The U.S. Food and Drug Administration has proposed changes to the nutrient requirements for infant formula, the first major review in about four decades.
The current rules date to the original infant formula legislation of the 1980s, and nutrition science has moved on since.
“It’s not so much that the standards are wrong,” Dr. Steven Abrams, a pediatric nutrition expert at the University of Texas at Austin’s Dell Medical School, told The Epoch Times. “There were some things that were perhaps left out because there’s new science in the last 40 years.”
The FDA is reviewing its requirements in three phases. The proposal addresses how much of certain nutrients babies need, whether amounts may be too much, and whether other ingredients should be required.
Which Nutrients Would Change and Why?
The FDA sets minimum amounts for required nutrients in infant formula, with maximum limits for some. These amounts are measured per 100 calories of prepared formula. The proposal would change the limits for four nutrients.
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Vitamin D: Meeting Babies’ Daily Needs
“Vitamin D changes will have the most significant impact on babies,” Dr. Karen Klawitter, a board-certified pediatrician, told The Epoch Times.
Vitamin D helps the body absorb calcium and build bone. Too little can cause rickets, a condition that weakens and softens bones. Infants need 400 international units (IU) a day. The FDA proposes doubling the minimum amount in formula from 40 IU to 80 IU per 100 calories and increasing the maximum from 100 IU to 120 IU.
Young babies may not drink enough formula to meet their daily vitamin D needs without supplementation, Abrams said. “This adjustment should make it so that that’s not necessary.”
For now, nothing changes. The proposal has not taken effect, and current guidelines still apply. According to the CDC, breastfed and partially breastfed babies generally need 400 IU of supplemental vitamin D daily. Exclusively formula-fed babies who drink at least 32 ounces daily generally do not need a vitamin D supplement. This amount provides approximately 400 IU or more in many standard formulas, although the exact amount varies by product.
Parents should discuss their baby’s vitamin D needs with their pediatrician before making changes.
Iodine: Getting the Right Amount
Iodine helps the body produce thyroid hormones, which are essential for growth and brain development. Too little iodine can reduce thyroid hormone production, while too much can temporarily interfere with the thyroid’s ability to make these hormones. Adults can usually adjust to excess iodine, but infants, especially those born prematurely, may have more difficulty doing so because their thyroid glands are still developing.
The FDA proposes increasing the minimum iodine content in formula from 5 mcg to 15 mcg per 100 calories while lowering the maximum from 75 mcg to 50 mcg. The changes are intended to provide enough iodine for healthy development while reducing the risk of excessive intake.
Manganese: Limiting Excess Intake
Manganese supports metabolism and growth, but excessive amounts can accumulate in the brain and potentially affect learning, behavior, and movement. The FDA proposes lowering the minimum manganese requirement from 5 mcg to 1 mcg per 100 calories and, for the first time, set a maximum of 50 mcg.
The primary concern surrounding manganese is potential toxicity, Abrams said. Infants are particularly vulnerable because they absorb more manganese from food and their bodies are less efficient at eliminating excess. The proposal reflects these risks, but it doesn’t mean currently marketed formulas have been shown to cause neurological harm.
Vitamin A: Changing What Counts
Vitamin A supports vision, immunity, and growth. Because the body stores it in fat, too much of certain forms can build up and be harmful. The FDA proposes lowering the minimum vitamin A content from 75 mcg to 70 mcg of retinol activity equivalents (RAE) per 100 calories of formula and the maximum from 225 to 120 mcg RAE.
The agency also proposes counting only “preformed” vitamin A, the form the body can use directly, toward the required levels. Beta-carotene, which the body converts to vitamin A, would no longer count toward vitamin A requirements because it’s unclear how much infants can convert into vitamin A. Manufacturers could still include it.
What May Come Next: DHA and Other Ingredients
Human milk provides an important reference for understanding infant nutrition, but scientists cannot simply copy its composition. Many of its components, including DHA and prebiotics, affect infant health in ways still being studied. “Infant formula can never entirely duplicate the benefits of human milk,” Abrams said. Formula remains a safe feeding option, and families should not be judged for choosing it, he said.
Some ingredients have already become common in formula, even without an FDA requirement. Nearly all U.S. formulas now contain DHA and ARA, fatty acids naturally found in breast milk that help support brain and eye development, though amounts vary, Abrams said. “Some formulas have more, some less.”
Manufacturers add these fatty acids partly to more closely resemble breast milk. Although DHA and ARA play important roles in development, studies haven’t consistently shown that adding them to infant formula improves vision or cognitive development.
The FDA plans to evaluate whether DHA and ARA should become required ingredients and, if so, what amounts should be included. Later phases of the review will also cover other nutrients, including choline, which is already required in formula but may be reassessed.
Deciding which ingredients should be required also involves cost. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) buys a large share of the infant formula in the United States, so each new requirement could potentially raise prices for the program and for families.
Should Parents Change Their Baby’s Formula?
Nothing needs to change. The proposed changes do not mean that current formulas are unsafe, and Abrams called the updates relatively minor.
“There are no reasons to switch formula brands,” Klawitter said.
For now, families can continue using an FDA-regulated formula appropriate for their baby’s needs. The CDC advises that no single formula brand is best for every infant. Klawitter recommends choosing an iron-fortified formula to help prevent iron deficiency anemia. She also noted that higher-priced formulas are not necessarily more nutritious. Price differences may reflect specialty ingredients, manufacturing costs, or marketing rather than meaningful nutritional advantages.
Parents should also follow preparation instructions carefully. Adding too much water can dilute essential nutrients, while too little water can place additional stress on an infant’s kidneys and digestive system.
The Takeaway
The FDA’s proposed changes aim to bring infant formula nutrient standards in line with current science. The review is still underway, with additional nutrients to be evaluated before the FDA issues a final rule.
If the changes are finalized, manufacturers would have three years after the rule takes effect to update their formulas and labels. In the meantime, parents can continue using currently marketed infant formulas, which the FDA says remain safe and nutritionally adequate.
