FSMA Guidance Document - Co-manufacturers Working with Brand Owner's Suppliers

FDA released a guidance document today that allows co-manufacturing companies more time to comply with supplier preventive controls when those co-manufacturing operations are involved in packing products for a brand owner where the suppliers of ingredients for the product are under the control of the brand owner.  The co-manufacturer's food safety plan will state that which activities of the supplier approval and supplier verification are under the brand owner's control.

From the Guidance document:
"If a contract prevents a co-manufacturer from being able to review a brand owner’s 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."

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-manufacturer’s 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
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-manufacturer’s 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.


https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM583490.pdf
Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food
Contains Nonbinding Recommendations
November 2017



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 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-manufacturer’s 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.

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.

Download the Guidance for Industry (PDF: 43KB)

Table of Contents
I.Introduction
II.Background
III.Discussion
IV.References