Federal Register #FDA-2026-N-10832

FDA proposes updated infant formula nutrient specifications and labeling requirements

The Food and Drug Administration proposes updates to infant formula nutrient specifications and labeling rules. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA). - Proposed changes: Revise minimum and/or maximum levels for four required nutrients, change units of measure for certain nutrients, allow a different source for one nutrient requirement, and update required labeling content. - Nutrients reviewed: Chloride, iodine, manganese, potassium, selenium, sodium, vitamin A, and vitamin D. FDA proposes changes to some requirements and finds existing levels for four nutrients remain appropriate. - Procurement details: This is a proposed regulatory rule, not a procurement or award. No products, services, quantities, part numbers, OEMs, or vendors are identified.

Description

The FDA proposes to amend regulations for nutrient specifications and labeling for infant formula as part of its phased review of infant formula nutrients. The proposal would change the minimum and/or maximum levels of four required nutrients, change units for certain nutrients, change a permitted nutrient source, and amend required labeling content. It also evaluates four additional nutrients and concludes their existing required levels remain appropriate. Comments are due March 2, 2027.

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