The US Food and Drug Administration (FDA) proposed its first major update to infant formula nutrient requirements since 1998. The proposal targets 4 nutrients and examines whether additional ingredients associated with infant neurodevelopment should become mandatory.
The proposed rule, announced under the Trump administration's Operation Stork Speed initiative, represents the first phase of the FDA's comprehensive review of the 30 nutrients currently required in infant formula marketed in the United States.
Under the proposal, the FDA would update requirements for iodine, manganese, vitamin A, and vitamin D, while reaffirming existing requirements for chloride, potassium, selenium, and sodium. The agency proposed changing the units of measurement for two nutrients.
Additionally, the FDA is seeking public input on whether ingredients commonly added to infant formula by manufacturers should become required components. These include arachidonic acid, docosahexaenoic acid, and L-carnitine, which data has suggested could contribute to neurodevelopmental health during infancy.
The FDA is conducting its nutrient evaluation in 3 phases. Subsequent evaluations will address remaining required nutrients, potential new nutrient requirements, and carbohydrate sources. The agency intends to consolidate the resulting changes into a single comprehensive final rule.
Separately, the FDA released new chemical contaminant testing data indicating that most infant formula samples tested contained low or nondetectable contaminant levels, consistent with findings released earlier in 2026.
To improve public access to monitoring results, the agency launched a dedicated Infant Formula Testing Webpage and an Infant Formula Chemical Contaminants Dashboard. Through its Closer to Zero initiative, the FDA is working toward establishing action levels for certain chemical contaminants in infant formula.
The proposed nutrient requirements are not yet final. Clinicians, industry members, and members of the public may submit comments through February 26, 2027.
