WASHINGTON, D.C. — The Food and Drug Administration is proposing changes to federal infant formula nutrient requirements for the first time in nearly three decades while releasing new contaminant testing results, a regulatory effort that could alter manufacturing standards for products consumed by American infants.
The proposed rule, issued last week as part of the Trump administration’s Operation Stork Speed initiative, would revise requirements for four nutrients and retain existing standards for four others. It represents the first phase of a broader review of the 30 nutrients currently required in infant formula sold in the United States.
The FDA also released chemical contaminant testing data showing that most formula samples contained low or nondetectable levels of contaminants, consistent with findings published earlier this year.
The actions were presented by Health and Human Services Secretary Robert F. Kennedy Jr. at the Amanda the Panda Children Center in Des Moines, Iowa.
The proposed nutrient revisions would affect iodine, manganese, vitamin A and vitamin D. Existing requirements for chloride, potassium, selenium and sodium would remain unchanged.
The agency also proposes changing the units of measurement for two nutrients and is seeking public input on whether additional ingredients should become mandatory components of infant formula.
Those ingredients include arachidonic acid, or ARA; docosahexaenoic acid, or DHA; and L-carnitine, which the FDA identified as having evidence of nutritional benefits, including contributions to neurological development during infancy.
The proposed changes are not yet binding. Manufacturers would be subject to revised requirements only after the FDA completes the rulemaking process and issues a final regulation.
The review marks the agency’s first comprehensive reassessment of infant formula nutrient requirements since 1998.
The FDA is conducting the review in three phases, with subsequent proposals expected to address remaining required nutrients, potential additional nutritional requirements and carbohydrate sources.
The agency intends to consolidate the resulting changes into a single comprehensive final rule rather than implement separate final regulations for each phase.
“Under President Trump’s leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades,” FDA Acting Commissioner Kyle Diamantas stated.
Separately, the FDA published additional chemical contaminant testing results as part of its continuing evaluation of infant formula safety.
The agency reported that most samples tested had low or nondetectable contaminant concentrations. The findings were consistent with earlier testing results, according to the FDA.
To make the information accessible, the agency introduced an Infant Formula Testing Webpage and an Infant Formula Chemical Contaminants Dashboard, allowing the public to review testing data.
The FDA is also evaluating potential action levels for certain chemical contaminants under its Closer to Zero initiative, which seeks to reduce exposure to contaminants in foods consumed by infants and young children.
The agency plans to continue monitoring contaminant concentrations and take regulatory action when warranted.
The nutrient rulemaking and contaminant monitoring are separate regulatory activities. The proposed nutrient changes concern the nutritional composition of infant formula, while the testing program evaluates the presence of chemical contaminants.
Public comments on the proposed nutrient requirements will be accepted through February 26, 2027.
Electronic comments can be submitted through www.regulations.gov using docket number FDA-2026-56789.
Written submissions may be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submissions should identify docket FDA-2026-56789, titled “Infant Formula Nutrient Requirements.”
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