Any company exporting food products to the United States must comply with the U.S. Food and Drug Administration (FDA) regulations on Prior Notice Filing. This requirement applies to both foreign and domestic shipments of food and beverages, covering packaged food, raw materials, dietary supplements, and drinks. The FDA introduced Prior Notice Filing under the Public Health Security and Bioterrorism Preparedness and Response Act to enhance food safety and protect the U.S. supply chain.

Prior Notice must be submitted to the FDA before any food shipment arrives at a U.S. port of entry. The filing provides detailed information about the product, the shipper, the consignee, the manufacturer, and the anticipated arrival time. This advance notification enables the FDA to review shipments, assess potential risks, and, if necessary, target inspections to prevent unsafe or non-compliant products from entering the country.

Failure to file Prior Notice, or submitting it incorrectly, can lead to severe consequences, including shipment delays, refusal of entry, detentions, or penalties. For exporters and importers, ensuring accuracy and timeliness of Prior Notice submissions is critical for avoiding costly disruptions in supply chains.

Prior Notice applies broadly to:

• Packaged foods and processed products
• Raw agricultural commodities and ingredients
• Beverages, including alcohol and juices
• Dietary supplements and nutraceuticals

Whether shipped by air, sea, rail, or truck, every food item must have a valid Prior Notice filing. The submission window varies depending on the mode of transport for instance, at least 2 hours before arrival by road and 4 hours before arrival by air.

XPRO America provides comprehensive Prior Notice Filing services to ensure your shipments meet FDA requirements. Our compliance experts handle the preparation and timely submission of Prior Notice, verify documentation, and monitor acknowledgments from FDA systems. With 24/7 support, we help global exporters prevent shipment delays, ensuring smooth clearance into the U.S.

By partnering with XPRO America, businesses can simplify the complex regulatory process, avoid penalties, and focus on growing their market presence in the U.S. Ensuring Prior Notice compliance is not just a legal requirement it is a crucial step toward building a trusted and reliable export operation.

Ensure smooth U.S. food imports with FDA Prior Notice Filing. XPRO America provides accurate, timely submissions for food, beverages, and raw materials.