FDA Proposes First Broad Update to Infant Formula Nutrient Standards Since 1998

The Trump administration announced proposed changes to infant formula nutrient requirements Oct. 29, beginning the first comprehensive review of those standards since 1998. Federal officials also released additional testing results showing low or undetectable chemical contaminants in most formula samples examined.

Health and Human Services Secretary Robert F. Kennedy Jr. announced the actions in Des Moines as part of Operation Stork Speed and the administration’s Make America Healthy Again initiative. The nutrient changes would require completion of the federal rulemaking process before taking effect.

“Parents deserve confidence in every bottle they feed their baby,” Kennedy said.

The proposal would revise requirements for iodine, manganese, vitamin A and vitamin D while retaining existing requirements for chloride, potassium, selenium and sodium. It also would change measurement units for certain nutrients.

The FDA is seeking public input on whether to require additional ingredients commonly included in formula, including arachidonic acid, known as ARA; docosahexaenoic acid, or DHA; and L-carnitine.

The proposal is the first of three planned phases examining the 30 nutrients currently required in infant formula. Later phases will address remaining nutrients, possible additional requirements and carbohydrate sources. The agency plans to combine the resulting changes into one comprehensive final rule.

Separately, the FDA released chemical contaminant testing results and introduced public resources intended to make the findings easier to review, including an infant formula testing webpage and a chemical contaminants dashboard.

According to the FDA’s testing page, its 2023–2025 market basket survey examined 312 samples across 16 brands. Testing covered heavy metals, pesticides, PFAS and other chemicals. Most samples contained undetectable or very low contaminant levels, although some findings prompted additional testing and follow-up with manufacturers.

The FDA cautioned that retail sampling provides a snapshot of available products and does not capture all variation between production lots. Detecting a contaminant also does not automatically mean a product is unsafe, the agency said.

The agency is continuing surveillance and working toward establishing action levels for certain contaminants through its broader Closer to Zero initiative.

Parents, caregivers, health professionals, researchers and manufacturers can submit comments on the nutrient proposal through Regulations.gov. The linked Federal Register notice lists a March 2, 2027, deadline and docket number FDA-2026-N-10832. Those details differ from the Feb. 26 deadline and docket number provided in the HHS announcement.