June 21, 2024

FDA Issues Updated Compliance For Infant Formula

The FDA has issued updated compliance for infant formula after the disastrous shutdown of Abbott Nutrition for cronobacter contamination in 2022 that caused severe shortages. The press release states that, “This effort is part of the FDA’s ongoing commitment to strengthen the safety, resiliency, and oversight of the infant formula industry.”

FDA Issues Updated Compliance For Infant Formula

The FDA released its internal evaluation of the response in 2022. It recommended that the agency review and update its compliance program to make sure it reflected the latest science on Cronobacter, and offered consistency and clarify for manufacturers on inspection and compliance activities.

The FDA has published its updated compliance program, which it says builds on the lessons learned over the last several years. Salmonella and Cronobacter are specifically referred to in the program, since those pathogens have been found in powdered infant formula.

The update includes instructions for annual environmental sampling of Cronobacter and Salmonella at powdered infant formula facilities. It provides instruction for notifying the FDA if any samples test positive for those pathogens, or if a sample has nutrients above or below required levels that the FDA has set.

The program also includes instructions for how positive tests for pathogens in products or the facility environment should immediately be escalated to a subject matter expert within the Human Foods Program.

Cronobacter is of special concern in these types of products, because while this infection is rare, it is often deadly, especially in infants of low birth weight, who are premature, and who have a compromised immune system. This pathogen can cause sepsis and meningitis in infants.

More background is supplied on the risks associated with Salmonella and Cronobacter in these products, along with the conditions that could lead to environmental contamination within the facility. And it expands on new requirements that were included in the Food and Drug Omnibus Reform Act of 2022.

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