FDA Proposes First Update to Infant Formula Nutrient Standards in Nearly 30 Years, Adjusting Iodine, Vitamin A, Vitamin D and Manganese
The U.S. Department of Health and Human Services (HHS) announced on October 29 that the Food and Drug Administration (FDA) has issued a proposed rule that would update nutrient requirements for infant formula marketed in the United States. It is the FDA's first comprehensive review of all infant formula nutrient requirements since 1998. HHS Secretary Robert F. Kennedy, Jr. made the announcement at Amanda the Panda Children Center in Des Moines, Iowa.
The actions are part of President Trump's Operation Stork Speed and the broader Make America Healthy Again initiative. The FDA took two actions: issuing the proposed nutrient rule, and releasing new chemical contaminant testing data showing that most infant formula samples tested had low or non-detectable levels of contaminants, alongside a new Infant Formula Testing Webpage and Chemical Contaminants Dashboard.
The proposed rule is the first phase of the FDA's three-phase review and covers eight of the 30 nutrients currently required in infant formula. Requirements for iodine, manganese, vitamin A, and vitamin D would be updated, while existing requirements for chloride, potassium, selenium, and sodium would be reaffirmed.
Under the proposal, the minimum level of iodine would rise from 5 micrograms per 100 kilocalories to 15, and the maximum would fall from 75 to 50. The minimum level of manganese would fall from 5 micrograms per 100 kilocalories to 1, with a new maximum of 50. Vitamin A would be measured in microgram retinol activity equivalents instead of International Units, with the minimum lowered to 70 micrograms per 100 kilocalories and the maximum to 120, and only preformed vitamin A counting toward the limits. Vitamin D would be measured in micrograms instead of International Units, with the minimum raised to 2 micrograms per 100 kilocalories and the maximum to 3. Labeling requirements would also be updated to match.
The FDA is also requesting public input on potential requirements for three ingredients that are not currently required but are commonly added by manufacturers: arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine. The agency said evidence supports that these nutrients contribute to neurodevelopmental health in infancy.
"Parents deserve confidence in every bottle they feed their baby," said HHS Secretary Robert F. Kennedy, Jr. "We are proposing stronger nutrient requirements, testing formula for contaminants, and putting the results directly in parents' hands. We will hold infant formula manufacturers to rigorous scientific standards and put babies' health first."
"Under President Trump's leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades," said FDA Acting Commissioner Kyle Diamantas. "We are stepping up to guarantee that American babies receive world class, gold-standard nourishment from day one."
The FDA said infant formulas currently on the market remain safe, and that the proposed changes are not driven by safety concerns but are meant to align standards with current science. Phases two and three will assess the remaining nutrients, potential new nutrient requirements, and carbohydrate sources. The FDA intends to consolidate all changes into a single comprehensive final rule, effective 60 days after publication in the Federal Register, with a proposed compliance date of three years from the effective date for industry to reformulate and relabel products.
Public comments on the proposed rule are due by February 26, 2027, under docket number FDA-2026-56789, and may be submitted through the regulations.gov public comment submission page.
Source: GSM · USA (original Chinese edition)
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