record of compliance. For foreign brands whose US importer participates in VQIP, there is a meaningful commercial advantage: shipments are less likely to be held at the border for examination, which reduces spoilage risk, storage costs, and delays in getting products to retailers or end consumers.
To qualify for VQIP, importers must have a track record free of significant food safety violations, must source from foreign suppliers who are certified under an FDA-recognised third-party certification scheme, and must pass an annual application review. For foreign food brands, this means that investing in recognised food safety certification — such as BRCGS, SQF, or an equivalent scheme accredited under the FDA's programme — can directly benefit your US market access by making you a more attractive supplier to VQIP-eligible importers.
If your brand is actively targeting growth in the US market, it is worth asking your existing or prospective US importer whether they participate in VQIP or are working toward qualification. The programme is relatively underutilised compared to its potential benefits, and brands that help their importers build the documentation and supplier certification infrastructure required can develop a stronger, more strategic commercial relationship as a result. Compliance investment at the supplier level creates tangible downstream value for everyone in the chain.
State-Level Food Labelling Requirements
Federal FDA labelling rules set the floor for food sold in the US, but several states have introduced additional requirements that apply to products sold within their borders. California's Proposition 65 is the most widely known, requiring businesses to provide clear and reasonable warnings before knowingly exposing anyone to chemicals listed by the state as causing cancer or reproductive harm. For food brands, this can affect products containing certain contaminants, additives, or naturally occurring substances that appear on the Proposition 65 list.
New York, Vermont, and a growing number of other states have introduced or are considering their own food labelling or ingredient disclosure requirements that go beyond federal standards. Genetically modified organism disclosure is one area where state-level rules have pushed ahead of federal frameworks, and the USDA's National Bioengineered Food Disclosure Standard was partly a federal response to this fragmented state-level activity. Foreign brands selling into the US through retail channels or DTC ecommerce need to understand that compliance with FDA federal rules does not automatically mean compliance in every state where their products are sold.
Building state-level labelling review into your US market entry process is a practical step that many foreign brands skip until a retailer or distributor raises an issue. A US regulatory consultant with experience across multiple states can help you identify the highest-risk requirements for your specific product category and target markets. Ensuring that your Shopify product listings accurately reflect allergen and ingredient information is one of the most controllable risk factors — and one of the easiest to address before you scale your US customer base.
Try Allergen Matrix free at saltai.app — no credit card required.
SaltAI Team
SaltAI builds focused Shopify apps for food merchants and general merchants. Every app is tested in production at a real food store — including Vanda's Kitchen — before it ships.