What Happened?

If you feed your baby infant formula, a new federal proposal would change the nutrient levels in that formula, which were set in 1985, with only selenium added in 2015. The Food and Drug Administration (FDA) published the proposal on Nov. 2, according to a Legis1 review of the FDA rulemaking. ​

  • Iodine: The minimum would triple, from 5 to 15 micrograms per 100 calories; the maximum would drop from 75 to 50.
  • Vitamin A: Both limits would fall, and beta-carotene would no longer count toward either.
  • Vitamin D: Both the minimum and maximum would rise, to 2 and 3 micrograms per 100 calories.
  • Manganese: The minimum would fall 80 percent, from 5 to 1 microgram per 100 calories, and a ceiling of 50 micrograms would be set for the first time.

Every one of the 326 formula products on the market would need new labels, even those whose nutrient levels do not change, because the rule would also switch the measurement units used for vitamins A and D.

Why Does it Matter to Me?

FDA says benefits are expected to accrue disproportionately to infants enrolled in the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), who represent about 50 percent of formula-fed infants in the U.S. The primary benefit FDA counted is avoided healthcare costs from vitamin D deficiency-induced late-onset hypocalcemia.

FDA estimates the rule would produce about $80.93 million in benefits per year against about $17.64 million in annual costs, measured in 2025 dollars over 2027 to 2036. Manufacturers bear the costs; relabeling alone is estimated at $836 per product, or roughly $272,666 across all 326 formula products.

The nutrient levels now in force were set in 1985, with only selenium added since then in 2015.

Both Sides, Now

The Department of Health and Human Services (HHS) framed the proposal as part of Operation Stork Speed and the Make America Healthy Again initiative. HHS Secretary Robert Kennedy Jr. said the administration seeks stronger nutrient requirements and testing transparency. HHS described the effort as part of Operation Stork Speed, announced by HHS and FDA on March 18, 2025. Congress did not authorize this proposal; it is an FDA regulatory action, and Congress could pass legislation to change or block the rule.

FDA itself acknowledged it cannot determine how large the reformulation costs would be for small formula makers, and found the rule "may have a significant economic impact on a substantial number of small entities." CNN reported that pediatrician Steven Abrams called the review overdue but said the phased process could mean changes take several years to reach formula cans.

What Happens Next?

This proposal covers only four of the 30 nutrients FDA is required to address; FDA plans to issue additional proposed rules before combining everything into one final rule. FDA is also asking the public whether docosahexaenoic acid (DHA), arachidonic acid (ARA) and alpha-linolenic acid should become required nutrients, and whether iron levels should change.

Compliance would not be required until three years after a final omnibus rule takes effect, and benefits would not begin accruing until 2031. Public comments on the current proposal are due March 2, 2027.

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