The U.S. Food and Drug Administration 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. This effort is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry.
In September 2022, the FDA released its internal evaluation of the infant formula response which recommended that the agency review and update its infant formula compliance program to ensure that it reflected the latest science on Cronobacter and offered consistency and clarity on our inspection and compliance activities. In November 2022, as part of the Cronobacter prevention strategy the agency committed to completing this review and update.
The FDA has now published its updated compliance program, which builds on lessons learned over the last several years to elaborate on our approaches for inspections, sampling, laboratory analysis, and imported infant formula products. For example, 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 is found to have nutrients that are 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.
More generally, additional background on the risks associated with Salmonella and Cronobacter in infant formula products, and the conditions that could lead to environmental contamination within the manufacturing facilities, is included in the updated compliance program. In addition, it further elaborates on new infant formula related requirements that were included in the Food and Drug Omnibus Reform Act of 2022.
All updates related to the FDA’s oversight of infant formula can be found on the FDA’s Infant Formula webpage.