FDA Prior Notice for Food Imports from China to the USA
A Prior Notice confirmation number does not mean FDA has cleared your shipment for entry.
The shipment can still be held, examined or refused if FDA identifies a problem with the notice or the food. For importers bringing food from China into the United States, misunderstanding what the confirmation number proves can delay release and add substantial port and cold-chain costs.
Most commercial shipments of FDA-regulated human or animal food require Prior Notice before arriving at the first US port, regardless of whether the product travels at ambient temperature or under chilled or frozen shipping conditions.
Specific exemptions apply, while certain meat, poultry and processed egg products under the exclusive jurisdiction of USDA’s Food Safety and Inspection Service follow a different import process. Importers must also assemble accurate product, manufacturer, party and shipment information before FDA’s deadline for the relevant transport mode.
This guide explains how to determine whether Prior Notice applies, assign the filing role, prepare the required information and manage changes before the shipment reaches the United States.
Does My Food Import from China Need FDA Prior Notice?
Most commercial shipments of human or animal food regulated by the US Food and Drug Administration (FDA) require Prior Notice before arriving at the first US port, regardless of whether the product travels at ambient temperature or under chilled or frozen conditions.
Applicability depends on two questions:
whether the product is a human food, animal food or feed regulated by FDA
whether a specific exemption applies
The first step is to identify which US agency has jurisdiction over the product.
Certain meat, poultry and processed egg products under the exclusive jurisdiction of USDA’s Food Safety and Inspection Service are outside the FDA Prior Notice requirements. However, an ingredient list containing meat or egg does not automatically place the finished product under FSIS. Composite foods and products with mixed ingredients require a product-specific review.
A low value, small quantity or description such as “sample” or “gift” does not create a general exemption.
For example, a packaged samples from China to a US buyer is still making a commercial shipment, even when the buyer does not pay for the products.
A jurisdiction review uses the product name, complete ingredient list, processing method, intended use and manufacturer information.
For frozen seafood shipped from China, the species and processing method can be especially relevant. The proposed HTS code and its FDA flag can support this assessment, but an HTS code alone does not establish whether Prior Notice is required.
Submitting FDA Prior Notice: Importer, Broker, or Freight Forwarder
FDA permits any individual with knowledge of the required information to submit Prior Notice. Importers are therefore not required to file personally.
For a food shipment from China, the practical decision is which party can combine the supplier, transport and US entry information without creating inconsistencies between the notice and the arriving cargo.
The filing party and confirmation handover should be established before the applicable deadline. A freight quotation, customs clearance arrangement or express booking does not by itself confirm that Prior Notice filing is included.
Customs Broker Filing Through the CBP Entry System
When the US customs broker submits Prior Notice through the CBP entry system, the Chinese supplier provides the product and manufacturer information, while the freight forwarder provides the confirmed routing and arrival details.
Keeping the Prior Notice and customs entry with the same destination-side filer can simplify data matching.
Freight Forwarder or Chinese Exporter Filing Through FDA PNSI
A freight forwarder or Chinese exporter can instead submit through FDA PNSI when filing support is included in the agreed service scope. The importer supplies the US party information, and the resulting confirmation number is shared with the importer and customs broker for the arrival process.
Importer Filing Directly Through FDA PNSI
Importers may also file through PNSI directly. This gives the importer direct control of the submission and confirmation number but requires the relevant information to be collected and maintained across every party involved in the shipment.
What Information Does FDA Prior Notice Require?
Prior Notice is submitted for each article of food rather than for the shipment as a whole.
A container or parcel holding several distinct food products may therefore require multiple submissions and confirmation numbers. General invoice descriptions such as “food products,” “frozen goods” or “samples” do not identify the food with enough precision.
Product and Manufacturer Information
The product record identifies what the food is, where it was produced and which facility or grower is connected to it. The required information can include:
FDA product code: The complete code corresponding to the food category, processing method, packaging and other product characteristics.
Product name: The common, usual or market name rather than a broad shipping description.
Quantity and packaging: The estimated quantity described from the largest shipping unit down to the smallest package.
Lot or code number: Required when applicable to the product, including certain acidified foods, low-acid canned foods and infant formula.
Manufacturer information: For processed food, the manufacturer’s name and applicable FDA facility registration information.
Grower information: For food in its natural state, the grower or consolidator details may be required instead of a manufacturer.
Country information: The FDA Country of Production, the country from which the food is shipped and any country that has refused entry to the product.
A complete ingredient list is not always entered as a separate Prior Notice field, but it may be needed to select the correct FDA product code.
Importer and Other Shipment Parties
Prior Notice identifies the submitter and, when different, the party transmitting the filing. It also records the shipper, importer, owner and ultimate consignee involved in the shipment.
These parties are not necessarily the same company. For example, an overseas buyer may own the food, a US entity may act as the importer, and a warehouse or distributor may be the ultimate consignee. Using one company’s details across every field can create inconsistencies with the commercial invoice, transport documents and customs entry.
Transport and Arrival Information
The filing connects the food with its expected movement into the United States. Depending on the entry type and transport mode, the required data can include:
the CBP entry or in-bond number, when available;
the first US port of arrival and the expected arrival date and time;
the transport mode and carrier name, SCAC or IATA code;
the bill of lading or air waybill number;
the vessel name and voyage number or the flight number; and
the container, railcar, trip or express tracking number, as applicable.
