FDA Food Import Rules: A Compliance Guide

Importing food into the United States means meeting four core FDA requirements: register the foreign facility, file Prior Notice for every shipment, maintain a Foreign Supplier Verification Program (FSVP), and ship a product that is correctly labeled and not adulterated. Miss any one and the shipment can be detained at the border. This guide walks through each requirement and the deadlines that actually matter.

The FDA and U.S. Customs and Border Protection (CBP) share the border. CBP controls entry; the FDA decides whether a food article is admissible. The importer of record — not the broker, not the foreign supplier — is responsible for getting it right.

The Four Requirements at a Glance

Each is independent. A registered facility with a perfect label can still be refused if Prior Notice was filed late.

Food Facility Registration

Any facility that manufactures, processes, packs, or holds food for U.S. consumption must register with the FDA under Section 415 of the Federal Food, Drug, and Cosmetic Act. Registration is free, and foreign facilities must also designate a U.S. agent.

Registration is not one-and-done. Facilities must renew between October 1 and December 31 of every even-numbered year — which makes the next renewal window October 1 through December 31, 2026. Miss the December 31 deadline and the FDA cancels the registration without notice, and product from that facility can no longer enter the country until it re-registers.

Prior Notice of Every Shipment

The FDA must receive advance notice of each imported food shipment so it can decide whether to inspect. Prior Notice is filed electronically, either through the FDA’s Prior Notice System Interface (PNSI) or through CBP’s ABI/ACE system at entry.

Timing is strict, and the clock starts when the FDA confirms the submission — not when you send it:

Prior Notice cannot be submitted more than 15 calendar days ahead through PNSI (30 days through ABI/ACE). A shipment that arrives without confirmed Prior Notice can be held at the port.

Foreign Supplier Verification Program (FSVP)

Under the FDA’s FSVP rule (21 CFR Part 1, Subpart L), the U.S. importer must verify that each foreign supplier produces food meeting U.S. safety standards. In practice that means a written program for each food from each supplier covering a hazard analysis, supplier evaluation, verification activities (such as audits or testing), corrective actions, and records.

Since July 24, 2022, FSVP importers must also provide a unique facility identifier — a DUNS number — when filing entry with CBP. The rule includes modified, lighter-touch requirements for very small importers and for food from certain small suppliers. We cover the audit side in detail in our guide to surviving an FDA FSVP audit.

Labeling and Adulteration

Imported food must carry an FDA-compliant label — statement of identity, net quantity, ingredient list, allergen declaration, and Nutrition Facts — and must not be adulterated. Allergen rules now cover nine major allergens, including sesame. The full requirements are in our FDA food labeling and packaging checklist.

If the FDA believes a shipment violates the law, it issues a notice of action that can lead to detention and, ultimately, a Notice of Refusal. See what a Notice of Refusal means and how to respond.

Frequently Asked Questions

Who is responsible for FDA food import compliance?

The U.S. importer of record. The FDA holds the importer — not the customs broker or the foreign supplier — accountable for facility registration, Prior Notice, the FSVP, and a compliant product.

Do I have to register if I only import, not manufacture?

The foreign facility that makes, processes, packs, or holds the food must register. As the importer, you are responsible for confirming that registration is current and for maintaining your own FSVP.

What happens if Prior Notice is late?

The shipment can be refused or held at the port until adequate Prior Notice is provided. Because the clock runs from the FDA’s confirmation, file well ahead of the minimum window for your mode of transport.

When is the next food facility registration renewal?

October 1 through December 31, 2026. Renewal is required every even-numbered year, and a missed deadline cancels the registration automatically.

Bringing food into the U.S. market rewards getting the paperwork right before the container ships. Reidel Law Firm advises importers on FDA registration, Prior Notice, and FSVP compliance on flat-fee terms. Get an import compliance memo.