HHS, FDA Announce Operation Stork Speed to Expand Options for Safe, Reliable, and Nutritious Infant Formula for American Families

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Mar 18, 2025, 15:50 ET

SILVER SPRING, Md., March 18, 2025 /PRNewswire/ -- Today, under the leadership of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., the U.S. Food and Drug Administration is taking steps to enhance its efforts to ensure the ongoing quality, safety, nutritional adequacy, and resilience of the domestic 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," said HHS Secretary Kennedy. "Helping each family and child get off to the right start from birth is critical to our pursuit to Make America Healthy Again."

The FDA is announcing a set of actions and initiatives focused on infant formula, such as beginning the nutrient review process and increasing testing for heavy metals and other contaminants. The agency is also encouraging companies to develop new infant formulas and clarify opportunities to help inform consumers about formula ingredients. These enhanced FDA commitments are focused on making sure a strong supply of the sole source of nutrition for formula-fed babies and children remains available for one of our nation's most vulnerable populations.

"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," said Acting FDA Commissioner Sara Brenner, M.D., M.P.H. "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."

The FDA uses its authorities, both longstanding and newly granted, to uphold the safety, nutritional adequacy and resilience of infant formula and the infant formula supply. The FDA is:

Starting the nutrient review required by law by issuing a Request for Information in the coming months to start the first comprehensive update and review of infant formula nutrients by the FDA since 1998
Increasing testing for heavy metals and other contaminants in infant formula and other foods children consume
Extending the personal importation policy
Encouraging companies to work with the FDA on any questions regarding increased transparency and clearer labeling
Communicating regularly with consumers and industry stakeholders as significant developments occur to ensure transparency, including information regarding nutrients and health outcomes
Collaborating with the National Institutes of Health and other scientific bodies to address priority scientific research gaps regarding short- and long-term health outcomes associated with formula feeding in infancy and childhood across the lifespan

The FDA remains committed to infant formula safety and nutritional quality and is taking all actions to ensure the U.S. infant formula supply ranks best in the world.

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