FDAs  
Voluntary Qualified Importer 
Program 
 
Guidance for Industry 
 
Additional copies are available from:  
Office of Enforcement and Import Operations 
Office of Regulatory Affairs  
Office of Global Regulatory Operations and Policy  
Food and Drug Administration  
12420 Parklawn Drive  
Rockville, MD  20857  
(Tel) 301-796-0356  
https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-rules-guidance-
industry 
You may submit either electronic or written comments regarding this guidance at any 
time.  Submit electronic comments to http://www.regulations.gov.  Submit written 
comments to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.  All comments 
should be identified with the docket number listed in the notice of availability that 
publishes in the Federal Register.  
 
For questions regarding this document, contact Office of Enforcement and Import 
Operations (ELEM-3108), Office of Regulatory Affairs, Food and Drug Administration, 
at 301-796-0356.  
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Office of Regulatory Affairs  
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine  
 
July 2023 
 
 
OMB Control No. 0910-0840 
Current expiration date available at 
https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0910-0840 
See additional PRA statement in Section IV of this guidance 
 
  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  Introduction ................................................................................................ 3 
II. Background ................................................................................................ 4 
III. Questions and Answers ............................................................................. 4 
A. Voluntary Qualified Importer Program Benefits ................................... 5 
B. Importer .................................................................................................. 7 
C. Eligibility ................................................................................................ 8 
D. Foreign Supplier Facility Certification................................................. 10 
E. VQIP Application ................................................................................. 12 
F. VQIP Quality Assurance Program ........................................................ 14 
G. Application Period and VQIP Fiscal Year ........................................... 18 
H. FDA VQIP Application Review ........................................................... 19 
I. VQIP Application Amendments ............................................................ 21 
J. VQIP User Fees ..................................................................................... 22 
K. Revocation of VQIP Participation ........................................................ 23 
L. Reinstatement of VQIP Participation ................................................... 25 
IV. Paperwork Reduction Act of 1995 ......................................................... 26 
V.  Document History ................................................................................... 28 
 
   
  2  Contains Nonbinding Recommendations 
 
FDAs  
Voluntary Qualified Importer Program 
 
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) 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 listed on the title page.  
 
I.  Introduction 
 
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables the Food 
and Drug Administration (FDA or the Agency) to better protect public health by helping 
to ensure the safety and security of the food supply.  It enables FDA to focus more on 
preventing food safety problems rather than relying primarily on reacting to problems 
after they occur.  FSMA recognizes the important role industry plays in ensuring the 
safety of the food supply, including the adoption of modern systems of preventive 
controls in food production.  Under FSMA, those that import food have a responsibility 
to ensure that their suppliers produce food that meets U.S. safety standards.   
FSMA also requires FDA to establish a voluntary, fee-based program for the expedited 
review and importation of foods from importers who achieve and maintain a high level of 
control over the safety and security of their supply chains.  This control includes 
importation of food from facilities that have been certified in accordance with FDAs 
program for Accreditation of Third-Party Certification Bodies to Conduct Food Safety 
Audits and to Issue Certifications (see FDAs third-party certification regulations at 21 
CFR part 1, subpart M), as well as other measures that support a high level of confidence 
in the safety and security of the food they import.  Expedited entry incentivizes importers 
to adopt a robust system of supply chain management and further benefits public health 
by allowing FDA to focus its resources on food entries that pose a higher risk to public 
health. 
 
This guidance document describes FDAs policy regarding participation in FDAs 
Voluntary Qualified Importer Program (VQIP) by importers of food for humans or 
animals.  This document provides guidance on: 
  The benefits VQIP importers can expect to receive; 
  The eligibility criteria for VQIP participation;  
  Instructions for completing a VQIP application; 
  Conditions that may result in revocation of participation in VQIP; and 
  Criteria for VQIP reinstatement following revocation.  
 
  3  Contains Nonbinding Recommendations 
 
This guidance document is presented in question and answer format.  This guidance 
document may be modified (in accordance with FDAs good guidance practice regulation 
(21 CFR 10.115)) as VQIP is implemented and evaluated.  FDAs guidance documents, 
including this guidance, do not establish legally enforceable responsibilities.  Instead, 
guidance describes the Agencys 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 Agency guidance means that something is suggested or 
recommended, but not required.  This guidance represents FDAs current thinking 
regarding what will be considered for participation in VQIP and how VQIP will expedite  
entry of imports.  However, we will consider alternative approaches and, as further 
discussed in this document, we retain our full authority with regard to import sampling 
and entry decisions. 
The pronouns I, me, you, and your are used in this guidance to refer to the 
importer who may want to participate in VQIP.  Agency and the pronouns we and 
our are used to refer to FDA.  The term food has the meaning given in section 201(f) 
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321(f)), except 
that, for the purposes of VQIP, food does not include pesticides as defined in 7 U.S.C. 
136(u).  
II. Background 
 
FSMA amended the FD&C Act by adding new section 806, Voluntary Qualified 
Importer Program (21 U.S.C. 384b).  Section 806(a)(1) requires FDA to establish the 
following: 
  A program for the expedited review and importation of food offered for 
importation by importers who voluntarily agree to participate in VQIP, and 
  A process, consistent with section 808 of the FD&C Act (21 U.S.C. 384d), for the 
issuance of a facility certification to accompany a food offered for importation by 
importers participating in VQIP.   
 
Section 806(a)(2) of the FD&C Act requires FDA to issue a guidance document related to 
participation in, revocation of such participation in, reinstatement in, and compliance 
with VQIP.  Section 806(d) states that in reviewing and making determinations on VQIP 
applications, FDA must consider the risk of the food to be imported based on factors such 
as the compliance history of the foreign supplier and the food safety practices of the 
importer. 
 
In accordance with section 806(a)(2) of the FD&C Act, FDA is issuing this guidance to 
provide information on the process for expedited review and importation of food under 
VQIP, the issuance of facility certifications required to accompany food imported under 
VQIP, the submission and review of VQIP applications (taking into account the factors 
set forth in section 806(d)), and other matters related to participation in, and compliance 
with, VQIP. 
 
III. Questions and Answers  
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A. Voluntary Qualified Importer Program Benefits 
 
A.1 What are the benefits of VQIP participation? 
 
Importers participating in VQIP will receive the following benefits: 
  FDA will expedite entry into the United States for all foods included in an 
approved VQIP application (VQIP foods).  FDA will set screening in its 
Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting 
(PREDICT) import screening system to recognize shipments of food which are 
the subject of an approved VQIP application to expedite the entry of such food.  
The system is designed to recognize the information and release the shipment 
immediately after the receipt of entry information, unless examination and 
sampling are necessary for public health reasons.  (See Question A.5.)  
  FDA will limit examination and/or sampling of VQIP food entries to for cause 
situations (i.e., when the food is or may be associated with a risk to the public 
health), to obtain statistically necessary risk-based microbiological samples, and 
to audit VQIP.  (See Question A.5.)   
  In the examination and/or sampling circumstances identified in the previous 
bullet, FDA will attempt, to the extent possible, to examine an entry and collect 
samples at the VQIP food destination or other location preferred by the VQIP 
importer.  If exportation is warranted, FDA will assist in fulfilling an importers 
request to U.S. Customs and Border Protection (CBP) to export from the port 
preferred by the importer. 
  FDA will expedite its laboratory analysis of for cause or audit samples of VQIP 
entries, to the extent possible in accordance with public health priorities. 
  FDA will maintain a VQIP Importers Help Desk dedicated to responding to 
questions and resolving issues raised by VQIP importers about VQIP food and 
this guidance document.  The VQIP Importers Help Desk will be available for 
assistance with completing the VQIP application and facilitating review of VQIP 
food that does not receive an immediate release.  
  FDA will post a publicly available list of approved VQIP importers on FDAs 
VQIP Web page at https://www.fda.gov/food/importing-food-products-united-
states/voluntary-qualified-importer-program-vqip.  VQIP importers may choose 
not to be listed on the VQIP importers list.  A VQIP importers decision to opt out 
of being listed on the publicly available list of approved VQIP importers will not 
have any effect on its participation. 
 
