The Food and Drug Administration (FDA) has proposed a new rule that would update the nutrient requirements for infant formula, marking the first significant change in nearly three decades. The Department of Health and Human Services (HHS), which oversees the FDA, announced the proposal, stating it aims to ensure infant formula continues to meet rigorous scientific standards.
The proposed rule would update requirements for specific nutrients including vitamin A, vitamin D, iodine, and manganese, while also reaffirming existing standards for chloride, potassium, selenium, and sodium. The agency also plans to modify the units of measurement for two nutrients and is seeking public input on the potential inclusion of ingredients not currently mandated but sometimes used by manufacturers. These include arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine, which some studies suggest are beneficial for infant growth and development.
This initiative is part of a broader review launched last year by the HHS and FDA to assess the nutritional quality of infant formula in the U.S. The FDA's "Operation Stork Speed" is examining whether current nutrient requirements need updating and if additional nutrients should be considered. Under current law, the HHS secretary is tasked with reviewing the list of required nutrients every four years, as deemed appropriate. Currently, the FDA specifies 30 nutrients that must be present in infant formulas, with minimum levels for all and maximum levels for 10. Essential nutrients like protein, fat, vitamins A, D, E, K, folic acid, iron, magnesium, and zinc are among those already required.
The agency indicated that future phases of the review will address remaining required nutrients, potential new nutrient requirements, and carbohydrate sources. The FDA will accept public comments throughout this process, with a final rule anticipated to encompass all proposed changes. Additionally, the FDA released new data from chemical contaminant testing of infant formula, finding that most samples contained low or undetectable levels of such contaminants.
"Parents deserve confidence in every bottle they feed their baby," HHS Secretary Robert F. Kennedy, Jr. said in a statement. "We will hold infant formula manufacturers to rigorous scientific standards and put babies' health first." The agency's review also comes amid past discussions about ingredients like seed oils in infant formula. While commonly included for essential fatty acids, some past concerns have been raised about their potential inflammatory effects, though other medical experts have stated seed oils can offer benefits such as improving insulin sensitivity and lowering cholesterol levels.