FDA Infant Formula Rules Set for Major Update After 30 Years

The US Food and Drug Administration (FDA) is preparing to propose an update to the nutritional requirements for infant formula, in what the agency describes as the biggest revision to these standards in nearly 30 years. The proposed rule aims to revisit the requirements governing the nutrients that manufacturers must provide in infant formula sold in the United States.

The announcement is significant for parents, paediatric healthcare providers and formula manufacturers because infant formula serves as an important source of nutrition for babies who are not breastfed or who need additional feeding support. Nutrient standards help establish a baseline for the nutritional adequacy of these products during a critical period of growth and development.

However, a proposal to change the rules does not mean that new requirements have already taken effect. The FDA must set out the proposed changes, explain their basis and follow the applicable rulemaking process before any new standards become binding. The practical implications for families will depend on the details of the proposal and the final rule, if adopted.

What Does the FDA’s Proposed Infant Formula Rule Include?

The FDA published its proposed rule on October 29, 2026, as the first phase of a broader review of infant formula nutrient requirements. The proposal focuses on eight of the 30 nutrients currently required in infant formula sold in the United States.

Rather than immediately introducing new mandatory ingredients, the agency is proposing to revise or reaffirm existing specifications for selected nutrients. It is also seeking public input on whether certain nutrients that manufacturers commonly add to formula should become subject to specific requirements in the future.

The eight nutrients covered in the first phase are:

• Iodine
• Manganese
• Selenium
• Sodium
• Potassium
• Chloride
• Vitamin A
• Vitamin D

These nutrients have different functions in the body, and their appropriate levels matter when formula provides some or all of an infant’s nutrition. The proposed changes reflect the FDA’s assessment of scientific evidence concerning infant nutritional needs.

The agency has structured the review in three phases because different nutrients require different levels of scientific assessment. The first phase addresses nutrients for which the FDA says its comprehensive evidence review is complete. Additional work will examine the remaining required nutrients and potential changes to the list of nutrients covered by the regulations.

How Could the Proposed Nutrient Standards Change?

The proposed rule would adjust the minimum or maximum permitted levels of some nutrients while retaining existing limits for others. It would also change the units used to measure vitamins A and D, aligning the requirements with the proposed specifications.

The proposed changes include the following:

Iodine

The FDA proposes increasing the minimum iodine level from 5 micrograms to 15 micrograms per 100 kilocalories. It would also lower the maximum from 75 micrograms to 50 micrograms per 100 kilocalories.

The change would narrow the permitted range, raising the minimum while lowering the maximum. Iodine is an essential nutrient involved in thyroid hormone production, which supports normal growth and development.

Manganese

The proposal would reduce the minimum manganese level from 5 micrograms to 1 microgram per 100 kilocalories and establish a maximum of 50 micrograms per 100 kilocalories.

Establishing both minimum and maximum specifications is important because nutritional standards must account for the need to provide adequate amounts without permitting unnecessarily high levels.

Vitamin A

The FDA proposes changing the measurement unit for vitamin A from international units to micrograms of retinol activity equivalents. It would lower the proposed minimum and maximum levels and limit the permitted forms of vitamin A counted toward those levels to preformed vitamin A rather than both preformed vitamin A and beta-carotene.

Vitamin A supports several important biological functions, including normal vision, immune function and growth. The proposed changes would establish revised specifications for its inclusion in infant formula.

Vitamin D

The proposal would increase the minimum vitamin D level from 40 international units to 80 international units per 100 kilocalories. It would also increase the maximum from 100 international units to 120 international units per 100 kilocalories.

Vitamin D is essential for calcium absorption and normal bone development. The proposed specifications would raise both the minimum and maximum permitted levels under the revised standard.

Nutrients whose existing limits would remain unchanged

The FDA proposes retaining the current minimum and maximum specifications for sodium, potassium, chloride and selenium. This means the first phase would not change every nutrient requirement under review.

The distinction matters because a comprehensive review does not necessarily lead to a revision of every existing standard. Where the agency concludes that current limits remain appropriate, retaining them can be part of an evidence-based regulatory update.

Will the FDA Require New Ingredients in Infant Formula?

The first proposed rule does not seek to add new mandatory nutrients to infant formula or remove any of the 30 nutrients currently required. Instead, it focuses on revising or reaffirming specifications for eight nutrients already covered by the regulations.

However, the FDA is inviting public input on the possibility of establishing requirements for nutrients that manufacturers commonly include voluntarily. These include docosahexaenoic acid (DHA), arachidonic acid (ARA) and L-carnitine.

DHA and ARA are fatty acids involved in biological processes relevant to early development. L-carnitine has a role in transporting fatty acids within cells. The FDA has indicated that there is evidence supporting the contribution of these nutrients to neurodevelopmental health in infancy, while their possible regulatory requirements will need further assessment.

Seeking comments on these substances does not mean the agency has decided to make them compulsory ingredients. Any future regulatory proposal would need to establish the scientific and regulatory basis for the change.

This distinction is important for parents interpreting news about formula ingredients. A nutrient being discussed by regulators is not the same as a new legal requirement, and manufacturers’ existing formulations may differ in the ingredients they include beyond the mandatory baseline.

Why Is the FDA Reviewing Infant Formula Standards Now?

