The FDA proposed an infant formula nutrient rule on Oct. 29 that would update requirements for iodine, manganese, vitamin A and vitamin D, the first step in the agency’s first comprehensive review of formula nutrients since 1998, HHS said.
The proposal binds no manufacturer yet. It is the first of three planned proposed rules, and the FDA plans to fold every change into one final rule. The gap since the last comprehensive review is 28 years, a calculation from the 1998 date.
What the FDA Proposed for Formula Nutrients
The review covers the 30 nutrients that U.S. formula must contain and proceeds in three phases. Later phases will address the remaining nutrients, possible new requirements and carbohydrate sources. In this first proposal, the FDA would update the requirements for four nutrients and reaffirm the existing requirements for chloride, potassium, selenium and sodium. That is eight of the 30 nutrients, or 27%, a calculation from the release’s lists. The proposal would also change the units of measure for two nutrients, which the release does not name.
HHS Secretary Robert F. Kennedy Jr. announced the proposal at Amanda the Panda Children Center in Des Moines, Iowa, under Operation Stork Speed and the Make America Healthy Again initiative. The agency is asking the public whether to require ingredients that manufacturers commonly add but are not required to include: arachidonic acid, known as ARA, docosahexaenoic acid, known as DHA, and L-carnitine. HHS said evidence links those ingredients to neurodevelopmental health in infancy.
How to Comment on the Infant Formula Proposal
Comments are due Feb. 26, 2027, through regulations.gov under docket FDA-2026-56789 or by mail to the FDA’s Dockets Management Staff at 5630 Fishers Lane, Room 1061, Rockville, Maryland. The window runs 120 days from the announcement, a calculation from the two dates. HHS gave no date for the second and third proposals or for the final rule, and none of the nutrient changes has an effective date.
What the Contaminant Testing Found
HHS announced a second action the same day: new chemical contaminant testing data. Most tested samples had low or nondetectable levels of chemical contaminants, the release said, consistent with findings the agency published earlier this year. The FDA launched an infant formula testing webpage and a chemical contaminants dashboard.
Under its Closer to Zero initiative, the FDA says it is working toward action levels for certain contaminants and will keep monitoring. Kennedy said, “Parents deserve confidence in every bottle they feed their baby.” Acting FDA Commissioner Kyle Diamantas framed the effort as a guarantee of gold-standard nourishment from day one. The comment period closes Feb. 26, 2027.
