On October 29, 2026, the FDA proposed updating infant formula nutrient requirements for the first time in nearly 30 years as part of the Trump administration's Operation Stork Speed. The initial phase proposes tripling iodine requirements, doubling vitamin D, and establishing new limits for manganese and vitamin A. The agency estimates the rule will cost manufacturers up to $31.7 million annually while potentially saving $81 million in medical costs related to infant hypocalcemia.
Infant formula nutrition standards
- ▪The Food and Drug Administration currently mandates 30 required nutrients in infant formula, establishing minimum levels for all 30 and maximum limits for 10.
- ▪The FDA proposed new nutrient limits and labeling rules for infant formula, marking the first nutrition update for baby formula in nearly 30 years
Proposed changes to nutrient requirements
- ▪The FDA's proposed rule triples the minimum required iodine in infant formula from 5 micrograms to 15 micrograms per 100 calories and establishes a new maximum upper limit of 50 micrograms.
- ▪The FDA proposed decreasing required vitamin A from 250 IU to 233 IU per 100 calories and changing its unit of measurement to retinol activity equivalents (RAE).
- ▪The FDA requested public feedback on potentially requiring long-chain fatty acids like ARA and DHA, as well as L-carnitine, which are currently optional additions in infant formula.
- ▪The FDA's proposed rule amends requirements for iodine, manganese, vitamin A, and vitamin D in infant formula while maintaining existing standards for chloride, potassium, selenium, and sodium.
- ▪The FDA proposed doubling the minimum required vitamin D in infant formula from 1 to 2 micrograms per 100 calories and raising the maximum allowable limit to 3 micrograms.
- ▪The FDA proposal reduces the minimum required manganese in infant formula from 5 micrograms to 1 microgram per 100 calories and establishes a maximum limit of 50 micrograms.
Timeline and rollout of updated formula standards
- ▪The FDA stated that scientific information used for final infant formula regulations will undergo external peer review, as required by law, before one final comprehensive rule is issued.
- ▪The FDA plans to execute its infant formula review in phases, following the first four nutrients with a batch of 12 nutrients, followed by 10 additional nutrients and carbohydrate sources.
- ▪Dr. Steven Abrams stated that because the FDA is updating nutrient standards piecemeal across multiple years, updated formula cans will likely not reach parents for several years.
Vitamin D in infant formula
- ▪Many parents currently supplement infant formula with extra vitamin D because current levels in formula fall below recommended amounts for babies.
- ▪Increasing vitamin D requirements in infant formula could potentially save nearly $81 million annually in medical costs associated with late-onset hypocalcemia diagnoses in infants.
Seed oils in infant formula
- ▪Physicians reported that seed oils can help lower glucose levels, improve insulin sensitivity, reduce bad LDL cholesterol, reduce triglycerides, and increase positive HDL cholesterol.
- ▪In June 2025, former FDA Commissioner Dr. Marty Makary advocated for removing seed oils from infant formulas, characterizing them as pro-inflammatory, though other physicians disputed that claim.
FDA background actions and Operation Stork Speed
- ▪The FDA launched Operation Stork Speed in March 2025 under the Trump administration to review formula nutrients, increase contaminant testing, and urge manufacturers to develop new products.
- ▪Under Operation Stork Speed, the FDA urged infant formula makers and supply-chain partners to increase supplier oversight following several product recalls and infant botulism cases.
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