The US Food and Drug Administration (FDA) has launched “Operation Stork Speed” to enhance oversight of the infant-formula category.
As part of the programme, the FDA aims to “enhance its efforts” to maintain the “quality, safety, nutritional adequacy, and resilience” of the infant formula in the US.
This initiative builds on the agency’s January announcement to “enhance” oversight of infant-formula production as part of its broader strategy to establish a “robust and nimble” supply chain.
In a statement, the US Department of Health and Human Services Secretary Robert F. Kennedy, Jr. said: “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.”
These efforts follow the February 2022 infant formula crisis, triggered by a product recall and nationwide shortages linked to Cronobacter sakazakii contamination at Abbott’s facility in Sturgis, Michigan.
The outbreak led to the plant’s closure, widespread recalls, and emergency imports, prompting a major FDA overhaul of infant-formula regulations.
Under Operation Stork Speed, the FDA is implementing actions such as a nutrient review process and increased testing for heavy metals and contaminants.
Additionally, the FDA is encouraging companies to improve transparency and labelling practices to ensure clearer information for consumers.
The regulator said in the coming months, it will initiate the “first comprehensive” update and review of infant formula nutrients since 1998.
FDA acting commissioner Sara Brenner said: “The FDA is deeply committed to ensuring that moms and other care-givers of infants and young children and other individuals who rely on infant formula for their nutritional needs have confidence that these products are safe, consistently available and contain the nutrients essential to promote health and well-being during critical stages of development and life.”
It is also encouraging the development of new infant formulas and providing clearer information about formula ingredients to consumers.
The agency said it is collaborating with the National Institutes of Health and other scientific bodies to address research gaps related to health outcomes from formula feeding.
When unveiling its plans to revamp infant-formula production in January, the FDA emphasised its collaboration with multiple government agencies, saying that “no single agency can resolve the vulnerabilities in the infant-formula market”.
