FDA proposes rule to update infant nutrient requirements

USA – The Food and Drug Administration has issued a proposed rule that, if finalized, would update infant formula nutrient requirements.

As part of its first comprehensive review of infant formula nutrients since 1998, the FDA issued the first of three planned proposed rules that, if finalized, would update infant formula nutrient requirements.

While that process moves forward, the FDA has released new chemical contaminant testing data showing that most infant formula samples had low or non-detectable levels of contaminants.

The proposed changes would help ensure that infant formula requirements reflect the available gold standard science to support infant growth and development.

These efforts will modernize infant formula standards and support the Trump Administration’s priority of ensuring that American families have access to safe and nutrient-dense options that give every baby a healthy start.

The FDA is conducting the review in three phases, allowing the agency to advance and receive public comment on evidence-based proposals as each phase of the review is completed.

Subsequent phases will assess the remaining required nutrients, potential new nutrient requirements, and carbohydrate sources. The FDA intends to consolidate final changes to infant formula nutrient requirements into a single comprehensive final rule.

This proposed rule would update requirements for iodine, manganese, vitamin A, and vitamin D and reaffirm existing requirements for chloride, potassium, selenium, and sodium.

It would also change the units of measure for two nutrients and request public input on potential requirements for ingredients that are currently not required in infant formula but commonly added by manufacturers due to their nutritional value.

There is evidence to support that nutrients, such as arachidonic acid (ARA), docosahexaenoic acid (DHA), and L-carnitine, contribute to neurodevelopmental health in infancy.

“Under President Trump’s leadership, we are modernizing our nutritional requirements for infant formula for the first time in nearly three decades,” said FDA Acting Commissioner Kyle Diamantas, J.D.

“By doing this, we are stepping up to guarantee that American babies receive world class, gold-standard nourishment from day one.”

The agency invites the public, including clinicians, doctors, parents, caregivers, the scientific community, industry, and others, to comment on the proposed rule. The comment period is open, and the deadline to submit comments is February 26, 2027.

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