HHS, FDA Initiate Comprehensive Review of Nutrients in Infant Formula

Department marks significant progress on Operation Stork Speed

WASHINGTON, DC—MAY 13, 2025— The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) today announced the next steps in Operation Stork Speed--a groundbreaking initiative to ensure the safety, reliability, and nutritional adequacy of infant formula for American families. The FDA issued a Request for Information (RFI) to begin the nutrient review process required by law for infant formula. Currently, infant formula must meet minimum and maximum levels of certain nutrients. While the FDA regularly reviews individual nutrient requirements for infant formula, this will be the first comprehensive review since 1998.

"Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center," said HHS Secretary Robert F. Kennedy, Jr. “Every child has a fundamental right to a healthy start. We’re giving parents the truth and the tools to make that happen. You can’t Make America Healthy Again if we don’t fix what nourishes our youngest and most vulnerable Americans.”

Through the RFI, the FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international. The agency also welcomes data on potential adjustments to existing minimum or maximum levels, recommendations for additional nutrients to consider, and how such changes may improve health outcomes.

Commenters will have 120 days to submit responses. Further information on how to submit a comment can be found here.

The FDA, under HHS leadership, launched Operation Stork Speed in March 2025, reaffirming the agency’s commitment to infant formula safety and nutritional quality. In addition to today’s RFI, the FDA is increasing testing for heavy metals and other contaminants in infant formula and other food consumed by children. The agency is also encouraging companies to work with the FDA on enhancing transparency and improving labeling clarity.

“Protecting our most vulnerable is not just a moral duty—it is our responsibility, said FDA Commissioner Martin A. Makary, M.D., M.P.H. “For many children, infant formula is their only source of nutrition. That’s why it’s absolutely crucial to continually assess the nutrition standards and incorporate gold standard science to ensure we are providing the safest, most effective nutrition possible.”

As part of the initiative, the FDA will convene a publicly accessible expert panel in June.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products.