FDA Proposes Major Overhaul of Infant Formula Nutrient Standards

The Food and Drug Administration announced on Thursday that it is proposing a new rule to update the nutrient requirements for infant formula. The Department of Health and Human Services, which oversees the FDA, stated in a release that this move represents the first major update to these standards in nearly 30 years.

The proposal would adjust the required levels of vitamin A, vitamin D, iodine, and manganese. It also reaffirms existing limits for chloride, potassium, selenium, and sodium. In addition to changing nutrient amounts, the rule would alter the units of measure for two specific nutrients. The agency is also soliciting public comment on whether to make certain optional ingredients mandatory. These include arachidonic acid, docosahexaenoic acid, and L-carnitine, which some studies link to improved infant growth and brain development.

HHS Secretary Robert F. Kennedy, Jr., addressed the changes in a statement. He said, "Parents deserve confidence in every bottle they feed their baby. We will hold infant formula manufacturers to rigorous scientific standards and put babies' health first."

This proposal follows an announcement last year that the agencies would review the nutrition quality of infant formula sold in the United States. That review, part of the Operation Stork Speed initiative, examined whether current nutrient requirements needed updating. Under current law, the HHS secretary reviews the table of required nutrients every four years as appropriate. The FDA currently specifies 30 nutrients that must be included in infant formulas, with minimum amounts set for all 30 and maximum amounts for 10 of them.

In June 2025, then-FDA commissioner Dr. Marty Makary discussed the potential removal of seed oils from infant formulas. He noted on Fox & Friends that these oils are generally believed to be pro-inflammatory. "We don't want babies with general body inflammation. Forty percent of our nation's kids have a chronic condition. Many of those are tied to inflammation and insulin resistance," Makary said. Other doctors have previously disagreed, suggesting that seed oils can help lower glucose levels and improve insulin sensitivity.

The FDA released new data alongside the proposal showing that most tested samples of infant formula had low or non-detectable levels of chemical contaminants. The agency said it will hold additional phases to examine remaining required nutrients and potential new requirements. It will issue one final rule to cover all proposed changes after considering public comment.