Kathryn Caves of Denver hadn’t intended to feed her newborn formula. But when her daughter was born early, breastfeeding proved more difficult than she had expected. Caves started her daughter on formula in the hospital while she worked to increase her breast milk supply, and continued to supplement with it throughout her baby’s infancy.

“So many people rely on formula—even people like me, who never intended to use it but came to rely on it,” Caves says. “It’s just what you have to do. You just kind of trust that it’s going to be safe.”

Shayla Hunter of Harrisburg, Pa., knew ahead of time that she would be buying formula because her son was born via a surrogate. “I did some research before he was born, about different ingredients and different formula companies and the claims they were making,” Hunter says. “You just want to make sure your kid is fed and getting what they need, but it’s so important for the formula to be clean, for their development.”

All parents want to feed their babies in a way that is nutritious and safe. For the millions of parents who rely on formula—because they can’t breastfeed, they choose not to, or they supplement breastmilk with formula—that formula is a crucial source of nutrition during their babies’ first important months of life. About 1 in 5 newborns in the U.S. start out eating formula exclusively, according to the Centers for Disease Control and Prevention. By 6 months of age, 3 out of 4 babies are consuming formula as part of their diet.

But despite being among the most tightly regulated foods on the market, infant formula isn’t necessarily spared from the effects of environmental pollution on its ingredients, or from contamination through the manufacturing process. Gaps in the formula industry’s safety procedures were on stark display during the 2022 formula shortage caused by a deadly bacteria found in a manufacturing facility. Staff and budget cuts at the Food and Drug Administration early this year may compound the issue and weaken oversight of infant formula production in the U.S. even further.

Arsenic
The problem: Arsenic is a heavy metal that is both naturally occurring and carcinogenic to humans. It originates in the earth’s crust, but can contaminate groundwater as well as soil and the food that grows in it. Arsenic pollution can also result from industrial processes such as fracking and pesticide manufacturing.

The Agency for Toxic Substances and Disease Registry has rated arsenic the most toxic substance in the environment, and the most toxic form of arsenic is known as inorganic arsenic, a known carcinogen for people of all ages. Consumer Reports tests in the past have found elevated levels of inorganic arsenic in fruit juice, baby food, and bottled water. 

“Arsenic in high levels, of course, is a poison,” says Mark R. Corkins, MD, professor of pediatrics at the University of Tennessee Health Science Center in Memphis. “Over time, it increases your risk for certain cancers. So, long term, arsenic is a big concern.”

The results: CR’s tests on baby formula involved two steps. An initial test measured total arsenic, and then a second test broke out the inorganic arsenic, the most toxic kind. 

Our tests found the highest inorganic arsenic level in Abbott Nutrition’s EleCare Hypoallergenic, at 19.7 parts per billion (ppb), and the second highest in Similac Alimentum at 15.1 ppb, also made by Abbott. Abbott told CR in a statement that the company had concerns about our methodology and that heavy metals exist in the environment and that these substances “may be present in trace amounts in food products, including all brands of infant formula and even human breast milk.” There are no established limits for arsenic in formula, but for comparison, the Environmental Protection Agency limits arsenic in municipal drinking water to 10 ppb; the FDA has the same limit for bottled water. 

We also calculated a “hazard quotient,” or the level below which no adverse health effects would be expected to occur, assuming a 3-month-old infant of average size eating an average amount each day. While most of the formulas we tested were below our hazard quotient for arsenic, in all, seven of the 41 formulas were over the limit, and two more were very close to it.

What the experts say: “This is a pretty outrageous situation, I must say,” said David Carpenter, MD, director of the Institute for Health and the Environment at the State University of New York at Albany, when he heard the results of CR’s tests. Both he and Corkins speculated that the source of the arsenic in the formula may be contaminated drinking water that was used during the manufacturing process before it was dehydrated for packaging—though it is not possible to know for sure. 

If the arsenic is coming from water used in the manufacturing process, it can be filtered out or otherwise removed. If, on the other hand, heavy metals are introduced through another ingredient, like a protein source, there is no easy way to extract them; the manufacturer has to instead source other ingredients that are not contaminated.

