FDA says infant formulas are safe

The FDA reports that the nation’s infant formula supply is safe after “the most rigorous review” of the products ever undertaken.

The testing program did not include foodborne pathogens such as Cronobacter, Listeria, Salmonella and E. coli. The agency tested for arsenic, cadmium, lead, mercury, 30 PFAS, 318 pesticides, 21 phthalates and 1 non-phthalate plasticizer.

The investigation was part of Operation Stork Speed, launched by the Food and Drug Administration in 2025 to ensure the safety of infant formula. This action followed a cronobacter outbreak in 2022.

“We have tested more infant formula than ever before, and the results are clear: Most products meet high safety standards – but even small exposures are important for newborns,” Health and Human Services Secretary Robert F. Kennedy Jr. said.

Testing found that “an overwhelming majority of samples had undetectable or very low levels of contaminants, confirming that the U.S. supply of infant formula is safe,” according to the FDA report.

However, the United States has not set any legal limits for metals in infant formula tested by the FDA. Therefore, when the FDA calls the formula “safe,” there is no standard behind that word.

Operation Stork Speed ​​is also looking at the nation’s supply of infant formula, which was significantly depleted after a recall by Abbott Nutrition following the cronobacter outbreak.

“We are doing everything we can to ensure our babies and infants have safe, high-quality infant formula options, supported by a resilient supply chain,” said FDA Commissioner Marty Makary.

The FDA tested 312 samples from 16 brands, but did not specify in its report which brands it tested. The types of formulas tested were: powder with 278 samples; 11 of concentrated liquid; and 23 ready to feed liquid. The protein sources included in the sample were 258 cow’s milk-based, 44 soy-based, and 10 amino acid-based.

“Among the products tested, the majority of infant formula samples had undetectable or very low levels of contaminants, confirming the safety of the infant formula supply in the United States,” according to the FDA report.

“Although contaminant levels were low, some samples had values ​​that triggered additional follow-up actions as part of the agency’s robust monitoring and surveillance efforts. This will include conducting more extensive testing and continuing to engage with manufacturers on measures to reduce contaminant levels to the lowest possible level.”

For each contaminant reported by the FDA, the following values ​​illustrate typical levels measured:

• Not detected: The quantity, if present, was too low for our testing methods to detect.
• Range: lowest to highest levels (concentrations) detected
• 95th percentile (shown as 95%): level below which 95% of samples fell (meaning only 5% of samples were higher)
• Median: Midpoint in a data set when numbers are ordered from lowest to highest. This displays a common number in the group.
• Parts per billion (ppb): one part per billion is the same as a drop of water in an Olympic swimming pool

The test results were as follows:

• Mercury was not detected in 296 of 312 samples (95 percent). Among all samples, concentrations ranged from not detected to 0.3 ppb. Given the high number of non-detections, no 95th percentile or median was calculated.
• Cadmium was not detected in 106 of 312 samples (34 percent). Among all samples, concentrations ranged from not detected to 1.5 ppb. 95 percent of all samples contained less than 1.1 ppb of cadmium. The median cadmium concentration was 0.2 ppb.
• Lead was not detected in 61 of 312 samples (20%). Among all samples, concentrations ranged from not detected to 1.1 ppb, with 95% of samples containing less than 0.5 ppb lead. The median lead concentration was 0.2 ppb.
• Arsenic was not detected in 18 of 312 samples (6 percent). Among all samples, concentrations ranged from not detected to 4.7 ppb. 95 percent of all samples contained less than 2.0 ppb arsenic. The median arsenic concentration was 0.5 ppb.
• Pesticides: Each of the samples was tested for 318 different pesticides, including glyphosate and glufosinate. 309 samples (99%) contained no detectable pesticides, and glyphosate and glufosinate were not detected in any samples. Given the high number of non-detections, no 95th percentile or median was calculated. Only three samples had detectable pesticide levels, all at very low concentrations: 0.25 ppb of chlorpyrifos in one sample, 0.20 ppb of malathion in another sample, and 0.20 ppb of piperonyl butoxide in a third sample.
• PFAS: Each of the samples was tested for 30 different PFAS compounds. Most PFAS compounds (25 of 30) were not found in any samples. Five PFASs were detected in a subset of samples at concentrations ranging from 0.51 ppt to 150 ppt, depending on the compound. The most commonly detected was perfluorooctanesulfonic acid (PFOS), found in half of the samples at detectable concentrations ranging from 0.51 to 6.0 ppt, with 95% of all samples containing less than 2.9 ppt PFOS. Given the high number of non-detections, the median was not calculated. PFAS levels are often reported in parts per trillion (ppt) because testing methods can detect these contaminants at extremely low concentrations. One part per trillion is equivalent to one second in 32,000 years, or one drop in 1,000 Olympic swimming pools.
• Phthalates: Each of the samples was tested for 21 phthalates and 1 phthalate-free plasticizer. Phthalates were not detected in 167 of 312 samples (54 percent). Among the compounds tested. Seven phthalates were not detected in any sample. Five phthalates were rarely detected (in less than 2 percent of samples). The remaining compounds detected had concentrations ranging from not detected to 145 ppb. The most commonly detected phthalate compounds were DEHP and DINP:
• DEHP was not detected in 253 of 312 samples (81 percent). Among samples, DEHP concentrations ranged from not detected to 57 ppb. Given the high number of non-detections, no 95th percentile or median was calculated. DINP was not detected in 260 of 312 samples (83 percent). Among samples, DINP concentrations ranged from not detected to 145 ppb. Given the high number of non-detections, no 95th percentile or median was calculated.
• Breast milk: Although this phase of testing focused specifically on infant formula, the FDA also tested a limited number (110) of breast milk samples from a single state breast milk bank for arsenic, cadmium, mercury, and lead. Overall, the majority of samples (85 percent) contained at least one detectable contaminant, while 17 samples (15 percent) detected no contaminants. Mercury demonstrated the highest detection rate at 61 percent, followed by cadmium at 57 percent, arsenic at 33 percent and lead at 30 percent.