Millions of families across the country rely on powder, concentrated liquid, or ready-to-feed formula as the primary source of nutrition for their infants (babies up to 12 months of age). Therefore, the safety and resiliency of infant formula manufacturing and distribution is critical to overall population health and well-being.

In late 2021 and 2022, the U.S. experienced a wake-up call concerning the vulnerabilities of this essential product. Supply chain issues sparked by the COVID-19 pandemic were worsened by labor shortages and further compounded by a large voluntary product recall and factory shut down (due to possible bacterial contamination) by one of three major formula producers in the country. Consumers predictably began stockpiling, which only exacerbated the shortage.

The incident clearly demonstrated that additional risk management planning was needed to prevent future supply chain disruptions. Therefore, in the spring of 2025, the U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) launched Operation Stork Speed, an initiative designed to help “ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic infant formula supply.”

Work completed by the National Academies of Sciences, Engineering, and Medicine a year earlier helped shape the initiative by providing valuable scientific guidance.  

For example, Operation Stork Speed calls for communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes. The National Academies 2024 report, Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States, examined existing challenges and identified marketplace vulnerabilities exposed during the shortage, including inadequate communication with the public, unique constraints faced by Women, Infants, and Children (WIC) program participants, and a lack of coordination between government and industry.

Specifically, the report described the extent to which actions taken by relevant stakeholders addressed these vulnerabilities, including:  

• The Access to Baby Formula Act (ABFA) of 2002, which required the U.S. Department of Agriculture and HHS to enter into a formal agreement to facilitate communication and coordination regarding supply chain disruptions, including recalls.

• The FDA’s 2023 Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market, which documented the agency’s observations during the 2022 shortage and described its immediate actions and future efforts such as providing education and communication materials for parents, caregivers, and medical providers.

• The Food and Drug Omnibus Reform Act (FDORA) of 2022, which called for improved accessibility of FDA’s educational materials, coordination with WIC to distribute the materials, and enhanced partnerships with health care providers and professionals; designated infant formula as a critical food; and charged FDA with developing an immediate national strategy to increase the resiliency of the infant formula supply chain, prevent supply disruptions, and ensure access to formula for caregivers. That strategy included adopting recommendations from the report.

Challenges in Supply, Market Competition, and Regulation of Infant Formula in the United States concluded that government officials tasked with monitoring supply conditions did not seem immediately aware that distributors of infant formula are important points of contact for information about flow of product. The government was unable to obtain information about where infant formula was in the supply chain, which hindered its ability to coordinate a whole-of-government response. The report recommended that HHS, including the HHS Supply Chain Coordinator and the Food and Drug Administration, work with the appropriate wholesalers and distributors of infant formula to develop risk management and disaster plans to prepare for potential shortages of critical foods.

Operation Stork Speed also kickstarted the first comprehensive update and review of infant formula nutrients by the FDA since 1998. Once again, work completed by the National Academies helped shape the effort. The 2025 consensus report, Protein Quality and Growth Monitoring Studies: Quality Factor Requirements for Infant Formula, examined and reported on the state of the science regarding methodologies for assessing the biological quality of protein in infant formula and the ability of infant formula to support normal physical growth.

The report concluded that, based on evidence related to the lack of use of the protein efficiency ratio (PER), to assess protein quality and review of relevant regulations in countries outside of the U.S., the preferred method of assessment of protein quality in infant formula should match the indispensable and conditionally indispensable amino acid composition of human milk. Additionally, the report recommended PER no longer be used as a measure of protein quality; instead, the human milk amino acid pattern (indispensable and conditionally indispensable amino acids) should be adopted as the reference pattern to assess the protein quality of infant formula.

The National Academies’ Food and Nutrition Board, the driving force behind both reports mentioned above, has more than 84 years of experience providing sound scientific guidance on nutrient requirements, including requirements from infant formula. As board director Ann Yaktine, PhD, MS, RD points out, “The infant formula shortage of 2022 provided an opportunity to course correct antiquated operations and implement more resilient practices. We were honored to provide such an important service in support of the U.S. government and families nationwide.”