FDA’s Infant Formula Testing Results Show Undetectable to Low Levels of Chemical Contaminants

The U.S. Food and Drug Administration (FDA) has released results after testing more than 300 infant formula products for chemical contaminants, finding most samples contained undetectable or low levels.

FDA described the testing as “the largest and most rigorous examination ever conducted” on chemical contaminants in infant formula available on the United States market.

“We tested more infant formula than ever before, and the results are clear: most products meet a high safety standard — but even small exposures matter for newborns,” said U.S. Health and Human Services Secretary Robert F. Kennedy, Jr. “We will hold manufacturers accountable and give parents honest, transparent data they can trust. Protecting our children’s health is nonnegotiable.”

Key Findings.

The agency tested 312 infant formula samples covering 16 brands, with multiple lots tested per brand, for lead, mercury, cadmium, arsenic, pesticides (including glyphosate and glufosinate), per- and polyfluoroalkyl substances (PFAS) and phthalates. Of the samples, 278 were powdered formula, 11 were concentrated liquid and 23 were ready-to-feed. FDA tested 258 cow's milk-based formulas, 44 soy-based and 10 amino acid-based.

The study generated more than 120,000 data points, the agency said. The samples were tested and analyzed in FDA laboratories.

FDA emphasized that contaminants can be present in foods, even in small amounts, due to their natural occurrence in soil, water and air. Modern testing methods can detect extremely small amounts of contaminants in food, but the detection of a contaminant does not automatically mean a product is unsafe.

Mercury was not detected in 296 samples (95%). Concentrations ranged from not detected to 0.3 ppb.

Cadmium was not detected in 106 samples (34%). Concentrations ranged from not detected to 1.5 ppb. 95% of all samples had less than 1.1 ppb of cadmium. The median cadmium concentration was 0.2 ppb.  

Lead was not detected in 61 samples (20%). Xoncentrations ranged from not detected to 1.1 ppb, with 95% of samples containing less than 0.5 ppb of lead. The median lead concentration was 0.2 ppb.

Arsenic was not detected in 18 samples (6%). Concentrations ranged from not detected to 4.7 ppb. 95% of all samples had less than 2.0 ppb of arsenic. The median arsenic concentration was 0.5 ppb.

Each of the samples was tested for 318 different pesticides, including glyphosate and glufosinate. 309 samples (99%) had no detectable pesticides, and glyphosate and glufosinate were not detected in any samples. Three samples had detectable pesticide levels, all at low concentrations: 0.25 ppb chlorpyrifos in one sample, 0.20 ppb malathion in another sample and 0.20 ppb piperonyl butoxide in a third sample.

Samples were tested for 30 different PFAS compounds. Most PFAS compounds (25 of 30) were not found in any samples. Five PFAS were detected in a subset of samples at concentrations ranging from 0.51 ppt to 150 ppt. The most commonly detected, Perfluorooctane sulfonic acid (PFOS), was found in half of samples at detectable concentrations ranging from 0.51 to 6.0 ppt, with 95% of all samples containing less than 2.9 ppt of PFOS.

Samples were tested for 21 phthalates and 1 non-phthalate plasticizer. Phthalates were not detected in 167 samples (54%). Among the compounds tested:

• Seven phthalates were not detected in any samples.
• Five were detected in fewer than 2% of samples.
• Remaining compounds 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 samples (81%). Concentrations ranged from not detected to 57 ppb.

DINP was not detected in 260 samples (83%). Concentrations ranged from not detected to 145 ppb.

Human Milk Testing.

In addition to formula testing, FDA also analyzed 110 human milk samples from a single state donor human milk bank for arsenic, cadmium, mercury and lead.  

Overall, the majority of samples (85%) had at least one detectable contaminant, while 17 samples (15%) had no detects of any contaminants.

Mercury demonstrated the highest detection rate at 61%, followed by cadmium at 57%, arsenic at 33% and lead at 30%. 

Follow-Up Testing.

While overall levels of contaminants in the infant formula samples tested were low, FDA said it is following up with additional testing as part of its ongoing monitoring and oversight efforts and will take additional action where appropriate. This includes conducting further testing for additional contaminants, testing infant formula products that have entered the U.S. market since this initial survey began, continuing to engage with manufacturers on measures to reduce the levels of contaminants to as low as possible and working to establish action levels for contaminants in infant formula. The agency said it will share results from follow-up testing.

This testing was conducted as part of Operation Stork Speed, the FDA’s Closer to Zero initiative, and the agency’s routine food surveillance work.

“As a father, I understand how important it is for parents to trust the safety of the food they give their children,” said Deputy Commissioner for Food Kyle Diamantas. “At the FDA, ensuring the health of America's next generation is vital. Through Operation Stork Speed and our Closer to Zero initiative, this testing—the first of its kind—reinforces that infant formula in the U.S. is a safe option for parents and caregivers who rely on it. We will continue working to drive contaminants to as low as possible through rigorous oversight.”

FDA said Kennedy will host chief executives from leading infant formula companies in May for a roundtable discussion focused on modernizing FDA’s infant formula oversight and continued implementation of Operation Stork Speed, which includes aspects of nutrition, chemical and microbiological food safety.

To read full testing results, click here.