FDA Reopens the Question of What Belongs in Infant Formula
Published Date: 5/14/2025
Notice
Summary
The FDA wants your input to review and possibly update the nutrient rules for infant formula sold in the U.S. This affects formula makers, parents, and caregivers who want the best nutrition for babies. Comments are open until September 11, 2025, so jump in now to help shape future formula standards—no extra costs yet, just your ideas!
Analyzed Economic Effects
3 provisions identified: 3 benefits, 0 costs, 0 mixed.
Possible changes to required nutrients and levels
FDA is specifically asking for data about revising the nutrient table in 21 CFR 107.100, including whether to change minimum or maximum levels, add maximums for the 20 nutrients that currently have only minimums, add new nutrients (for example, docosahexaenoic acid and arachidonic acid), or remove existing nutrients. The input will help FDA decide what, if any, regulatory actions to take in the future.
FDA opens nutrient review; comments due
The FDA is starting a formal review of nutrient requirements for infant formula intended for healthy, full-term infants and is asking for information and data. You can submit electronic or written comments to docket FDA-2025-N-1134 through September 11, 2025.
Operation Stork Speed: more contaminant testing
As part of 'Operation Stork Speed,' FDA announced it will increase testing for heavy metals and other contaminants in infant formula to help ensure a safe, reliable supply. This action is aimed at protecting infants who often rely on formula as their sole source of nutrition.
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