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A Request for Information (RFI) issued by the FDA will review required minimum and maximum levels of certain nutrients in infant formula products.
May 19, 2025
By: Mike Montemarano
Associate Editor, Nutraceuticals World
The U.S. Food and Drug Administration (FDA) has issued a Request for Information to begin a review process of the nutrient content of infant formula products, in the latest step of “Operation Stork Speed,” a broader initiative by the U.S. Department of Health and Human Services (HHS) to enhance efforts to ensure the quality, safety, nutritional adequacy, and supply resilience of the infant formula supply.
Currently, infant formula must meet minimum and maximum levels of certain nutrients, and this will be the first comprehensive review of those requirements conducted since 1998, the agency stated.
“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, FDA is seeking public input to help determine whether existing nutrient requirements should be revised based on the latest scientific data, including international findings. The agency welcomes data on potential minimum or maximum level requirements, recommendations for additional nutrients to consider, and how such changes can improve health outcomes.
To submit a comment, more information can be found here.
In addition to the RFI, the agency is increasing testing for heavy metal and other contaminants in infant formula and other food consumed by children.
“Protecting our most vulnerable is not just a moral duty. It is our responsibility,” said FDA Commissioner Martin A. Makary, MD, MPH. “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, FDA reported that it will convene a publicly accessible expert panel in June.
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