IN Brief:
- The FDA issued its first proposed rule in a three-phase review of all 30 nutrients required in US infant formula on 29 October 2026.
- Proposed changes affect iodine, manganese, and vitamins A and D, while existing requirements for four other nutrients would be retained.
- Any eventual reformulation and labelling changes would follow a consolidated final rule, with a proposed three-year compliance period after the final rule takes effect.
The US Food and Drug Administration has proposed revisions to the nutrient requirements governing infant formula sold in the United States, setting out changes to iodine, manganese, vitamin A, and vitamin D. The proposal, issued on 29 October 2026, is the first stage of a comprehensive examination of the 30 nutrients currently required in infant formula. Four other nutrients are covered in the same stage, but their existing specifications would be retained.
The proposed rule changes the permitted minimum and maximum values for iodine, lowers the minimum for manganese and introduces a maximum for it, and adjusts the specifications for vitamins A and D. The FDA is also proposing changes to the units used for the two vitamins and to the labelling that communicates nutrient content. These remain draft regulatory requirements, subject to public comment and later final rulemaking, rather than limits that manufacturers must already meet.
Under the draft specifications, iodine would rise from a minimum of 5 to 15 micrograms per 100 kilocalories, while its maximum would decrease from 75 to 50 micrograms. Manganese would have a lower minimum of 1 microgram per 100 kilocalories, instead of 5 micrograms, together with a new maximum of 50 micrograms. These paired thresholds matter during formulation: a premix must deliver adequate amounts at the finished product’s specified energy density without pushing concentrations above the upper bound.
For vitamin A, the minimum would change from the equivalent of 75 to 70 micrograms retinol activity equivalents per 100 kilocalories, and the maximum from 225 to 120 micrograms. The measurement basis would shift from International Units to retinol activity equivalents. Only preformed vitamin A would count towards satisfying the required range, rather than the existing approach that also counts beta-carotene. The proposed changes consequently cover both the quantity of a nutrient and the form that can be credited against the specification.
Vitamin D would also be stated in micrograms instead of International Units. Its minimum would double from the equivalent of 1 to 2 micrograms per 100 kilocalories and its maximum would rise from 2.5 to 3 micrograms. Finished-product analysis, vitamin premix specifications, and the nutrient declarations on labels would need to use the same basis if these provisions enter into force. A units conversion alone is different from the proposed change to the allowable concentration range.
Chloride, potassium, selenium, and sodium have also been reviewed in this first phase, but the agency has proposed retaining their current minimum and maximum specifications. Chloride would remain at 55–150 milligrams per 100 kilocalories, potassium at 80–200 milligrams, sodium at 20–60 milligrams, and selenium at 2–7 micrograms. Their inclusion provides a broader review record without implying that all eight nutrients require changed formulation targets.
The rule would apply to products meeting the US statutory definition of infant formula, subject to specified exemptions. British and EU compositional rules are separate, so manufacturers supplying several territories must work from the applicable requirements for each destination. Where a product is supplied across markets, changes to a US specification may prompt a review of export recipes and labels, but they would not automatically change the requirements imposed elsewhere.
Eight nutrients form the first of three review phases covering the full list of 30 required nutrients. A second phase will address other vitamins, choline, and inositol, while the third will address protein, fat, minerals, and related nutritional questions. The FDA expects separate proposals for those phases and intends to consolidate any final changes into a single rule. Its staged assessment allows consultation on the first group while research on more complex nutrients continues.
The agency is also seeking views on whether nutrients commonly included voluntarily, such as docosahexaenoic acid, arachidonic acid, and L-carnitine, should become subject to new requirements. None is being added as a mandatory nutrient by the first proposal. The distinction matters to product development: an invitation to submit evidence about a possible future rule does not itself require a new ingredient, specification, or label declaration in current production.
The regulatory timetable remains prospective. The FDA plans for a comprehensive final rule to take effect 60 days after its publication in the Federal Register, with manufacturers then given a proposed three-year compliance period for reformulation and relabelling. Comments on the first-phase proposal are invited for 120 days after its Federal Register publication, scheduled for 2 November 2026. Any resulting specifications or implementation dates remain open to change during rulemaking.
Existing infant formula production continues under current US nutrient specifications while the FDA receives comments and reviews the remaining nutrient groups. If the proposed ranges are ultimately adopted, affected manufacturers would have to reconcile ingredient premixes, assay methods, batch release limits, and product labels against the final text. The FDA says its nutrient review is a proactive update based on developing nutritional evidence, rather than a finding that formula currently on sale is unsafe.
