FDA Food Business Registration: What US Online Food Sellers Must Know
Food businesses selling in the US must register with the FDA under FSMA. Here is what online food sellers need to know about FDA registration requirements.
The FDA Food Safety Modernization Act (FSMA) requires food manufacturing facilities to register with the FDA. Online food sellers that manufacture, process, pack, or hold food for US consumers may be required to register — including foreign businesses exporting to the US.
Who Must Register
Domestic and foreign facilities that manufacture, process, pack, or hold food for human consumption in the US must register with the FDA unless specifically exempt. Exemptions include farms, restaurants, and certain retail food establishments.
For online food businesses: if you manufacture food (bake, cook, preserve, produce) and sell it to US consumers, you likely need to register, regardless of your size.
How to Register
Registration is done through the FDA's Unified Registration and Listing System (FURLS). Registration is free for domestic facilities. Foreign facilities must designate a US agent.
Biennial registration renewal is required (every even-numbered year).
What Registration Means
Registration gives the FDA the ability to conduct facility inspections and request records. It also means the FDA can suspend your registration if the facility is found to be a source of serious food safety risk.
FSMA Preventive Controls
Most registered food manufacturing facilities must also implement a written food safety plan under FSMA's Preventive Controls rule. This includes hazard analysis, preventive controls, and monitoring/corrective action procedures.
UK and International Sellers Exporting Food to the US
If you are a UK-based or international food business selling directly to US consumers through your Shopify store, FDA registration almost certainly applies to you. The FSMA rules do not make a distinction based on business size or geography — what matters is whether your facility manufactures, processes, packs, or holds food destined for human consumption in the United States. A small artisan producer in London shipping biscuits or preserves to American customers falls within the same regulatory framework as a large commercial food factory.
Foreign facilities that must register are also required to appoint a US agent — a person or company physically located in the United States who can act as a point of contact for the FDA. This agent must be available during normal US business hours and can receive communications on your behalf. Selecting a reliable US agent is not a bureaucratic formality; the FDA will use this contact for inspection notices, record requests, and urgent food safety communications, so it is worth choosing someone with genuine availability and an understanding of food regulatory matters.
Beyond registration itself, international sellers must also consider US Customs and Border Protection requirements, prior notice rules under FSMA, and any state-level labelling obligations that may apply to their product categories. The complexity of exporting packaged food to the US is significant, and FDA registration is really the starting point of a broader compliance journey. Sellers based outside the US are strongly advised to engage a regulatory consultant familiar with both FDA requirements and the specific product categories they sell before making their first commercial shipment.
Record-Keeping and Documentation Requirements
Once registered, food facilities are subject to FDA record-keeping requirements that are detailed and specific. Under FSMA, facilities must maintain records that allow the FDA to identify the immediate previous source of food and the immediate subsequent recipient — this is known as the one-step-forward, one-step-back traceability standard. For small online food businesses, this means maintaining supplier invoices, batch records, and customer order records in a format that can be produced quickly if the FDA requests them during an inspection or investigation.
Records must generally be retained for a minimum of two years, though some categories of records carry different retention periods depending on the product type and the specific FSMA rule that applies to your facility. Records can be stored electronically, which is convenient for online sellers already managing their operations through platforms like Shopify, but the FDA requires that electronic records be retrievable and legible within a reasonable timeframe. It is good practice to back up records in at least two locations and to ensure that former employees or third-party platforms are not the sole holders of critical documentation.
Building a simple, consistent record-keeping system from the start is far less burdensome than attempting to reconstruct documentation after the fact. Many small food businesses find that a combination of their Shopify order history, a spreadsheet for batch and ingredient records, and scanned supplier invoices is sufficient to meet the basic one-step traceability requirement. The key is consistency — every batch produced should be logged at the time of production, not retrospectively, and records should clearly link ingredients to finished products and finished products to customer shipments.
Labelling Requirements That Accompany Registration
FDA registration does not exist in isolation — it sits alongside a detailed set of labelling obligations that apply to packaged food sold to US consumers. The FDA's labelling rules require a statement of identity, a net quantity declaration, a nutrition facts panel, an ingredient list, and the name and address of the manufacturer, packer, or distributor. For online sellers using Shopify, this means that both your physical product label and your product listing pages should present information in a way that is accurate, complete, and consistent with FDA requirements.
Allergen labelling is one of the most critical components of FDA food labelling compliance. The Food Allergen Labeling and Consumer Protection Act (FALCPA) requires that the nine major US allergens — milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, and sesame — be declared clearly on the label of any packaged food that contains them. This applies whether the allergen is an intentional ingredient or is present as a result of shared equipment or cross-contact. Failing to declare an allergen correctly is one of the most common causes of FDA-initiated food recalls in the United States.
For Shopify store owners selling food to US consumers, presenting allergen information clearly and accurately on your product pages is not just good practice — it is a legal requirement. Customers with food allergies rely on accurate online product information to make safe purchasing decisions, and the consequences of an undisclosed allergen can be life-threatening. Ensure your US food business's Shopify store displays FALCPA-compliant allergen information with Allergen Matrix at saltai.app.
Registration Suspension and Enforcement
The FDA has the authority to suspend the registration of a food facility if it determines that food manufactured, processed, packed, or held by that facility has a reasonable probability of causing serious adverse health consequences or death. Registration suspension is a serious enforcement action that effectively prohibits the facility from operating — any food introduced into US commerce from a suspended facility is considered adulterated and can be detained or refused entry at the border. For online food businesses, suspension would mean an immediate halt to all US sales.
The FDA also has the power to conduct mandatory recalls under FSMA, which represents a significant expansion of its pre-FSMA authority. Previously, most food recalls were voluntary. Now, if a registered facility refuses to voluntarily recall a potentially dangerous product, the FDA can order a mandatory recall. Coupled with the ability to access facility records and conduct inspections, this makes the FSMA registration framework a genuinely powerful regulatory tool that online food sellers should take seriously from day one of their US operations.
Avoiding enforcement actions starts with proactive compliance rather than reactive fixes. Maintain your registration details accurately in FURLS, renew on time during even-numbered years, respond promptly to any FDA correspondence, and keep your food safety plan and records up to date. If the FDA contacts you — whether through your US agent or directly — treat the communication as urgent. Delays in responding to FDA requests can escalate a minor compliance issue into a formal enforcement matter far more quickly than most small business owners anticipate.
Practical First Steps for Online Food Sellers
If you are an online food seller who has not yet determined whether FDA registration applies to your business, the most practical first step is to map your activities against the regulatory definitions. Ask yourself whether your facility manufactures, processes, packs, or holds food — if the answer to any of these is yes, and your customers include US consumers, registration is almost certainly required. Review the exemptions carefully, because some small businesses do qualify, but do not assume exemption without checking the specific criteria against your actual operations.
Once you have confirmed that registration applies, create an account in the FDA's FURLS system and gather the information you will need: your facility address, the food product categories you handle, your US agent's contact details if you are a foreign facility, and emergency contact information. The registration process itself is straightforward and free of charge for domestic facilities. Having all your information prepared before you begin will make the process faster and reduce the likelihood of errors in your registration record.
After registration is complete, turn your attention to the broader compliance picture — your food safety plan, your record-keeping system, and your product labelling. These three areas are where most small food businesses encounter gaps, and addressing them systematically will put you in a strong position if the FDA ever contacts you. Compliance is not a one-time task; it requires ongoing attention as your product range, suppliers, and processes evolve over time.
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.