October 16, 2020
The U.S. Food and Drug Administration (FDA) is issuing guidance establishing a U.S. Agent Voluntary Identification System (VIS) for food facility registration. The VIS is intended to be used in conjunction with our food facility registration database, the Food Facility Registration Module (FFRM), to streamline and expedite the U.S. agent verification process.
U.S. and foreign food facilities that are engaged in the manufacturing, processing, packing or holding of foods for consumption in the United States are required to register with the FDA under the Federal Food, Drug and Cosmetics Act. Registered foreign food facilities are also required to have a U.S. Agent who acts as a communications link with FDA.
The VIS works in conjunction with the FDA’s food facility registration database to allow U.S. agents to independently identify the facility or facilities they are representing. The FDA will then provide the U.S. agent with an identification number for their facilities. Additionally, foreign food facilities now have the option of providing the identification number of their U.S. agent during registration. When a foreign facility uses a U.S. agent identification number in accordance with the VIS and the name of the facility matches the facility name and address the U.S. agent has identified, FDA will consider that verification without taking any additional steps to verify the U.S. agent—thus facilitating the process of providing a food facility registration number.
The guidance document provides additional information about the VIS process through questions and answers. More information about food facility registration can be found at Registration of Food Facilities and Other Submissions.