Contains Nonbinding Recommendations 
Supply-Chain Program Requirements 
and Co-Manufacturer Supplier Approval 
and Verification for Human Food and 
Animal Food: Guidance for Industry  
    Additional copies are available from:  
Office of Food Safety HFS-300 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
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College Park, MD  20740 
(Tel) 240-402-2166 
or 
Center for Veterinary Medicine HFV-200 
Food and Drug Administration 
7519 Standish Place 
Rockville, MD 20855 
(Tel) 240-402-6246 
http://www.fda.gov/FoodGuidances 
You may submit electronic or 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 Docket No. FDA-2017-D-5996.   
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition 
Center for Veterinary Medicine 
November 2017  Contains Nonbinding Recommendations 
Table of Contents  
 
 
 
I.    Introduction   
 
II.    Background  
 
III.   Discussion  
 
IV.  References  
 
 
 
    Contains Nonbinding Recommendations 
Supply-Chain Program Requirements 
and Co-Manufacturer Supplier Approval 
and Verification for Human Food and 
1
Animal Food: Guidance for Industry   
 
 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA, the 
Agency, 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 is intended for persons who participate in certain co-manufacturing agreements 
in the production of human or animal food.  By co-manufacturing, we mean a contractual 
arrangement whereby one party (the brand owner) arranges for a second party (the co-
manufacturer) to manufacture/process human or animal food on behalf of the first party.  
 
FDA has established requirements for a supply-chain program for raw materials and other 
ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied 
control in two regulations.  The first regulation, which we established in 21 CFR part 117, is 
entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive 
Controls for Human Food (part 117). The second regulation, which we established in 21 CFR 
part 507, is entitled Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based 
Preventive Controls for Food for Animals (part 507). Also, in our regulation entitled Foreign 
Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP 
regulation; established in 21 CFR part 1, subpart L) we established that an importer that is a 
receiving facility is deemed to be in compliance with most of the requirements of the FSVP 
regulation for a food it imports, as long as the importer is in compliance with the supply-chain 
program requirements of part 117 or part 507 rule for that food. When an importer that is a 
receiving facility is in compliance with the supply-chain program requirements, the only 
                                                 
1 This guidance has been prepared by the Office of Food Safety in the Center for Food Safety and Applied Nutrition 
in cooperation with the Center for Veterinary Medicine and Office of Regulatory Affairs at the U.S. Food and Drug 
Administration.   
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  Contains Nonbinding Recommendations 
requirement of the FSVP regulation that applies is the requirement for importer identification at 
entry (21 CFR 1.509).   Current industry co-manufacturing arrangements may include a supply-
chain program established and implemented by the brand owner, the co-manufacturer, or both. 
This guidance advises such persons of specific circumstances in which FDA does not intend to 
take enforcement action regarding a co-manufacturers compliance with the supply-chain 
program requirements. 
 
Not all co-manufacturers are required to have supply-chain programs.  If there are no hazards 
requiring supply-chain-applied controls in the raw materials and other ingredients used by a co-
manufacturer, then the co-manufacturer does not need a supply-chain program, and this guidance 
is not applicable.  This guidance is applicable when the brand owner approves and specifies to 
the co-manufacturer which suppliers must be used and there is a hazard that requires a supply-
chain-applied control.  Note, the brand owner is not considered the supplier of the co-
manufacturer under the regulations if the brand owner does not manufacture/process the food, 
raise the animal, or grow the food that is provided to the co-manufacturer.  
 
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (21 
CFR 10.115).  This guidance is immediately effective because FDA has determined that prior 
public participation is not feasible or appropriate (21 CFR 10.115(g)(2)).  
 
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  
 
This guidance concerns three regulations that we have established in Title 21 of the Code of 
Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety 
Modernization Act (FSMA; Pub. L. 111353).2 These three regulations are part 117 (published 
in the Federal Register on September 17, 2015, 80 FR 55907), part 507 (published in the 
Federal Register on September 17, 2015, 80 FR 51670), and the FSVP regulation (published in 
the Federal Register of November 27, 2015, 80 FR 74226). Subparts A, B, and F of part 117 
include current good manufacturing practice (CGMP) requirements for manufacturing, packing, 
or holding human food.  Subparts A, C, D, E, F, and G of part 117 include requirements for 
domestic and foreign facilities that are required to register under section 415 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) to conduct a hazard analysis and 
implement risk-based preventive controls for human food (the human food preventive controls 
requirements).  Subpart G of part 117 establishes requirements for a supply-chain program for 
those raw materials and other ingredients for which a receiving facility has identified a hazard 
requiring a supply-chain-applied control. 
 
