FDA Will Continue Enforcement Discretion Policy Relevant to Certain Co-Manufacturers under FSMA.

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. “Co-manufacturing” is when 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 by way of a contractual arrangement.

Under the supply-chain program, the FDA has established requirements for raw materials and other ingredients for which a receiving facility has identified a hazard requiring a supply-chain-applied control. Three of the rules created to implement the FSMA program requirements – Preventive Controls for Human Foods, Preventive Controls for Animal Food, and the Foreign Supplier Verification Programs – mandate 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.

In November 2017, the agency enacted a two-year enforcement discretion policy for compliance with certain supply chain requirements in response to some concerns that were expressed by the industry. Those concerns regarded some situations where supply chain requirements could conflict with existing contracts between brand owners and the firms the brand owners select to supply 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 the enactment of the enforcement discretion policy, the FDA learned of additional challenges the industry is facing in trying to meet the supply-chain requirements. The FDA will continue its enforcement discretion policy while working to better understand the challenges expressed and consider possible solutions. The FDA will be extending the policy and will notify the public of how long the policy will be extended in another notice in the Federal Register.

mdi Consultants has been involved with many clients on various projects and specializes in dealing with human and animal food compliance, foreign suppliers, and the FSMA. If you need any assistance with the enforcement discretion policy or other regulations, please contact us for a free consultation.

We will continue to monitor any updates pertaining to the enforcement discretion policy moving forward. If you have any questions about the supply-chain program and the FDA, how this can affect your company and how we can help or for any of your regulatory requirements.

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