The Agency may suspend any or all of these benefits as necessary to protect public health 
or in the case of an unforeseen emergency. 
 
 
 
 
A.2 When will I receive the VQIP benefits? 
 
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VQIP benefits will begin October 1 following your acceptance into the program and will 
last through September 30 of the following year (VQIP fiscal year), except as noted in 
Question H.4.  (See Section E and Section G for VQIP application information.) 
 
A.3 What information should be submitted at entry to identify a VQIP food? 
 
In addition to the entry data elements you normally transmit during the import process, 
you should provide the VQIP Affirmation of Compliance (AofC) code and your VQIP 
application number to identify the entry as a VQIP food.  (See Question H.9 and VQIP 
Portal User Guide https://www.fda.gov/media/113346/download.)   For each VQIP food 
entry, you should ensure the import entry information matches the information in your 
VQIP application for the food.   
 
A.4 Will FDA expedite entry of a VQIP food that is part of a mixed entry (i.e., the entry 
includes VQIP food and food that is not covered by my VQIP)? 
 
FDA will expedite only the line entry associated with the VQIP food.  A non-
participating food will be subject to normal FDA line entry review procedures, including 
routine examination and sampling, when applicable.  Although FDA will attempt, to the 
extent possible, to expedite the entry of the VQIP food, entry delays may occur for a 
VQIP food that cannot be readily separated from a non-VQIP food to allow for FDA 
examination or sampling of the non-VQIP food.  For this reason, it may be beneficial to 
ensure that VQIP foods can be easily segregated from non-VQIP foods and moved into 
commerce. 
 
A.5 Under what circumstances will FDA examine or sample a VQIP food?   
 
A VQIP food may be subject to for cause examination when we determine the food is 
or may be associated with a risk to public health.  For example, during an investigation of 
an outbreak or illness associated with the type of food or with a foreign supplier covered 
by your approved VQIP application, FDA may examine and sample the VQIP food, even 
if there is no specific information implicating the VQIP food in the outbreak or illness.  
VQIP food may, at times, also be subject to microbiological sampling related to specific 
risk-based surveillance assignments.  However, surveillance sampling of a VQIP food 
will be a low priority and FDA may exclude VQIP food from such sampling altogether if 
we can obtain adequate statistically-based, non-biased, non-VQIP food samples.  If 
surveillance sampling of a VQIP food is necessary, FDA will collect a domestic-import 
sample (i.e., collect the sample after the food has been released from import status and 
entered into domestic commerce).   FDA may also periodically conduct audit 
examinations, which may include sampling and a review of the labeling as it relates to the 
risk of the food, to verify your compliance with VQIP.  A sample collected under this 
type of audit examination will also be collected as a domestic-import sample.  Thus, 
surveillance sample collection will not delay entry of the VQIP food.  FDA laboratories 
will schedule sample analyses to ensure that a VQIP food sample receives priority over 
non-VQIP food samples collected during the investigation, to the extent possible in 
accordance with public health priorities.  The FDA VQIP Importers Help Desk will be 
  6  Contains Nonbinding Recommendations 
 
available for assistance regarding the status of VQIP foods undergoing review or analysis 
to minimize delays. 
 
A.6 Will FDA work with CBP to facilitate resolution of entry-related matters for VQIP 
foods under CBPs control? 
 
FDA will work with CBP to provide expedited entry for VQIP foods.  If you encounter 
an entry delay by CBP and you believe FDA can help to facilitate a resolution with CBP, 
you may contact the FDA VQIP Importers Help Desk for assistance.  (See Question A.1.) 
 
B. Importer 
 
B.1 Who can participate in VQIP? 
 
You must be a food importer to participate in VQIP.  For the purposes of VQIP, the 
importer is defined as the person that brings food, or causes food to be brought, from a 
foreign country into the customs territory of the United States (section 806(g) of the 
FD&C Act).  A VQIP importer can be located outside the United States.  Persons who 
may be a VQIP importer include the manufacturer, owner, consignee, and importer of 
record of a food, provided that the importer can meet all the criteria for participation 
described in this guidance. 
 
B.2 Should I be the importer of record to be a VQIP importer? 
 
As a VQIP importer you may also be, but need not be, the CBP importer of record.  CBP 
defines the importer of record for a food as the person or firm responsible for making 
entry and payment of import duties, fees, and taxes for the food.  Under 19 U.S.C. 
1484(a)(2)(B), the importer of record can be the owner or purchaser of the food or, when 
designated by the owner, purchaser, or consignee, a broker licensed by CBP.     
 
B.3 Is the VQIP importer the same as an importer under other FDA regulations 
applicable to importers of food? 
 
The VQIP importer may be, but is not necessarily, the same as an importer as defined in 
the Foreign Supplier Verification Program (FSVP) regulations or the juice and seafood 
hazard analysis and critical control point (HACCP) regulations.  For the purposes of this 
guidance, the FSVP or HACCP importer means the importer who, for a specific food, is 
subject to the importer requirements in FDAs FSVP regulation, (21 CFR part 1, subpart 
L) or the requirements applicable to importers in the juice or seafood HACCP regulations 
(21 CFR 120.14 and 123.12, respectively).  Under both the FSVP and the HACCP 
importer regulations, the importer is the U.S. owner or consignee at the time of entry into 
the United States or the U.S. agent or representative of the foreign owner or consignee at 
the time of entry into the United States (21 CFR 1.500 (FSVP)); 21 CFR 120.3(h) (juice 
HACCP); and 21 CFR 123.3(g) (seafood HACCP)).  An FSVP or HACCP importer must 
be located in the United States.  When the FSVP or HACCP importer for a food is a U.S. 
agent or representative for the foreign owner or consignee, the U.S. agent or 
  7  Contains Nonbinding Recommendations 
 
representative is responsible for meeting the FSVP or HACCP requirements with respect 
to that food. 
 
However, as stated in Question B.1, a VQIP importer does not have to be located in the 
United States.  If you are a VQIP importer that is located in the United States, you may 
also be the FSVP or HACCP importer.  If you are a VQIP importer who is also the FSVP 
or HACCP importer for the food, you should meet the requirements of the applicable 
FSVP or HACCP regulations.  Otherwise, you should ensure that the applicable 
requirements are met by the FSVP or HACCP importer.  (See Question C.1, number 6.) 
 
C. Eligibility 
 
C.1 What are the eligibility criteria for participation in VQIP? 
 
