INTERNATIONAL TRADE LAW
Importing Food Into the U.S.: FDA Rules
Importing food into the United States means complying with the FDA and the Food Safety Modernization Act (FSMA) on top of normal customs entry — and the obligations fall heavily on the importer. Three requirements matter most: filing Prior Notice of every shipment, ensuring the foreign facility is registered, and running a Foreign Supplier Verification Program (FSVP) to confirm your supplier meets U.S. safety standards. Miss any of them and your food can be detained or refused at the border. This guide walks the FDA framework for food importers — a specialized layer over the general import process.
Prior Notice for Every Shipment
The FDA requires an electronic Prior Notice for every imported food shipment, filed before the goods arrive at the U.S. port. It tells the FDA what’s coming so it can decide whether to examine the shipment. Missing or inaccurate prior notice is one of the most common reasons food is held at entry, so it’s the first thing to get right.
Facility Registration
Foreign facilities that manufacture, process, pack, or hold food for U.S. consumption generally must be registered with the FDA, and that registration must be current. As the importer, you should confirm your supplier’s facility is registered — prior notice references the facility’s registration, and an unregistered facility means problems at the border. (An importer that doesn’t itself manufacture, process, pack, or hold food generally needn’t register, but still must meet the other requirements.)
The Foreign Supplier Verification Program (FSVP)
FSVP is the requirement that puts food safety responsibility squarely on the importer. Under FSVP, you must perform risk-based verification that the food you import was produced to meet applicable U.S. safety standards — before you import it. Key elements:
- Designate a Qualified Individual (QI) to develop and oversee the program and evaluate suppliers.
- Evaluate the supplier and the food’s risks, and verify compliance through appropriate activities (which can include audits, sampling, or records review).
- Identify yourself at entry — FSVP importers must provide a unique facility identifier (a DUNS number) with the entry filing.
FSVP is a documented program, not a one-time check, and the FDA conducts FSVP inspections of importers.
What Happens If You Don’t Comply
| Failure | Consequence |
|---|---|
| No/late Prior Notice | Shipment held or refused at the port |
| Unregistered facility | Entry problems; potential refusal |
| No FSVP / inadequate FSVP | FDA enforcement; import refusal; the food deemed adulterated/misbranded in effect |
Food that doesn’t meet requirements can be detained, refused, and required to be exported or destroyed — an expensive outcome that good compliance avoids.
Frequently Asked Questions
What does the FDA require to import food?
Primarily three things: an electronic Prior Notice for every shipment, a registered foreign facility that manufactures/processes/packs/holds the food, and a Foreign Supplier Verification Program (FSVP) under which the importer verifies the supplier meets U.S. safety standards. Normal customs entry applies on top of these.
What is FSVP?
The Foreign Supplier Verification Program, an FSMA requirement that makes food importers responsible for verifying — through risk-based activities and a designated Qualified Individual — that imported food was produced to meet applicable U.S. food-safety standards before it’s imported.
Do I need to register with the FDA to import food?
Foreign facilities that manufacture, process, pack, or hold the food must be registered. An importer that doesn’t itself perform those activities generally isn’t required to register, but must still file prior notice and comply with FSVP and other applicable requirements.
What happens if imported food doesn’t meet FDA requirements?
It can be detained and refused entry, and may have to be exported or destroyed. Common triggers are missing prior notice, an unregistered facility, or an inadequate FSVP, all of which are avoidable with proper compliance.
Food importing is an FDA compliance project as much as a customs one, and the importer carries the responsibility. Reidel Law Firm helps food importers build FSVP and FDA compliance programs on flat-fee terms. Get an import compliance memo.
