By Policy Center’s Legislative and Regulatory Policy Team

Our work shaping and reporting on national mental health policy is made possible through a 2023-2024 capacity grant from the Perigee Fund.

Since the Abbott infant formula recall in February 2022, the U.S. Food and Drug Administration (FDA) has been working to expand consumer access to infant formula products while also ensuring safety and nutritional adequacy. The Food and Drug Omnibus Reform Act of 2022 required the FDA to develop a national strategy addressing formula shortages. According to the strategy titled Immediate National Strategy to Increase the Resiliency of the U.S. Infant Formula Market: “The immediate strategy represents a first step toward issuing, with input from the National Academy of Science, Engineering and Medicine (NASEM), a long-term national strategy in 2024 to improve preparedness against infant formula shortages by outlining methods to improve information-sharing, recommending measures for protecting the integrity of the infant formula supply chain, and preventing contamination. The longer-term strategy will explore new approaches to help facilitate entry into the market of new infant formula manufacturers to increase supply,mitigate future shortages, recommend necessary authorities to gain insight into the supply chain and risks for shortages.”

The FDA has published status updates on its infant formula response activities through December 2023.

Current Strategy Execution

On March 13th, 2024, the Federal Trade Commission (FTC) released a report titled “Market Factors Relevant to Infant Formula Supply Disruptions” which aims to analyze the long-term features that led to the disruptions of the U.S. infant formula market. The report also offers policymakers considerations to enhance the supply chain's resilience.

Over the course of the last month, an ad hoc committee of the National Academies of Sciences, Engineering, and Medicine has begun to examine and report on challenges in supply, market competition, and regulation of infant formula in the United States. Specifically, the committee will assess and evaluate:

Characteristics of the U.S.infant formula market
Supply challenges and market competition
Marketing differences across the United States compared to the European Union
Other related information

During its most recent closed session, held on March 25th, the NASEC committee worked to develop a comprehensive report detailing its findings and recommendations, including suggestions for infant formula manufacturers. These recommendations aim to address issues related to supply and market competition in the United States, as outlined in H.R. 2617 of the FY2023 Omnibus Bill.

For inquiries and feedback regarding the project, the committee lists regulation@nas.edu as the best way to contact responsible staff officers Katherine Delaney and Patricia Cuff.

Impact on Maternal Mental Health

The impact of the 2022 formula shortage was felt by mothers across the country, negatively impacting the mental health of moms from Wisconsin to Washington, DC.

In the first study of its kind, George Washington University examined the experiences of mothers during the formula shortage via in-depth qualitative interviews. The study identified several common themes about how the shortage affected mothers, including the following:

The shortage had adverse impacts on mothers’ mental and emotional health
Mothers reported significant financial and intangible costs resulting from the shortage
The shortage led to changes in infant feeding practices, including ones that could be detrimental to an infant’s health