World

FDA Proposes First Infant Formula Nutrition Update in Nearly Three Decades

By Brenda Goodman

The U.S. Food and Drug Administration has announced a proposal to revise the nutrient requirements for infant formula, marking the first review of formula nutrition in almost 30 years, Acting Director Kyle Diamantas said on Thursday. The review is part of the Trump administration’s Operation Stork Speed initiative, introduced in March 2025.

The first phase of the review would change four of the 30 nutrients that must be added to formula: iodine, manganese, vitamin A and vitamin D.

• Iodine – essential for thyroid hormone production and brain development – would be tripled from 5 µg to 15 µg per 100 calories, with a new upper limit of 50 µg. • Manganese – a trace mineral that supports enzyme function and bone growth – would be reduced from 5 µg to 1 µg per 100 calories, with a new limit of 50 µg. • Vitamin A – important for vision, immune function and cell growth – would be lowered from 250 IU to 233 IU per 100 calories, and the unit of measure would shift from IU to retinol activity equivalents (RAE). • Vitamin D – which aids bone and tooth development and prevents rickets – would be doubled from 1 µg to 2 µg per 100 calories, and the maximum allowed would increase to 3 µg.

The proposal also reaffirms the existing requirements for chloride, potassium, selenium and sodium.

Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School, praised the first phase as “really well done” and “very well thought‑out,” but noted that the review is being conducted in stages. He said parents are unlikely to see changes on formula labels for several years.

The FDA’s staff scientists conducted the review and will submit the proposal for peer review, as required by law. U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said the agency is “proposing stronger nutrient requirements, testing formula for contaminants, and putting the results directly in parents’ hands.”

Abrams highlighted the increase in vitamin D as the most consequential change, noting that current formula levels are slightly below the recommended amount for infants. Adding more vitamin D could potentially save about $81 million each year in medical costs related to late‑onset hypocalcemia.

The FDA also invited public input on nutrients that are not currently required but are often added by manufacturers, such as long‑chain fatty acids ARA and DHA, and L‑carnitine. The agency said it will consider whether to make these nutrients mandatory.

Diamantas said the nutrient review is ongoing and that subsequent phases will evaluate all remaining required nutrients, potential new requirements and carbohydrate sources. He also reported that recent testing for chemical contaminants in infant formula continues to be reassuring.