The Food and Drug Administration (FDA) has launched “Operation Stork Speed,” a new initiative to review infant formula ingredients and strengthen safety measures. Announced on Tuesday, the effort aims to improve the quality, safety, and availability of infant formula in the U.S.
The move comes in response to the 2022 infant formula crisis, which left American families scrambling for safe alternatives after the FDA temporarily shut down Abbott Nutrition’s Michigan facility due to bacterial contamination. The closure led to nationwide recalls and a supply chain disaster that exposed vulnerabilities in the market.
An investigation by the Office of Inspector General for the Department of Health and Human Services (HHS) later found that the FDA was slow to react to warning signs at the plant, a failure that contributed to months of shortages.
Now, under the leadership of HHS Secretary Robert F. Kennedy Jr., the FDA is seeking to ensure such a crisis does not happen again. “The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and children who rely on them,” Kennedy said in a statement. He called the initiative a “critical” step in his broader “Make America Healthy Again” agenda.
As part of the plan, the FDA has outlined several key actions, including conducting its first comprehensive review of infant formula nutrients since 1998. The agency will also increase testing for heavy metals and other contaminants in formula and extend its personal importation policy, which allows individuals to bring formula from overseas sources under certain conditions.
The initiative will also encourage companies to develop new infant formula options and improve transparency regarding ingredients and labeling. Additionally, the FDA plans to work with the National Institutes of Health and other scientific organizations to address research gaps on the long-term health impacts of formula feeding.
Acting FDA Commissioner Sara Brenner emphasized the importance of the effort, stating, “The FDA is deeply committed to ensuring that moms and other caregivers of infants and young children… have confidence that these products are safe, consistently available, and contain the nutrients essential to promote health and wellbeing.”
The agency says it will issue a Request for Information in the coming months to formally begin the nutrient review process, while also increasing communication with consumers and industry stakeholders.
With the memory of the 2022 formula crisis still fresh, the administration is under pressure to demonstrate that lessons have been learned. Whether “Operation Stork Speed” can successfully rebuild trust and prevent future disruptions remains to be seen.