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May 14, 2025

FDA to review nutrients in baby formula: 3 things for parents to know

WATCH: FDA to launch review of nutrients in infant formula

The U.S. Food and Drug Administration plans to review the nutrition quality of infant formula sold in the United States, a review the agency says is the first of its kind in over 30 years.

The FDA said Tuesday that the review -- part of its "Operation Stork Speed" initiative -- will look at whether current nutrient requirements need to be updated, including whether additional nutrients need to be considered.

"Every child deserves a healthy start," Health and Human Services Secretary Robert F. Kennedy Jr., whose agency oversees the FDA, said in a statement Tuesday. "By taking a hard, honest look at the nutrients in infant formula, we're ensuring that parents have the tools to give their children the best nutrition from the very beginning."

The FDA's announcement comes three years after a baby formula shortage escalated to a national crisis due to a voluntary product recall of the one of the country's top baby formula producers.

Here are three questions answered for parents and caregivers.

1. What is the timing of the FDA's review?

It remains unclear at this time how long the nutrient review and could take.

To begin the review, the FDA issued a request for information, as required by law, on Tuesday.

The FDA also is seeking public input about whether existing nutrient requirements should be revised based on the latest scientific data. As of now, the FDA is accepting information from the public up until Sept. 11.

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The FDA will then convene a public panel in early June.

Under current law, the HHS secretary reviews the table of required nutrients every four years as appropriate.

2. What should parents look for in infant formula?

PHOTO: Stock photo of baby formula powder being prepared.
Sod Tatong/Getty Images
Stock photo of baby formula powder being prepared.

Since many organs rapidly develop in the first year of life, infants have special nutritional needs -- missing even a few days of formula can be harmful for an infant's development. Parents are encouraged to talk to their pediatrician about their child's nutritional plan.

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According to ABC News chief medical correspondent Dr. Tara Narula, parents should closely read the label of infant formula and make sure the formula is fortified with iron.

If parents are using a powder formula, they should make sure the water they are adding to the formula is clean, according to Narula.

Both Narula and the American Academy of Pediatrics warn against trying to make your own homemade infant formula using store-bought ingredients.

Homemade formulas "are risky … and may not be safe or meet your baby's nutritional needs," the AAP warns. Going above the maximum dose of a substance can be dangerous -- many nutrients are toxic to infants at high concentrations -- and the FDA reports that some babies fed homemade formula have been hospitalized for hypocalcemia (low calcium), which can cause seizures and heart problems.

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3. What nutrients are required to be in infant formula?

The FDA currently specifies 30 nutrients that must be included in infant formulas. There are minimum amounts for all 30 nutrients and maximum amounts for 10 nutrients, according to the agency.

Among the nutrients currently required are protein and fat, as well as vitamins A, D, E, K, folic acid, iron, magnesium and zinc.

The FDA is the federal agency that oversees the "safety, nutritional adequacy, packaging, and labeling" of infant formula products, according to its website.

When an infant formula is brought to market, FDA investigators are tasked with ensuring it meets federal nutrition and labeling requirements. The FDA is also the agency tasked with conducting annual inspections of facilities that manufacture infant formulas and making sure the water used to manufacture formulas meets federal safety standards.