U.S. Agent Voluntary Identification 
System (VIS) for Food Facility 
Registration: Guidance for Industry 
You may submit written comments regarding this guidance at any time.  Submit electronic 
comments to https://www.regulations.gov.  Submit written comments on the guidance to the 
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.  All comments should be identified with the title of the 
guidance document.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
October 2020  Contains Nonbinding Recommendations 
Table of Contents  
 
 
 
I.    Introduction  
 
II.    Background  
 
III.   Discussion  
 
  U.S. Agent Voluntary Identification 
System (VIS) for Food Facility 
Registration: Guidance for Industry1   
 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
 
 
I.  Introduction  
 
The purpose of this guidance document is to announce that FDA has established a U.S. Agent 
Voluntary Identification System (VIS) in conjunction with our food facility registration database, 
the Food Facility Registration Module (FFRM).The purpose of the VIS is to ensure the accuracy 
of U.S. agent information and enable U.S. agents to independently identify the facility or 
facilities for which the agent has agreed to serve. This guidance provides information for U.S. 
agents and foreign facilities importing food into the U.S. who choose to utilize the VIS.  
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe our current thinking on a topic and should be 
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  
The use of the word should in FDA guidances means that something is suggested or 
recommended, but not required.  
 
II.  Background  
 
FDA has established the U.S. Agent Voluntary Identification System (VIS) in conjunction with 
our food facility registration database to ensure the accuracy of U.S. agent information and 
enable U.S. agents to independently identify the facility or facilities for which the agent has 
agreed to serve. The VIS allows a U.S. agent to directly provide FDA with their contact 
information and the name of the facility or facilities for which the agent agrees to serve. FDA 
will then provide the U.S. agent with an identification number that the agent can provide to the 
                                                 
1 This guidance has been prepared by the Office of Compliance Division of Field Programs and Guidance in the 
Center for Food Safety and Applied Nutrition at the U.S. Food and Drug Administration.    Contains Nonbinding Recommendations 
facilities that the U.S. agent agrees to represent. Foreign food facilities now have the option of 
providing the identification number of their U.S. agent during registration.  
 
Under  1.231(a)(5) and 1.231(b)(7)2, after a foreign facility submits registration, FDA will 
verify that the person identified as the U.S. agent for the foreign facility has agreed to serve as 
the U.S. agent. FDA will not confirm registration or provide the foreign facility with a 
registration number until the U.S. agent has confirmed that the agent has agreed to serve as the 
U.S. agent for that facility.  The VIS provides a streamlined U.S. agent verification process.  
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 the U.S. agent has identified, FDA will 
consider that verification and will provide the facility with a registration number without taking 
any additional steps to verify the U.S. agent. 
 
III.  Questions and Answers 
 
Question: What information will a U.S. agent need to provide to register with VIS?  
 
Answer: The information to be collected from the U.S. agent is specified in 21 CFR 1.232(c)(1), 
including name, full address, phone number, email address, and emergency contact phone 
number. U.S. agents have the option provide the name and address of the facility or facilities for 
which the agent agrees to serve. Inclusion of the facility name and address will assist FDA with 
validating the facility/agent listing relationship.  
 
Question: How does a U.S. agent enter information in the VIS? 
 
Answer: The U.S. agent must first obtain an account for the FDA Unified Registration and 
Listing System (FURLS), where they can then obtain access to FFRM. Upon entering FFRM, the 
U.S. Agent can access the VIS from the main menu where they will be able to enter their 
information, verify the information provided, and obtain their unique U.S. agent ID number. 
 
Question: What information will a U.S agent need to provide to foreign food facilities they 
agree to represent?  
 
Answer: When a U.S. agent provides information through the VIS, FDA will issue the U.S. 
agent an identification number. The U.S. agent can provide this identification number to foreign 
facilities the agent agrees to represent. Foreign facilities will have the option to provide either the 
required U.S. agent identification information or the U.S. agent identification number when the 
foreign facilities register, update, or renew their registration with FDA. Under  1.231(a)(5) and 
1.231(b)(7), FDA will not confirm a foreign facilitys registration or provide a registration 
number until the U.S. agent has confirmed that the agent has agreed to serve as the U.S. agent. If 
                                                 
2 Beginning January 4, 2020, registrants must submit registrations, registration renewals, updates, or cancellations to 
FDA electronically, unless FDA has granted a waiver under 21 CFR 1.245 (see 21 CFR 1.231(a)(2) and (b), 
1.234(d), and 1.235(d)). For more information, see Questions and Answers Regarding Food Facility Registration 
(Seventh Edition): Guidance for Industry. Available at: https://www.fda.gov/regulatory-information/search-fda-
guidance-documents/guidance-industry-questions-and-answers-regarding-food-facility-registration-seventh-edition 
 
  Contains Nonbinding Recommendations 
the U.S. agent identification number and the information that the U.S. agent provides about the 
facility in VIS match, FDA will consider the use of the identification number as a verification 
under  1.231 (a)(5) and 1.231(b)(7). When the confirmation notification of a foreign facility 
registration is sent to the facility, a confirmation will also be sent to the U.S. agent to ensure that 
the U.S. agent is aware of the connection with each foreign facility registration. In addition, the 
facility will also be listed under the U.S. agents VIS account as a facility which they are 
currently representing, enabling the U.S. agent to see and verify that the agent has agreed to 
represent all listed facilities. 
 
