Importing Food into the U.S.: FDA Prior Notice and FSVP Explained

Food is the most heavily gated category that crosses the U.S. border. On top of the normal customs entry that any imported product needs, the U.S. Food and Drug Administration (FDA) layers on its own set of requirements under the Bioterrorism Act of 2002 and the FDA Food Safety Modernization Act (FSMA). If any one of those requirements is missing or wrong, FDA can hold, detain, or refuse the shipment even after Customs and Border Protection (CBP) is satisfied. A truck of Mexican produce sitting at the Otay Mesa commercial crossing can clear CBP and still be stopped by an FDA hold, and the two agencies answer to different rules.

This guide walks through the four things FDA looks at on almost every food import: the food facility registration behind the product, the Prior Notice filed before the shipment arrives, the Foreign Supplier Verification Program (FSVP) that names a responsible U.S. importer, and the agency-specific requirements from FDA and USDA that trigger exams and holds. Getting all four aligned before the cargo moves is the difference between a clean release and a load parked at the border accruing storage.

The Four Filings That Gate Every Food Import

Importing food is not one approval, it is a stack of them, and they sit with different parties. Understanding who owns each piece is the first step, because FDA does not care whose job you thought it was when a shipment gets held.

For most human and animal food shipments, FDA expects to see all four of the following tied together at entry. Meat, poultry, processed egg products, and catfish are the major exceptions, since those fall under USDA rather than FDA (covered further below).

• Food facility registration: the manufacturer, processor, packer, or holder of the food must be registered with FDA and have an active registration number.
• Prior Notice: an advance electronic notice to FDA that a specific food shipment is arriving, filed before it reaches the border.
• FSVP importer: a named U.S. party responsible for verifying the foreign supplier meets U.S. safety standards, identified at entry with a unique facility identifier.
• Product and compliance data: correct FDA product codes and affirmations of compliance transmitted through the ACE entry so FDA can screen the line electronically.

FDA Food Facility Registration (the Foundation)

Under the Bioterrorism Act and FSMA, any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with FDA. This applies to foreign facilities too. A grower or plant in Mexico that ships product to the U.S. through Otay Mesa generally needs an FDA food facility registration, and that registration must be active at the time the food is offered for import.

Registration is free and is completed through FDA’s FURLS system, which issues an 11-digit registration number. A foreign facility is also required to designate a U.S. Agent who lives in or maintains a place of business in the United States and serves as FDA’s point of contact. Registration is not one-and-done: it must be renewed biennially, during the period from October 1 to December 31 of each even-numbered year. A lapsed or expired registration is one of the quiet reasons shipments get flagged, because the number no longer validates when the entry is screened.

Certain operations are exempt from registration, including farms, retail food establishments, restaurants, and nonprofit food establishments. But the exemption is narrow and specific. If a facility processes or packs product beyond primary farming activity, it usually crosses into registration territory.

Prior Notice: Timing, Contents, and Penalties

Prior Notice is FDA’s advance warning system. Before a food shipment arrives in the United States, FDA must receive and confirm notice of it so the agency can decide whether to review or examine the load. Prior Notice is separate from the customs entry, though it is usually transmitted through the same ACE/ABI channel by the customs broker, and can also be filed through FDA’s Prior Notice System Interface (PNSI).

The timing rules are strict and are measured against the shipment’s arrival. Prior Notice may be submitted no more than 15 calendar days before arrival, and it must be submitted and confirmed no less than the following windows before the food arrives, depending on how it travels.

• By road: no less than 2 hours before arrival.
• By rail or by air: no less than 4 hours before arrival.
• By water: no less than 8 hours before arrival.
• By international mail: before the food is mailed to the United States.

What Prior Notice Must Contain, and What Happens If It Is Wrong

A complete Prior Notice identifies the article of food (including its FDA product code), the manufacturer, the grower where applicable, the shipper, the country of production, the country from which the food is shipped, the importer, owner, and ultimate consignee, and the anticipated arrival information. It also references the FDA registration number of the facility that made or held the food.