                                                 
2 For more information on the Agencys implementation of FSMA, see http://www.fda.gov/fsma. 
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  Contains Nonbinding Recommendations 
Part 117 defines a receiving facility as a facility that is subject to the human food preventive 
controls requirements and that manufactures/processes a raw material or other ingredient that it 
receives from a supplier.  Part 117 defines a supplier as the establishment that 
manufactures/processes the food, raises the animal, or grows the food that is provided to a 
receiving facility without further manufacturing/processing by another establishment, except for 
further manufacturing/processing that consists solely of the addition of labeling or similar 
activity of a de minimis nature.  Part 117 defines a supply-chain-applied control as a preventive 
control for a hazard in a raw material or other ingredient when the hazard in the raw material or 
other ingredient is controlled before its receipt.  
 
For domestic and foreign facilities that are required to register, subparts A, B, and F of part 507 
include CGMP requirements and subparts A, C, D, E, and F of part 507 include requirements to 
conduct a hazard analysis and implement risk-based preventive controls for animal food (the 
animal food preventive controls requirements).  Subpart E of part 507 establishes requirements 
for a supply-chain program for raw materials and other ingredients for which a receiving facility 
has identified a hazard requiring a supply-chain-applied control.  The provisions and 
applicability of part 507, subpart E, and the definitions established in part 507 for receiving 
facility, supplier, and supply-chain-applied control are analogous to those of part 117. 
 
Under the FSVP regulation, importers are required to develop, maintain, and follow a foreign 
supplier verification program that, among other things, provides adequate assurance that foreign 
suppliers are producing food in compliance with processes and procedures that provide at least 
the same level of public health protection as those required under section 418 of the FD&C Act 
(which authorized the supply-chain programs in 21 CFR parts 117 and 507) (see 21 CFR 
1.502(a)).  An importer that is a receiving facility subject to section 418 of the FD&C Act is 
deemed to be in compliance with the requirements of the FSVP regulation, except the importer 
identification requirements in 21 CFR 1.509, if the importer has established and implemented a 
risk-based supply-chain program in compliance with 21 CFR part 117, subpart G or part 507, 
subpart E (21 CFR 1.502(c)(3)). 
 
Under the definition of receiving facility established in parts 117 and 507, co-manufacturers 
that are subject to the human food or the animal food preventive controls requirements and that 
manufacture/process a raw material or other ingredient received from a supplier are receiving 
facilities.  Co-manufacturers that are receiving facilities that have identified a hazard in a raw 
material or ingredient requiring a supply-chain-applied control are required to approve their 
suppliers for those raw materials or other ingredients.  However, the supply-chain provisions 
permit an entity other than the receiving facility (e.g., permit the brand owner) to determine, 
conduct, or both determine and conduct, appropriate supplier verification activities, provided that 
the receiving facility documents its review and assessment of the other entitys applicable 
documentation.  (See 21 CFR 117.415(a)(3) and 507.115(a)(3).)  Specifically, the rules allow for 
a co-manufacturer to base its verification of suppliers on review of adequate documentation of 
the brand owners supplier verification activities.   
 
 
 
 
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  Contains Nonbinding Recommendations 
III.  Discussion  
 
Industry has expressed concerns that the requirements of the supply-chain program would 
require revisions to contracts between brand owners and their suppliers to allow brand owners to 
share certain information (e.g., audits of suppliers) with co-manufacturers, and that establishing 
new contracts would take a significant period of time, impeding their ability to meet compliance 
dates (Ref. 1).   
 
As noted in section II, the supply-chain program provisions permit a co-manufacturer to review 
and assess documentation of a brand owners determination, conduct, or both determination and 
conduct, of appropriate supplier verification activities, provided that the co-manufacturer 
documents its review and assessment of the brand owners applicable documentation.  (See 21 
CFR 117.415(a)(3) and 507.115(a)(3).)  If a contract prevents a co-manufacturer from being able 
to review a brand owners documentation of supplier verification activities, the co-manufacturer 
would not be able to verify suppliers based on its review of that documentation.  Consequently, 
the co-manufacturer would need to conduct supplier verification activities (e.g., on-site audits) 
that might otherwise not be required.  
 