To be eligible to participate in VQIP, you should meet all of the following criteria, some 
of which are discussed in more detail in questions cross-referenced in a particular 
criterion: 
1.  You have at least a 3-year history of importing food into the United States.  Your 
import history may be based on the shared importation history of previous or 
parent companies, such as those that have been involved in a merger. Your import 
history is based on importation of all foods, including food that may not be 
covered under VQIP. 
2.  You have a Dun & Bradstreet (D&B) Data Universal Numbering System (DUNS) 
number.  (See Questions E.3 and E.4.) 
3.  You use paperless filers/brokers who received acceptable results during their last 
FDA Filer Evaluation.  (See Question E.10.)  The filer/broker is the person 
responsible for (1) submitting entry and entry summary data on the food into the 
Automated Commercial System (ACS) or Automated Commercial Environment 
(ACE) and (2) submitting import documents into the International Trade 
Auxiliary Communication System (ITACS) or through CBPs Document Imaging 
System (DIS). 
4.  No food you import, including a food you do not intend to include under VQIP, is 
subject to detention without physical examination under an Import Alert or a 
Class 1 recall at the time you submit your application. 
5.  Neither you nor the non-applicant entities associated with a VQIP food are subject 
to an ongoing FDA administrative or judicial action (e.g., Import Alert, 
injunction, debarment), or have a history of significant non-compliances relating 
to food safety (e.g., an Official Action Indicated (OAI) FDA inspection 
classification with no documentation of appropriate corrective actions; one or 
more voluntary Class 1 recalls relating to food safety).  Non-applicant entities 
are those entities associated with a VQIP food that conduct activities throughout 
the supply chain necessary for ensuring that the eligibility requirements of VQIP 
are met.  Non-applicant entities associated with a VQIP food include, but are not 
limited to, the FSVP or HACCP importer of the food (if other than you), the 
foreign supplier of the food, and the filer/broker. 
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6.  If you are the FSVP or HACCP importer for a VQIP food, you are in compliance 
with the supplier verification and other importer responsibilities under the 
applicable FSVP, juice HACCP, or seafood HACCP regulations.  If you are not 
the FSVP or HACCP importer for a VQIP food, you identify the FSVP or 
HACCP importer for the food and ensure that the FSVP or HACCP importer is in 
compliance with the applicable FSVP or HACCP regulations. 
7.  You have a current facility certification issued in accordance with FDAs third-
party certification program for each foreign supplier of food you intend to import 
under VQIP.  (See Question D.1.)  
8.  You develop and implement a VQIP Quality Assurance Program (QAP).  Your 
written QAP is submitted with your VQIP application.  (See Section F.) 
9.  Within the past 3 years, you have not been the subject of any CBP penalties, 
forfeitures, or sanctions that are related to the safety or security of any FDA-
regulated product that you imported or offered for import.  (See 
http://www.gpo.gov/fdsys/pkg/USCODE-2011-title18/pdf/USCODE-2011-
title18-partI-chap47-sec1001.pdf for information about the types of fines and 
penalties levied by CBP.) 
10. You pay the annual VQIP user fee before October 1 of the year in which you 
intend to participate.  (See Question J.2.) 
  
C.2 May I obtain the food I import under VQIP from any foreign supplier? 
 
Yes.  You may obtain the food you import under VQIP from any foreign supplier, 
provided the foreign supplier is not subject to detention without physical examination 
under an Import Alert and has a current food facility certification issued by a third-party 
certification body accredited under section 808 of the FD&C Act and in accordance with 
FDAs third-party certification regulation.  For the purposes of VQIP, the foreign 
supplier will be the same as in the FSVP regulation, meaning that for an article of food, 
the establishment that manufactures/processes the food, raises the animal, or grows the 
food that is exported to the United States without further manufacturing/processing by 
another establishment, except for further manufacturing/processing that consists solely of 
the addition of labeling or any similar activity of a de minimis nature (see 21 CFR 1.500 
(definition of foreign supplier)). 
 
C.3 Why should I have at least 3 years of experience importing food into the United 
States to participate in VQIP? 
 
FDA believes 3 years of food import history is the minimum needed to adequately 
evaluate your application for participation in VQIP.  FDA will review the history for all 
food you imported into the United States during the past 3 years, not just the food you 
wish to import under VQIP.  If you have imported food for more than 3 years, we may 
extend our review to additional years as necessary to adequately evaluate your 
compliance history.  For example, if you have infrequently imported foods for 5 years, 
we may review your entire 5-year import history.  Also, for example, if we find violations 
relating to the food, foreign supplier, or importer during the past 3 years, we may review 
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more than 3 years of your import history to evaluate your history of follow-up actions for 
achieving compliance. 
 
C.4 Should I be a participant in CBPs Customs-Trade Partnership Against Terrorism (C-
TPAT) program to be eligible to participate in VQIP? 
 
Participation in C-TPAT is not directly linked to participation in VQIP.  However, FDA 
encourages you to participate in C-TPAT to ensure the food you import under VQIP also 
receives entry benefits provided by CBP under C-TPAT.  Food security and food defense 
for VQIP are discussed further below in Question F.3, V. Food Defense Policies and 
Procedures. 
 
D. Foreign Supplier Facility Certification 
 
D.1 What certification for a foreign supplier do I need to have? 
 
Under section 806(d) of the FD&C Act, you must have a facility certification issued 
consistent with section 808 of the FD&C Act regarding accreditation of third-party 
certification bodies, also known as auditors, for each foreign suppliers facility from 
which you want to import a food under VQIP.  For the purposes of section 808 of the 
FD&C Act, facilities are not limited to registered facilities under section 415 of the 
FD&C Act (e.g., a farm is a facility for purposes of VQIP) (see 21 CFR 1.600 (definition 
of facility)).  The foreign suppliers facility must have a facility certification, which 
would be issued following a regulatory audit conducted by a third-party certification 
body accredited under FDAs third-party certification regulations (accredited 
auditor/certification body (see 21 CFR 1.653)).  Either you or the foreign supplier may 
request the regulatory audit required for facility certification. 
 
An FDA inspection of the foreign supplier would not meet the requirement under section 
806(d) of the FD&C Act because an FDA inspection does not result in a facility 
certification consistent with section 808 of the FD&C Act as stated in section 806(d).  
 
D.2 What is a facility certification? 
 
A facility certification is an attestation, issued for purposes of section 801(q) or 806 of 
the FD&C Act by an accredited third-party certification body, after conducting a 
regulatory audit and any other activities necessary to establish whether a facility complies 
with the applicable food safety requirements of the FD&C Act and FDA regulations.  
Any food that an importer wishes to be covered under VQIP should be within the scope 
of the facility certification. 
 
D.3 What is a regulatory audit? 
 
A regulatory audit, for purposes of VQIP, is an audit of a foreign suppliers facility by an 
accredited third-party certification body, in accordance with FDAs third-party 
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certification regulation.  The results of the audit are used to determine whether a foreign 
supplier is eligible for a facility certification, as described in Question D.2. 
 
D.4 Can I import a raw agricultural commodity under VQIP? 
 
Yes, you can import a raw agricultural commodity under VQIP.  You must have a current 
facility certification for the farm.  (See Question D.1.)  You should include in your VQIP 
application the certification number assigned by the accredited third-party certification 
body who issued he facility certification.   
 
D.5 Must I include a copy of the foreign suppliers facility certification in my VQIP 
application? 
 
No.  However you must provide the certification number assigned by the accredited 
certification body who issued the facility certification.  FDA will use the certification 
number you provide in your application to verify there is a current foreign supplier 
facility certification.   
 
D.6 How often must a foreign suppliers facility from which I import food under VQIP 
be re-certified? 
 