The FDA’s comprehensive review is intended to ensure that nutritional standards reflect current scientific understanding of infant growth and development. The agency says the review represents the most thorough evaluation of infant formula nutrient requirements since 1998.

Although the FDA regularly reviews individual nutrient requirements, a comprehensive assessment involves examining a wider body of evidence. This includes nutrient reference values, the composition of human milk, international infant formula standards and clinical research published since the previous comprehensive review.

The process also builds on public input gathered through an earlier request for information. The agency has described the review as part of Operation Stork Speed, an initiative focused on expanding access to safe, reliable and nutritious infant formula in the United States.

Infant formula is a particularly important product category because babies may rely on it as their sole source of nutrition or use it alongside breastfeeding. Nutritional standards therefore need to account for the needs of infants during a period when growth and development are rapid.

Regulatory requirements also give manufacturers a consistent framework for developing and evaluating products. Updating those requirements can help ensure that the standards used across the industry remain aligned with the evidence available to regulators.

What Happens Next? The FDA’s Three-Phase Review

The October 29 proposal is the first stage of a wider review rather than the final word on infant formula composition. The FDA has divided the work into three phases to allow it to assess different nutrient groups according to the complexity and volume of available evidence.

Phase 1: Eight nutrients

The first phase covers iodine, manganese, selenium, sodium, potassium, chloride, vitamin A and vitamin D. The FDA has completed its comprehensive evidence review for this group and published its initial proposed regulatory changes.

Phase 2: Additional vitamins and related nutrients

The second phase will address vitamin E, thiamine, riboflavin, niacin, pantothenic acid, vitamin B6, vitamin B12, folic acid, biotin, vitamin C, choline and inositol. The FDA says its comprehensive evidence review for this group is underway, with the findings expected to inform a future proposed rule.

Phase 3: Macronutrients, minerals and other potential requirements

The third phase will cover protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium and vitamin K. The agency will also evaluate potential additional nutrients, including DHA, ARA, alpha-linolenic acid and L-carnitine, as well as carbohydrate sources.

Because this group includes complex nutritional questions, the FDA has engaged an external organisation to conduct a comprehensive evidence review, with agency scientists overseeing the work.

Once the three phases have progressed, the FDA intends to consolidate the resulting changes into a single comprehensive final rule. The agency says this approach is intended to provide a cohesive regulatory framework while reducing unnecessary disruption to infant formula production and supply.

Will the Proposed Rules Affect Parents Immediately?

No immediate change to the nutritional requirements follows simply from publication of the proposed rule. The FDA must consider public comments and complete the rulemaking process before final requirements can take effect.

The proposal includes a public comment period lasting 120 days from publication of the relevant Federal Register notice. Input from parents, healthcare professionals, researchers and manufacturers can help the agency assess the proposed specifications and their practical implications.

If the final comprehensive rule changes the requirements, the FDA proposes that it become effective 60 days after publication in the Federal Register, with manufacturers given three years from the effective date to comply with the new specifications.

This proposed transition period is relevant because changing nutrient levels can require manufacturers to reformulate products, revise labels, evaluate ingredients and adjust production processes. A gradual implementation period can provide time for these changes while helping maintain access to infant formula.

The FDA has also indicated that it will coordinate with the US Department of Agriculture on potential implications for the Special Supplemental Nutrition Program for Women, Infants, and Children, commonly known as WIC. The proposed changes would not have an immediate impact on the programme.

What Parents Should Know About Infant Formula Safety

The announcement of a proposed nutrition rule should not be interpreted as a declaration that currently marketed infant formulas are unsafe. The FDA says the changes are intended to align nutritional standards with current scientific understanding rather than respond to a specific safety concern about existing products.

Currently marketed infant formulas remain subject to applicable regulatory requirements. The agency reviews new formulas for nutritional adequacy and oversees requirements intended to protect product quality and safety.

Parents should continue to select formula appropriate for their baby’s needs and consult a paediatric healthcare professional when they have questions about feeding, growth, allergies or specialised formula products. A proposed change in nutrient specifications is not, by itself, a reason to switch a baby’s formula.

Families should also avoid changing the concentration of formula by adding extra powder or water beyond the manufacturer’s instructions. Incorrect preparation can affect the nutritional content and safety of the feed.

Why the Proposed Update Matters for Families and Manufacturers

The FDA’s proposal could have implications for both the products families purchase and the processes manufacturers use to produce them. For parents, the main significance is the agency’s effort to ensure that regulatory standards keep pace with evolving scientific knowledge about infant nutrition.

For manufacturers, any final changes could require adjustments to nutrient levels, formulation processes, ingredient specifications and product labels. Companies would need to assess their existing products against the final requirements and plan any necessary changes within the permitted compliance period.

For healthcare professionals, updated standards may provide a revised regulatory basis for evaluating infant formula composition. However, the proposal alone does not establish that one currently available brand is nutritionally superior to another.

The most important next steps are the completion of the public comment process, publication of subsequent proposals for the remaining nutrient groups and eventual development of the comprehensive final rule.

The FDA’s planned update marks a significant step in the modernisation of US infant formula nutrition standards. Whether the proposed changes become final will depend on the evidence, public feedback and regulatory review. Until then, the existing requirements remain the applicable standards, and families can continue using appropriately marketed infant formula according to its instructions and their healthcare professional’s advice.