The US Food and Drug Administration (FDA) has proposed changes to nutritional requirements for infant formula, marking the first comprehensive review of the country's infant formula nutrient standards since 1998.
Announced on October 29, 2026, the proposed rule represents the first phase of a broader review of the 30 nutrients currently required in infant formula marketed in the United States.
Editorial Insight
Key Highlights
Important points readers should notice.
The FDA announced the proposed rule on October 29, 2026.
It represents the first comprehensive review of infant formula nutrient requirements since 1998.
The first phase covers eight of the 30 currently required nutrients.
Proposed changes affect iodine, manganese, vitamin A and vitamin D.
Existing requirements for chloride, potassium, selenium and sodium would be reaffirmed.
The FDA is seeking public input on ARA, DHA and L-carnitine. Most infant formula samples tested had low or non-detectable chemical contaminant levels, according to the FDA.
The proposal would revise requirements for four nutrients: iodine, manganese, vitamin A and vitamin D. It would reaffirm existing requirements for four others: chloride, potassium, selenium and sodium.
Under the proposed changes, the FDA plans to increase the minimum iodine requirement while reducing its maximum permitted level. For manganese, the proposal would lower the minimum requirement and introduce a maximum limit.
The agency has also proposed changes to vitamin A and vitamin D requirements, including adjustments to their measurement units and permitted levels in infant formula.
Editorial Analysis
Why This Matters
Infant formula is an important source of nutrition for babies who are not exclusively breastfed. Its nutritional composition is therefore a significant public-health and consumer-safety issue. The FDA's proposed changes could influence how infant formula is formulated, labelled and manufactured in the United States if the rule is finalised. The review is also relevant to parents and caregivers because it examines whether existing nutritional standards reflect current scientific understanding of infant growth and development. For manufacturers, any final changes could require adjustments to product formulations, labelling and production processes. The FDA has clarified that currently marketed infant formulas remain suitable for use under existing regulations. The proposed review is intended to modernise nutritional standards, not to warn that current products are unsafe.
The proposal would change the minimum and maximum levels of vitamin A and vitamin D to reflect the agency's assessment of current scientific evidence.
In addition to the eight nutrients covered in this phase, the FDA is seeking public input on ingredients that are not currently mandatory but are commonly added by manufacturers. These include arachidonic acid (ARA), docosahexaenoic acid (DHA) and L-carnitine, which have been studied for their potential contributions to infant development.
The FDA is conducting the comprehensive review in three phases. Subsequent phases will assess the remaining required nutrients, potential additional nutrient requirements and carbohydrate sources.
The agency intends to consolidate the resulting changes into a single comprehensive final rule after completing the review process and considering public feedback.
Alongside the proposed rule, the FDA released new chemical contaminant testing data for infant formula. According to the agency, most tested samples showed low or non-detectable levels of chemical contaminants.
The agency has invited parents, caregivers, healthcare professionals, researchers, manufacturers and other interested parties to submit comments on the proposal.
The proposed requirements are not yet in effect. Existing regulations continue to apply while the rulemaking process is underway.
