INTERNATIONAL TRADE LAW
How to Import Food Products: FDA Rules
Importing food into the United States means clearing the FDA before the goods can enter — and the FDA’s rules apply on top of the customs entry, not instead of it. Three obligations sit at the core: the foreign producer’s facility must be registered with the FDA, you must file Prior Notice of each shipment, and you generally must run a Foreign Supplier Verification Program (FSVP) confirming your supplier meets U.S. safety standards. Meat, poultry, and egg products follow a separate USDA track. Get these in place before the container ships, because food is one of the most-detained categories at the border.
First, Know Who Regulates Your Product
Most food is regulated by the FDA, but meat, poultry, and processed egg products fall under the USDA’s Food Safety and Inspection Service (FSIS) — a different and stricter regime. Foreign establishments must be approved before shipping FSIS-regulated products to the U.S., and FSIS reinspects those shipments at the port of entry. The rest of this guide covers the FDA path, which applies to produce, packaged foods, seafood, beverages, and most other groceries.
The Three FDA Obligations
| Requirement | What it does | Who it falls on |
|---|---|---|
| Facility registration | Foreign facility registers with FDA and renews biennially | The foreign producer/processor |
| Prior Notice | Electronic notice to FDA before each shipment arrives | The importer or filer |
| FSVP | Risk-based verification that the supplier meets U.S. standards | The U.S. importer |
Facility registration comes from the Food Safety Modernization Act (FSMA). Any foreign facility that manufactures, processes, packs, or holds food for U.S. consumption must register with the FDA and renew that registration every two years. An unregistered facility’s food can be held at the border.
Prior Notice must be submitted to the FDA electronically before a food shipment arrives. It lets the FDA decide, through its risk-based screening system, whether to examine the shipment. No Prior Notice means the food can be refused and held.
FSVP is the obligation most new importers miss. Under the FSMA Foreign Supplier Verification Program rule, the U.S. importer must verify — through hazard analysis, supplier evaluation, and activities such as audits or testing — that each foreign supplier produces food meeting U.S. safety standards. The importer of record for FSVP purposes is the U.S. owner or consignee, and you must identify yourself with a unique facility identifier on the entry.
Labeling Has to Comply Before It Arrives
A food product’s label must meet FDA requirements at the time of entry — fixing it afterward is expensive and sometimes impossible. For FDA-regulated foods that means a compliant Nutrition Facts panel, an accurate ingredient list, country-of-origin marking, and allergen labeling under the Food Allergen Labeling and Consumer Protection Act (FALCPA). FALCPA covers the major food allergens — milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans, and sesame, which became the ninth listed allergen in 2023. (Note that FSIS-regulated meat and poultry products are not subject to FALCPA.) For the general rules that apply across product types, see our guide to import labeling requirements.
Don’t Forget the Customs Side
The FDA rules sit on top of the ordinary customs entry. You still need to be the importer of record, classify the food under the correct HTS code, post a customs bond on formal entries, and pay any duty. Perishable and agricultural foods may also trigger USDA permit or treatment requirements. Treat the FDA clearance and the customs entry as two parallel tracks that both have to be clean before the goods move.
Frequently Asked Questions
What do I need to import food into the U.S.?
The foreign facility must be FDA-registered, you must file Prior Notice before the shipment arrives, and you generally must maintain a Foreign Supplier Verification Program for the supplier. On the customs side you need an entry, the correct HTS classification, and a bond on formal entries. Compliant FDA labeling has to be in place at entry.
What is FSVP and who has to do it?
The Foreign Supplier Verification Program requires the U.S. importer of a food to verify that its foreign supplier produces the food in line with U.S. safety standards. It applies to the U.S. owner or consignee of the food at the time of entry, with some exemptions (for example, certain foods already covered by other FDA controls).
Are meat and poultry imported the same way as other food?
No. Meat, poultry, and egg products are regulated by the USDA’s FSIS, which requires the foreign country and establishment to be approved in advance and reinspects shipments at the port. Those products follow the USDA track, not the FDA food path described here.
Can the FDA stop my food at the border?
Yes. The FDA can detain and refuse food that appears to violate U.S. law — for example, food from an unregistered facility, without Prior Notice, with non-compliant labeling, or that fails examination. Refused food must generally be exported or destroyed.
Importing food cleanly means lining up FDA registration, Prior Notice, FSVP, and compliant labeling before the customs entry is even filed. Reidel Law Firm helps food importers map those obligations on flat-fee terms, with a plain-English compliance memo and direct attorney access. Get a flat-fee import compliance memo.
