Recognition of Acceptable Unique 
Facility Identifier (UFI) for the Foreign 
Supplier Verification Programs 
Regulation: Guidance for Industry 
 
 
Additional copies are available from:  
Office of Compliance 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
College Park, MD  20740 
(tel) 240 701-5986 
http://www.fda.gov/FoodGuidances 
  
Division of Compliance (HFV-230) 
Center for Veterinary Medicine 
Food and Drug Administration 
7519 Standish Place, 
Rockville, MD  20855 
(tel) 240 402-7002 
 
 

You may submit electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to http://www.regulations.gov.  Submit written comments on the guidance 
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 FDA-2011-N-0143. 
 
 
 
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 
 
 
March 2017  
Table of Contents 
 
 
 
I.  Introduction 
 
II.  Background 
 
III.  Recognition of Acceptable Unique Facility Identifier (UFI) 
 
 
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  Recognition of Acceptable Unique Facility 
Identifier (UFI) for the Foreign Supplier 
Verification Programs Regulation: 
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Guidance for Industry  
 
 
 
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 
 
This guidance specifies FDAs current thinking on what unique facility identifier (UFI) FDA 
recognizes as acceptable for purposes of the Foreign Supplier Verification Programs (FSVP) 
regulation established in Title 21 of the Code of Federal Regulation, Part 1, subpart L as part of 
our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353).  The 
pronoun you is used in this guidance to refer to the importer.   
 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe 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 guidances means that something is suggested or 
recommended, but not required. 
 
II.  Background 
 
FDA issued the rule on FSVPs for importers of food for humans and animals on November 27, 
2015 (80 FR 74225).  The FSVP regulation, codified in 21 CFR 1.500 through 1.514, specifies 
the foods and importers to which the FSVP regulation applies and establishes various 
                                                           
1 This guidance has been jointly prepared by the Office of Compliance in the Center for Food Safety and Applied 
Nutrition, the Office of Surveillance and Compliance in the Center for Veterinary Medicine, and the Division of 
Import Operations in the Office of Regulatory Affairs at the U.S. Food and Drug Administration. 
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  requirements, including the requirement for importer identification for food offered for entry into 
the United States (21 CFR 1.509(a)). 
 
In the FSVP proposed rule, FDA initially proposed to require that for each line entry of food 
product offered for importation into the United States, the FSVP importers name and Dun & 
Bradstreet (D&B) Data Universal Numbering System (DUNS) number identifying the FSVP 
importer be provided (78 FR 45729 at 45762, July 29, 2013).   
 
In response to comments, in the FSVP final rule we replaced this proposed provision with a 
requirement that for each line entry of food product offered for importation into the United 
States, the FSVP importer provide its UFI recognized as acceptable by FDA (21 CFR 1.509(a)).  
We stated in the final rule that we anticipated issuing guidance specifying which UFI(s) we 
recognized as acceptable and that we expected to recognize DUNS numbers as being acceptable 
(80 FR 74226 at 74301).  In addition, the final rule requires that for each line entry of food 
product offered for importation into the United States, the FSVP importer must also provide  the 
importers name and electronic mail address (21 CFR 1.509(a)). 
 
III.  Recognition of Acceptable Unique Facility Identifier (UFI) 
 
At this time, FDA recognizes the DUNS number, assigned and managed by D&B, as an 
acceptable UFI for the purpose of compliance with the FSVP regulation.   
 
Currently, FDA finds the DUNS number appropriate to meet Agency needs to accurately identify 
FSVP importers so we can effectively implement, monitor compliance with, and enforce the 
FSVP requirements.  The DUNS number is available free of charge to all importers, and can be 
obtained by contacting D&B by phone at 866-705-5711 or via email at govt@dnb.com, or by 
visiting D&Bs Web sites at http://www.dnb.com/duns-number.html or 
https://fdadunslookup.com.  Although a DUNS number may be obtained within a few business 
days, in some circumstances it could take up to 45 days or more.  
 
If you anticipate being unable to provide a DUNS number to identify yourself as the FSVP 
importer of a food product at entry, you may contact FDAs Division of Import Operations at 1-
301-796-0356 or via email at FDAImportsInquiry@fda.hhs.gov prior to offering your product 
for import into the United States. 
 
 
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