Background

The Food and Drug Administration announced Nov. 3 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.

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 certain raw materials and ingredients and conduct supplier verification activities (although there is some flexibility allowing them to rely on such activities conducted by brand owners). Co-manufacturers may need detailed information from brand owners to meet this requirement, the FDA states, and based on input from the food industry more time is needed to establish new contracts that will allow such information sharing.

As a result, the FDA does not intend to take enforcement action for two years (until Nov. 6, 2019) against co-manufacturers that are not in compliance with certain supply chain program 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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