FDA Prior Notice

FDA prior notice is advance notification to the U.S. Food and Drug Administration of each shipment of food arriving in the United States. It comes from the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act), which requires FDA to receive prior notification of food, including animal feed, imported or offered for import. FDA says the advance notice lets it, with CBP's support, target import inspections more effectively. The rules are in 21 CFR part 1, subpart I.

What counts as food

The rule applies to food for humans and animals imported for use, storage or distribution in the US, including gifts, trade and quality-control samples, food moving through the US to another country, food for future export and food for a Foreign Trade Zone (21 CFR 1.277(a)). FDA's examples include fruits, vegetables, seafood, dairy products, eggs, animal feed and pet food, food ingredients and additives, dietary supplements, infant formula, beverages including alcoholic drinks and bottled water, bakery goods, snack foods, candy and canned foods (1.276). Food contact substances and pesticides are not food for this purpose.

It does not apply to food carried for personal use, homemade food sent as a personal gift, food imported and exported without leaving the port of arrival, or meat, poultry and egg products under USDA's exclusive jurisdiction (1.277(b)).

Deadlines

Prior notice must be submitted and confirmed by FDA no less than (21 CFR 1.279(a)):

• 8 hours before arrival at the port of arrival by water
• 4 hours before arrival by air or by rail
• 2 hours before arrival by road

It cannot be filed too early either: no more than 30 calendar days before the anticipated arrival through ACE, or 15 days through FDA's Prior Notice System Interface (1.279(b)). The clock starts when FDA confirms the notice for review, not when you send it.

Who files and how

Any person with knowledge of the required information can submit it, and may use another person to transmit it (1.278). It must be filed electronically, in English, either through CBP's ABI/ACE interface, which is what a customs broker normally uses, or through the FDA Prior Notice System Interface (PNSI); if the broker's system or ACE is down, PNSI must be used (1.280). FDA replies with a Prior Notice (PN) Confirmation Number. For a notice filed through PNSI, that number must accompany the food when it arrives and be given to CBP or FDA (1.279(g)).

What the notice contains

• The FDA product code, the common name and the quantity, from the largest container to the smallest package
• The manufacturer and its FDA registration number for processed food, or the grower if known for food in its natural state
• The country of production, the shipper and the country the food is shipped from
• The anticipated port, date and time of arrival
• The importer, owner and ultimate consignee
• The carrier's SCAC or IATA code, the bill of lading or air waybill number, the vessel name and voyage or flight number, and the container numbers
• Any country that has refused entry to the food

What happens without it

Food that arrives with no prior notice, inaccurate prior notice or untimely prior notice (unless FDA has already reviewed a late notice and advised CBP) is subject to refusal of admission under section 801(m)(1) of the Federal Food, Drug, and Cosmetic Act. Unless it is exported immediately with CBP's agreement, it must be held in the port of entry unless CBP or FDA directs otherwise (21 CFR 1.283(a)). If refused food with no prior notice is not exported, prior notice must be filed within 10 calendar days of the refusal (1.283(c)).

Prior notice is separate from FDA's review of the entry itself. A confirmed notice starts the clock; FDA can still examine, sample or refuse the food as a partner government agency.

How it works with Airlift

Airlift is an FMC-licensed NVOCC and not a licensed customs broker, so prior notice for food it carries is filed by the licensed broker handling the entry. For ocean shipments, give the broker the vessel name, voyage, bill of lading and container numbers from your booking early, and the manufacturer's registration number from your supplier. See customs clearance through licensed brokers.