Under section 808(d)(1) of the FD&C Act, to maintain eligibility for importation under 
VQIP, the foreign supplier of a VQIP food must obtain re-certification annually.  Further, 
under FDAs third-party certification regulation, an accredited certification body may 
issue a certification for a term of up to 1 year, (21 CFR 1.653(b)(1)).  Although FDA 
anticipates that most foreign supplier facility certifications will have a term of 1 year, an 
accredited certification body may find it appropriate in some circumstances to issue the 
certification for a shorter term (e.g., based on seasonal productions).  This may require 
the facility to be re-audited and re-certified more frequently (e.g., when there are multiple 
seasonal productions during a year).   
 
D.7 What should I do if a foreign suppliers facility certification expires during the VQIP 
fiscal year? 
 
You are responsible for ensuring that all foreign supplier facility certifications on which 
you rely in your VQIP application are current.  Therefore, you should manage your 
facility certifications to ensure that your certification is current.  You should coordinate 
with your foreign supplier to ensure a third-party regulatory audit is conducted and a 
current facility certification is issued before the expiration of a certification you 
referenced in your VQIP application.  If you encounter circumstances that prevent you 
from obtaining a new certification by the time a current certification expires, you should 
promptly inform FDA that you are in the process of getting the new facility certification.  
You should update your VQIP application with the current certification number.  FDA 
will initiate revocation of your participation in VQIP if you import under VQIP a food 
that is not covered by a current facility certification.  (See Question K.1.)  If you 
determine you will no longer import a food under VQIP after the certification for the 
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facility producing the food expires, you should remove the food from your VQIP 
application when the certification expires. 
 
E. VQIP Application 
 
E.1 How do I submit an application to participate in VQIP? 
 
To submit an application to participate in VQIP, you will: 
a.  Establish an online account on the FDA Industry Systems Web site at 
www.access.fda.gov.  The information in your online account will autopopulate 
into your VQIP application.  You can update or change information in your online 
account at any time. 
b.  Each year, between January 1 at 12:00 a.m. Eastern Standard Time (EST) and 
May 31 at 11:59 p.m. EST, submit, online, a Notice of Intent to Participate in 
VQIP and your application to participate in VQIP during the next fiscal year, 
beginning October 1 (section 806(c) of the FD&C Act).    
 
Additional information on completing and submitting a VQIP application is provided in 
Section G.  (See VQIP Portal User Guide https://www.fda.gov/media/113346/download.) 
 
E.2 What information will I need to complete my VQIP application? 
 
The VQIP application is divided into Sections A-G as follows: 
Section A.  Applicant and Firm Information 
Section B.  Foreign Supplier Verification Program (FSVP) and Hazard Analysis 
and Critical Control Point (HACCP) Importer Information 
Section C.  Quality Assurance Program 
Section D.  Filer/Broker Information 
Section E.  Foreign Supplier Facilities and Foods 
Section F.  Comments 
Section G.  Summary 
Section H.  e-Signature   
 
To complete your application, you will need information to accurately fill in the fields in 
each section of the online VQIP application.  You will also need to attach your QAP.  A 
VQIP tutorial and resources for completing your application will be posted on FDAs 
VQIP Web page at https://www.fda.gov/food/importing-food-products-united-
states/voluntary-qualified-importer-program-vqip.  (See VQIP Portal User Guide 
https://www.fda.gov/media/113346/download.) 
 
E.3 What is a DUNS number?   
 
A DUNS number is a unique nine-digit business identification number provided by the 
company D&B.  Upon request, D&B will assign a DUNS number for each physical 
location of a business.  
 
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E.4 How may I obtain a DUNS number? 
   
You may obtain a DUNS number by contacting D&B at 866-705-5711 or via e-mail to 
govt@dnb.com.  All entities doing business with the U.S. government can receive a 
DUNS number free of charge.  Although a DUNS number may be obtained within a few 
business days, in some circumstances it could take up to 45 days or more. 
 
E.5 How is a DUNS number used in my VQIP application? 
 
For VQIP, FDA will use the DUNS number as the unique identifier for your specific 
location and for each non-applicant entity listed in your VQIP application (e.g., foreign 
suppliers, filers/brokers, and FSVP and HACCP importers).  You will provide your 
DUNS number in your application.  In addition, you will enter the address or DUNS 
number for each non-applicant entity listed in your VQIP application.  If you enter the 
address, the system will autopopulate the DUNS number, if available.  If you enter the 
non-applicant entities DUNS numbers, the system will autopopulate the address fields. 
 
E.6 How long will my draft application be maintained in the VQIP application system? 
 
FDA will maintain your draft application in the online VQIP application system for 2 
years after the last date that you saved the draft until you complete and submit your 
application.  After you complete and submit your application, a draft will no longer be 
available. 
 
E.7 Will I be informed of FDA changes to the status of my VQIP application? 
 
Yes.  FDA will send an email to the contact person provided in your VQIP application 
when the status of your application changes.  Also, you may check the status of your 
application on your VQIP Application home page at http://www.access.fda.gov.  The 
status will be indicated as one of the following, as applicable: 
Draft, Not Submitted 
Submitted 
Approved 
Disapproved 
Notice of Intent to Revoke 
Notice of Revocation 
Revoked  
 
E.8 Do I need to resubmit my VQIP QAP each year that I apply for VQIP? 
 
No.  You do not need to resubmit your VQIP QAP each year that you submit a VQIP 
application if there are no changes to the QAP last submitted to the Agency.  However, 
you should ensure that your QAP is current and promptly submit updates to your VQIP 
QAP food safety and food defense policies and procedures, as applicable, as you make 
changes throughout the VQIP fiscal year.  As part of the application process, you will 
confirm that your QAP is current. 
  13  Contains Nonbinding Recommendations 
 
 
E.9 How can I obtain information for determining my filer/brokers compliance status 
with FDA? 
 
The FDA Filer Evaluation Program monitors the accuracy of entry data transmitted 
electronically to FDA by filers/brokers.  The best way to determine the status is to build a 
relationship with the filer/broker.  They can provide you with the latest FDA evaluation  
results.  You may also obtain information about a filer/brokers compliance status from 
FDA Filer Evaluation Outcomes at https://www.fda.gov/industry/actions-
enforcement/filer-evaluations#outcome.   
 
E.10 Can I use a filer/broker whose compliance status is not on the FDA Filer Evaluation 
Outcomes list? 
 
A filer/broker who is not listed on FDA Filer Evaluation Outcomes list has not been 
evaluated by FDA.  If your filer/broker has not been evaluated by FDA when you apply, 
you or the filer/broker may request FDA to conduct a filer evaluation.  The results of the 
evaluation will be included in the list of FDA Filer Evaluation Outcomes after FDA 
completes the evaluation.  If the filer/broker received acceptable results for its FDA Filer 
Evaluation, you may use the filer/broker for VQIP entries.   
 
E.11 How can I contact FDA about my VQIP application? 
 
You may contact the VQIP Importers Help Desk for assistance in completing your VQIP 
application.  
 
Refer to the contact information on FDAs VQIP Web page at 
https://www.fda.gov/food/importing-food-products-united-states/voluntary-qualified-
importer-program-vqip for the most up to date links, phone number, and email contact 
information. 
 
You may also check the status of your application on your VQIP Application home page 
at http://www.access.fda.gov. 
 
F. VQIP Quality Assurance Program 
 
F.1 What is a VQIP Quality Assurance Program (QAP)? 
 
