HHS and FDA Initiate Review of Infant Formula Nutrients

FDA issues guidance to increase supply of infant formula — Photo courtesy of Getty Images/netrun78

The U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) recently revealed the next steps in Operation Stork Speed – an 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 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,” says 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. The agency also welcomes data on potential adjustments to minimum or maximum levels, as well as recommendations for additional nutrients and how such changes may improve health outcomes.

Commenters will have 120 days to submit responses. Information on how to submit a comment can be found on the Federal Register’s website.

The FDA, under the HHS’s leadership, launched Operation Stork Speed in March, reaffirming the agency’s commitment to infant formula safety and nutritional quality. In addition to the 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 it on enhancing transparency and improving labeling clarity.

“Protecting our most vulnerable is not just a moral duty — it is our responsibility,” says FDA Commissioner Martin A. Makary. “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.