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FDA Allows Co-Manufacturers More Time to Meet FSMA Rule Requirements

The Food and Drug Administration announced on 3 November the availability of a guidance designed to give certain co-manufacturers more time to meet supplier approval and verification requirements under three rules implementing the Food Safety Modernization Act. By “c0-manufacturing,” the FDA refers to 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.

According to the FDA, regulations on preventive controls for human and animal foods and the Foreign Supplier Verification Program require co-manufacturers to approve their suppliers of raw materials and ingredients requiring a supply-chain-applied control and conduct supplier verification activities. However, the supply-chain provisions permit an entity other than the receiving facility (e.g., 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 entity’s applicable documentation. Specifically, the rules allow for a co-manufacturer to base its verification of suppliers on review of adequate documentation of the brand owner’s supplier verification activities.

However, industry has expressed concerns that the requirements of the supply-chain programme 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 certain compliance dates. 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, the FDA is announcing that, under certain circumstances and on a temporary basis (until 6 November 2019), it does 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 programme requirements related to supplier approval and supplier verification. This enforcement discretion is conditional on these activities being divided between the brand owner and the co-manufacturer.

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