2026-22273·DEPARTMENT OF HEALTH AND HUMAN SERVICES

Infant Formula Nutrient Requirements

Proposed RuleComment Period OpenComments open

Published: Nov 2, 2026
Comments close: Mar 2, 2027
Citation: 91 FR 69040
Docket: Docket No. FDA-2026-N-10832
Agencies: DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration

Proposed rule.

Summary

The Food and Drug Administration (FDA) is proposing to update the rules that set the nutrient levels and labeling requirements for infant formula. The changes are part of a staged, science‑based review aimed at making sure that the amounts of key vitamins and minerals in formula match the latest nutritional research and safety data. The proposal would adjust the minimum or maximum amounts for four required nutrients, revise how those nutrients are measured, allow a different source to satisfy one nutrient requirement, and modify the information that must appear on formula labels. At the same time, the agency has reviewed four additional nutrients and decided that the existing limits are still appropriate. The rule is issued by the FDA, which operates under the U.S. Department of Health and Human Services. It primarily affects manufacturers of infant formula, who would need to alter product formulations and packaging to comply, as well as health‑care providers and parents who rely on accurate labeling to choose safe products for babies. The proposed rule was published in the Federal Register on November 2, 2026 (91 FR 69040). Written comments must be submitted by March 2, 2027. After the comment period, the FDA will review the input, possibly make further revisions, and then issue a final rule that will establish the new nutrient standards and labeling requirements.

AI-generated summary — verify against the Federal Register text.

Official abstract

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.