Question: What is the benefit to U.S. agents and foreign facilities to utilize the VIS?  
   
Answer: The U.S. agent identification number can be used to facilitate verification for purposes 
of  1.231(a)(5) and 1.231(b)(7).  The speed with which verification can be accomplished  
provides an incentive for foreign facilities to use U.S. agents who have created a VIS account. 
The efficiency of this process allows for automatic assignment of a registration number when the 
U.S. agent adds the facility name and address to their profile and when the foreign facility lists 
the U.S agent identification number to their registration submission. Additionally, because U.S. 
agents would have direct access to a list of facilities identifying them as U.S. agent, they would 
have an incentive to use the identification system, which we anticipate will limit the number of 
unauthorized and/or fraudulent U.S. agent listings. U.S. agents can also electronically notify 
FDA that they decline to serve as or no longer serve as the U.S. agent for a foreign facility via 
the VIS. 
 
Question: How will a foreign facility identify a U.S. agent who is in the VIS?  
 
Answer: It is the responsibility of the U.S. agent to share their identification number with the 
facilities for whom they agree to serve as U.S. agent. FDA does not intend to publish a list of 
U.S. agents who are participating in the VIS. The foreign facilities have the option of providing 
the identification number for the U.S. agent in its registration rather than the specific U.S. 
agents contact information required for food facility registrations (, name, address, email 
address, phone number).3 After using the identification number, and if the foreign facility name 
matches a facility name the U.S. agent identified in the system, we consider the use of that 
identification a verification for purposes of 21 CFR 1.231(a)(5) and 1.231(b)(7). We then provide 
the facility with a registration number without FDA taking any additional steps to verify the U.S. 
agent as provided in 21 CFR 1.231(b)(6), and the U.S. agent contact information in the system 
will then be linked and automatically populated in the foreign facility registration. If the facility 
does not have the U.S. agent identification number, the facility still has the option to provide the 
required information (name, full address, phone number, and email address) for the U.S. agent 
(see 21 CFR 1.232(c)(1)). 
Question: What happens if a foreign facility designates a U.S. agent that does not agree to serve 
 
as the U.S. agent or who declines the assignment?  
 
                                                 
3 See 21 CFR 1.232(c)(1) (requiring foreign facilities to provide the name, full address, phone number, and email 
address for the foreign facilitys U.S. agent). 
  Contains Nonbinding Recommendations 
Answer: U.S. agents in the VIS system will be notified any time a foreign facility registers with 
FDA using their U.S. agent identification number. Although we consider the use by a foreign 
facility of a U.S. agent identification number to be confirmation that the U.S. agent agrees to 
serve in that capacity for that foreign facility when a facility name matches a facility name the 
U.S. agent has identified, U.S. agents can nevertheless reject the assignment via the VIS or 
contact FDA in the event the U.S. agent is falsely identified in a food facility registration. If the 
U.S. agent does not agree to serve or declines the assignment, FDA will notify the foreign 
facility that they will need to identify a valid U.S. agent within 30 days for the registration to be 
confirmed.   Once a registration is confirmed and a U.S. agent has been accurately identified, the 
U.S. agent may decline to serve as the U.S. agent at any time.   If the U.S. agent wishes to no 
longer serve the already-registered foreign facility, the foreign facility will have 60 calendar days 
to update the facilitys registration with a new U.S. agent (21 CFR 1.234(a)).  
 
Question: How often should U.S. agents  update information in the VIS?  
 
Answer:. Food facilities must update their registrations within 60 calendar days of any change to 
any required information, including required U.S. agent information such as the name, full 
address, phone number, and email address of the U.S. agent (21 CFR 1.234(a)).  Because the VIS 
functions as the repository for U.S. agent information for a foreign facility, the U.S. agent should 
update required U.S. agent information in the VIS within 60 calendar days of a change to the 
previously-submitted information. Updates can be submitted online through the VIS. In addition, 
any updates to the U.S agents information will be updated on the registration of facilities which 
they have agreed represent. 
 
 
Question: Are U.S. agents who utilize the VIS subject to renewal requirements akin to biennial 
registration renewal requirements for food facilities?  
 
Answer: No.   U.S. agents who utilize the VIS do so voluntarily, and there is no requirement for 
renewing participation in the VIS.  However, we encourage U.S. agents who use the VIS to 
regularly review their information to ensure it is up-to-date and to also review the facilities 
associated with their identification number in the VIS that they are representing. If the U.S. agent 
fails to update their information within 60 days of a change, FDA would consider the foreign 
facility registration to be out-of-date because facilities must update their registration within 60 
calendar days of any change to any of the required registration information (21 CFR 1.234(a)).  
Question: What is the process for U.S. agents to notify FDA if they are no longer serving as the 
U.S. agent for a foreign facility?  
 
Answer: The U.S. agent may notify FDA of its intention by sending an e-mail to 
FURLS@FDA.gov. This e-mail should include the information previously provided on the 
registration form regarding the U.S. agent (i.e., name, address, phone number, email address) and 
the name(s) and either address(es) or registration number(s) of the facility or facilities from 
which the U.S. agent wishes to be removed. Alternatively, U.S. agents who have VIS accounts 
may decline/reject facility assignments via their VIS profile. The facility will be notified that 
they are no longer serving as their U.S. agent and asked to find another agent within 60 calendar 
days. 
  Contains Nonbinding Recommendations