Your VQIP QAP is a compilation of the written policies and procedures you will use to 
ensure adequate control over the safety and security of the foods you import.  You may 
use any format to organize your QAP to include all foods and all of your written policies 
and procedures under your VQIP.   
 
F.2 May I use written policies and procedures that are in my existing quality assurance 
program and that also apply to VQIP? 
 
  14  Contains Nonbinding Recommendations 
 
Yes, you may submit your existing written policies and procedures that satisfy the 
requirements of the VQIP QAP.  If you submit a QAP that includes but is not limited to 
the policies and procedures that are applicable to your VQIP QAP, you should identify 
the specific policies and procedures that you are submitting for your VQIP QAP.  For 
example, you may provide a list of references to each applicable document title and page 
number under each QAP heading.  Your QAP should cover all foods you wish to import 
under VQIP.  Your QAP is submitted as part of your VQIP application.  (See Question 
E.8.) 
 
F.3 What should be included in my VQIP QAP? 
 
Your VQIP QAP should include the following components, as applicable: 
 
I. Table of Contents 
 
Provide a Table of Contents that lists the information included in your VQIP QAP.  
 
II. Corporate Quality Policy Statement  
 
Provide your corporate quality policy statement relating to food safety and security 
throughout the supply chain.  Explain how the quality policy is communicated to all 
employees throughout the organization and to non-applicant entities involved in 
implementing your VQIP QAP.  Describe how you will ensure that employees and non-
applicant entities receive and understand the corporate quality policy statement. 
 
III. Organizational Structure and Functional Responsibilities  
 
Provide an organizational chart or written explanation of the management structure of 
your organization, including those responsible for implementing your VQIP QAP.    
Provide a written explanation of the functional responsibilities for individuals within your 
organization involved in developing, implementing, and maintaining your VQIP QAP, 
including the name and title of the individual who has responsibility for administering 
your VQIP QAP.   
 
Identify the functional responsibilities of the non-applicant entities needed to implement 
your VQIP QAP and how those responsibilities are communicated from your 
organization to those entities (e.g., contracts).  For example, identify your foreign 
suppliers responsibility relating to conducting a recall of a non-compliant imported food 
distributed in the United States.  
 
IV. Food Safety Policies and Procedures  
 
Provide a written description of the policies and procedures you will implement to ensure 
food safety from source to entry into the United States (e.g., temperature and storage 
controls).  Include policies and procedures documents in your VQIP QAP, as follows: 
  15  Contains Nonbinding Recommendations 
 
  If the food is subject to the FSVP or HACCP importer regulations and you are the 
FSVP or HACCP importer, provide a statement affirming you have established 
procedures to ensure compliance with applicable FSVP or HACCP regulations.   
  If the food is subject to the FSVP or HACCP importer regulations and you are not 
the FSVP or HACCP importer, include procedures for ensuring the FSVP or 
HACCP importer is in compliance with the applicable FSVP or HACCP 
regulations.  For example, your procedures may include:   
  determining that an FSVP or HACCP importer is not subject to an FDA 
o
enforcement action  
  obtaining annual written assurance or attestation from an FSVP or 
o
HACCP importer that they are in compliance with the applicable FSVP or 
HACCP regulations.  
  Provide written procedures for maintaining current foreign supplier certifications 
required under section 806(d) of the FD&C Act and any applicable food 
certifications required under section 801(q) of the FD&C Act (21 U.S.C. 381(q)). 
  Provide your procedures for controlling the safety of each VQIP food throughout 
the transportation supply chain, including compliance with FDAs sanitary 
transport rule, if applicable. 
  Provide written procedures for communicating information to FDA and others 
(e.g., non-applicant entities, consumers) relating to food and foreign supplier non-
compliances that pose a risk to public health.  Identify the scope of 
communications that will be limited to within the organization, and the criteria 
for, as appropriate, communicating non-compliances to your foreign supplier and 
other regulatory authorities (e.g., U.S. Federal, State, and local authorities and 
foreign authorities).  
  Provide written procedures for corrective actions to address food and foreign 
supplier non-compliances that pose a risk to public health.  Include procedures to 
trace and track non-compliant food,  prevent further distribution of the food, and  
initiate recall if necessary.  Also, include procedures for working with a non-
compliant foreign supplier to correct the problem, criteria for discontinuing use of 
a foreign supplier, and procedures to identify alternate suppliers for a food. 
 
V. Food Defense Policies and Procedures  
 
Provide a written description of your food defense system, as applicable.  You should 
provide your procedures for ensuring your foreign suppliers food defense system is in 
compliance with FDAs Mitigation Strategies to Protect Food Against Intentional 
Adulteration regulation (intentional adulteration regulation) (21 CFR part 121), if 
applicable.  In addition, you should provide your procedures for controlling the security 
of each VQIP food throughout the transportation supply chain.  Your food defense 
system policies and procedures do not need to include foods that are not subject to the 
intentional adulteration regulations.  If your food defense system includes participation in 
CBPs C-TPAT (Level 2 or Level 3) and you acknowledge your participation in C-TPAT 
in your application, you do not need to provide additional information regarding your 
transportation food defense procedures. 
 
  16  Contains Nonbinding Recommendations 
 
VI. Qualifications  
 
Identify the qualification requirements for employees responsible for implementing the 
VQIP QAP.  Include: 
  Requirements relating to knowledge of the FD&C Act and implementing 
regulations that apply to the foods and the foreign suppliers of foods you import 
under VQIP (e.g., current good manufacturing practices (CGMPs), produce 
safety, FSVP, preventive controls, juice HACCP, seafood HACCP, low-acid 
canned food, intentional adulteration, sanitary transport, and food labeling), and 
  The qualifications (e.g., knowledge, skills, and training) required for each 
employee who has responsibilities relating to developing, implementing, and 
maintaining the QAP. 
 
VII. QAP Implementation 
 
Provide your procedures for ensuring your VQIP QAP is current and appropriately 
implemented, including procedures for auditing and updating the QAP and for providing 
updates to the QAP in your VQIP application. 
 
VIII. Records 
 
Provide your written procedures for establishing and maintaining records relating to the 
structure, processes, procedures, and implementation of your VQIP QAP.  Your 
procedures should specify that all written records relating to establishing and maintaining 
your QAP are to be legible and made available to FDA upon request.  You may keep 
records in a language other than English.  However, you will need to provide FDA with 
an English translation of any requested records within a reasonable time.  
 
  The QAP structure, processes, and procedures documents: 
  Should be signed and dated by the individual who has overall 
o
responsibility for the QAP. 
  Should indicate their effective date. 
o
  Should be maintained for as long as they are in effect.   
o
  The records you establish and maintain to implement your QAP: 
  Should be signed and dated by the responsible individual, as indicated in 
o
your QAP. 
  Should be maintained for at least 2 years after they are created. 
o
 
IX. Definitions 
 
Define terms used in your VQIP QAP, as necessary to facilitate understanding and 
implementation of the QAP. 
 
X. References 
 
  17  Contains Nonbinding Recommendations 
 
Provide references to information or sources used to develop and implement your QAP, 
as appropriate. 
 
G. Application Period and VQIP Fiscal Year  
 
G.1 When do I submit my VQIP application? 
 
You can submit your VQIP application between January 1 at 12:00 a.m. EST and May 31 
at 11:59 p.m. EST.  
 
G.2 When is the VQIP fiscal year? 
 
The VQIP fiscal year is the same as the U.S. Federal government's fiscal year, which 
begins October 1 at 12:00 a.m. EST and ends September 30 at 11:59 p.m. EST.  The 
VQIP fiscal year is the period for which approved VQIP applicants will receive benefits.  
 