“There is no excuse for having arsenic in baby food or formula,” Carpenter says. “Absolutely none. The industry should be bending over backward to be certain it’s not there.”

The problem: Another heavy metal in the natural-but-still-toxic category is lead. While lead is known for harming child development through exposure to paint and old pipes, it can also contaminate food through the soil it’s grown in, or through water used for irrigation. The neurological effects of lead on babies and children exposed to it can be profound. 

Whereas arsenic exposure presents a more troubling long-term risk, lead has more serious immediate implications, Corkins says. Lead exposure has been linked to attention deficit hyperactivity disorder, behavior problems, and lowered IQ. “Because of the way it affects brain development, when you’re talking about kids, in the short term I worry more about lead.”

Given its pervasive nature in the environment, though, it is difficult to get water or food to be truly free of lead. This is why the FDA’s oversight plan is called Closer to Zero. Its guidance to manufacturers of food for babies or toddlers is to keep lead at or under 10 or 20 ppb, depending on the ingredients, but Closer to Zero guidance doesn’t include formula. The EPA takes action only if a public water supply is found to have lead over 15 ppb, even though its “non-enforceable goal” is 0 ppb. 

The results: As we had expected, CR’s tests found lead in almost all the formulas. Lead levels ranged from 1.2 ppb to 4.2 ppb, which is below the FDA’s Closer to Zero goal, but CR’s experts believe those levels are too high. They prefer to use the more conservative Maximum Allowable Dose Level (MADL) set by the California Office of Environmental Health Hazard Assessment because it is the most protective standard available. In 18 of the formulas we tested, the lead intake for the average 3-month-old would fall between 50 and 100 percent of the more conservative MADL limit.

This is important because formula isn’t the only potential source of lead exposure for most babies. There’s also household dust and soil, for instance, or other foods for babies over 6 months who eat both formula and solids. CR tested powdered formula in its dry form, but mixing with tap water that contains any lead would also increase the daily exposure level.

What the experts say: “It’s virtually impossible to get to zero with lead,” says Steven Abrams, MD, professor of pediatrics at the University of Texas at Austin Dell Medical School. “Having said that, the lower the better.”

“We know that there is no safe level of lead exposure,” says Hannah Gardener, a professor in the department of neurology at the University of Miami who has researched heavy metal contamination in infant formulas. “Obviously babies need to eat. So there needs to be plenty of food and formula choices at the lowest end of the range of contamination. Manufacturers need to do many things to protect consumers, including rigorous and repeated testing of their products and disclosing the contamination levels to consumers.”

The problem: CR also tested all the formulas for PFAS. Sometimes called “forever chemicals,” PFAS are human-made pollutants that are as pervasive in the environment as they are long-lasting in our bodies. New research seems to come out every day about the potential harm done to human immunity, fertility, and longevity as the PFAS we are exposed to accumulates in our blood. 

The results: CR’s scientists were not surprised to find at least some of the thousands of PFAS compounds in almost all the formulas we tested. However, many of the compounds present are more obscure, and less widely understood, than the so-called legacy compounds whose health risks are well known, and for which the EPA has set limits in drinking water. The only one of these older compounds we found in the formulas was PFOS, and we found it in several formula products. 

These results aren’t included in the chart below because we tested only one sample from each type of formula, which isn’t a robust enough test to say which products have it and which ones don’t. But CR believes that this is a subject that deserves a closer look.

What the experts say: “I don’t think parents can choose their way away from PFAS in their infant’s diet—it’s more of a closer to zero mentality that we need to start taking, when it comes to PFAS in food,” says Courtney Carignan, an environmental epidemiologist at Michigan State University in East Lansing. However, testing and filtering the drinking water you use to mix powdered formula is a good action step for parents concerned about PFAS, according to Carignan.