For shipments moving through an express operator, the tracking number can replace certain arrival and transport fields.
FDA Prior Notice Filing Deadlines by Transport Mode
FDA must electronically receive and confirm Prior Notice before the food arrives at its first US port. The minimum lead time is determined by how the shipment physically reaches the United States.
Road: FDA must receive and confirm the notice at least two hours before the food reaches the US port of arrival.
Rail: The minimum period is four hours before arrival.
Air: The minimum period is also four hours before arrival.
Ocean: FDA must receive and confirm the notice at least eight hours before the vessel reaches the first US port.
International mail: Prior Notice must be submitted and confirmed before the food is sent.
The filing period is calculated from the local arrival time at the first US port, not from the shipment’s departure time in China. For ocean freight from China to Los Angeles, the vessel’s arrival in Los Angeles is the relevant reference point.
Express does not have a separate Prior Notice deadline. An express shipment arriving by air follows the air requirement, while one entering by road follows the road requirement.
Prior Notice can also be submitted too early. A submission made through FDA PNSI can be filed no more than 15 calendar days before the anticipated arrival date, while a submission transmitted through the CBP entry system can be filed no more than 30 calendar days in advance.
From October 1, 2026, Prior Notice for food arriving by international mail must also include the name of the mail service and the mail tracking number.
Which Shipment Changes Require a New Prior Notice?
Not every change after FDA confirmation requires a new Prior Notice. The result depends on which part of the confirmed submission has changed.
When the transport mode changes, the replacement Prior Notice must satisfy the filing deadline for the new mode.
A vessel rollover, revised ETA or change to the anticipated US port does not require a new Prior Notice solely because the arrival information changed. However, the customs broker and other parties managing the entry still need the revised details so that the customs entry and transport records reflect the actual shipment.
When resubmission is required, a notice filed through FDA PNSI should be cancelled in PNSI before the replacement is submitted. If the original notice was transmitted with the CBP entry, the filer handles the cancellation through the CBP entry process.
What a Prior Notice Confirmation Number Does and Does Not Prove
After FDA confirms the filing, two questions remain: what the confirmation number records and what FDA can still review before the food is released.
What the Confirmation Number Shows
The number confirms three points:
Submission received: FDA received the Prior Notice electronically.
Initial completeness: The required fields were complete and facially valid when submitted.
Submission record: FDA assigned a number and recorded the submission time for that food article.
For a notice filed through FDA PNSI, the confirmation number must accompany the shipment and be available at arrival. International mail parcels must show the number on the customs declaration.
Why the Food Can Still Be Held or Refused
FDA can still determine that the information is inaccurate or that the shipment arrived before the applicable minimum filing period had elapsed. The confirmation number also does not validate the manufacturer’s registration, approve the product or label, establish compliance with other FDA import requirements or release the shipment from FDA and CBP control.
Separate concerns involving the food, manufacturer or entry information can therefore lead to examination, a hold or refusal even after a confirmation number has been issued.
Cold-chain consequence: During customs clearance for a reefer container, an FDA hold may require continued reefer power, cold storage, additional handling and more terminal time. The confirmation number is part of the arrival documentation, not a release instruction for the cargo.
How Does Gerudo Logistics Support Food Shipping from China?
Gerudo Logistics is a China-based freight forwarder specialising in reefer, temperature-controlled and regulated cargo shipping from China to global markets.
With operations across major Chinese ports, we coordinate origin collection, export formalities, air and ocean freight, customs support and destination delivery according to the cargo and route.
For food imported into the United States, Gerudo Logistics also coordinates the shipment information required for FDA Prior Notice with the importer and the appointed US customs broker or filing party. The filing arrangement is aligned with the confirmed cargo and transport plan, while the wider shipment continues under the agreed freight and destination service scope.
Contact Gerudo Logistics to review the product, route and service requirements before booking.
Frequently Asked Questions About FDA Prior Notice
Do I Need Prior Notice If the Manufacturer Is Already FDA-Registered?
Yes. Food facility registration applies to the manufacturer or other qualifying facility, while Prior Notice applies to each imported food article. An active facility registration does not replace the shipment-specific filing.
Is There a Fee for Filing FDA Prior Notice?
FDA does not charge a fee for submitting Prior Notice through PNSI. A customs broker, freight forwarder or other service provider may charge for preparing and transmitting the filing.
Do I Need a New Prior Notice for Every Food Shipment?
Yes. Food facility registration applies to the facility, while Prior Notice applies to each imported food article, so an active registration does not replace the shipment-specific filing. In 2026, facilities required to register must renew between October 1 and December 31; registrations not renewed by the deadline are considered expired.
Does Food in Transit Through the United States Need Prior Notice?
Generally, yes. Prior Notice applies to food entering the United States for transshipment, further processing and export, or storage and export. Food exported without leaving the port of arrival falls under a separate exclusion.
Is FDA Prior Notice Required Only for Food Imports?
Yes. FDA Prior Notice applies to imported human and animal food, including food ingredients, beverages, dietary supplements and animal feed. FDA also regulates products such as drugs, medical devices, cosmetics and tobacco, but those products follow different FDA entry requirements rather than the food Prior Notice process.
