FDA Proposes Infant Formula Nutrient Limits in First Major Update in Nearly 30 Years

The Food and Drug Administration proposed new nutrient limits and labeling rules for infant formula on Thursday, in the first major update to the standards in nearly 30 years. The proposal is the first of three planned rules from the agency's first comprehensive review of infant formula nutrients since 1998.

Health and Human Services Secretary Robert F. Kennedy, Jr. announced the proposal at Amanda the Panda Children Center in Des Moines, Iowa. "Parents deserve confidence in every bottle they feed their baby," Kennedy said. He said the administration was proposing stronger nutrient requirements, testing formula for contaminants, and putting the results directly in parents' hands. FDA Acting Commissioner Kyle Diamantas said the agency was modernizing the nutritional requirements for infant formula for the first time in nearly three decades, so that American babies receive nourishment that meets current science from day one.

What the rule would change

The rule, if finalized, would amend the limits for four required nutrients: iodine, vitamin A, vitamin D and manganese. It would also establish a maximum level for manganese for the first time. The proposal would change how vitamins A and D are measured, allow a new source of vitamin A, and revise labeling requirements. The agency reviewed four other nutrients, chloride, selenium, potassium and sodium, and concluded that the current required levels for those nutrients are appropriate.

The proposal also asks for public input on ingredients that most manufacturers already add but that are not currently required, including arachidonic acid, known as ARA, docosahexaenoic acid, known as DHA, and L-carnitine. The FDA said there is evidence that these ingredients contribute to brain development in infancy. Infant formula sold in the United States currently must contain 30 required nutrients, and the agency is reviewing them in three phases. Later phases will cover the remaining nutrients, possible new nutrient requirements, and carbohydrate sources. The FDA said it intends to combine the final changes into a single comprehensive final rule, and that it will conduct an external peer review of the scientific information used to develop any final rule.

Cost, comments and contaminant testing

The FDA estimated the changes would cost formula manufacturers between 8.4 million and 31.7 million dollars a year, with a primary estimate of 17.6 million dollars a year. The public, including clinicians, parents, caregivers, scientists and industry, can comment on the proposed rule until February 26, 2027, through the federal docket numbered FDA-2026-56789.

The agency also released new chemical contaminant testing data on Thursday, which it said showed that most samples had low levels of contaminants, or levels that could not be detected. It launched a new Infant Formula Testing webpage and a Chemical Contaminants Dashboard so parents can explore the results, and said it is working toward action levels for certain contaminants under its Closer to Zero initiative.

Part of Operation Stork Speed

The proposal comes out of Operation Stork Speed, which the FDA launched last year. The program began the nutrient review and increased testing for heavy metals and other contaminants in infant formula, while urging companies to develop new products. The FDA has also urged the industry and its supply chain partners to exercise substantive oversight of their suppliers, following several product recalls and recent cases of infant botulism. The agency has said more proposed rules covering the remaining nutrient specifications will follow before one final rule is issued.