The problem: We also tested for bisphenol A (BPA) and acrylamide, two more chemicals that are known to be harmful to babies’ health. BPA is a human-made chemical used to make plastics more sturdy, and research has demonstrated its tendency to leach out of plastic into food, as well as its propensity to interfere with normal hormone functioning. BPA is banned from use in baby bottles and infant formula containers—according to experts, any BPA found in formulas could be from a plastic container used to hold one of its ingredients.

Acrylamide may not be as well known as the others above; it’s what’s called a “process contaminant,” the byproduct of a chemical reaction that occurs during the manufacturing process. The FDA has previously warned consumers about acrylamide in high-carbohydrate foods that are made with high-temperature cooking, like fried and baked potatoes and cereal. We decided to test for its presence in formula because, while the FDA has not yet set limits for acrylamide in food, the EPA has classified it as a likely carcinogen. 

The results: Our tests detected BPA and acrylamide in just one formula—Enfamil’s Nutramigen, a commonly recommended alternative to cow’s milk formula for babies sensitive to milk protein. Mead Johnson, the maker of the formula, disputed CR’s finding, 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.” The other 40 formulas in our test contained no BPA or acrylamide. And while manufacturers often replace BPA with similar compounds, such as BPS or BPF, that may pose the same health concerns, we did not find these in any formula.

What the experts say: The results of CR’s tests show great improvement within the industry. Experts we spoke to were glad to hear that only one formula contained BPA, and said that if we had done this same test 10 years ago, we likely would have found much more. Still, BPA is harmful in small amounts, so it is still concerning to detect it at all in something meant for newborns.

“BPA has hormone-like activities, which means it doesn’t take very much to exert a very powerful influence,” says Patricia Hunt, PhD, a professor at Washington State University’s School of Molecular Biosciences in Pullman. “BPA’s effects on development are concerning, because babies’ brains and bodies are still developing, and there are so many different organ systems that can be affected.”

We tested all the formulas for two other heavy metals, too: cadmium and mercury, which each carry their own health risks. Mercury was not detected in any of the formulas, and cadmium was found in such low levels that CR’s experts do not find it concerning. 

The tests also included an analysis of each formula’s potassium content. This was a check on the formula’s nutrition content, not its potential contamination. In 2024 the FDA put out warnings for certain formulas because they had excessive levels of potassium, which can be dangerous. The good news here is that none of the potassium levels measured in CR’s tests were over the maximum limit set by the FDA. Some of the formulas tested below the lower limit, but they weren’t so low as to be of concern.

And here’s the best news for parents: Aside from the most concerning results for arsenic, lead, BPA, and acrylamide, our tests found that there are still many safer infant formula options widely available on the market.

To determine the potential risk posed by the infant formulas in CR’s tests, we used internationally recognized health-based daily exposure limits for lead, inorganic arsenic, cadmium, mercury, BPA, and acrylamide. Our results indicate which products had comparatively higher levels, and are not assessments of whether a product exceeds a legal standard. We used those levels because there are no federal limits for contaminants in infant formula, and CR’s scientists believe these levels are the most protective available. Read the full methodology (PDF) and see the full test results (PDF).

We tested 41 types of formula, made by 14 companies, but the U.S. market is almost completely dominated by just a handful of formula manufacturers. About half of all formula bought in the U.S. is bought through the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC), and almost all of that is made by just two companies: Abbott and Mead Johnson. Abbott makes Similac and EleCare, while Mead Johnson makes Enfamil and PurAmino. 

So what these two companies do has an enormous impact on the formula market as a whole—just look at the ripple effect that shutting down one Abbott plant in 2022 had on the entire nation’s formula supply. 

A third company, Perrigo, is responsible for making many familiar store brands—including Costco’s Kirkland Signature, Sam’s Club’s Member’s Mark, Target’s Up&Up, and Walmart’s Parent’s Choice, as well as Dr. Brown’s. 

Together the formula made by these three companies—Abbott, Mead Johnson, and Perrigo—makes up 79 percent of the U.S. market, according to 2022 estimates.

