FDA Says Testing Reveals Domestic Infant Formula Supply Is Safe

The U.S. Food and Drug Administration on April 29 said tested samples of infant formula available in the country contained very low levels of contaminants, confirming that the nation’s supply is safe for consumption.

The agency tested more than 300 samples across 16 infant formula brands sold nationwide, screening them for contaminants including heavy metals such as arsenic, cadmium, lead and mercury, as well as pesticides, synthetic chemicals and phthalates.

The majority of samples had undetectable or very low levels of contaminants, the agency said.

The FDA applied the Environmental Protection Agency’s drinking water limits to assess infant formula, as unlike the EU, the U.S. does not specify heavy metal standards.

“The amount was so minuscule that is very encouraging to give families, physicians comfort in that it seems that infant formulas are very safe,” said Valeria Cohran, professor of pediatrics at Northwestern University Feinberg School of Medicine.

MORE TESTING UNDERWAY

Health Secretary Robert F. Kennedy Jr. has pushed to reduce food chemicals and launched an infant formula nutrient review last year.

Kennedy will host a roundtable with industry executives in May.

While overall contaminant levels were low, additional testing was initiated for some samples, the FDA said. The regulator tested powders, ready-to-feed liquids and concentrated liquids.

The agency plans to continue testing.

U.S. dietary guidelines largely do not consider exposure risk for contaminants, underscoring the need for stronger research, said Katarzyna Kordas, associate professor, epidemiology and environmental health, at the University at Buffalo.

Mercury was not detected in 95% of samples, lead was not detected in 20% and 99% of samples had no detectable pesticides. Most PFAS compounds were also not found.

The agency also tested a small number of human milk samples, finding that most contained at least one detectable contaminant, while 15% showed none.

Small amounts of contaminants can occur naturally in foods, including infant formula and breast milk, or enter through environmental exposure during production.

“Producing infant formula at scale in the U.S. is a matter of national security, and these results affirm the safety of our domestic supply,” Abbott, maker of Similac, said on Wednesday, adding that its U.S. formulas meet heavy metal limits set by the EPA, the European Commission and Health Canada.

Laura Modi, CEO of baby formula company Bobbie, also said it will work with the FDA to establish federal standards for heavy metals in infant formula.