# 2025-08419: FDA Reopens the Question of What Belongs in Infant Formula

2025-08419, Infant Formula Nutrient Requirements; Request for Information, is a Federal Register notice from Health and Human Services Department, Food and Drug Administration published 2025-05-14, effective Either electronic or written comments on the notice must be submitted by September 11, 2025.; PRIA reads it as touching household money (as of 2026-10-19).

- Canonical: https://policyrisk.com/federal-register/2025-08419
- As of: 2026-10-19
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-08419
- Title: Infant Formula Nutrient Requirements; Request for Information
- Type: Notice
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 90 FR 20475
- Published: 2025-05-14
- Effective: Either electronic or written comments on the notice must be submitted by September 11, 2025.
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-10-19

## In one line

FDA Reopens the Question of What Belongs in Infant Formula

## 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!

## Abstract

The Food and Drug Administration (FDA or we) is requesting information and data to begin the nutrient review process for infant formula. We are taking this action, in part, to continue to ensure the nutritional adequacy of infant formula sold in the United States. We intend to use the information and data to help determine what type(s) of actions, if any, should be taken.

## Effects PRIA read

- FDA opens nutrient review; comments due: benefit, low. 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: benefit, low. 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.
- Possible changes to required nutrients and levels: benefit, medium. 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…

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## Sources
- [2025-08419 on federalregister.gov](https://www.federalregister.gov/documents/2025/05/14/2025-08419/infant-formula-nutrient-requirements-request-for-information)
- [2025-08419 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-05-14/pdf/2025-08419.pdf)

## Related
- [Previous: 2025-08418, Agency Information Collection Request. 30-Day Public Comment Request](https://policyrisk.com/federal-register/2025-08418)
- [Next: 2025-08420, Agency Information Collection Request. 30-Day Public Comment Request](https://policyrisk.com/federal-register/2025-08420)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-08419 (as of 2026-10-19).