FDA Proposes Iodine and Manganese Updates to Infant Formula Standards

Parents buying infant formula in the United States face potential changes to ingredient requirements. The Food and Drug Administration announced the first of three proposed rule changes on Thursday. This marks the agency's first comprehensive review of formula standards in nearly 30 years.

The initial proposal updates specific nutrient levels. The draft rule modifies requirements for iodine, manganese, vitamin A, and vitamin D. It also reaffirms current standards for chloride, potassium, selenium, and sodium. Additionally, the agency proposes changing the units of measure for two specific nutrients.

Manufacturers often add ingredients that are not currently mandatory but are considered beneficial. The FDA is seeking input on setting requirements for arachidonic acid, docosahexaenoic acid, and L-carnitine. Agency documents note that evidence suggests these components support neurodevelopmental health in infants.

Healthcare professionals, parents, and researchers can submit public comments on the draft rule. The deadline for these submissions is February 26. The FDA intends to combine the outcomes of all three review phases into a single final rule. Future phases will examine additional required nutrients, potential new additions, and carbohydrate sources.

Alongside the regulatory proposal, the agency released new chemical contaminant testing data. The FDA tests U.S. sold formula for pesticides, PFAS, phthalates, and heavy metals including arsenic, cadmium, lead, and mercury. The report states that most samples showed low or non-detectable levels of these contaminants. The agency described the findings as reassuring.

Public access to this data has expanded through a newly launched online dashboard. The FDA said it will continue monitoring contaminant levels and take action when appropriate. HHS Secretary Robert F. Kennedy Jr. addressed the release in a statement.

Parents deserve confidence in every bottle they feed their baby, Kennedy said. Under President Trump's Operation Stork Speed and Make America Healthy Again agenda, the department is proposing stronger nutrient requirements and testing formula for contaminants. The goal is to place results directly in parents' hands while holding manufacturers to rigorous scientific standards.