FDA and HHS Announce Next Steps in “Operation Stork Speed”
Thursday, May 15, 2025
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  • FDA and the Department of Health and Human Services (HHS) have announced the next steps in “Operation Stork Speed,” a program intended to enhance the “quality, safety, and nutritional adequacy” of infant formula products, as we have previously blogged. FDA issued a Request for Information (RFI) to begin the required nutrient review process for infant formula, which must meet minimum and maximum levels of certain nutrients.
  • Through the RFI, FDA is seeking public input regarding “whether existing nutrient requirements should be revised based on the latest scientific data, including international,” as well as potential adjustments to existing levels, additional nutrients to consider, and how these changes may improve health outcomes. Comments will be due 120 days after the RFI is published in the Federal Register, which is scheduled for May 14, 2025.
  • FDA will also increase testing for heavy metals and other contaminants in infant formula and food for children and is encouraging companies to work with the Agency on “enhancing transparency and improving labeling clarity.” FDA intends to convene a publicly accessible expert panel in June as part of the Operation Stork Speed initiative.
  • Keller and Heckman will continue to monitor the program and other developments related to infant formula.
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