FDA Rebalances the Tiny Nutrient Math Behind Infant Formula
Published Date: 11/2/2026
Proposed Rule
Summary
The FDA is updating the rules for nutrients in infant formula to make sure babies get the right nutrition. They’re changing the amounts of four key nutrients, how some are measured, and what’s allowed as a source, plus tweaking the labels. Companies and parents should know these changes could affect formula products soon, with feedback open until March 2, 2027.
Analyzed Economic Effects
8 provisions identified: 7 benefits, 1 costs, 0 mixed.
Iodine levels raised and capped
If your baby drinks infant formula, the FDA proposes to raise the minimum iodine level from 5 micrograms/100 kcal to 15 micrograms/100 kcal and lower the maximum from 75 micrograms/100 kcal to 50 micrograms/100 kcal. These changes are intended to reduce the risk of inadequate iodine intake in formula-fed infants.
Vitamin A units and limits changed
The FDA proposes to change vitamin A labeling from International Units (IU) to microgram Retinol Activity Equivalents (µg RAE), lower the minimum vitamin A from 75 µg RAE/100 kcal to 70 µg RAE/100 kcal, lower the maximum from 225 µg RAE/100 kcal to 120 µg RAE/100 kcal, and allow only preformed vitamin A (not beta-carotene) to count toward those levels. These changes aim to reduce excessive vitamin A exposure in infants and change how vitamin A is reported on labels.
Vitamin D minimum and maximum increased
The FDA proposes to change vitamin D labeling from IU to micrograms (µg), increase the minimum vitamin D from 1 µg/100 kcal (40 IU/100 kcal) to 2 µg/100 kcal (80 IU/100 kcal), and increase the maximum from 2.5 µg/100 kcal (100 IU/100 kcal) to 3 µg/100 kcal (120 IU/100 kcal). FDA quantifies benefits from avoided healthcare costs associated with vitamin D deficiency-induced late-onset hypocalcemia.
Manganese minimum cut and maximum added
The FDA proposes to lower the required minimum manganese level in infant formula from 5 micrograms/100 kcal to 1 microgram/100 kcal and to establish a new maximum level of 50 micrograms/100 kcal. The intent is to limit excessive manganese exposure in formula-fed infants.
Manufacturer relabeling, reformulation, and admin costs
FDA estimates manufacturers would incur costs for relabeling, reformulation, and administrative Before First Processing notification submissions. Annualized industry costs over 10 years are estimated to range from $8.4 million to $31.7 million, with a primary estimate of $17.6 million at a 7 percent discount rate.
Net quantified benefits and costs
FDA quantifies annualized benefits over 10 years from the proposed rule ranging from $18.8 million to $171.7 million (primary $80.9 million) at a 7 percent discount rate, and annualized costs ranging from $8.4 million to $31.7 million (primary $17.6 million) at a 7 percent discount rate. FDA states benefits include avoided healthcare costs from vitamin D deficiency and other qualitative health benefits.
Four nutrients left unchanged
The FDA assessed chloride, selenium, potassium, and sodium and concluded the current required levels in Sec. 107.100 remain appropriate, meaning no changes to minimum or maximum levels for these four nutrients are proposed in this rule.
Label unit changes and voluntary IU display
The FDA proposes changing label units for vitamin A from IU to µg RAE and for vitamin D from IU to µg. Labels may also voluntarily show IU in parentheses immediately after the µg RAE or µg declarations. These changes affect how nutrient amounts are displayed on infant formula packaging.
Key Dates
Department and Agencies
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