Study finds lead, arsenic in some infant formulas

USA Today

19-03-2025

Study finds lead, arsenic in some infant formulas
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Most infant formulas tested by Consumer Reports during a recent investigation came back clear, though a few contain potentially harmful levels of lead and arsenic, which could pose health risks for young children, the organization said Tuesday.
The Consumer Reports investigation also found per-and polyfluoroalkyl substances (PFAs) in almost all the infant formulas it tested and one that contained both bisphenol A (BPA) and Acrylamide. In high doses, many of these substances can cause health issues, particularly for infants and younger children as they develop.
But the makers of some of the infant formulas highlighted are challenging the investigation, its methods and results, pointing out that many of the substances are found naturally in the environment and that their formulas are safe.
Consumer Reports said the good news from its investigation was that most of the samples it tested did not pose health risks, "demonstrating that it's possible to produce baby formula without these dangerous contaminants and that safer alternatives are widely available."
Consumer Reports also launched a petition calling on Health and Human Services Department Secretary Robert Kennedy, Jr., to ensure the FDA has the staffing and resources necessary to keep infant formula safe.
What did Consumer Reports find?
Sana Mujahid, manager of CR's food safety and research, said parents should not panic as a result of the findings, but should talk to their pediatrician about potentially switching formulas.
In an interview with USA TODAY, Mujahid acknowledged that the contaminants found during testing are found naturally in the environment and that "consumers are exposed to them through various pathways. But we want levels to be as low as possible in infant formula."
Muajahid said there were a number of formulas tested that did not have elevated levels of contaminants.
Consumer Reports' food safety team tested 41 different powdered infant formulas, including well-known brands such as Enfamil and Similac, new startups, popular store brands and imported formula brands..
Among its findings:
Arsenic: Consumer Reports found the highest levels of inorganic arsenic in Abbott Nutrition's EleCara Hypoallergenic (19.7 parts per billion) and the second highest in Similac Alimentum (15.1 ppb), also made by Abbott. By comparison, the U.S. Environmental Protection Agency limits inorganic arsenic in municipal drinking water to 10 ppb, Consumer Reports said. While most of the formulas Consumer Reports tested had arsenic levels below levels of concern, eight formulas were over Consumer Report's risk level and two more were very close to it. Inorganic arsenic is the most toxic form of arsenic and is a known carcinogen for people of all ages. It can contaminate groundwater as well as soil and the food that grows in it.
Consumer Reports found the highest levels of inorganic arsenic in Abbott Nutrition's EleCara Hypoallergenic (19.7 parts per billion) and the second highest in Similac Alimentum (15.1 ppb), also made by Abbott. By comparison, the U.S. Environmental Protection Agency limits inorganic arsenic in municipal drinking water to 10 ppb, Consumer Reports said. While most of the formulas Consumer Reports tested had arsenic levels below levels of concern, eight formulas were over Consumer Report's risk level and two more were very close to it. Inorganic arsenic is the most toxic form of arsenic and is a known carcinogen for people of all ages. It can contaminate groundwater as well as soil and the food that grows in it. Lead: Consumer Reports found lead at some level in 34 out of the 41 formulas tested, ranging from 1.2 ppb to 4.2 ppb, with the highest level found in Neocate Hypoallergenic. None of the formulas tested had levels that exceeded the Maximum Allowable Dose Level (MADL) set by California, a metric Consumer Reports chose for its tests to ensure child safety. However, 18 of the formulas had lead levels that made up 50 to 100% of the California standards. Exposure to lead can have profound neurological effects on babies. Lead can contaminate food through the soil it is grown in or through water used for irrigation.
PFAS: Many of the PFAS compounds Consumer Reports found in its tests are less widely understood than 'legacy PFAS' chemicals whose health risks are well known and for which the EPA has set limits in drinking water. Consumer Reports did find PFOS, one of the older PFAS compounds, in several models of formula. But Consumer Reports only tested one sample from each brand, so more testing is needed to definitively say which brands have PFAS and which ones don't, the organization said.
BPA and Acrylamide: Consumer Reports found BPA and Acrylamide in just one formula: Enfamil's Nutramigen, which is a commonly recommended alternative to cow's milk formula for babies sensitive to milk protein. Research has found that BPA can leach out of plastic into food and that it is an endocrine disruptor in humans. Acrylamide is a byproduct of a chemical reaction that occurs during the manufacturing process and is classified by the EPA as a likely carcinogen.
Companies respond to investigation
Both Abbott Nutrition, the maker of Similac, and Enfamil challenged the results of the investigation to Consumer Reports, in comments that were included in the report, and said heavy metals or chemicals are never intentionally added to their products. They also said trace levels of heavy metals in the food supply are not an issue that is unique to infant formula.
In a statement shared with USA TODAY, Abbott said "Abbott's infant formulas are safe, and parents can use them confidently. Heavy metals are naturally occurring in the environment, including in the soil, water, or air where foods are grown. As a result, they can be present in low levels in almost anything we eat or drink, including in baby food, all brands of infant formula, fruits and vegetables, and even human breast milk.
"The results reported by Consumer Reports for our infant formulas meet the regulations for heavy metals already set by the European Commission and Health Canada. Moreover, these results are reported in parts-per-billion."
One part per billion, Abbott said, is equal to a grain of sand in 730 pounds of sand.
Abbott said it has a multi-step quality process for heavy metals to ensure levels are below the relevant regulatory requirements in each of the countries it serves. "Individual ingredients that we believe may contain trace heavy metals (due to absorption from the natural environment) are tested during the qualification process before we approve them for use in our products."
Abbott also has an ongoing surveillance testing program "to ensure that our supplier and ingredient qualification process is working as intended."
Mead Johnson Nutrition, the maker of Enfamil, also provided USA TODAY with a statement. The company said parents and pediatricians have trusted its products for nearly 120 years and that it took all testing, including by Consumer Reports "very seriously."
