FDA’s newly updated compliance program builds on lessons learned over the last several years to elaborate on the agency’s approaches for inspections, sampling, laboratory analysis, and imported infant formula products. For example, one update is the inclusion of instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. The compliance program also provides instruction for FDA notification should a sample test positive for Cronobacter or Salmonella, or if a sample is found to have nutrients that are above or below required levels per the FDA’s infant formula regulation.

Additionally, the compliance program includes instructions for how product or environmental positives identified during records reviews should be immediately escalated to the appropriate subject matter expert within the FDA Human Foods Program.

More generally, background on the risks associated with Salmonella and Cronobacter in infant formula products, as well as the conditions that could lead to environmental contamination within the manufacturing facilities, have been added to the updated compliance program. The program also elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.