G.3 Do I need to submit a new VQIP application each year? 
 
Yes.  You must submit an application for each fiscal year you want to participate in 
VQIP.  However, the online VQIP application system is designed to allow you to use 
data from the previous years application to populate your new application.  Prior to 
beginning the process of submitting a new application for a subsequent year, if you 
intend to use information from your current application, you should ensure that your 
current application is up-to-date (i.e., you have submitted all amendments that apply to 
your current application).  When you create your new application for a subsequent year, 
you can add a new food from a new foreign supplier and the required information relating 
to the new food.  (See VQIP Portal User Guide 
https://www.fda.gov/media/113346/download.) 
 
G.4 Will FDA send VQIP participants a reminder to submit an application for the next 
VQIP fiscal year? 
 
Yes.  It is the importers responsibility to submit a Notice of Intent to Participate and a 
new application if they intend to participate in VQIP during the next fiscal year.  In 
December of each year, FDA will send participating VQIP importers an email reminder 
of this responsibility.  
 
G.5 Will my VQIP application be kept confidential by FDA? 
 
We will protect confidential information in your VQIP application from disclosure, 
consistent with applicable statutes and regulations, including 5 U.S.C. 552(b)(4), 18 
U.S.C. 1905, and 21 CFR part 20.  We will share information in your application with 
other government agencies, such as CBP, in accordance with applicable law.  This will 
allow CBP to recognize VQIP applicants and the VQIP foods they offer for entry into the 
United States.  In addition, we will share the status of the application with other 
  18  Contains Nonbinding Recommendations 
 
government agencies, if appropriate.  This will be done in accordance with applicable 
statutes, regulations, and agreements between agencies. 
 
H. FDA VQIP Application Review 
 
H.1 How will FDA review my VQIP application? 
 
FDA will review your application for completeness and data accuracy and will evaluate 
your eligibility for VQIP in accordance with the criteria set forth in this guidance 
document.  FDA will review your compliance history and the compliance history of all 
foods and foreign suppliers listed in your VQIP application and all non-applicant entities 
associated with the import transaction within the supply chain for each food, including 
your filers/brokers.  FDA will also review your QAP to evaluate whether you are 
adequately controlling factors relating to the safety and security of the food you intend to 
import under your VQIP.   
 
If you are a C-TPAT participant, FDA will verify your participation in the C-TPAT 
program.  During a VQIP inspection, FDA may review your transportation food defense 
procedures.  If you are not in good standing with C-TPAT, we will consider whether 
factors relating to your C-TPAT participation status affect your eligibility for VQIP.  If 
you decide not to reapply for C-TPAT, your decision would only affect your VQIP 
eligibility if it was related to a food safety issue. 
 
H.2 Will FDA inform me of the reasons for disapproval if my application is not 
approved? 
 
Yes.  During FDA review of your application, if we identify deficiencies which you may 
be able to readily correct during the application period, we will permit you to correct the 
deficiencies.  However, if corrections are not made or FDA otherwise determines that 
you are not eligible to participate in VQIP, we will disapprove your application and 
inform you of the reasons for the disapproval.   
 
H.3 What are some reasons for FDA disapproval of my VQIP application? 
 
Some reasons for FDA disapproval of your application include: 
  Your application is incomplete;  
  Your QAP is inadequate (e.g., your policies and procedures do not ensure that 
food safety requirements are met);  
  You do not meet one or more of the VQIP eligibility requirements (see Question 
C.1) and you do not provide an adequate alternative or justification; 
  You provide inaccurate data or information; or  
  You make false or fraudulent statements in your application.    
 
H.4 Will FDA conduct an inspection before I receive VQIP benefits?   
 
  19  Contains Nonbinding Recommendations 
 
FDA ordinarily will conduct a VQIP inspection after your application is approved and 
prior to October 1 of the first year that you participate in VQIP.   However, if FDA does 
not complete the VQIP inspection prior to October 1, when the VQIP fiscal year begins, 
receipt of VQIP benefits will not be delayed pending that inspection, unless FDAs 
inspection is significantly delayed or prevented because of actions or omissions by the 
VQIP importer or by restrictions in travel or access to a foreign VQIP importer that 
prevent FDA inspection of a foreign VQIP importer (e.g., Department of State 
restrictions, safety concerns).      
 
H.5 What is the scope and purpose of the VQIP inspection? 
 
FDA will conduct a VQIP inspection to verify that you meet the VQIP eligibility criteria 
and have fully implemented the food safety and food defense systems established in your 
QAP.  The inspection will typically include a review of the written procedures and 
records demonstrating compliance with VQIP.  If you are both the VQIP and FSVP 
Importer for one or more foods you import under this program, FDA may also conduct an 
FSVP inspection to assess your compliance with the FSVP regulations.  FDA may also 
request a copy of food labels for the foods you include in your application, to determine 
if there are labeling violations relating to the risk of the food (e.g., failure to disclose an 
allergen).  You will be asked to address any label deficiencies.  FDA will notify you 
regarding the results of the VQIP inspection. 
 
H.6 What additional information may FDA ask me to submit during Agency review of 
my VQIP application?  
 
FDA may ask you to submit additional documentation to support your application.  For 
example, if you are the FSVP or HACCP importer, FDA may request a copy of the 
hazard analysis required under FSVP for a food listed on your VQIP application or the 
results of any laboratory tests used to comply with FSVP or HACCP regulations for a 
food listed on your VQIP application.  If you are not the FSVP or HACCP importer, FDA 
may request you to obtain the information from that importer.  FDA may also request 
copies of any food labels for foods included in your application, to determine if there are 
labeling violations relating to the risk of the food (e.g., failure to disclose an allergen). 
 
H.7 How will FDA contact me if the Agency needs additional information to support my 
VQIP application? 
 
If FDA needs additional information about your application, we will contact the person 
listed in your application via phone and email. 
 
H.8 How often will FDA evaluate me for VQIP eligibility? 
 
The first year that you submit a VQIP application, FDA will review all aspects of your 
application and conduct an inspection to verify your eligibility.  The inspection will 
ensure that you are implementing the food safety and food defense systems, if applicable, 
stated in your QAP.  It will also typically include a review of the labeling for your VQIP 
  20  Contains Nonbinding Recommendations 
 
food related to the risk of the food, and the written procedures and records demonstrating 
compliance with VQIP.  Thereafter, we will reevaluate your eligibility at least once every 
3 years that you participate in VQIP (section 806(e) of the FD&C Act).  An event such as 
an outbreak or recall linked to a food included in your VQIP application (or a similar 
food), a new hazard associated with a VQIP food, or intelligence data related to 
violations associated with one or more entities (e.g., foreign supplier, filer/broker) listed 
on your VQIP application may prompt FDA to reevaluate your eligibility, including 
conducting an inspection, more frequently than once every 3 years.  In addition, FDA 
will review and evaluate changes to your application as needed, including changes you 
make when you submit a new application.   
 
H.9 How will FDA inform me that my application is approved? 
 
After FDA approves your application, we will send an email to the contact person 
provided in your VQIP application. The message will include the VQIP Affirmation of 
Compliance (AofC) code you will use to identify entries of VQIP foods.  
 
This message may be used to provide confirmation of your participation in VQIP to other 
parties you do business with if you have chosen to opt out of being listed on the VQIP 
importers list.  
 