If a food shipment arrives without adequate Prior Notice, or with inaccurate Prior Notice, FDA can refuse it admission. Refused food is held at the port or moved to a secure facility, at the importer’s expense, and it cannot be delivered, sold, or moved into commerce until the notice is corrected and confirmed. For a perishable produce load crossing at Otay Mesa, a Prior Notice error is not a paperwork nuisance, it is spoilage risk measured in hours. The practical rule is simple: file it correctly and confirm it before the truck reaches the border, not after.

FSVP: The Importer’s Verification Obligations

The Foreign Supplier Verification Program is the FSMA requirement that puts a named, accountable U.S. party behind imported food. The FSVP importer is generally the U.S. owner or consignee of the food at the time of entry. If there is no U.S. owner or consignee at entry, it is the U.S. agent or representative of the foreign owner, designated in writing. This party must be identified at the line level in the ACE entry with its name, email address, and a unique facility identifier (currently the DUNS number). A missing or invalid FSVP DUNS is a common cause of FDA entry rejections.

Being the FSVP importer is an active, documented responsibility, not a title. The importer must build and maintain a program that shows the foreign supplier is producing food that meets U.S. safety standards, and the records have to be in English and available to FDA within 24 hours of request. The core duties include:

• Hazard analysis: identify the known or reasonably foreseeable hazards for each food (biological, chemical including radiological, and physical).
• Evaluate risk: assess the hazard and the foreign supplier’s performance to determine appropriate verification.
• Approve suppliers: use approved suppliers and document the basis for approval.
• Verification activities: conduct supplier verification such as annual on-site audits, sampling and testing, or review of the supplier’s food safety records, matched to the risk.
• Corrective actions and reassessment: act when a problem is found, and reassess the FSVP at least every three years or when new information arises.
• Modified and exempt categories: food already covered by FDA’s seafood or juice HACCP rules, certain dietary supplements, alcoholic beverages, and qualified small importers or suppliers have modified or reduced requirements, but the importer still must confirm the category actually applies.

USDA, Other Agencies, and Avoiding Holds at Otay Mesa

Not all food is FDA food. USDA’s Food Safety and Inspection Service (FSIS) regulates meat, poultry, processed egg products, and catfish, and those cannot rely on FDA registration and Prior Notice alone. FSIS product must come from a foreign country and establishment that USDA has certified as having an equivalent inspection system, and it is re-inspected at an official import inspection establishment before it enters commerce. USDA’s Animal and Plant Health Inspection Service (APHIS) governs plant and animal health: many fresh fruits and vegetables need a permit or a phytosanitary certificate, some commodities are prohibited or restricted, and wood packaging must meet ISPM 15 heat-treatment or fumigation standards. USDA’s Agricultural Marketing Service (AMS) can also impose grade and quality inspection under marketing orders for commodities such as avocados and tomatoes, which matters heavily for Otay Mesa produce lanes.

Because Otay Mesa is a primary commercial produce and food gateway from Mexico, FDA and USDA screening is heavy and routine there. Avoiding a hold comes down to making the electronic entry match reality before the cargo moves.

When a line is flagged, FDA issues one of a few outcomes: a May Proceed, a request for samples, a field exam or label review, or a detention. Products or firms under an FDA Import Alert may face Detention Without Physical Examination (DWPE), where the burden shifts to the importer to prove the shipment complies. Clean, consistent transmission data is what keeps a food entry moving through both agencies without the truck ever leaving the compound.

• Transmit the correct FDA product code and required affirmations of compliance for each food line.
• Confirm the manufacturer’s FDA registration is active and its number validates before filing.
• File and confirm Prior Notice inside the required window, tied to the actual arrival plan.
• Identify a valid FSVP importer with a working DUNS on every applicable line.
• Route FSIS meat, poultry, egg, and catfish products through an official USDA import establishment, and carry APHIS permits or phytosanitary certificates where the commodity requires them.