Importing food into the United States is not a single filing. It is a chain of separate requirements, run by two different federal agencies, that all have to be satisfied before your shipment reaches a store shelf. Miss one link and FDA can hold your product at the port, no matter how good the product itself is.
This guide walks through the process in order, from your first registration to your first shipment and beyond.
Step 1: Confirm your product is regulated as “food” by FDA
Most items you would expect (packaged foods, beverages, spices, snacks, animal food and pet treats) fall under FDA’s food authority. Some categories have extra layers on top of the general food rules: dietary supplements, infant formula, and low-acid or acidified canned foods each have their own additional requirements, covered in Step 3.
If you are not sure which bucket your product falls into, this is the first thing to nail down, since it determines almost everything downstream.
Step 2: Register your facility with FDA
Every facility that manufactures, processes, packs, or holds food for consumption in the US must register with FDA before that food enters the country. This applies to foreign facilities as well as domestic ones. Registration is done electronically through FDA’s Food Facility Registration Module and requires:
- Legal facility name and physical address
- Owner, operator, or agent in charge
- Emergency contact information
- Food product categories handled at the facility
- A DUNS number for the facility
If your facility is located outside the US, you must also designate a U.S. Agent as part of registration. The U.S. Agent is a US-based individual or company who serves as FDA’s point of contact for that facility: receiving communications, coordinating inspections, and standing in for the foreign facility on US soil. The U.S. Agent does not take ownership of your shipments and is not a substitute for the importer of record.
Step 3: Check for product-specific registrations
General facility registration is the floor, not the ceiling. Depending on what you are importing, you may also need:
- Low-acid canned foods (LACF) or acidified foods: a separate FDA process filer registration and scheduled process filing for each product and container, on top of standard facility registration.
- Dietary supplements: compliance with DSHEA, including a New Dietary Ingredient (NDI) notification if your product contains an ingredient not marketed in the US before October 15, 1994.
- Infant formula: a distinct, more intensive registration and notification pathway.
Skipping a product-specific requirement is one of the most common reasons a shipment gets flagged even after the facility itself is properly registered.
Step 4: Build your Foreign Supplier Verification Program (FSVP)
This is the step most new importers underestimate, and it is worth separating clearly from Step 2. FSVP and U.S. Agent are two different obligations, held by two different parties, and confusing them is one of the most common mistakes we see:
- The U.S. Agent is tied to the foreign facility and handles FDA communication for that facility.
- FSVP is the U.S. importer’s responsibility, not the foreign supplier’s. If you are the US owner or consignee of the food at the time it enters the country, you are the FSVP importer, and FDA holds you accountable for it, not your overseas supplier.
Under FSVP, the US importer must, for each food and each foreign supplier: conduct a hazard analysis, verify the supplier controls those hazards adequately (through audits, sampling, testing, or records review), and maintain documentation showing this was actually done. There is no single “FSVP form.” It is an ongoing verification program you build, document, and can produce for FDA on request.
Step 5: Get your labeling right before you ship
FDA’s food labeling rules (largely under 21 CFR Part 101) cover the Nutrition Facts panel, ingredient statement, allergen declarations (including sesame as a major allergen under the FASTER Act), and net quantity statement. Labels that are compliant in your home country are very often not compliant here without changes.
One frequent point of confusion: a country of origin marking is a US Customs and Border Protection (CBP) requirement, under the Tariff Act of 1930, not an FDA labeling requirement. You need to satisfy both agencies, but they are separate obligations with separate rules.
Step 6: File Prior Notice before every shipment
Prior Notice is required for every food shipment entering the US, without exception, and it is filed per shipment, not once per year. You can file it through FDA’s Prior Notice System Interface (PNSI) or through CBP’s ABI/ACE system.
Timing matters and varies by mode of transport: FDA generally needs to receive and confirm Prior Notice at least 8 hours before arrival by water, 4 hours before arrival by air or rail, and 2 hours before arrival by road. If Prior Notice is not submitted and confirmed before arrival, FDA can refuse admission to the shipment outright.
Step 7: Clear the shipment through US Customs
Prior Notice gets FDA’s attention on your shipment. It does not clear customs by itself. Your customs broker or importer of record still needs to file the standard CBP entry: HTS classification, valuation, customs bond, and any applicable duties. FDA and CBP work off shared data but are separate reviews, and a clean FDA Prior Notice does not exempt you from normal CBP entry procedures.
Step 8: Be ready for FDA examination, holds, and import alerts
FDA reviews incoming food shipments and can select any of them for sampling or physical examination at the port. If a shipment is flagged, it can be detained while FDA reviews it, and in some cases the product or shipper ends up on an FDA Import Alert, which triggers automatic detention for future shipments until you demonstrate the underlying issue is resolved.
Reconditioning, relabeling, or providing additional documentation can sometimes clear a detained shipment, but the fastest way to avoid this step entirely is getting Steps 1 through 7 right the first time.
Step 9: Keep your registration current
FDA food facility registration is not permanent. It must be renewed every two years, during the Biennial Registration Renewal window of October 1 through December 31 of each even-numbered year. Miss the window and your registration is automatically cancelled, which blocks future shipments until you re-register from scratch. Note that this renewal cadence applies to facility registration specifically; FSVP and Prior Notice obligations are ongoing and are not tied to this two-year cycle.
FAQs
Yes, if your facility is located outside the US. Every foreign food facility registering with FDA must designate a U.S. Agent as part of that registration. If your facility is domestic, a U.S. Agent is not required.
A U.S. Agent represents the foreign facility to FDA. FSVP is a separate obligation held by the US importer to verify that a foreign supplier’s food is safe. You can have both, and most foreign-sourced food imports involve both, but they are not interchangeable and are not held by the same party.
Every two years, during the Biennial Registration Renewal window of October 1 through December 31 of even-numbered years.
FDA can refuse admission to the shipment. Prior Notice has to be submitted and confirmed before the shipment arrives, not filed after the fact.
Yes. The FDA can select any shipment for sampling or examination, and a detention does not automatically mean something was done wrong. It does mean you need documentation ready (FSVP records, labeling, registration status) to resolve it quickly.
Get help with the process
Importing food into the US touches FDA registration, FSVP, Prior Notice, and CBP entry, often at the same time and on a shipment-by-shipment basis. FDA Entry Point serves as your U.S. Agent and helps you build and maintain the compliance pieces around it, so shipments move instead of sitting at the port.