HHS, FDA Unveil Next Steps in Infant Formula Nutrient Review

May 13, 2025 by Dan McCue
HHS, FDA Unveil Next Steps in Infant Formula Nutrient Review
(Photo by Ben Kerkx via Pixabay)

WASHINGTON — The Department of Health and Human Services and the Food and Drug Administration have issued a request for information related to their recently initiated review of the nutrients contained in infant formula.

Announced in March, “Operation Stork Speed” is intended to ensure the “ongoing quality, safety, nutritional adequacy and resilience” of the infant formula supply in the United States.

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.

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

“Operation Stork Speed brings radical transparency to ingredients in infant formula and puts science front and center,” said Health Secretary Robert F. Kennedy Jr. in a written statement. 

“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,” Kennedy said.

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.  

Anyone wishing to comment will have 120 days to submit their responses.

In addition, the FDA is increasing its testing for heavy metals and other contaminants in infant formula and other food consumed by children.

At the same time, the agency is encouraging companies to work with it 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 Makary, M.D., in a written statement. 

“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,” Makary said.

Dan can be reached at [email protected] and @DanMcCue

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