By David Fairfield, Senior Vice President, Feed
The U.S. Food and Drug Administration (FDA) announced Nov. 6 that it will continue its enforcement discretion policy for compliance with certain Food Safety Modernization Act (FSMA) supply-chain program requirements that may apply to receiving facilities that are co-manufacturers.
FDA’s enforcement discretion potentially applies to entities that participate in certain “co-manufacturing” agreements in the production of human or animal food. By “co-manufacturing,” FDA means 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.
Three of the FSMA-related rules – 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 when an identified hazard requires a supply-chain-applied control. These requirements are designed to ensure suppliers are appropriately addressing hazards.
Significantly, 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 FDA’s enforcement discretion is not applicable. In contrast, the enforcement discretion does apply when the brand owner approves and specifies to the co-manufacturer which suppliers must be used and a hazard exists that requires a supply-chain-applied control.
In November 2017, FDA announced a two year enforcement discretion policy for compliance with certain supply chain requirements in response to industry 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. 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. FDA responding by announcing it will continue its enforcement discretion policy and interaction with stakeholders to better understand these challenges and to consider possible solutions to address them.