Infant Formula Nutrient Review Underway in FDA’s Operation Stork Speed

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced the next steps in Operation Stork Speed, an initiative designed to ensure the safety, reliability and nutritional adequacy of the U.S. infant formula supply.

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, the agency said.

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 data. The agency said it 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. More information on how to submit a comment can be found here.

The FDA launched Operation Stork Speed in March. The agency said it is increasing testing for heavy metals and other contaminants in infant formula and other food consumed by children. FDA encourages companies to work with the agency on enhancing transparency and improving labeling clarity.

As part of the initiative, 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 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.”

“Protecting our most vulnerable is not just a moral duty — it is our responsibility,” added 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.”