FDA would double the vitamin D floor in infant formula

Infant formula sold in the U.S. would have to carry twice as much vitamin D under a rule the Food and Drug Administration proposed Oct. 29. The minimum would rise from 40 to 80 international units per 100 calories, according to the proposed rule. It publishes in the Federal Register on Nov. 2.

This is the FDA’s first comprehensive review of formula nutrients since 1998. The first step covers 8 of the 30 nutrients every U.S. formula must contain. Two more proposed rules will follow, and the agency plans to fold all of the changes into one final rule.

What would change

Four nutrients get new limits, all measured per 100 calories:

• Vitamin D: the minimum doubles to 80 IU, or 2 micrograms. The maximum rises from 100 IU to 120 IU.
• Iodine: the minimum triples from 5 to 15 micrograms. The maximum falls from 75 to 50 micrograms.
• Vitamin A: the minimum falls from 250 IU to about 233 IU. The maximum falls from 750 IU to 400 IU. Only preformed vitamin A would count toward the limits. Beta carotene would not.
• Manganese: the minimum drops from 5 to 1 microgram, and formula gets a maximum for the first time, 50 micrograms.

Labels would list vitamins A and D in micrograms. Makers could keep the IU figure in parentheses.

Chloride, potassium, selenium and sodium keep their current limits. The FDA found those still match the science.

The money

Vitamin D helps the body absorb calcium and build bone. Too little can cause low blood calcium and rickets.

The FDA counted one benefit: medical costs avoided from late onset hypocalcemia, low blood calcium linked to vitamin D deficiency. It calls that estimate a lower bound. Benefits come to $80.9 million a year over 10 years at a 7% discount rate. Costs come to $17.6 million a year, paid by manufacturers to reformulate, relabel and file paperwork.

About half of formula fed infants in the U.S. are in WIC, the federal nutrition program for low income women, infants and children, the rule says. The FDA expects them to get a larger share of the benefit, because they are more likely to be fed only formula.

The timeline

Store shelves will not change soon. The FDA proposes a compliance date 3 years after the final rule that completes all three phases. The rule’s own analysis assumes benefits start in 2031.

Public comments are open. The HHS release lists a Feb. 26, 2027 deadline. The Federal Register filing sets the deadline at 120 days after publication, which falls on March 2, 2027, under docket FDA-2026-N-10832.

The agency also asked for comment on ingredients many makers add but the law does not require, such as the fatty acids DHA and ARA and the nutrient L carnitine.

The same day, the FDA posted new contaminant testing data for formula and a public dashboard. HHS said most samples showed low or non detectable levels. The agency proposed cadmium limits for baby food the week before.

“Parents deserve confidence in every bottle they feed their baby,” HHS Secretary Robert F. Kennedy Jr. said in the release.

Why it matters

For many infants, formula is the only food for months. Its nutrient table is their whole diet. This rule rewrites part of that table for the first time in a generation, with more vitamin D and iodine and a ceiling on manganese. New formulas are years away. The comment period, open into early 2027, is when parents, pediatricians and makers can weigh in.