The FDA has updated its Infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The compliance program is designed to comprehensively outline the agency’s approach for inspections, sample collection, sample analysis, and compliance activities to help ensure that infant formula products in the U.S. food supply are safe and nutritious. The updates include instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program provides instruction for FDA notification should a sample test positive for Cronobacter or Salmonella or if a sample has nutrients above or below required levels per the FDA’s infant formula regulation. The compliance program also includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the Human Foods Program. The program further elaborates on new infant formula-related requirements included in the Food and Drug Omnibus Reform Act of 2022. @ https://www.fda.gov/food/cfsan-constituent-updates/fda-issues-updated-compliance-program-infant-formula
