- The U.S. Food and Drug Administration’s (FDA) proposed rule on infant formula nutrient requirements has advanced to the White House Office of Information and Regulatory Affairs (OIRA) for review. According to the OIRA docket, the proposal, titled “Infant Formula Nutrient Requirements,” was received for review on October 14, 2026, and is being developed as an economically significant proposed rule.
- The proposed rule is a key component of the Trump Administration’s Operation Stork Speed initiative, launched in 2025 to reevaluate the nutrient composition of infant formula marketed in the United States. As part of that effort, FDA issued a request for information (RFI) seeking data on infant health outcomes, the adequacy of existing nutrient requirements, and whether adjustments to current minimum and maximum nutrient levels may be warranted.
- Although the contents of the proposed rule have not yet been released publicly, administration officials have previously identified infant formula composition as an area of interest. Public statements by HHS leadership have highlighted concerns around ingredients such as corn syrup solids and seed oils, for example.
- Any significant revisions to infant formula nutrient requirements could have substantial implications for manufacturers, including potential reformulation efforts, ingredient sourcing considerations, supply chain impacts, and associated costs.
- While FDA has not announced a publication date, completion of OIRA review is generally one of the final steps before publication of a proposed rule.
- Keller and Heckman will continue to monitor developments related to FDA’s infant formula modernization efforts and will provide updates as additional information regarding the proposal becomes available.
