Families who use infant formula could see changes to the federal nutrition standards that govern what manufacturers must include in their products, under a Food and Drug Administration proposal.
The Department of Health and Human Services and the FDA said last year that they would review the nutrition quality of infant formula in the US through the FDA's 'Operation Stork Speed' initiative. HHS announced Thursday that the proposal is the first of three planned stages in that review.
HHS Secretary Robert F. Kennedy, Jr. said: 'Parents deserve confidence in every bottle they feed their baby.' Kennedy said the department would hold formula manufacturers to rigorous scientific standards and put babies' health first.
The FDA currently requires infant formulas to contain 30 nutrients. All 30 have minimum amounts, while 10 also have maximum amounts. Under current law, the HHS secretary reviews the required-nutrient table every four years as appropriate.
The proposed rule would revise requirements for iodine, manganese, vitamin A and vitamin D. It would retain the existing requirements for chloride, potassium, selenium and sodium, while altering the units used to measure two nutrients.
The agency is also asking for public comment on whether arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine should become required ingredients. Manufacturers sometimes add those ingredients already, and the FDA said evidence suggests they contribute to neurodevelopmental health in infants.
Later phases will consider other required nutrients, possible new requirements and carbohydrate sources. The FDA intends to bring the changes together in one final rule.
The administration in 2025 began the first comprehensive review in decades of nutrients required under FDA regulations. The FDA estimates that reformulating and relabelling products to implement the changes would cost manufacturers between $8.4 million to $31.7 million annually.
Alongside the proposal, the FDA released results from chemical-contaminant testing of infant formula products sold in the US. The agency tests for pesticides, PFAS, phthalates and heavy metals including arsenic, cadmium, lead and mercury. Most samples had 'low or non-detectable levels of chemical contaminants,' the FDA said, and the results are available on a newly launched public dashboard.
Public comments on the proposed rule are due by Feb. 26.
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