FDA plans to update infant formula nutrition requirements for first time in nearly 30 years

FDA Begins Broad Review of Infant Formula Nutrition Standards

Activelifezero.com – Federal health officials are moving to revise the nutritional rules governing infant formula in the United States, opening the first major review of those requirements in nearly three decades. The initial proposal focuses on four nutrients—iodine, manganese, vitamin A and vitamin D—and is part of the Trump administration’s Operation Stork Speed initiative, announced in March 2025.

Kyle Diamantas, the Food and Drug Administration’s acting director, said Thursday that the review represents the agency’s first comprehensive reassessment of formula nutrition since the late 1990s. Infant formula is a primary or exclusive food source for many babies during their earliest months, making its nutrient standards especially consequential for growth and development.

The FDA’s first phase addresses four of the 30 nutrients currently required in formula. Additional reviews are planned: a group of 12 nutrients is expected to follow within roughly the next year, with another set of 10 to be considered afterward. The agency also plans to examine the remaining required nutrients, possible additions to the list and the carbohydrate sources used in formula products.

Vitamin D proposal could have the biggest effect

Among the first recommendations, a proposed increase in vitamin D may carry the most significant practical impact, said Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School. Current formula vitamin D levels sit somewhat below the recommended amount for babies, and some parents already provide supplemental vitamin D.

Vitamin D is important because it helps the body take in calcium and phosphorus from food. The proposed rule estimates that increasing its level in formula could save nearly $81 million annually in medical expenses related to late-onset hypocalcemia, a condition involving low calcium levels in the blood.

Abrams, an infant nutrition specialist, welcomed the scientific work behind the opening phase and described it as overdue. He said the approach to the first four nutrients was carefully developed, while also raising concern that evaluating the overall list in separate stages could delay visible changes for families.

“These changes that they’re recommending today are not going to be something that’ll show up on the can of formula potentially for several years,” Abrams said.

That timeline matters for parents trying to understand what the announcement means at the store. The proposal does not immediately alter the formula currently available on shelves. Any final regulatory action would need to work through the required review process before manufacturers make changes to products and labels.

How the FDA evaluated possible updates

FDA staff scientists conducted the nutrition review, which will next go through peer review as required by law. In considering revisions, the agency examined several forms of evidence: nutrient reference values needed to support healthy growth and development, levels that could be harmful to infants, the nutrient makeup of human milk, standards used in other countries and scientific studies published since 1998.

The review also extends beyond nutrients that are already mandatory. The FDA is seeking public feedback on substances frequently included voluntarily by formula manufacturers but not required under current US standards. Those include long-chain fatty acids such as ARA and DHA, along with L-carnitine, which assists the body in breaking down fats and using them in tissues.

“There’s evidence that these nutrients contribute to neurodevelopment and health in infancy. And we want to hear from the scientific community, from clinicians, from industry, and the public as we consider whether or not to make these nutrients mandatory in the U.S. infant formula supply,” Diamantas said.

Public input could help determine whether those commonly added ingredients should become standard across the US formula supply. The question is particularly important because not every formula product necessarily contains the same optional ingredients or the same amounts of them.

Operation Stork Speed also includes contaminant testing

The nutrition proposal is one part of a wider federal effort focused on infant formula. Health and Human Services Secretary Robert F. Kennedy Jr. said the administration’s agenda combines stronger nutrient requirements with testing for contaminants and public access to the results.

“Parents deserve confidence in every bottle they feed their baby,” US Health and Human Services Secretary Robert F. Kennedy Jr. said in a news release. “Under President Trump’s Operation Stork Speed and Make America Healthy Again agenda, 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.”

Officials also offered an update Thursday on continuing chemical-contaminant testing. Diamantas said the most recent results remain reassuring, although the testing work is ongoing.

For families, the announcement signals a long-term reassessment rather than an immediate change to feeding guidance or products. Formula remains a closely regulated food designed to provide nutrition for infants, and the FDA’s staged review is intended to determine whether standards written decades ago still reflect current evidence. As the next phases proceed, the agency will weigh scientific input, clinical perspectives, industry comments and public feedback before deciding which requirements should ultimately change.