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FDA Proposes More Iodine and Vitamin D in Infant Formula in Its First Nutrient Rewrite Since 1998

A proposed rule published on 29 October would triple the iodine minimum, double vitamin D, cap manganese for the first time and lower vitamin A, with 120 days for comment and three years to comply.

Outspoken Digest Health Desk

Friday, October 30, 2026/2 min read

A clear plastic baby bottle with a brown teat, filled with milk to just above the 100 millilitre mark, standing on a blue surface, photographed on 17 April 2020, an illustrative image of a formula bottle and not of any product in the FDA proposal
Photo: Miya via Wikimedia Commons (CC BY-SA 4.0)

The US Food and Drug Administration has proposed the first change to the nutrient rules for infant formula since 1998. A proposed rule published on Thursday 29 October would raise the required iodine and vitamin D, cut the allowed vitamin A and manganese, and reaffirm four other minerals, in the first of three phases covering all 30 nutrients the law requires in formula sold in the United States.

The proposal, published under docket FDA-2026-N-10832, is part of the administration's Operation Stork Speed, announced in March 2025. Acting FDA director Kyle Diamantas announced it alongside new contaminant testing data, which ABC News reported found low or non-detectable levels of chemical contaminants in most samples. Health Secretary Robert F. Kennedy Jr. said parents deserve confidence in every bottle.

What would change in the formula on the shelf?

Four nutrients move, per 100 kilocalories of formula, according to the FDA's own summary:

  • Iodine: the minimum rises from 5 to 15 micrograms and the maximum falls from 75 to 50. Iodine is needed for thyroid hormone and brain development.
  • Vitamin D: the minimum doubles from 40 IU (1 microgram) to 2 micrograms, and the maximum rises from 100 IU to 3 micrograms. The agency estimates the change could avoid nearly $81 million a year in costs linked to late-onset low blood calcium in infants, CNN reported.
  • Vitamin A: the unit changes to retinol activity equivalents, the minimum falls from 75 to 70 micrograms RAE and the maximum from 225 to 120, and only preformed vitamin A would count.
  • Manganese: the minimum drops from 5 to 1 microgram and a first-ever maximum of 50 micrograms is set.

Chloride, potassium, selenium and sodium keep their current ranges. The FDA is also asking for public input on whether DHA, ARA and L-carnitine, which many manufacturers already add, should become mandatory; the rule does not yet require them.

When would parents see different formula?

Not soon. Comments are due 120 days after Federal Register publication. The FDA plans two further proposed rules, one after a review of 12 vitamins now under way and another covering protein, fat, iron, calcium and other macronutrients and minerals, then a single consolidated final rule. Manufacturers would have three years from that rule's effective date to reformulate and relabel. Steven Abrams, a paediatrician at the University of Texas Dell Medical School, told CNN the update was overdue and the first phase well done, but criticised the piecemeal approach; he expects changes to take several years to reach cans.

On vitamin D, the practical effect is modest. Current formula sits slightly below the recommended intake, which is why many paediatricians already advise a drop supplement for formula-fed infants, CNN noted. The FDA says products now on the market remain safe, and that the proposal has no immediate effect on the WIC programme.

This article reports a regulatory proposal and is not medical advice. Decisions about how to feed an infant, including whether to supplement with vitamin D or to change formula, belong with a paediatrician or clinician who knows the child's history.

The review the law asks for every four years has not happened in 28 years. Whether the FDA keeps its stated pace, with the second phase due in about a year, will decide whether the first babies fed under the new standards are born this decade.

Published in The Outspoken Digest

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