FDA has released an updated infant formula compliance program for FDA investigators, laboratory analysts, and compliance officers. The program is designed to outline the agency’s approach for inspections, sample collection, sample analysis, and compliance as part of its effort to strengthen the safety, resiliency, and oversight of the formula industry.
In September 2022, FDA released its internal evaluation of the ifant formula response, which recommended that the agency review and update its compliance program to ensure it reflected the latest science on Cronobacter.
The agency says the updated program builds on lessons learned over the last several years to expand on its approaches for inspections, sampling, laboratory analysis, and imported 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.
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.
Additional background on the risks associated with Salmonella and Cronobacter in 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 related requirements included in the Food and Drug Omnibus Reform Act of 2022.
All updates related to the oversight of infant formula can be found on FDA’s infant formula webpage.