There is a requirement to give the FDA prior notice of importing shipments containing food items into the USA.
Full Guidance on the FDA Prior notice requirements can be found on the FDA Website
The FDA must be notified in advance of any shipments of food for humans and other animals that are imported into the U.S., unless the food is exempt from Prior Notice.
- Fish and seafood
- Dairy products
- Raw agricultural commodities for use as food or as components of food
- Animal feed (including pet food)
- Food and feed ingredients
- Food and feed additives
- Dietary supplements and dietary ingredients
- Infant formula
- Beverages (including alcoholic beverages and bottled water)
- Live food animals
- Bakery goods
- Snack foods
- Canned foods
Which Food Imports Require Prior Notice
Prior Notice is required for imports of all foods subject to the relevant regulation. However, in some cases, some exemptions may apply. Please visit FDA Guidance for more information.
What If You Fail to Give Adequate Prior Notice
Food that is imported or offered for import with inadequate Prior Notice is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a "Prohibited Act" under the laws FDA administers. FDA has provided its staff with enforcement guidance containing the agency's policies on refusals, holds, injunctions, prosecution, and debarment related to failure to provide timely and accurate Prior Notice or otherwise comply with FDA Prior Notice regulations.
Note: Prior Notice guidance documents are available to the public and posted on FDA’s website. FDA will continue to update these as appropriate.
GIVING PRIOR NOTICE OF AN IMPORTED FOOD SHIPMENT
How to Give Prior Notice
Prior Notice must be submitted electronically through the following system:
The FDA Prior Notice System Interface (PNSI) is available 24 hours a day, 7 days a week. FDA’s and CBP’s computer systems enable you to submit Prior Notice as part of the entry process. This will avoid duplication of information.
When to Give Prior Notice of a Shipment
FDA must electronically receive and confirm Prior Notice before a food shipment arrives at the first port in the United States (port of arrival). The deadline for submitting Prior Notice depends on the mode of transportation used for shipment.
Except in the case of food arriving by international mail, FDA must receive and confirm a Prior Notice: 1) no more than 30 days before a shipment arrives, if Prior Notice is submitted via ABI/ACS; or 2) no more than 15 days before a shipment arrives, if Prior Notice is submitted via FDA’s PNSI.
Getting Help With Prior Notice
FDA offers an online tutorial on how to use the FDA Prior Notice System Interface. The FDA PNSI has Help features and interactive feedback to assist the submitter and minimize spelling mistakes and omissions. In addition, FDA has two offices that can provide assistance with Prior Notice:
FDA Industry Systems Help Desk answers technical and computer-related questions about the Prior Notice System Interface
Hours: 7:30 AM – 11 PM U.S Eastern Time
Phone: 1-800-216-7331 or 301-575-0156
FAX: 1-866-573-2804 or 301-436-2804
Email: http://www.accessdata.fda.gov/scripts/email/cfsan/bioterrorismact/helpf2.cfm and complete the form
FDA Prior Notice Center answers questions about Prior Notice policies, procedures and interpretations
Hours: 24 hours per day, 7 days per week
For assistance with ACS transmissions, contact your CBP client representative.