You may also check the status of your application on your VQIP Application home page 
at http://www.access.fda.gov. 
 
I. VQIP Application Amendments 
 
I.1 What amendments to my VQIP application should I make after the application is 
approved to ensure that I maintain eligibility to participate in VQIP? 
 
To maintain your eligibility in VQIP (see Question C.1) and avoid revocation, you should 
promptly amend your VQIP application to provide information or documentation when 
you take any of the following actions: 
  Remove a food listed on your VQIP application that is subject to an ongoing FDA 
administrative or judicial action (e.g., Import Alert, seizure). 
  Remove a foreign supplier listed on your VQIP application who is the subject of 
an ongoing FDA administrative or judicial action (e.g., Import Alert, injunction, 
suspension of registration). 
  Remove an FSVP or HACCP importer of a food who is the subject of an ongoing 
FDA administrative or judicial action (e.g., Import Alert, debarment). 
  Remove a filer/broker who does not meet the VQIP filer/broker requirements. 
  Provide updates to your QAP food safety or food defense policies or procedures  
(see Question F.3 regarding Food Safety Policies and Procedures and Food 
Defense Policies and Procedures). 
  Provide a current facility certification issued by an accredited auditor/certification 
body.   
  Provide information or documentation requested by FDA to correct deficiencies. 
  21  Contains Nonbinding Recommendations 
 
 
I.2 What amendments am I permitted to make to my VQIP application for business 
purposes during the VQIP fiscal year?  
 
As necessary for your business purposes, you can amend your VQIP application to: 
  Add a food from a foreign supplier already in your VQIP; 
  Remove a food, the foreign supplier of a food, or the FSVP or HACCP importer 
for a food; 
  Replace a foreign supplier or FSVP or HACCP importer for a food that is already 
listed in your VQIP application as long as the foreign supplier has a current 
facility certification as described in C.1.7; and 
  Add or remove a filer/broker.  
 
I.3 What changes to my VQIP application are not permitted during the VQIP year?   
 
During the VQIP fiscal year, you may not amend your application to add a new food 
from a foreign supplier who is not in your VQIP.  You may add a new food from a 
foreign supplier who is not in your VQIP when you submit your VQIP application for the 
subsequent VQIP fiscal year.  
 
I.4 What are the consequences if I do not submit to FDA changes I make to the food 
safety and food defense policies and procedures in my VQIP QAP? 
 
If FDA determines you made changes to your QAP food safety or food defense policies 
and procedures without promptly revising the QAP in your application, depending on the 
nature of the changes, FDA may initiate revocation of your participation in VQIP.  (See 
Question K.1.) 
 
J. VQIP User Fees  
 
J.1 Must I pay a user fee to participate in VQIP? 
 
Yes.  Section 743 of the FD&C Act (21 U.S.C. 379j-31) requires that each importer 
participating in VQIP pay a fee to cover FDAs costs of administering the program.  FDA 
will charge the VQIP user fee on an annual basis for each VQIP fiscal year that you are 
approved to participate in VQIP.  After FDA approves your application, you must pay the 
user fee before October 1, the start of the VQIP fiscal year, to begin receiving benefits for 
that VQIP fiscal year. 
 
J.2 What will happen if I do not pay the VQIP user fee before October 1?   
 
If you do not pay the user fee before October 1, you are not eligible to participate in 
VQIP.  For the first year your VQIP application is approved, if you do not pay the user 
fee before October 1, your VQIP benefits will not begin on October 1.  If you 
subsequently pay the user fee, FDA will begin your benefits after we receive the full 
payment.  For a subsequent year, if you do not pay the user fee before October 1, FDA 
  22  Contains Nonbinding Recommendations 
 
will send a Notice of Intent to Revoke your participation in VQIP.  If you do not pay the 
user fee within 30 days of the date of the Notice of Intent to Revoke, we will revoke your 
participation in VQIP.  (See Question K.1.) 
 
J.3 If FDA conducts the VQIP inspection after October 1 and finds deviations that may 
affect my eligibility to participate in VQIP, will the Agency refund the VQIP user fee? 
 
No. If FDA finds deviations after October 1 that may affect your eligibility to participate 
in VQIP, we will send you a Notice of Intent to Revoke your participation in VQIP.  The 
Notice of Intent to Revoke will indicate that you have 30 days to make corrections.  (See 
Question K.2.)   
 
J.4 If I withdraw from VQIP or FDA revokes my participation in VQIP, will I receive a 
refund of the VQIP user fee? 
 
No.  FDA will not refund the VQIP user fee for any reason. 
 
J.5 Where can I locate the VQIP user fee rates for current and past fiscal years?   
 
On or before August 1 each year, FDA will publish a Federal Register notice announcing 
the VQIP user fee schedule for the next VQIP year.  Current and past VQIP fiscal year 
user fee rates can also be found at https://www.fda.gov/industry/fda-user-fee-
programs/voluntary-qualified-importer-program-user-fees.  
 
K. Revocation of VQIP Participation  
 
K.1 Can FDA revoke my participation in VQIP? 
 
Yes.  FDA may: 
  Revoke your participation in VQIP based on evidence that you do not meet one or 
more of the VQIP eligibility requirements (see Question C.1), or 
  Immediately revoke your participation in VQIP based on evidence that you 
participated in smuggling or other fraudulent activities (see Question K.3).   
Revocation of your participation in VQIP will apply to all foods you import under VQIP.   
 
K.2 How will FDA notify me of a potential revocation of my participation in VQIP? 
 
If FDA has credible evidence that you do not meet one or more of the VQIP eligibility 
requirements, FDA will send a Notice of Intent to Revoke your participation in VQIP by 
email to the contact person identified in your VQIP application.  The Notice of Intent to 
Revoke will explain the basis for the proposed revocation.  The Notice of Intent to 
Revoke will indicate that, within 30 days of the date of the Notice of Intent to Revoke, 
you must make corrections and provide FDA with evidence of the corrections.  Benefits 
will continue for those 30 days unless FDA believes there is a risk to public health.  If all 
corrections cannot be made within 30 days, you can submit a corrective action plan that 
includes detailed steps and a timeline for correction.  If you do not respond or you do not 
  23  Contains Nonbinding Recommendations 
 
submit an adequate corrective action plan within 30 days, FDA will revoke your 
participation in VQIP.  FDA will send a Notice of Revocation by email to the contact 
person identified in your VQIP application.  Revocation of benefits will be effective on 
the date on which FDA sends the Notice of Revocation email.  If after revocation, you 
believe you have made corrections to support reinstatement, you may contact FDA. FDA 
will review your request to determine if your corrective actions support reinstatement of 
your benefits for the remainder of the VQIP fiscal year.  (See Section L.) 
 
If  FDA obtains credible evidence that you participated in smuggling or other fraudulent 
activities, FDA will immediately revoke your participation in VQIP.  Examples of 
activities that may lead to immediate revocation include declaring an entry as a VQIP 
food when it is not or otherwise attempting to smuggle a product into the United States.  
In such cases, FDA will send a Notice of Immediate Revocation to the contact person 
listed in your application.  The Notice of Immediate Revocation will identify FDAs 
reason for immediately revoking your participation in VQIP.  If you believe revocation 
was in error, you may contact FDA upon receipt of this notice.  Your VQIP participation 
and, thus, VQIP benefits will stop for all of your VQIP foods on the day that FDA sends 
the Notice of Immediate Revocation.  FDA will not reinstate your participation in VQIP 
for the remainder of the VQIP fiscal year.  FDA will not approve your VQIP applications 
for subsequent years, unless you provide sufficient evidence of affirmative steps to 
ensure that fraudulent activity does not occur again.  Additionally, revocation of VQIP 
participation does not prevent the Agency from taking other enforcement actions, if 
warranted. 
 
