FDA Prior Notice Required for Imports of All Food Products to the U.S.
Prior Notice must be filed with the U.S. Food and Drug Administration for all food offered for import into the United States. Prior notice consists of the following information that must be provided to the FDA before arrival of the shipment at the first U.S. port:
- Product information, including quantity, packaging type, number of packages, related facilities (e.g., name of manufacturer), and FDA Product Code
- Country of origin
- Country from which the article is shipped
- Anticipated port of arrival
- Anticipated arrival date
- Anticipated arrival time
- Whether the shipment has been denied entry into another country
You will also need to submit documentation of your shipment, including a bill of lading, airway bill or tracking number, as appropriate.
If you fail to file a timely Prior Notice, the FDA will not authorize release of your food product, and the Customs and Border Patrol will not allow entry of the shipment. If you fail to file within the required timeframe depending on the method of shipment, you may be subject to significant fines and penalty fees.
If you don’t file any Prior Notice, your shipment may be:
- Held at the port of arrival
- Directed to a secure facility so long as you pay a bond, or
- Exported
Prior Notice must be given no more than 15 days before the date of arrival if filed through the FDA’s Prior Notice System Interface system, or no more than 30 days before the date of arrival if filed through the Customs and Border Patrol’s Automated Broker Interface system.
Note, you must also have the manufacturer’s FDA Food Facility Registration Number in order to submit a Prior Notice. This number is generated when a manufacturer registers with the FDA.
U.S. Imports can help with facility registration and Prior Notice filings.
