RFK Jr. is reviewing baby formula rules for the first time in 30 years. What’s at stake?

In the seven months since Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Food and Drug Administration would review infant formula ingredients and nutrition for the first time in nearly 30 years, hundreds have submitted public comments demanding more rigorous testing for heavy metals and contaminants and urging that any assessment be based on science.
The initiative, dubbed “Operation Stork Speed,” has unleashed comments from parents who have expressed concerns about the sugar content in formula and complained about the seed oils used to deliver essential fatty acids to infants.
The plan is tied to a growing movement in nutrition and chronic disease prevention called the Make America Healthy Again Movement, which has pushed the administration to take a harder line on processed ingredients.
Registered dietitians, nurses and doctors, meanwhile, have urged the Trump administration to ensure it avoids sowing doubt about the overall safety of infant formula.
Health and Human Services said in May that the aim of “Operation Stork Speed” was to “ensure the safety, reliability, and nutritional adequacy of infant formula for American families.”
But it comes as many parents are expressing their anxieties on social media, trading tips on how to buy European baby formulas online and discussing how to make their own at home.
Doctors for America, an advocacy group, warned in a letter to the FDA that “parents are faced with a constant bombardment of misinformation, especially via social media, and pediatricians worry that parents may see this FDA initiative as a warning that infant formulas in this country are not safe for consumption.”
That worry, the group added, “can spiral into attempts at making homemade formulas, paying for expensive, non-FDA regulated international formulas, or relying solely on insufficient maternal breast milk production in order to feed their infant. These alternatives carry grave risks.”
Here’s what to know about the FDA’s review of infant formula and what pediatricians say about claims related to formula.
Is infant formula safe?
About 75% of infants in the United States are using formula by the age of 6 months, according to the Centers for Disease Control and Prevention.
The FDA requires that formulas contain minimum levels of more than a dozen ingredients such as protein, fat, vitamins and minerals. Manufacturers must follow strict quality control procedures, including testing for nutrient content and safety.
Facilities can also be regularly inspected to ensure that their manufacturing practices meet federal standards designed to prevent contamination and ensure consistency.
But sometimes problems arise.
The FDA can issue recalls if a formula is found to be unsafe, improperly labeled or nutritionally inadequate such as in the 2022 Abbott recall and the 2023 Reckitt recall after an outbreak of Cronobacter sakazakii, a foodborne pathogen that can be deadly for infants and those with weakened immune systems.
In March, Consumer Reports tested 41 types of infant formula and found that while many products were safe, some contained “potentially harmful levels” levels of heavy metals including inorganic arsenic, lead, BPA, acrylamide and PFAS, according to their results. These chemicals are found in everyday products and data on their harm is not concrete.
Operation Stork Speed will seek to increase “testing for heavy metals and other contaminants in infant formula and other food consumed by children,” HHS said.
The March report also emphasized that there are still many formulas on the market that have undetectable and low levels of these contaminants – which experts say do not seem to warrant concern. And despite the 2022 and 2023 outbreaks, both U.S. and international health officials say that infant formula, when properly manufactured and prepared, is a safe and nutritionally adequate alternative for babies who are not breastfed.
The FDA has convened an expert panel, opened public comments on to review the current nutrient requirements for infant formula and launched a research program with the National Institutes of Health.
The agency said it will also work on increasing breastfeeding rates though the Special Supplemental Nutrition Program for Women, Infants, and Children or other policies. The FDA has not offered additional details on what else the program will do.
“FDA will modernize nutrient requirements for formula, increase testing for heavy metals and other contaminants to help ensure access to high-quality and healthy infant formula sold in the United States, and encourage companies to develop new infant formulas,” HHS said in an email.
How much seed oil is in infant formula?
Infant formulas are designed to mimic breast milk with a blend of proteins, fats, carbohydrates, vitamins and minerals.
Amy Reed, a registered dietitian and spokesperson for the Academy of Nutrition and Dietetics, said seed oils are added to infant formulas to mimic the fat content in breast milk. Seed oils come from a variety of plants including soybeans, canola, corn and sunflower.
“We know breast milk is the gold standard, but when we mimic it in formula, every ingredient is there to support an infant’s growth and development, not to harm it,” Reed said.
But many have raised concerns about seed oils, fearing the ingredient causes inflammation.
“I don’t understand why we put seed oils/vegetable oils in baby formula,” one commenter on the FDA website said. Another said, “Get the Seed Oils out of the food we are feeding to the most important asset we have in our country, our youth. It is insanity and can not be justified any longer.”
Nutrition scientists say there has been no evidence to prove the claims that seed oils are inflammatory.
A systematic review of 15 clinical trials found no consistent evidence that increased intake of linoleic acid – found in many seed oils – raises inflammatory markers in humans. More recent research of nearly 1,900 people even found that higher blood levels of linoleic acid were associated with lower indicators of inflammation and improved cardiometabolic health.
“Thirty percent of children have a food-caused chronic disease and that’s what should worry parents the most, not the safety of FDA approved formula,” said Jerold Mande, an adjunct nutrition professor at Harvard T.H. Chan School of Public Health who previously served in senior food and nutrition policy positions at the Agriculture Department and the FDA.
What about sugar and corn syrup?
While some American formula companies rely on corn syrup solids or maltodextrin for carbohydrates, dietitians emphasize that these products remain tightly regulated by the FDA.
The bigger concern, according to Mande, is added sugar. He said that while formula overall is safe and well regulated, American products contain more sugar than is necessary, and it should be cut.
“MAHA deserves an A for bringing these diet, disease and food causes to a political priority, but their approach to strong science has been troubling,” Mande said.
He stressed that changing long-standing formula requirements without strong scientific evidence could do harm.
Barry M. Popkin, a nutrition professor at the University of North Carolina Gillings School of Global Public Health, said early exposure to sugar in formula can shape a child’s preference for sweet foods later in life.
These sugars are not required for nutrition but are included to improve taste, Popkin said, reflecting broader American dietary habits. Reducing it, he said, would be “the most meaningful, important change that would not impact the required elements in formula today.”
What should I know about European formula?
Operation Stork Speed will also explore making it easier for parents to import formula for personal use.
Some pediatricians caution against buying infant formula from Europe, even though they are nutritionally adequate, because of the lack of FDA oversight once they enter the U.S.
Imported cans may not be labeled according to U.S. standards, which makes it harder for parents to follow preparation instructions correctly. There is also the risk of counterfeit or improperly stored formulas when purchased through unofficial online sellers.
For these reasons, pediatricians generally advise parents to use FDA-approved formulas sold through American retailers.
The FDA strongly advises parents to not give their infants homemade formula, noting that it has “received reports of hospitalized babies who had been fed homemade infant formula” that have had low calcium or inadequate amounts of necessary nutrients required for development in the first year of life.
What does the formula industry say?
As the debate over ingredients plays out among parents and pediatric nutrient experts is still underway, industry groups and formula makers say they are ready to work with the administration.
The Infant Nutrition Council of America, the group that represents manufacturers of infant formulas and toddler milks, said in a statement that they are “committed to working with Secretary Kennedy, HHS, and the FDA on Operation Stork Speed to ensure domestic infant formula products continue to meet the highest evidence-based standards for nutrition and safety, supported by clinical research, while strengthening supply resiliency to meet the nutritional needs of families, caregivers, and infants who rely on our products.”
Abbott Nutrition, one of the nation’s biggest formula manufacturers, said it welcomes “opportunities to contribute our expertise, including through Operation Stork Speed” to improve formula standards and safety.