FDA proposes first major update to infant formula nutrient standards in 30 years

The U.S. Food and Drug Administration (FDA) has proposed a new rule to update nutrient requirements for infant formula, marking the first significant overhaul of these standards in nearly three decades. The proposal is part of the “Operation Stork Speed” initiative, a review process launched to ensure nutrition quality and safety.

The first phase of the proposed rule targets four specific nutrients: iodine, manganese, vitamin A, and vitamin D. Key changes include tripling the minimum iodine requirement, establishing a first-ever upper limit for manganese, and adjusting the minimum and maximum levels for vitamin D. The rule also proposes changing the unit of measurement for vitamin A to retinol activity equivalents (RAE).

Additionally, the FDA plans to reaffirm existing requirements for chloride, potassium, selenium, and sodium. The agency is seeking public input on whether to include ingredients not currently required, such as arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. While the changes are intended to modernize standards, the FDA noted that current formulas on the market remain safe, and recent testing showed low or non-detectable levels of chemical contaminants in most samples.