US FDA proposes new infant formula levels for vitamins A and D, iodine, and manganese

The US FDA is proposing to update infant formula requirements for eight of the 30 nutrients and is seeking public comments for 120 days from publication, to March 2, 2027.

In two further phases, the FDA says it will consider addressing the remaining nutrients, potentially adding new ones, such as arachidonic acid (ARA) and docosahexaenoic acid (DHA). After all the changes, the agency aims to create a single comprehensive final rule. 

The first phase proposes retaining chloride, potassium, selenium, and sodium levels while adjusting iodine and manganese minimum and maximum levels. 

The FDA also proposes changing vitamin A and D measurement units and their required levels, with updated labeling requirements. 

Once the changes have been finalized, the FDA says the final rule will be effective 60 days after publication in the Federal Register and will give manufacturers a compliance period of three years.

The FDA expects infants to benefit from reducing the risk of vitamin D deficiency, reducing insufficient iodine intake, and limiting excessive vitamin A and manganese exposure. The agency emphasizes that the proposed changes are not driven by safety concerns, but by an effort to align requirements with current science.

Altering maximum and minimum levels

The FDA is proposing to retain the levels for chloride (55 mg/100 kcal to 150 mg/100 kcal), potassium (80 mg/100 kcal to 200 mg/100 kcal), selenium (2 µg/100 kcal to 7 µg/100 kcal), and sodium (20 mg/100 kcal to 60 mg/100 kcal).

In the second phase of the infant formula review, the FDA will address vitamin E, thiamine, riboflavin, niacin, pantothenic acid, vitamin B6, vitamin B12, folic acid, biotin, vitamin C, choline, and inositol.Meanwhile, the agency wants to increase iodine minimum levels (5 µg/100 kcal to 15 µg/100 kcal) and decrease maximum levels (75 µg/100 kcal to 50 µg/100 kcal). 

For manganese, it proposes decreasing the minimum levels of manganese from 5 µg/100 kcal to 1 µg/100 kcal and establishing a maximum level of 50 µg/100 kcal.

Vitamins A and D

For vitamin A, the proposal changes the unit of measure from international units (IU) to micrograms of retinol activity equivalents (µg RAE). It also proposes decreasing the minimum level for the nutrient from 250 IU (75 µg RAE)/100 kcal to 70 µg RAE/100 kcal and decreasing the maximum level from 750 IU (225 µg RAE)/100 kcal to 120 µg RAE/100 kcal. 

Additionally, the FDA proposes that only preformed vitamin A would count toward required levels, not beta-carotene.

The same unit of measure change is suggested for vitamin D, from IU to µg. The agency wants to increase the minimum level of vitamin D from 40 IU (1 µg)/100 kcal to 2 µg/100 kcal (80 IU/100 kcal) and increase the maximum level from 100 IU (2.5 µg)/100 kcal to 3 µg/100 kcal (120 IU/100 kcal).

Wider evaluations

In the second phase of the infant formula review, the FDA will address vitamin E, thiamine, riboflavin, niacin, pantothenic acid, vitamin B6, vitamin B12, folic acid, biotin, vitamin C, choline, and inositol. 

In phase three, the agency will review protein, fat, linoleic acid, iron, copper, zinc, calcium, phosphorus, magnesium, and vitamin K. It says that it may evaluate potential additional nutrients, including DHA, ARA, alpha-linolenic acid, L-carnitine, and carbohydrate sources.

The agency has not set a final deadline but has committed to completing its comprehensive review of all infant formula nutrients “as quickly as possible.”

The FDA’s infant formula review falls under Operation Stork Speed, the agency’s initiative to strengthen the safety, quality, and supply of infant formula. It is also a requirement under the Federal Food, Drug, and Cosmetic Act, which directs the FDA to undertake such reviews every four years, as appropriate.

In other updates, the agency is seeking public feedback on new guidance to help manufacturers reduce cadmium in processed foods for babies and young children. Public comments on the new draft guidance are open until December 22, 2026.