"We employ stringent testing protocols for heavy metals, and our acceptable ranges ensure compliance with all major international regulations including the U.S. FDA," Mead Johnson said. "We are concerned that a singular report of this type, without scientific, regulatory and environmental context, can lead to oversimplified statements that can cause concern among parents and caregivers about products that are absolutely safe, potentially leading them to seek out alternatives that may be less safe and nutritious."
In a response to Consumer Reports about it's Enfamil Nutramigen product, which had results of BPA and acrylamide, Mead Johnson disputed Consumer Report's findings, saying it "contradicts hundreds of results from several years of testing done on both raw materials and finished products by Mead Johnson's food safety experts under a food safety program specifically tailored to infant formula," Consumer Reports said in its report.
A Neocate spokesperson told USA TODAY: "The safety and quality of our formulas is of the utmost importance and we can say with confidence that our Neocate formula is safe for babies to consume. Heavy metals are present in the air, water and soil and, as a result, extremely small, trace amounts of heavy metals cannot be completely avoided. We do not add these elements to our products, nor can they be extracted from ingredients. We understand Consumer Reports conducted testing of dry formula powder. If they had tested the formula mixed with water in accordance with instructions, the already minimal trace levels found would be further diluted 7 times.
"The U.S. Food and Drug Administration has not yet set safety levels for heavy metals in baby formula. However, our formula is within levels set forth as safe in EU and applicable California guidance," Neocate said.
An FDA spokesperson told Consumer Reports that it has tested baby formula for contaminants as part of a Total Diet Study, and found no PFAs in those samples, no acrylamide, and only low or no detectable levels of lead, total arsenic and cadmium.
Consumer Reports said the FDA studies have been limited and while a new survey focused on infant formula began in 2023, that data has not yet been released. The FDA did not respond to a USA TODAY inquiry for further comment by deadline.
The FDA on Tuesday announced a new initiative focused on infant formula called Operation Stork Speed. It will include a nutrient review process and increasing testing for heavy metals and other contaminants. Brian Ronholm, Consumer Reports director of food policy, said the FDA initiative, announced after the organization shared its findings, was encouraging.
What consumers should do
Parents should not panic when looking at the results of this investigation, said Dr. Mark Corkins, division chief of pediatric gastroenterology and professor of pediatrics at the University of Tennessee Health Science Center and Le Bonheur Children's.
"It should be something that's informative and you take it as a guide," Corkins told USA TODAY.
Corkins, who is not affiliated with the investigation and was contacted by Consumer Reports for comment on its report, also said that the contaminants are naturally found in everything.
"There's always been some different low-level of contamination in the food we eat anyway," he said during an interview. "The only worry is if the levels are too high."
"For parents, it's like OK, you look at this report and you know that there's probably some in everything. If there's something that's high or above the levels where it's not considered safe even for the drinking water, then it's probably a good idea to avoid those," he said. But, Corkins warns against parents trying to make their own infant formula, which can be unsafe. It's also important to discuss any changes in formula with your pediatrician since some formulas are specialty formulas.
Here are tips from Consumer Reports, in light of its investigation:
Keep these test results in perspective: "Environmental pollutants are pervasive in our food supply and all of the contaminants CR (Consumer Reports) detected in formula have been found in breast milk, food, and water in previous studies," the organization said.
Talk to your pediatrician: Consumer Reports suggests talking to your pediatrician if you are thinking about switching your baby's formula.
Never try to make your own formula or offer alternative foods: Getting the right concentrations of nutrients, electrolytes, and fluid in formula is crucial, and virtually impossible to do at home, experts say.
Use clean water to mix your powdered formula: The EPA sets limits on contaminants in tap water for most of the country, but not every part of it. If you drink water from a well, for instance, that water is not regulated by the EPA. It's a good idea to get well water tested for heavy metals and PFAS before using it, said Consumer Reports. You can contact your local health authorities with questions, and if you have concerns about environmental pollutants particular to your area, consider using bottled water or investing in a filtration system.
'Parents shouldn't have to worry that the infant formula they are feeding their newborn might contain toxic chemicals that could endanger their young child's health,' said Brian Ronholm, director of food policy at Consumer Reports. 'At a time when many federal agencies are facing staffing cuts, it is critical for HHS Secretary Kennedy to make sure the FDA has the resources necessary to ensure that all infant formula is free of dangerous levels of harmful contaminants.'
Food safety: Girl Scout cookies may contain heavy metals. Why is our food like this?
Food safety is in the news
The Consumer Reports investigation also comes on the heels of news that a group found the presence of heavy metals and the herbicide glyphosate in Girl Scout cookies. The Girl Scouts defended their cookies, saying they are safe to eat, that its products are manufactured according to current safety standards and any substances found in cookies come from environmental exposure.
An analysis commissioned by Moms Across America and GMO Sciences said Girl Scout cookie samples contained heavy metals, including aluminum, arsenic, cadmium, lead and mercury.
With modern testing giving scientists the ability to find parts per billion or trillion, contaminants can probably be found in many household food products, Jerold Mande, an adjunct professor of nutrition at Harvard's School of Public Health and a former senior policy official at the FDA and the U.S. Department of Agriculture's food safety programs previously told USA TODAY.
A Consumer Reports study in 2023 showed levels of heavy metals in baby food products were improving, but still "concerning."
Betty Lin-Fisher is a consumer reporter for USA TODAY. Reach her at [e-mail] or follow her on X, Facebook or Instagram @blinfisher and @blinfisher.bsky.social on Bluesky. Sign up for our free The Daily Money newsletter, which will include consumer news on Fridays, here.