Why It Matters
The U.S. Food and Drug Administration is proposing changes to required nutrients in infant formula, including a higher vitamin D level. The review is the first comprehensive nutrition assessment of formula requirements in nearly 30 years.
What Happened
The FDA’s staff scientists conducted the review as part of the Trump administration’s Operation Stork Speed initiative, announced in March 2025. The first phase covers four of the 30 required nutrients: iodine, manganese, vitamin A and vitamin D.
Kyle Diamantas said the review is the first nutrition examination of infant formula requirements in nearly three decades. The proposal would increase vitamin D in formula, while the FDA is also requesting public input on arachidonic acid, docosahexaenoic acid and L-carnitine, which manufacturers commonly add.
The review will be submitted for peer review as required by law. The broader examination remains underway, and the FDA said recent testing for chemical contaminants continues to produce reassuring results.
By the Numbers
- Nearly 30 years since the previous formula nutrition review
- Four of 30 required nutrients included in the first phase
- 12 nutrients planned for review during the next year or so
- 10 additional nutrients planned for a later batch
- Nearly $81 million in potential annual medical-cost savings from adding more vitamin D
Zoom Out
Later phases will examine the remaining required nutrients, possible additions to the nutrient list and carbohydrate sources. The FDA will consider studies beginning in 1998 as part of the continuing review.
Dr. Steven Abrams, a pediatrician and professor at the University of Texas’ Dell Medical School who specializes in infant nutrition, said the proposed changes would not appear on formula containers immediately and could take several years.
What’s Next
The FDA will seek public input on ARA, DHA and L-carnitine before continuing its review of the remaining nutrients. Health and Human Services Secretary Robert F. Kennedy Jr. said, “Parents deserve confidence in every bottle they feed their baby.”