Status Update on FDA’s Infant Formula Response Activities

Since the Abbott infant formula recall in February 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agency’s infant formula response and the Reagan-Udall foundation’s evaluation of the FDA’s Human Foods Program (conducted at FDA’s request) to identify areas for improvement within the Agency. While work continues on all fronts, the FDA is committed to transparency. Below is an update on actions the FDA has taken, and those underway, to strengthen the safety and resiliency in the supply of nutritious infant formula. Additionally, the Agency has published a more specific progress update on the actions taken to meet the recommendations in the FDA’s Evaluation of the Infant Formula Response.

December 2023 Status Update

Safety of Infant Formula

• In FY23, FDA conducted 47 routine annual inspections of foreign and domestic facilities that produce infant formula (including some that also produce medical foods), meeting FDA’s assignment targets for FY23. Appropriate follow-up actions were taken as warranted. Importantly, FDA had set targets to inspect facilities that produce infant formula annually, even prior to a requirement to do so established in the Food and Drug Omnibus Reform Act of 2022.
• In September 2023, the FDA released an update on its strategy to prevent Cronobacter sakazakii illnesses associated with the consumption of powdered infant formula, originally released in November 2022. The update included notable actions 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 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 and goes into effect in 2024. The FDA, along with CSTE and CDC, have been meeting regularly to discuss how best to support implementation of this new notification process.
  • Released an update to chapter 29 of the Bacteriological Analytical Manual (BAM) with an updated method for testing powered infant formula samples for Cronobacter. The improved method reduces background interference which greatly reduces the risk of false positive results and provides additional guidance to find Cronobacter colonies on recommended agar plates. The FDA is collaborating with the CSTE to share this method with state partners across the U.S. to help build capacity for testing for Cronobacter in powdered infant formula.
    • In June 2024, CSTE released additional materials addressing Clinical Specimen, Isolate Submission, and Communications and Product Testing Recommendations, related to Cronobacter illnesses in infants, in close consultation with FDA and CDC.
    • Infant Formula
    • Cronobacter sakazakii
    • New resource on handling infant formula safely in both English and Spanish.

    Resiliency in the Supply of Nutritious Infant Formula

    • At the height of the supply challenges, FDA staff worked daily with clinicians and hospitals to address crucial issues of specialty and medically necessary formula supply for infants with serious metabolic diseases who were dependent on highly specialized formulas.
    • The FDA supported our colleagues at HHS to mobilize Operation Fly Formula to arrange for emergency air transport of large volumes of formula at the peak of the crisis.
    • The FDA worked with Customs and Border Protection (CBP) to implement legislation that provided temporary relief for infant formula importers from tariffs during the latter half of 2022.
    • The FDA helped to expand access to infant formula by temporarily exercising enforcement discretion, on a case-by-case basis, for certain infant formula requirements. Twelve firms that manufacture infant formula have brought various infant formula products into the U.S. market under FDA’s exercise of enforcement discretion; this increased the number of firms supplying product to the U.S. market from 2021 to 2022.
      • The FDA conducted an expedited review of certain food safety and nutrition records associated with the firms and products prior to issuing letters of enforcement discretion.
      • The FDA also adjusted import screening criteria to help facilitate the immediate importation of millions of pounds of infant formula and infant formula base powder (an ingredient used in producing infant formula products).
      • During October and November 2022, FDA hosted a four-part webinar series to provide detailed information about the transition plan for infant formulas marketed under the exercise of enforcement discretion and to address questions.
      • Eight firms that manufacture infant formula are currently participating in the transition plan to bring their formula products into compliance with all U.S. requirements for infant formula after having previously received a letter of enforcement discretion from FDA.
      • The FDA continues working to review and provide feedback to infant formula manufacturers on their deliverables under the transition plan guidance (e.g., protein efficiency ratio rat bioassay, growth monitoring study, requests for exemptions) and to answer questions received from firms about requirements for new infant formula submissions.
      • To date, FDA has received several new infant formula submissions well ahead of the timeframe outlined in the transition plan guidance and is diligently working to review.
      • FDA staff continue to meet regularly with infant formula manufacturers to discuss current and forecasted production and to identify potential distribution issues.
      • As of September 2023, functionality of 21 Forward, which was built and maintained via contract, has moved in-house to FDA’s Office of Digital Transformation.
      • The committee’s work is underway and its progress can be followed on NASEM’s website.

