By Coral Beach on November 4, 2023
Following the 2022 infant formula supply crisis and associated fatal infections, the FDA has revised its infant formula compliance program. The outbreak of Cronobacter infections in the fall of 2021, resulting in five infant cases, two of which were fatal, extended into early 2022. In response, Abbott Nutrition recalled Similac infant formula powder and other brands in February 2022, causing a nationwide shortage and inconveniencing parents who had to travel long distances in search of formula for their infants.
The FDA's investigation revealed Cronobacter contamination in Abbott's production plant in Sturgis, MI. The agency also discovered that Abbott had conducted product testing that yielded positive results for Cronobacter, which had not been reported to the FDA. After congressional hearings and a whistleblower complaint, FDA officials launched an internal investigation in May 2022, leading to the development of the new compliance program.
This comprehensive infant formula compliance program covers FDA investigators, laboratory analysts, and compliance officers. According to an FDA statement, it outlines the agency's approach to inspections, sample collection, sample analysis, and compliance activities, ensuring the safety and nutritional quality of infant formula products in the U.S. food supply.
The updated compliance program mandates entities to adhere to revised instructions for annual environmental sampling at powdered infant formula production facilities. These sampling tests must include Cronobacter and Salmonella. Notification to the FDA is required if testing reveals the presence of either pathogen. Additionally, the agency must be informed if nutrient levels deviate from the FDA's infant formula regulation.
The program outlines procedures for immediately escalating product or environmental positives identified during records reviews to the relevant subject matter expert within the Human Foods Program at the FDA. It provides background information on the risks associated with Salmonella and Cronobacter in infant formula products and conditions leading to environmental contamination within manufacturing facilities.
The updated compliance program also expands on new infant formula-related requirements introduced in the Food and Drug Omnibus Reform Act of 2022. For the latest information on the FDA's oversight of infant formula, interested Parties can refer to the FDA's Infant Formula webpage.
News from: www.foodsafetynews.com