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The F.D.A. Is Reviewing Infant Formula for the First Time in Decades

June 13, 2025
in News
The F.D.A. Is Reviewing Infant Formula for the First Time in Decades
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Last week, the Food and Drug Administration convened a panel of nutrition scientists, pediatricians and other experts to discuss the first comprehensive review of infant formula nutrient requirements since 1998.

The review is part of an initiative, called “Operation Stork Speed,” which health secretary Robert F. Kennedy Jr. announced in March to improve the safety and quality of the U.S. infant formula supply.

Many health experts have applauded the effort, but some also worry that it could raise unnecessary fears that infant formulas in the United States are unsafe.

In a Fox News segment last Friday, Dr. Marty Makary, the F.D.A. commissioner, implied that common ingredients in formulas, like seed oils, may be harmful to health, mentioning them alongside contaminants with known health effects like lead and arsenic.

“Moms want baby formula without seed oils, without corn syrup, without added sugar, without arsenic and lead and other heavy metals,” Dr. Makary said in the segment.

We asked several scientists who specialize in infant health and nutrition to weigh in on four concerns Dr. Makary and other F.D.A. officials have raised about infant formulas in the United States. These products are safe, they said, but there are ways to make them better.

Out-of-Date Formula Standards

The claim: The nutrient requirements for infant formula are overdue for a review.

What experts say: This is true.

Since the nutrition standards for infant formulas were set in 1980, there have been few updates to them, said Tom Brenna, a professor of pediatrics at the University of Texas at Austin Dell Medical School who participated in the F.D.A. panel. The standards include requirements for nutrients like fat, protein, vitamins and minerals. Research since then has suggested that some of the levels should be adjusted.

And there is no F.D.A. requirement for a fatty acid called docosahexaenoic acid, or DHA, which is important for brain development, Dr. Brenna said. Most formula manufacturers have chosen to include it in their products, but not all of them add enough to be beneficial, he said, so the F.D.A. should set a minimum level.

Seed Oils

The claim: Soybean oil, safflower oil, sunflower oil and other seed oils — which are used in all U.S. infant formulas — may cause inflammation in babies, which could lead to chronic health problems.

What experts say: There is no solid evidence that seed oils cause inflammation or other health issues in babies.

Seed oils have been used in infant formulas, including in Europe, for 50 or so years without “the slightest suggestion of any problem,” said Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin Dell Medical School.

Manufacturers use seed oils because they provide essential fatty acids, including one called linoleic acid, which is found in breast milk and is necessary for infant growth and healthy skin. Linoleic acid is required in all infant formulas.

It would probably be difficult to replace the seed oils in formulas with other sources of fatty acids, such as palm oil or olive oil, Dr. Brenna said. These oils are not as rich in linoleic acid, and in some cases could be more expensive.

That said, it’s possible that infants don’t need as much linoleic acid as is currently required in formula, Dr. Brenna said. It’s reasonable, he said, to look into whether lower levels may be better, which could make it easier for manufacturers to use other oils. The F.D.A. should review the research on linoleic acid and several other fats to determine amounts that are healthiest for babies, he added.

Corn Syrup

The claim: Many formulas contain corn syrup, which may cause health problems later in life.

What experts say: This is true, but requires context.

Many formulas in the United States do contain a powdered version of corn syrup and other added sugars, and there are valid concerns about them, said Michael Goran, a professor of pediatrics at the Keck School of Medicine at the University of Southern California. Dr. Goran and his colleagues have found links between formulas with corn syrup and greater risks of childhood obesity when compared with other formulas, for example.

The corn syrup used in these products is replacing some or all of the lactose used in other widely available formulas. (Lactose is the same sugar found in breast milk.) Parents may buy these lower lactose or lactose-free products because they are described as “gentle” or easier to digest, and they may think their babies’ fussiness is caused by lactose intolerance, Dr. Goran said. But that marketing is misleading, he said; lactose intolerance is rare in infants.

Formulas made with corn syrup or other added sugars aren’t as healthy for babies as those that contain only lactose. Lactose-only formulas are more nutritionally similar to breast milk, Dr. Goran said.

The F.D.A. should consider requiring labels for formulas that contain added sugars, and limiting how much they can contain, said Kai Ling Kong, an associate professor of pediatrics at the University of Missouri-Kansas City School of Medicine.

Heavy Metals

The claim: Infant formulas should be tested more frequently for heavy metals.

What experts say: This makes sense.

In a recent test of 41 infant formulas, Consumer Reports found that roughly half of them contained concerning levels of toxic chemicals, including arsenic and lead.

The long term health effects of heavy metals in formula have not been well studied, but experts say that there is no level of arsenic and lead that is safe to consume. Exposure to high levels of these metals can cause long-term damage to a child’s brain, leading to a lowered I.Q. and behavioral problems.

It’s not possible to completely remove these metals from infant formulas: They are naturally occurring and near-ubiquitous in the soil and groundwater, said Emily Bair, a pediatric dietitian who has researched heavy metal levels in infant food. But there are ways to reduce their levels, by using ingredients from areas of low pollution, for example, or using a water supply during manufacturing that is tested for heavy metals.

The F.D.A. does not currently enforce any limits on heavy metals in infant formula, said Michael Hansen, a senior scientist at Consumer Reports. To him, the administration’s plan to increase heavy metal testing is long overdue.

Still, experts and some Democratic members of Congress have questioned the plan. What would regulators do if they found high levels of heavy metals? And how realistic would it be to increase testing, given the F.D.A.’s recent staff cuts?

“We can talk all day about the need for safer products, but ultimately you have to have a plan for oversight and staff to carry that out,” Ms. Bair said.

Ms. Hilliard, the H.H.S. spokeswoman, said the department is “fully equipped to review current standards and expand testing and oversight.”

Alice Callahan is a Times reporter covering nutrition and health. She has a Ph.D. in nutrition from the University of California, Davis.

Teddy Rosenbluth is a Times reporter covering health news, with a special focus on medical misinformation.

The post The F.D.A. Is Reviewing Infant Formula for the First Time in Decades appeared first on New York Times.

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