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FDA Extends FSMA Enforcement Discretion for Certain Co-Packers

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The Arlington, Virginia-based American Frozen Food Institute (AFFI) has received notice that the US Food and Drug Administration (FDA) will continue 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.

“The frozen food industry is committed to advancing food safety through a comprehensive, risk-based approach to FSMA implementation that will continue to provide Americans with the safest possible food supply,” said AFFI President and CEO Alison Bodor. “We commend FDA for providing co-manufacturers and brand owners with additional time to overcome contractual and logistical barriers to compliance with the supplier verification requirements.”

For example, there are challenges co-manufacturers and brand owners are facing in complying with the Preventive Controls for Human Food supply chain requirements under FSMA. To comply with these 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 contracts.

AFFI requested an extension to the enforcement discretion to allow for further consultation between FDA and industry to resolve these compliance challenges.

Due to AFFI’s request, and others received by the agency, FDA will continue its enforcement discretion policy while working with stakeholders to understand challenges and opportunities to address these situations.