Baby formula has been playing by the same nutrient rulebook since 1998. Now the Food and Drug Administration wants to update it. The agency issued the first of three planned proposed rules on Thursday, and this one would update infant formula nutrient requirements.
Here’s the part to know before anything else: this infant formula rule is a proposal, not a final rule. Nothing changes in the can you’re feeding your baby today.
What the infant formula rule would change
HHS says this is the first comprehensive review of the nutrient standards since 1998. The proposal would update requirements for vitamin A, vitamin D, iodine and manganese, according to syndicated coverage of the announcement. It would also reaffirm the existing requirements for chloride, potassium, selenium and sodium.
Reuters reports the rule would set a maximum level for manganese. It would also change how vitamins A and D are measured, allow a new source of vitamin A and revise labeling requirements. Two nutrients would get new units of measure.
The agency is also asking the public about some ingredients. These aren’t currently required, but some manufacturers add them anyway: ARA, DHA and L-carnitine. In plain English, the FDA wants to hear whether those should become mandatory.
Why this baby formula rule matters for your family
Here’s the thing: if you’re a parent, the practical answer for now is “nothing to do.” The formula in your pantry meets today’s rules, and any new standard is a long way from store shelves.
This is the first of three installments. The next two proposed rules are planned to cover the remaining required nutrients, possible new nutrient requirements and carbohydrate sources. Only after all three will the FDA issue one final rule covering every change.
The FDA does not approve formulas before they hit the market. Makers notify the agency before selling a new formula, and every formula has to meet the federal nutrient requirements. When those requirements change, every manufacturer has to follow.
The agency also released new chemical contaminant testing data on infant formula. It says most samples showed “low or non-detectable levels of chemical contaminants.” Reuters adds that the FDA has urged formula makers to watch their suppliers closely. That follows several recalls and recent infant botulism cases. Recalls are a recurring headache for families, as with the kids’ toothpaste recall we covered recently.
HHS Secretary Robert F. Kennedy Jr. framed the move as a matter of trust: “Parents deserve confidence in every bottle they feed their baby.”
How we got here, and what comes next for infant formula standards
This didn’t come out of nowhere. The administration launched Operation Stork Speed in March 2025. It covers nutrient content, contaminant testing and label transparency. A public request for information followed that May. The push also follows the 2022 formula shortage, which left plenty of parents hunting for cans store to store.
The proposal cleared White House budget office review on Wednesday, according to Bloomberg Law as relayed by iHeart. From here, the FDA says it will run an external peer review of the science behind any final rule.
We don’t yet have the exact numeric limits for the nutrients. We also lack the deadline for public comments, and we won’t guess at either. Those details will be in the official Federal Register notice.
Federal safety reviews are hardly limited to formula. The FDA also recently cleared an AI breast cancer risk score, and its recall notices keep coming, like the Gatorade recall over undeclared dyes.
One more caution for the week ahead: headlines about “new formula rules” will fly fast. Some will make it sound like the can in your cabinet just changed. It didn’t. Keep following your pediatrician’s advice and don’t switch formulas over a proposal.
The real question now is how many nutrients end up on the changed list when the third rule lands. And how long will the whole process take?