K.3 How might FDA learn of deviations that impact my participation in VQIP? 
 
FDA may obtain information relating to a potential deviation from the criteria for your 
VQIP participation through FDA activities (e.g., an FSVP inspection of a VQIP 
participant) or from other sources.  FDA will review information obtained to determine 
whether a deviation exists and, if so, whether the nature and scope of the deviation 
warrant the revocation of your VQIP eligibility.  Sources from which FDA may obtain 
information relating to potential deviations include:   
  You or other VQIP participants 
  FSVP and HACCP importers 
  Filers/brokers  
  Recall data and reportable food registry data 
  FDA inspection reports and laboratory analytical results 
  Third-party certification bodies 
  Foreign suppliers 
  Other regulatory government agencies (e.g., CBP, U.S. Department of 
Agriculture, States, foreign regulatory authorities) 
 
K.4 If I encounter a problem with a VQIP food or a foreign supplier, what action should I 
take to avoid revocation? 
 
  24  Contains Nonbinding Recommendations 
 
Your participation in VQIP is based on your ability to maintain a high level of control 
over the safety and security of your supply chain for the foods you import under VQIP.  
You are responsible for promptly reporting to FDA all deviations that may impact your 
eligibility to participate in VQIP and your plans for correcting the deviations.  Your 
VQIP QAP should include procedures for taking prompt corrective actions, for updating 
your procedures as necessary to prevent future occurrences of the problem, and for 
notifying FDA.  (See Section F., VQIP Quality Assurance Program.) 
 
K.5 If my VQIP participation is revoked, will I lose benefits provided by other Federal 
importer programs in which I participate? 
 
Decisions relating to a loss of benefits or revocation from other Federal importer 
programs, such as CBPs C-TPAT program, will be made by the agencies that oversee 
those programs.  However, in the interest of FDAs continued collaboration with our 
Federal partners, FDA will share VQIP revocation information with other Federal 
agencies, when appropriate, in accordance with applicable statutes, regulations, and 
agreements between agencies.  
 
L. Reinstatement of VQIP Participation   
 
L.1 How can I obtain reinstatement of my participation in VQIP or VQIP benefits after a 
revocation? 
 
When revocation is based upon evidence that you do not meet one or more of the VQIP 
eligibility requirements, you may request FDA to reinstate your VQIP participation and 
VQIP benefits at any time after you have corrected the deviations associated with your 
revocation.  Your request should include documentation of actions you have taken to 
correct or resolve all of the deviations.  The following are examples of information you 
might submit to support your request for reinstatement: 
  If you have been subjected to CBP penalties, forfeitures, or sanctions within the 
past 3 years, you may need to provide documentation that you have made all 
necessary corrections and have settled the matter with CBP. 
  If you used a filer/broker who was not in good standing with FDA, you may need 
to: 
  Document that the filer/broker received additional training to ensure 
o
improvements in the information submitted to FDA on your behalf,  
  Use a new filer/broker that is in good standing with FDA, or  
o
  Revise your QAP to establish procedures to ensure that you use only 
o
filers/brokers that are in good standing with FDA. 
  If you used a foreign supplier who did not have a valid facility certification, you 
may need to remove the foreign supplier and foods received from the foreign 
supplier from your VQIP application and revise your QAP as necessary to ensure 
that you maintain current certifications for your foreign suppliers. 
  If your revocation is based on a food safety deviation by the foreign supplier, and 
documentation alone (e.g., revised SOPs, revised HACCP plans, batch records) is 
not sufficient to show that the foreign supplier has adequately corrected the food 
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safety deviation, you may need to obtain a new third-party facility certification of 
the foreign supplier. 
 If your QAP is deficient or outdated, you may need to document appropriate
revisions to address the deficiencies and update your VQIP application with
applicable revisions to your QAP.
FDA will review your request for reinstatement as soon as possible after it is received. 
Prior to approving your reinstatement, FDA will verify whether you have implemented 
the appropriate corrective actions.  FDA may verify your corrective actions by 
conducting an inspection or by reviewing your documentation of the corrective actions, 
as appropriate.  If your VQIP benefits are not reinstated during the fiscal year in which 
they are revoked, you may apply for VQIP for the next fiscal year by submitting a new 
application during the application period.  Your application should include 
documentation of action taken to correct or resolve the basis for your ineligibility that 
caused the revocation. 
FDA will not reinstate your participation in VQIP if your participation was immediately 
revoked based on evidence of smuggling or other fraudulent activity.  (See Question J.4.) 
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the 
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 
(44 U.S.C. 3501-3520).   
The time required to complete this information collection is estimated to average 240-260 
hours per respondent initially, and 36-46 hours per respondent annually thereafter, 
including the time to review instructions, search existing data sources, gather the data 
needed, and complete and review the information collection.  Send comments regarding 
this burden estimate or suggestions for reducing this burden to: 
Department of Health and Human Services 
Food and Drug Administration 
Office of Operations 
FDA PRA Staff 
PRAStaff@fda.hhs.gov 
The guidance also refers to previously approved collections of information found in FDA 
regulations.  The collections of information regarding food labeling have been approved 
under OMB Control No. 0910-0381; the collections of information regarding Low Acid 
Canned Food have been approved under OMB Control No. 0910-0037; the collections of 
information regarding Third-Party Certification Bodies to Conduct Food Safety Audits 
and to Issue Certifications have been approved under OMB Control No. 0910-0750; the 
collections of information regarding Current Good Manufacturing Practice and Hazard 
Analysis and Risk-Based Preventive Controls for Human Food have been approved under 
OMB Control No. 0910-0751; the collections of information regarding Current Good 
26  Contains Nonbinding Recommendations 
 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for 
Food for Animals have been approved under OMB Control No. 0910-0789; the 
collections of information regarding the Foreign Supplier Verification Program have been 
approved under OMB Control No. 0910-0752; the collections of information regarding 
the Sanitary Transportation of Human and Animal Food have been approved under OMB 
Control No. 0910-0773; and the collections of information regarding Focused Mitigation 
Strategies to Protect Food Against Intentional Adulteration have been approved under 
OMB Control No. 0910-0812. 
 
An agency may not conduct or sponsor, and a person is not required to respond to, a 
collection of information unless it displays a currently valid OMB control number.  
The OMB control number for this information collection is 0910-0840 (To find the 
current expiration date, select the most recent ICR Ref. No. at 
https://www.reginfo.gov/public/do/PRAOMBHistory?ombControlNumber=0910-
0840). 
 
  27  Contains Nonbinding Recommendations 
 
V.  Document History 
  
Status of  Timing of  Type of  Description of Changes 
Guidance  Current  Revisions 
Version 
Draft  June 2015  Level 1  First version 
guidance 
Final  November  Level 1  Edits made as described in the Federal Register 
guidance  2016  notice at: 
https://www.federalregister.gov/documents/2016
/11/14/2016-27252/voluntary-qualified-
importer-program-guidance-for-industry-
availability 
Final  March 2022  Level 2  Edits made to update PRA information and to 
guidance  update links throughout the guidance 
Final  July 2023  Level 2  Edit to PRA address 
guidance 
 
 
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