      Operational Improvements

      • FDA has revised its internal consumer complaint procedure to strengthen the escalation process to better define when certain consumer complaints need to be escalated to senior officials. This change involves rapid escalation of reports of serious illness or death to the highest levels of the agency and specifically addresses triggers for escalation of reports of any hospitalization or death involving an infant.
      • The FDA has also established new procedures for managing complaints from whistleblowers and confidential sources.
      • The FDA’s Office of Operations (OO) initiated procedures to improve the tracking of accountable mail, which may include complaints, through the point of delivery to ensure that such mail is received and acted upon in a timely manner.
      • The FDA has completed the resource needs assessment to establish a critical foods cadre, whose purpose will be to focus solely on the inspection and oversight of critical foods, including infant formula. Hiring for the cadre is currently underway, and specialized training programs are continuously being developed, piloted, and deployed as a part of that effort.
      • The Office of Regulatory Affairs (ORA) has expanded the agency’s capacity to test for Cronobacter to all seven ORA laboratories.
      • All FDA laboratories have received new procedures for escalating significant testing results to senior leaders.
      • The FDA has significantly expanded and improved a required infant formula online training course for investigators and other appropriate staff to ensure every infant formula inspection is robust, thorough, and focused on the most critical aspects of the infant formula manufacturing process.
      • The FDA staff who conduct or support inspections of powdered infant formula manufacturers attended an interactive in-person powdered infant formula inspection workshop with specific training on conducting infant formula inspections in January 2023. The workshop provided critically relevant and timely inspectional information for investigators and other appropriate staff, including updates from lessons learned during previous inspections.
      • The FDA updated its compliance program for infant formula.
        • The FDA hosted a webinar in October 2023 to brief field investigators, compliance officers, and managers on significant updates to the compliance program.
        • In 2022, prior to FDA’s evaluation of the infant formula response, CFSAN began amending its instructions to ORA related to inspections of infant formula and medical food facilities. The changes provided additional considerations for environmental sampling, a renewed focus on the supply chain requirements under the Preventive Controls for Human Food Rule, and scheduling adjustments to minimize potential supply chain disruptions.
        • In addition, the agency is using expanded 21st Century Cures hiring authorities to hire many positions related to the OCF as well as other positions, which will help to support infant formula oversight and regulation. This has included the hiring of a Chief Critical Foods Officer, a Senior Advisor for Critical Foods Enforcement and Compliance,] a Senior Regulatory Counsel for Critical Foods, and a Medical Officer for Critical Foods.

        The FDA continues to seek additional authority through the FY24 budget request to require that, among other things, manufacturers report to FDA final product positive test results for relevant pathogens, including those that have not left the manufacturer’s control; conduct more frequent environmental monitoring in their facilities to identify relevant pathogens; and maintain the results of such testing for FDA inspection, either in person or remotely. The combination of these new authorities would empower the FDA to work with firms in real time to resolve issues around product positive findings and better assure the safety of product entering the market.

        The FDA appreciates the continued collaboration with the infant formula industry, retailers, educators, and federal partners to strengthen the resiliency and safety of infant formula in the United States.

        For more information

        • Status Update on FDA’s Infant Formula Response Activities - March 2023
        • Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula
        • Strategy to Help Prevent Cronobacter sakazakii Illnesses Associated with Consumption of Powdered Infant Formula
        • Letter to the Infant Formula Industry
        • Enforcement Discretion to Manufacturers to Increase Infant Formula Supplies
        • Infant Formula
        • Cronobacter sakazakii