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Importers Get Extension of Enforcement Discretion on Some FSMA Rule Requirements

Wednesday, November 13, 2019
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration announced Nov. 6 that it is continuing an enforcement discretion policy regarding compliance with supplier approval and verification requirements under three rules implementing the Food Safety Modernization Act.

FDA regulations on preventive controls for human and animal foods and the Foreign Supplier Verification Program require co-manufacturers that are receiving facilities and/or importers that produce food for brand owners to approve suppliers and conduct certain supplier verification activities. However, industry previously noted that to comply with this requirement co-manufacturers often need detailed information about the suppliers that only the brand owner has and that cannot be shared because of confidentiality clauses in the contracts between brand owners and the firms they select to supply their co-manufacturers.

As a result, the FDA announced in November 2017 an enforcement discretion policy intended to give brand owners two years to adjust their contracts so that supply chain-related information could be shared with co-manufacturers. Since that time, however, the FDA has learned of additional challenges the industry is facing in trying to meet the supply chain requirements. To allow more time to work with stakeholders to better understand these challenges and consider possible solutions, the FDA is continuing its enforcement discretion policy for an as-yet-unspecified period of time.

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