FDA Cronobacter Update

Today, the agency is providing an update on the significant actions that have been taken to advance the goals of the strategy, including: * Continuous collaboration with industry, coalitions, academia, and consumer groups to better understand and explore ways to enhance the safety of powdered infant formula. * Issuance of a letter (http://www.fda.gov/media/166044/download?attachment ) to the powdered infant formula industry to share current safety information and a call to industry to take prompt action to improve processes related to the safe production of powdered infant formula. * Initiation of hiring to establish a dedicated cadre of investigators to conduct infant formula inspections. * Initiation of hiring of staff to support the new Office of Critical Foods. * Supporting the Council of State and Territorial Epidemiologists (CSTE) position on elevating Cronobacter to a nationally notifiable disease, which was successfully adopted by the CSTE on June 29, 2023. * Updating and reorganizing infant formula related materials on FDA.gov to provide both consumers and industry with more accessible information, including: - Infant Formula (http://www.fda.gov/food/resources-you-food/infant-formula ) - Cronobacter sakazakii (http://www.fda.gov/food/foodborne-pathogens/cronobacter-sakazakii ) Initiating work with the National Advisory Committee on Microbiological Criteria for Foods (NACMCF)(http://www.fsis.usda.gov/policy/advisory-committees/national-advisory-committee microbiological-criteria-foods-nacmcf/2021 ) to address knowledge gaps regarding Cronobacter sakazakii. The updated prevention strategy webpage includes a full list of actions that have been taken to date. While these actions are specific to work guided by the prevention strategy, the FDA has continued to undertake additional steps to enhance its regulatory oversight of the infant formula industry. This includes the recent issuance of three warning letters (http://www.fda.gov/news events/press-announcements/fda-issues-warning-letters-three-infant-formula-manufacturers ) to infant formula firms in August 2023. The letters reinforce the importance of instituting and maintaining appropriate corrective actions when pathogens are detected to ensure compliance with the FDA’s laws and regulations. In addition, the FDA is continuing to advance work to strengthen the resiliency of the infant formula market, including through the issuance of an Immediate National Strategy (http://www.fda.gov/food/infant-formula-guidance-documents-regulatory information/immediate-national-strategy-increase-resiliency-us-infant-formula-market ), initiating work with the National Academics of Science, Engineering and Medicine to help inform long term plans for strengthening the infant formula market and through ongoing work to enhance and expedite infant formula reviews. Infant formula firms are also now required to develop, maintain and implement, as appropriate, risk management plans to identify and evaluate risks to the supply of the critical food, such as infant formula, and ways to mitigate such risks.