Prior Notice is a notification issued to FDA prior to the importation of an article of food for human or animal consumption into USA. This includes 50 US states, District of Columbia, Puerto Rico only. The US territories are not covered under this definition.
Food that is imported with inadequate Prior Notice is subject to refusal and detention at the port of entry.
For Prior Notice, food includes all foods for human or animal consumption, irrespective of intended use.
Prior Notices are considered inadequate:
- When there is either no prior notice submitted, or
- The information submitted in prior notice is inaccurate, or
- The prior notice is not submitted in accordance with required timeframes.
The requirement for prior notice is not based on the requirement of FDA registration. FDA registration is required for facilities that are engaged in manufacturing, processing, packing or holding of food for consumption in USA. Prior Notice is required for articles of food imported into US.
There are two online systems available that may be used to file Prior Notices namely., FDA’s PNSI and CBP’s ABI/ACS. For a prior notice submitted via CBP’s ABI/ACS, you may not submit prior notice more than 30 calendar days before the anticipated date of arrival. For a prior notice submitted via the FDA’s PNSI, you may not submit prior notice more than 15 calendar days before the anticipated date of arrival.
The requirement of Prior Notice does not apply to:
- Food for personal use that accompanies the individual.
- Home made food sent as personal gift to another individual in US.
- Food that is imported & then exported and doesn’t not leave the port of arrival.
- Meat and Poultry food products regulated exclusively by USDA.
- Food brought in diplomatic bags.
Any person with knowledge of the required information may submit prior notice for an article of food being imported.
Timeframes for submitting Prior Notice:
For foods arriving by international mail –
- For foods arriving by road, 2 hours before arrival;
- For foods arriving by rail or by air, 4 hours before arrival;
- For foods arriving by water, 8 hours before arrival
For foods arriving by Express Couriers like FEDEX – before the food is sent
Liberty Management Group LTD is one of the leading FDA consulting groups in the USA. LMG provides assistance with Prior Notice, FDA registration and other FDA regulations.
Namrata
FDA Regulatory Consultant
support@libertymanagement.us
Published on: February 06, 2019
how can search my manufacturer food facility registration number ? FDA registration number is required for prior notice filing.
Food facility FDA registration number is confidential you can not search online, you need to contact the manufacturer for the registration number.
I am exporting 5 food products with different flavors , do I need to issue 5 prior notices or prior notice for each flavors?
Hello Alicia,
As per FDA, a separate prior notice must be submitted for each article of food that has a different complete FDA product code, different package size, or different manufacturer or grower. If that is the case with you, you will need separate prior notices and hence separate confirmation numbers.
FDA has detained my product even after issuing prior notice, what could be the reason for that and can you help me?
FDA may have detained your products because of an inadequate prior notice. A prior notice is considered inadequate when either the information on it is inaccurate (example: invalid FDA registration number, incorrect shipment details etc) or if it was not submitted within the required timeframes. LMG can help you file timely, accurate and adequate prior notices.
My product is held up at the port. I am already registered. Please help me issue a prior notice so i could release my products.
Sorry, a prior notice must be issued before the shipment arrives in US. Since your products are already here, please contact your custom broker for assistance with release of goods.