United States, the U.S. Food and Drug Administration (FDA) has announced updates to its infant formula compliance program for investigators, laboratory analysts, and compliance officers. The objective of these updates is to provide comprehensive guidance on the FDA’s approach to inspections, sample collection, sample analysis, and compliance activities, with the ultimate goal of ensuring the safety and nutritional quality of infant formula products in the U.S. food supply.

The FDA’s commitment to strengthening the infant formula industry’s safety and resilience was underscored by an internal evaluation of the infant formula response in September 2022. This evaluation recommended a review and update of the compliance program to align it with the latest scientific knowledge regarding Cronobacter, as well as to enhance clarity and consistency in inspection and compliance activities. As part of its Cronobacter prevention strategy, the FDA committed to this review and update in November 2022.

Key highlights of the updated compliance program include:

1. Environmental Sampling: The program now includes instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. This proactive measure aims to identify potential contamination risks within manufacturing facilities.
2. Sample Analysis: The compliance program outlines procedures for FDA notification in the event that a sample tests positive for Cronobacter or Salmonella, or if nutrient levels in a sample fall above or below the required thresholds as per FDA regulations for infant formula.
3. Escalation Protocols: In cases where product or environmental positives are identified during records reviews, the compliance program directs immediate escalation to the appropriate subject matter expert within the Human Foods Program, ensuring swift response to potential issues.
4. Risk Assessment: The updated program provides additional information on the risks associated with Salmonella and Cronobacter in infant formula products, as well as conditions that may contribute to environmental contamination within manufacturing facilities.
5. Legislative Updates: The compliance program also elucidates new requirements related to infant formula, as outlined in the Food and Drug Omnibus Reform Act of 2022.

The FDA’s commitment to transparency and safety in the infant formula industry is evident through these comprehensive updates. Stakeholders and the public can access all information related to the FDA’s oversight of infant formula on the agency’s Infant Formula webpage.

These measures represent a significant step forward in ensuring the safety and nutritional integrity of infant formula products, aligning with the FDA’s ongoing dedication to protecting public health and maintaining the highest standards of product quality and safety.

Source:https://www.fda.gov/media/161689/download?attachment