FDA Proposes First Major Update to US Infant Formula Standards in Nearly 30 Years

The US Food and Drug Administration (FDA) has proposed the first comprehensive update to infant formula nutrient requirements since 1998. Announced on October 29, 2026, by the US Department of Health and Human Services (HHS), the proposal aims to align infant formula nutrient standards with current scientific evidence on infant growth and development.

The proposed rule is part of the FDA's three-phase review of the 30 nutrients currently required in infant formula marketed in the United States. The first phase sets requirements for iodine, manganese, vitamin A, and vitamin D, while reaffirming existing requirements for chloride, potassium, selenium, and sodium. The proposal also includes changes to the units of measurement for two nutrients.

The FDA is seeking public feedback on whether certain nutrients that are not currently mandatory but are commonly added to infant formula should be considered for future requirements. These include arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine, which have been associated with aspects of infant neurodevelopment.

The agency plans to address the remaining required nutrients, potential new nutrient requirements, and carbohydrate sources in the next two phases. It intends to combine the changes into a single comprehensive final rule after completing the review process.

Alongside the proposed nutritional changes, the FDA released new chemical contaminant testing data for infant formula. According to the agency, most tested samples had low or non-detectable levels of chemical contaminants, consistent with findings released earlier in 2026. The FDA has also introduced an Infant Formula Testing webpage and a chemical contaminants dashboard to make the results accessible to the public.

The public comment period for the proposed rule is open until February 26, 2027. Comments can be submitted through Regulations.gov under docket number FDA-2026-56789. The proposal is not yet a final regulation.

Source: https://news.docthub.com/fda-proposes-first-major-update-to-us-infant-formula-standards-in-nearly-30-years-N2673