The USDA, FDA, and other federal partners continue to work diligently to protect the health of infants who are fed using infant formula.
USDA's Response to the Infant Formula Shortage
WIC state agencies provide infant formula to mothers who choose this feeding method. WIC state agencies are required by law to have competitively bid infant formula rebate contracts with infant formula manufacturers.
In response to the 2022 infant formula recall and supply shortage, USDA worked closely with the White House, HHS, and FDA to support families, including those that participate in FNS nutrition programs.
On June 30, 2023, USDA completed the final phase of "Unwinding Infant Formula Flexibilities in WIC," which extended the expiration date for certain waivers based on infant formula supply and availability.
To increase the diversity of and support a stable supply of infant formula in the U.S., FDA allowed certain infant formula products to be imported, sold, and/or distributed in the U.S. under enforcement discretion.
Click each image for more information on each waiver type.
Information on vendor substitutions waivers.
To ensure that infants in WIC got the formula they needed, FNS supported WIC state agencies with guidance, that waived certain regulatory requirements to allow WIC state agencies to authorize and issue certain infant formulas imported under the FDA’s Infant Formula Enforcement Discretion Policy.
FNS supports its program operators with timely information, including infant formula safety tips, on its infant formula webpage. USDA continues to work collaboratively with federal partners to support WIC stakeholders and ensure participants get the safe and nutritious foods they need.
Implementation of the Access to Baby Formula Act (ABFA) of 2022
USDA is implementing the Access to Baby Formula Act of 2022 (PL 117-129), signed into law by President Biden on May 21, 2022. USDA has provided questions and answers about the WIC AFBA Final Rule.
FDA's Infant Formula Strategies
The FDA has published two national strategies to increase the resiliency of the U.S. infant formula market and prevent Cronobacter sakazakii illnesses associated with powdered infant formula.
- The national strategy to increase the resiliency of the U.S. infant formula market describes actions the FDA will take to protect against future contamination and other potential causes of shortages, and ensure parents and caregivers have access to infant formula and the information they need.
- The strategy to help prevent Cronobacter sakazakii illnesses associated with powdered infant formula outlines actions the FDA will take to broaden scientific understanding of Cronobacter sakazakki, improve oversight of safe production of powdered infant formula, and enhance communications and engagement with industry, consumers, federal, state, local, and other public health partners about infant formula safety.
- The FDA provided constituent updates on Nov. 15, 2022 and Sept.20, 2023 on its work to advance this strategy.
- FDA's updated prevention strategy webpage includes a list of actions that have been taken to date.
In January 2024, FDA posted a Status Update FDA’s Infant Formula Response Activities.