FDA launches nationwide review of infant formula safety, supply chain operation

The FDA is reviewing baby formula safety, quality, and supply after the 2022 recall and shortages. The plan includes testing for contaminants, updating nutrition standards, and improving labels to keep formula safe and available.

On March 18, the U.S. Food and Drug Administration, led by the U.S. Department of Health and Human Services, announced it had started reviewing the domestic infant formula supply.

According to the U.S. Government Accountability Office, the federal government buys around 40% of formula in the U.S. for its food assistance program for low-income mothers and children, known as the Supplemental Nutrition Program for Women, Infants, and Children (WIC).

The FDA notes that its newly launched initiative, Operation Stork Speed, aims to ensure the quality, safety, nutritional adequacy and resilience of the infant formula supply.

“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,” HHS Secretary Kennedy said. “Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again.”

As part of the review process, the FDA also requested that companies consider developing a new infant formula and be transparent about the ingredients used so that consumers can make better purchasing choices.

The agency is also focused on the strength of the supply chain as it looks to limit shortages of essential nutrition.

“The FDA is deeply committed to ensuring that moms and other caregivers 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 wellbeing during critical stages of development and life,” Acting FDA Commissioner Sara Brenner, M.D., M.P.H. said. “Whether breastfed, bottle fed or both, the rising generation must be nourished in a way that promotes health and longevity over the course of their lives.”

Here is a breakdown of actions the FDA plans to take:

• Request information to begin a comprehensive update and review of the nutrients in infant formula
• Increase testing of heavy metals and other contaminants in formula and children’s foods
• Extending the personal importation policy
•  Work with companies on transparency and labeling
• Maintain process transparency with the public and stakeholders
• Work with the scientific community to study the short- and long-term health effects of formula feeding

In 2022, Abbott Nutrition voluntarily recalled infant formula produced at a plant in Sturgis, Michigan, and stopped operations after four infants were hospitalized and two deaths were connected to infant formula. FDA and independent environmental testing were positive for Cronobacter sakazakii, but said they were different strains than those collected from the patients.

This comprehensive review follows the 2022 baby formula crisis, that resulted from Abbott Nutrition’s voluntary recall. This recall and supply-chain issues caused by the COVID-19 pandemic led to widespread shortages and affected the supply in baby formula and the government's ability to supply it to the families participating in WIC.

The FDA says this will be the first time since 1998 that a review of infant formula nutrients is being completed.

For official guidelines, safety updates and product recalls, visit the FDA Website.