FDA to Continue Leniency with Co-packers Supplier Control Where Brands Have Oversight

FDA announced that they will continue to provide 'enforcement discretion' with supply chain controls for co-packers where the brand companies they are packing for have oversight over those suppliers.  In these cases, the co-packer is packing under contract for the brand company, and that brand company has chosen and then manages the suppliers who provide raw materials to the co-packer.

Certainly if the brand companies want the control over the supply chain to the co-packer, then they should be responsible for the supply chain control components and should have the procedures and documentation to support that.  This FDA announcement does not go that far, outside of providing an out for the co-packer.

From the announcement, "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."

From the previously published guidance establishing enforcement discretion:
"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)."

FDA Constituent Update
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-supply-chain-program-requirements-and-co-manufacturer-supplier-approval-and
FDA Continues Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA
November 6, 2019

The FDA will be continuing its enforcement discretion policy for compliance with certain FDA Food Safety Modernization Act (FSMA) supply-chain program requirements applicable to receiving facilities that are co-manufacturers.

Three of the rules created to implement FSMA - Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – require co-manufacturers that are receiving facilities and/or importers that produce food for the brand owners to approve suppliers and conduct certain supplier verification activities. These requirements are designed to ensure suppliers are addressing hazards requiring a supply-chain-applied control.

Previously, industry expressed concerns that in some situations the supply chain requirements could conflict with existing contracts between brand owners and the firms the brand owners select to supply their co-manufacturers. To comply with the supply-chain program requirements, co-manufacturers often need detailed information about suppliers that only the brand owner has, and that cannot be shared because of confidentiality clauses in the contracts between brand owners and the co-manufacturers’ suppliers.

In November 2017, the FDA announced an enforcement discretion policy until November 6, 2019 for compliance with certain supply-chain program requirements related to supplier approval and supplier verification. The enforcement discretion was intended to give brand owners more time to work with suppliers to adjust contracts so that supply-chain related information could be shared with co-manufacturers.

Since that time, FDA has learned of additional challenges industry is facing in trying to meet the supply-chain requirements. The FDA will continue its enforcement discretion policy while advancing its work with stakeholders to better understand these challenges and to consider possible solutions to address these situations. We intend to announce the extension in a forthcoming notice in the Federal Register. In the meantime, co-manufacturers should continue to comply with other applicable requirements for which they are responsible under the Federal Food, Drug, and Cosmetic Act.