An FDA Prior Notice is a mandatory filing required before any shipment of food, beverages, supplements, or pet food can legally enter the United States.
The requirement traces back to the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, passed by Congress after the September 11 attacks heightened concern about the security of the food supply chain. Before this law, the FDA had very limited visibility into food entering the United States until it had already arrived at a port of entry. Prior Notice closes that gap: it requires anyone shipping food into the US to tell the FDA, in advance, exactly what's coming, who made it, where it's from, and how and when it will arrive.
Why does the FDA require this?
The stated purpose of Prior Notice is twofold. First, it gives the FDA the ability to review shipment information before goods arrive, so inspectors can flag potentially unsafe or non-compliant products for inspection at the border rather than after they've already entered the domestic supply chain. Second, it creates a paper trail that helps the FDA respond quickly in the event of a foodborne illness outbreak or suspected act of food terrorism, since they can trace which shipments, manufacturers, and routes were involved.
In practice, for the vast majority of small and mid-sized exporters, Prior Notice is simply a mandatory compliance step rather than something that results in additional scrutiny. The FDA receives an enormous volume of Prior Notices daily, and most shipments with accurate, complete filings move through without incident.
What information does a Prior Notice actually include?
A complete Prior Notice filing includes several categories of information about the shipment:
- Product information — a description of the product, its FDA product code, and the quantity being shipped
- Manufacturer information — the name, address, and FDA registration number of the facility that manufactured, processed, or packed the product
- Shipper and importer information — who is sending the shipment and who is receiving it in the US
- Transportation details — the mode of transportation (land, air, sea, or mail), the carrier, and the anticipated port of arrival
- Timing information — the expected date and time of arrival
Each of these fields needs to be accurate and consistent with the actual shipment. A mismatch between what's filed and what arrives, such as a different product code or an incorrect manufacturer, is one of the most common reasons a Prior Notice gets flagged or a shipment gets held for review.
Who is legally required to file?
The Prior Notice requirement applies to anyone shipping food, beverages, dietary supplements, or pet food from outside the United States into the United States, regardless of the size or nature of the business. This includes large commercial importers, but it also includes small e-commerce businesses shipping individual orders directly to customers, and even shipments that might seem too small to warrant this level of scrutiny.
There's a common misconception that small, individual, direct-to-consumer shipments are exempt because they're not large commercial freight. In most circumstances, this isn't accurate. If you are a business shipping food products to customers in the US, each shipment typically needs its own Prior Notice, even if it's just a handful of items going to one household.
What happens if you don't file, or file incorrectly?
A missing or invalid Prior Notice gives US Customs and Border Protection grounds to refuse admission of the shipment. In practice this usually means the shipment is held at the port of entry until the issue is resolved, which can mean significant delays, additional storage or demurrage fees, and in some cases the shipment being returned to origin or destroyed, particularly for perishable goods.
For a business that ships to the US regularly, even occasional Prior Notice issues can create a pattern that draws additional scrutiny to future shipments. This is part of why getting Prior Notice right consistently, not just occasionally, matters for maintaining a smooth and predictable cross-border shipping operation.
Is Prior Notice the same as a customs declaration?
No. Prior Notice is specifically an FDA requirement focused on food safety and security, separate from the customs entry and declaration process handled by Customs and Border Protection for duties, tariffs, and general import admissibility. A shipment can have a completely valid customs declaration and still be held if its Prior Notice is missing or incorrect, because the two systems serve different regulatory purposes and are checked independently.