FDA Prior Notice requirements for imported food: timing, confirmation number, and FBA shipments

Updated 2026-09-24

What prior notice is

FDA must be notified before food for humans or animals is imported or offered for import into the United States. The rule is 21 CFR Part 1, Subpart I. The point, FDA says, is to let the agency target inspections at the port and to see whether there is credible information that the shipment presents a serious risk.

Dietary supplements are food for this purpose. A pallet of ashwagandha capsules booked into FBA is an article of food offered for import. Cosmetics are not food; they do not use this prior-notice system. They have their own MoCRA filings, which do not replace Customs entry.

When it has to be in

21 CFR 1.279 sets the clock from arrival at the port, except for international mail. By road, not less than 2 hours before arrival. By rail, 4 hours. By air, 4 hours. By water, 8 hours. International mail must be notified before the food is sent.

You also cannot file too early. Through ABI/ACE/ITDS, not more than 30 calendar days before the anticipated arrival. Through FDA’s Prior Notice System Interface (PNSI), not more than 15 calendar days. FDA replies with a Prior Notice Confirmation Number. That number has to travel with the goods.

Who files it on an FBA shipment

Prior notice can go in through CBP’s Automated Broker Interface, which is how most commercial entries already talk to FDA, or through PNSI if you are not filing a full CBP entry at that moment, including some mail and in-bond movements.

Amazon as the fulfilment centre is the place the goods are going. It is not, by default, the person who submitted prior notice. If your forwarder assumed “FBA handles FDA,” and nobody transmitted notice, the shipment is the one that sits.

How this sits next to facility registration and the US agent

Prior notice is per shipment. Facility registration is per plant, renewed every two years. The US agent is the communications contact on a foreign facility’s registration. Three different filings. A registered plant with a named agent can still have a shipment held for missing prior notice.

If the foreign facility is not registered at all, the food is held at the port until it is. Getting prior notice right will not cure an unregistered plant.

What we do, and what we do not

We register the facility and name the US agent. Food or supplement facility registration is $299, or $499 with a year of agent. We are not a customs broker and we do not transmit prior notice as a standing service. If a shipment is already on hold, send us the Notice of FDA Action so we can see whether the charge is notice, registration, or the product itself.

Common questions

Does a sample or a small parcel still need prior notice?

Prior notice is required for food imported or offered for import, unless an exemption in the prior-notice rule applies. Quantity is not, by itself, a free pass. Mail has its own timing: notice before the food is sent.

Is prior notice the same as an FDA product registration?

No. Prior notice tells FDA a specific article of food is arriving. Facility registration tells FDA a plant exists. Product listing under MoCRA is a cosmetics filing and is not prior notice.

What if the plane arrives early?

If the goods arrive before the anticipated time, they can be refused and held until the prior-notice timeframe has elapsed or processing is complete. If FDA has already fully processed the notice, early arrival alone is not a reason to refuse.

Can I file prior notice after the container is at the pier?

The rule requires the notice to be submitted and confirmed before the listed arrival times. A notice filed after arrival is late. Late notice is how cargo becomes a hold.

Does the US agent file prior notice?

Not by virtue of being the agent. The agent is the FDA communications contact on the facility registration. A broker or the importer typically transmits prior notice. The agent can be authorised to do other jobs; those jobs have to be written down.

Sources

• FDA, Filing Prior Notice of Imported Foods — 21 CFR Part 1 Subpart I; ABI/ACE and PNSI — fda.gov
• 21 CFR 1.279 — when prior notice must be submitted (2 / 4 / 4 / 8 hours; 15- and 30-day outer limits) — ecfr via Cornell LII
• FDA, Importing Human Foods — purpose of prior notice; facility registration at entry — fda.gov
• FDA, Prior Notice of Imported Food Questions and Answers (Edition 3) — fda.gov

This guide is general information about FDA prior notice, not legal advice, and it does not create a client relationship. Confirm the mode of transport and the filer on your own shipment before you treat these hours as your timetable.