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US updated infant formula compliance procedures

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On October 6, 2023, the U.S. Food and Drug Administration (FDA) announced an update to its infant formula compliance procedures. The compliance program provides a comprehensive description of testing, sample collection, sample analysis, and implementation of compliance measures, as well as methods for handling imported infant formula products, to ensure the safety and nutrition of infant formula products in the U.S. food supply, and to enhance the safety, flexibility, and oversight of the infant formula industry.

 

For example, the update includes annual environmental sampling of infant formula facilities for Cronobacter and salmonella. If a sample tests positive for Cronobacter or Salmonella, or if the nutrient content found in the sample is higher or lower than the required levels set by FDA for infant formula, this compliance program guides FDA's actions and responses. This compliance program also includes background that creates risks associated with salmonella and Cronobacter in infant formula products, as well as conditions that could lead to environmental contamination within the production facility.


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