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GUIDANCE DOCUMENT

Guidance for Industry: Supply-Chain Program Requirements and Co-Manufacturer Supplier Approval and Verification for Human Food and Animal Food November 2017

Final
Docket Number:
FDA-2017-D-5996
Issued by:
Guidance Issuing Office
Center for Food Safety and Applied Nutrition
Center for Veterinary Medicine

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.

Download the Guidance


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2017-D-5996.