To provide time for contracts to be revised to allow co-manufacturers to review all necessary 
documentation from the brand owner, FDA is announcing that, under certain circumstances and 
on a temporary basis, we do not intend to take enforcement action against a receiving facility that 
is a co-manufacturer, and that is not in compliance with certain supply-chain program 
requirements for food manufactured for the brand owner.  Specifically, we do not intend to take 
enforcement action regarding 21 CFR 117.410(d) and 117.415(a)(3) or 21 CFR 507.110(d) and 
507.115(a)(3) in the circumstances described below.  Furthermore, we do not intend to take 
enforcement action under the FSVP regulation against an importer who is relying on 21 CFR 
1.502(c)(3) but whose supply-chain program is subject to enforcement discretion regarding 21 
CFR 117.410(d) and 117.415(a)(3) or 21 CFR 507.110(d) and 507.115(a)(3) in the 
circumstances described below. 
 
Supplier Approval 
FDA does not intend to take enforcement action under the following circumstances: (1) a brand 
owner conducts supplier approval activities, (2) the co-manufacturer describes these activities in 
its food safety plan, and (3) the co-manufacturer conducts any necessary supplier approval 
activities not conducted by the brand owner.  For example, FDA does not intend to take 
enforcement action when a brand owner (rather than the co-manufacturer) evaluates supplier 
performance as part of approving a supplier, the co-manufacturers food safety plan states that 
the brand owner will consider supplier performance before a supplier is approved, and the co-
manufacturer conducts any other necessary supplier approval activities (e.g., hazard analysis of 
the food).  The co-manufacturer is always responsible for following written procedures for 
receiving raw materials and other ingredients, and documenting use of the procedures (21 CFR 
 117.420 and 507.120).   
 
Supplier Verification 
FDA does not intend to take enforcement action under the following circumstances: (1) a brand 
owner determines and/or conducts supplier verification activities for its co-manufacturer, (2) the 
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  Contains Nonbinding Recommendations 
co-manufacturer describes these activities in its food safety plan, and (3) the co-manufacturer 
conducts any necessary supplier verification activities not conducted by the brand owner.  For 
example, FDA does not intend to take enforcement action when an audit is determined to be the 
appropriate supplier verification activity but a co-manufacturer does not independently obtain a 
supplier audit or review the conclusions of a supplier audit obtained and reviewed by the brand 
owner, the co-manufacturers food safety plan states that the brand owner will obtain and review 
audits of the supplier, and the co-manufacturer conducts any other necessary supplier verification 
activities (e.g., sampling and testing of the raw material or other ingredient).   
 
We do not intend to take enforcement action regarding the affected provisions until November 6, 
2019.  
 
Co-manufacturers to whom this policy applies still must comply with the importer identification 
requirements in 21 CFR 1.509, if they are also FSVP importers.  Under 21 CFR 1.509(a), for 
each line entry of food product offered for importation into the United States, the importer must 
provide its name, electronic mail address, and unique facility identifier recognized as acceptable 
by FDA electronically when filing entry with U.S. Customs and Border Protection.  FDA has 
recognized the Dun & Bradstreet Data Universal Numbering System (DUNS) number as an 
acceptable unique facility identifier for the FSVP rule.  When a food product under FDA 
oversight is offered for entry into the United States, the U.S. Customs and Border Protection 
(CBP) Automated Commercial Environment (ACE) system will prompt the filer to transmit an 
FSV entity role code indicating the entry line is subject to the FSVP regulation and currently 
subject to FSVP enforcement.  For more information on importer identification, consult 
Guidance for Industry:  Compliance with Providing an Acceptable Unique Facility Identifier for 
the Foreign Supplier Verification Programs Regulation, available at 
https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm.   
 
   
IV.  References  
The following references are on display in the Division of Dockets Management, Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov.  FDA has verified the Web site 
addresses, as of the date of this document, but Web sites are subject to change over time.  
 
1. Letter from Grocery Manufacturers Association to Dr. Stephen Ostroff, Acting Commissioner 
of Food and Drugs, February 7, 2017.   
 
 
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