# Infant Formula Nutrient Requirements

The Food and Drug Administration published this proposed rule in the Federal Register on November 2, 2026. Comments are due by March 2, 2027.

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## What the agency says

The Food and Drug Administration (FDA or we) proposes to amend the regulations on nutrient specifications and labeling for infant formula as part of its phased, comprehensive review of infant formula nutrients. This action, if finalized, would amend the minimum and/or maximum levels of four required nutrients, change the unit of measure for certain nutrients, change the permitted source to meet one of the nutrient requirements, and amend the content of the required labeling. This action also includes a comprehensive assessment of four additional nutrients for which we conclude that the current required levels remain appropriate and reflect the best available scientific evidence on infant nutritional requirements and safe intake levels.

## Key facts

- Document number: 2026-22273
- Type: Proposed rule
- Action: Proposed rule
- Agency: Health and Human Services Department; Food and Drug Administration
- Published: November 2, 2026
- Comments due: March 2, 2027
- Dates: Either electronic or written comments on the proposed rule must be submitted by March 2, 2027.
- Docket: Docket No. FDA-2026-N-10832
- Regulation ID (RIN): 0910-AJ34
- Code of Federal Regulations: 21 CFR 107; 21 CFR 184
- Topics: Food additives; Food labeling; Infants and children; Nutrition; Reporting and recordkeeping requirements; Signs and symbols
- Pages: 50

[The document on federalregister.gov](https://www.federalregister.gov/documents/2026/11/02/2026-22273/infant-formula-nutrient-requirements) [PDF](https://www.govinfo.gov/content/pkg/FR-2026-11-02/pdf/2026-22273.pdf) [Comment on regulations.gov](http://www.regulations.gov/commenton/FDA-2026-N-10832-0001)

## Other documents from the Food and Drug Administration

| Document | Type | Published |
| --- | --- | --- |
| [Food Additive Petitions; Change of Address](https://specstream.ai/data/federal-rules/food-additive-petitions-change-of-address-2026-22663) 2026-22663 | Final rule | Nov 6 |
| [Medical Devices; Ear, Nose, and Throat Devices; Classification of the External Mechanical Stimulator for the Relief of Congestion](https://specstream.ai/data/federal-rules/medical-devices-ear-nose-and-throat-devices-classification-of-the-exte-2026-22657) 2026-22657 | Final rule | Nov 6 |
| [Medical Devices; Hematology and Pathology Devices; Classification of the Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm](https://specstream.ai/data/federal-rules/medical-devices-hematology-and-pathology-devices-classification-of-the-2026-22593) 2026-22593 | Final rule | Nov 5 |
| [Medical Devices; Neurological Devices; Classification of the Prognostic Assessment Software of Mild Cognitive Impairment](https://specstream.ai/data/federal-rules/medical-devices-neurological-devices-classification-of-the-prognostic-2026-22590) 2026-22590 | Final rule | Nov 5 |
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| [Medical Devices; Anesthesiology Devices; Classification of the Over-the-Counter Device To Assess Risk of Sleep Apnea](https://specstream.ai/data/federal-rules/medical-devices-anesthesiology-devices-classification-of-the-over-the-2026-22182) 2026-22182 | Final rule | Oct 30 |
| [Medical Devices; Anesthesiology Devices; Classification of the Spinal Imaging System for Neuraxial Procedures](https://specstream.ai/data/federal-rules/medical-devices-anesthesiology-devices-classification-of-the-spinal-im-2026-22181) 2026-22181 | Final rule | Oct 30 |
| [Medical Devices; Radiology Devices; Classification of the Radiology Software for Referral of Findings Related to Fibrotic Lung Disease](https://specstream.ai/data/federal-rules/medical-devices-radiology-devices-classification-of-the-radiology-soft-2026-22180) 2026-22180 | Final rule | Oct 30 |

[Everything from the Food and Drug Administration](https://specstream.ai/data/federal-rules/agency/food-and-drug-administration) · [Rules on food additives](https://specstream.ai/data/federal-rules/topic/food-additives) · [Rules on food labeling](https://specstream.ai/data/federal-rules/topic/food-labeling) · [Rules on infants and children](https://specstream.ai/data/federal-rules/topic/infants-and-children) · [Published in November 2026](https://specstream.ai/data/federal-rules/month/2026-11)

Read from the Federal Register API, last updated 2026-11-10. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/).