We Navigate Complex FDA Requirements

Food products rank among the most heavily regulated goods in U.S. commerce.  All food imported into the U.S. must meet the same requirements for food safety and food labeling as food produced within U.S. borders.  These requirements are very complex.  U.S. Food Imports shoulders the burden of navigating complex FDA requirements so you don’t have to.

FDA Solutions

FDA Services Include:

  • FSMA Food Safety Foreign Supplier Verification

  • FDA Prior Notice Filings

  • U.S. Agent Food Facility Registration Services

  • Label Reviews

  • Food Canning Establishment Registration and Process Filings (FCE/SID)

  • Small Business Nutrition Labeling Exemptions

FSMA Food Safety Foreign Supplier Verification


U.S. food import requirements have changed dramatically with enactment of a new law, the Food Safety Modernization Act.  Importers must now verify that suppliers are manufacturing food or growing produce in a manner that provides the same level of food safety standards as U.S. regulations through the use of onsite audits, sampling and testing of product and other means.  Importers that fail to properly verify the food safety practices of the foreign suppliers are subject to criminal penalties imposed by the U.S. federal government.

U.S. Food Imports provides all necessary supplier verification services to ensure the entry of food products into the U.S. We verify:

  • Hazard Analysis and Risk-Based Preventive Controls Rule for Human Food Compliance
  • Hazard Analysis and Risk-Based Preventive Controls Rule for Animal Food Compliance
  • Produce Safety Rule Compliance
  • Compliance with Laws on Adulteration of Food and Food Contact Surfaces
  • Allergen Labeling Compliance

FDA Prior Notice Filings

Notice of food imported for use, storage or distribution in the U.S. is required to be communicated to the U.S. Food and Drug Administration before arrival in a port of entry with limited exceptions.  Prior notice must be submitted electronically to FDA in English through the U.S. Customs and Border Protection Automated Broker Interface (ABI) or the FDA Prior Notice System Interface.

Prior Notice must be submitted with FDA for foods:

  • Arriving by land by road, no less than 2 hours before arriving at the port of arrival
  • Arriving by land by rail, or by air, no less than 4 hours before arriving at the port of arrival
  • Arriving by water, no less than 8 hours before arriving at the port of arrival
  • A separate timetable applies for food arriving by international mail

Violations of the Prior Notice requirement can lead to refusal of admission, and federal civil and criminal penalties.  U.S. Food Imports ensures that Prior Notice requirements are properly met.


U.S. Agent Food Facility Registration Services

All foreign food facilities that process, pack or hold food for human or animal consumption in the U.S. are required to register with FDA electronically or by paper/fax, before they export food to the U.S. and reregister every two years.  Reregistration must be done on even numbered years from October 1 to December 31.  Foreign food facilities are also required to appoint an agent in the U.S. to serve as a communication link between FDA and the foreign facility.

U.S. Food Imports provides food facility registration services including:

  • Preparing and filing food facility registrations with FDA
  • Serving as the FDA Food Facility Registration Agent
  • Serving as the FDA Emergency Contact for food facilities

U.S. Food Imports Food Facility Registration Service includes:

  • Biennial preparation and filing of Food Facility Registration
  • Advance notification of Food Facility Registration
  • Immediate notification of FDA inquiries
  • Forwarding of all FDA correspondance