FDA Prior Notice is Required For Each Dietary Supplement Shipment

Prior Notice must be provided to the U.S. Food and Drug Administration (FDA) for all dietary supplements offered for import into the United States. Prior notice consists of the following information that must be provided before arrival of the shipment at a U.S. port:

• Information about the product, including quantity, packaging type and number of packages, manufacturer information, and FDA Product Code 
• Country 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 dietary supplements, 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.