The U.S. Food and Drug Administration (FDA) has published a Long-Term National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, building upon an immediate national strategy published in March 2023, which initiated first steps and research toward a long-term strategy. The long-term strategy is informed by studies of challenges facing the U.S. infant formula market conducted by the National Academies of Sciences, Engineering, and Medicine (NASEM).

Efforts by FDA to increase the resiliency and safety of the U.S. infant formula supply were prompted by the infant formula crisis of 2022, in which the nation faced a critical shortage of infant formula following a recall of product contaminated with Cronobacter sakazakii, resulting in the temporary shutdown of Abbott Nutrition’s Sturgis, Michigan facility, a major producer of formula in the U.S. Following the crisis, FDA commissioned NASEM to evaluate the U.S. infant formula market before and during the shortage, considering FDA’s response to the events. NSAEM’s report, which made recommendations to federal agencies about actions required to prevent future shortages, helped inform FDA’s newly released, long-term strategy.

Since 2022, FDA has taken several actions to improve the safety and availability of infant formula, such as entering a consent decree with Abbott Nutrition, meeting inspection targets for infant formula production facilities in 2023 and 2024, issuing warning letters to three formula manufacturers, implementing its commodity-specific prevention strategy for C. sakazakii contamination in powdered infant formula, updating the compliance program for infant formula, and participating in reviews of FDA’s processes related to infant formula oversight. The agency is also working with major domestic infant formula producers to increase infant formula production, which is highly concentrated to a small number of manufacturers. For example, in 2022, four companies controlled 99 percent of the infant formula market; in 2024, the number of major manufacturers was down to three.

The long-term strategy prioritizes actions to enhance oversight of infant formula and prevent contamination, protect the integrity of the infant formula supply chain and incentivize new entrants to the U.S. market, support collaboration to strengthen the infant formula supply chain, ensure stakeholders have the most up-to-date information on infant formula and improve information sharing, and gain additional tools and authorities to further enhance FDA’s oversight of infant formula.

Improving Oversight of Safe Infant Formula Production

An area in which FDA will focus its efforts is ensuring safe production of infant formula by conducting food safety inspections of all manufacturers on an annual basis, at minimum, and setting annual sampling targets for foreign manufacturers to test for microbiological quality. FDA will also continue evaluating and improving infant formula training for inspectors and relevant staff by holding workshops.

Moreover, the agency will continue to implement its prevention strategy for C. sakazakii in powdered infant formula. This includes leveraging new information received from NACMCF on industry and public health interventions to address Cronobacter infections associated with powdered infant formula, and communicating best practices with industry based on the latest scientific information. Finally, FDA will enact structural changes and process improvements, including enhanced processes for handling consumer and whistleblower complaints throughout the agency, based on recommendations from the Office of the Inspector General (OIG).

Strengthening Resiliency and Collaborating With Partners to Ensure Infant Formula Safety

FDA has gained significant visibility into the state of the U.S. infant formula market since 2022, and the agency intends to leverage this enhanced visibility to identify and mitigate vulnerabilities in the infant formula supply chain by monitoring stock and assessing and predicting risks and disruptions. Additionally, to increase the diversity and availability of the national supply, FDA is improving its support for manufacturers seeking to market formula in the U.S., identifying areas in which redundancy can be created, and exploring harmonization with international regulatory requirements for infant formula.

The long-term strategy also outlines how FDA intends to collaborate with other federal, state, and local partners to increase the resiliency and safety of the infant formula supply. Notably, FDA will continue to communicate and collaborate with Council of State and Territorial Epidemiologists (CSTE), as Cronobacter has recently become a nationally notifiable disease. The agency will also leverage partnerships with the U.S. Department of Health and Human Services (HHS), the U.S. Centers for Disease Control and Prevention (CDC), and other agencies to ensure industry, consumers, medical professionals, and other stakeholders receive the most up-to-date information on infant formula, as well as to develop communication materials to be used in the event of future recalls or supply disruptions.

Authorities, Regulations, and Guidances for Infant Formula

While Congress has recently granted FDA additional authorities related to infant formula, the agency is still requesting resources to hire more staff and experts to increase pre-market notification review capacity, as well as more food safety inspectors. The agency also seeks the mandatory authority for remote access of records for all critical food manufacturers, and is working with Congress to require manufacturers of critical foods to give sufficient advanced notice when they decide to discontinue a critical food that is likely to lead to a meaningful disruption, as well as to encourage manufacturers to implement Redundancy Risk Management Plans (RRMPs) and modernize manufacturing plants and equipment.

Additionally, FDA will continue to evaluate all new scientific, production, and regulatory information to determine if an update is needed to existing regulations, including requirements for pathogen testing in finished infant formula product.