CR sent questions to all the companies about the types of contaminants they test their ingredients and products for, their thresholds for allowed contaminants, and what the companies thought might be the sources of any of the contaminants that we found in our tests. We also reached out to companies producing formulas where we didn’t find contaminants, to try to learn what they were doing right.

Similac and EleCare manufacturer Abbott Nutrition and Enfamil manufacturer Mead Johnson both sent detailed responses to CR’s test results and questions. These companies, which dominate the formula market, have products that appear in every category, from “Top Choices” to “Worse Choices.” Both companies challenged CR’s results and emphasized that 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. 

“Abbott has a multi-step quality process in place for heavy metals to ensure that levels satisfy all relevant regulatory requirements in all countries we serve,” wrote Hakim Bouzamondo, MD, a vice president at Abbott Nutrition, adding that he disagreed with CR’s using California’s extra-conservative metrics to assess risk. 

A Mead Johnson spokesperson described the company’s “stringent testing protocols” and wrote that the company is “committed to providing the highest levels of quality and safety for all our infant formula products as is evidenced by the fact that parents and pediatricians have trusted our infant nutritional products for nearly 120 years.”

Perrigo, which makes Dr. Brown’s formula and many popular store brands we tested, including Kirkland, Parent’s Choice, Member’s Mark, and Up&Up, also told us that it routinely screens its formulas for heavy metals. “These compounds and PFAS are also found in breast milk,” a spokesperson wrote. “Their levels in infant formula are insignificant and well below regulations in the United States and around the world.”

The parent company for Kabrita, a goat-milk-based formula we put in our Worse Choices category because it contained both arsenic and lead in our tests, told CR that the levels we found fall under regulatory limits, and said that it is unique in publishing its heavy metal testing data on its website for every can of formula it sells.

ByHeart, whose formula landed in our Good Choices category, told us that “It is ByHeart’s goal to limit [heavy metals] to the lowest levels reasonably achievable,” which it strives to do through constant testing and careful supplier selection.

Danone, the maker of the Neocate formula in our Good Choices category, said that while the FDA has not yet set safety levels for heavy metals in baby formula, Danone stays within EU guidelines. Danone’s other two formulas in our test, from Happy Baby Organics and Aptamil, are no longer for sale in the U.S. but fell in the Top Choices range based on testing.

Bobbie’s formulas are all in our Top Choices category, including its Baby’s Only Organic brand. Laura Modi, Bobbie’s CEO and co-founder, told CR, “We pride ourselves on being test obsessed,” adding that “not a single batch leaves the facility until it goes through 2,000 quality checkpoints.”

A2, Bubs, and the makers of Earth’s Best, HiPP, Holle, and Kendamil did not respond to CR’s requests for comment.

Just because consuming toxins is to some extent a fact of life does not mean that food manufacturers cannot and should not do better, CR’s food safety experts say—especially manufacturers of a food as crucial to health and development as infant formula.

“Manufacturers should be continuously testing all of their incoming raw ingredients, their processes, their packaging, and their outgoing products for contaminants like these,” says James E. Rogers, PhD, Consumer Reports’ director of product and food safety research and testing. “The fact that some levels in our tests are lower than others—and many are nondetectable—just shows that it is possible to make safer food.”

That infant formula is regulated at all is a relatively new phenomenon, and it’s the direct result of the activism of two extremely motivated mothers. 

Carol Laskin and Lynne Pilot both had baby boys who got severely ill and were treated at the hospital in 1979 due to a chloride deficiency after one formula company quietly changed its ingredients. Laskin remembers when she learned that the formula was the source of her son’s medical issues and called the FDA to alert them. She asked what the exact regulations were for baby formula. She was shocked to hear the answer: “There aren’t any.” Whatever guidelines existed were voluntary, he said.

“I said, ‘How can you not have any regulation of baby formula? It’s the only nutrition that some kids get for the first six months of their lives, how can you justify that?’” Laskin recalls today. “He said, ‘We’ve been trying for years to get Congress to give us the power.’”

“I said, ‘That’s insane. I’m going to change that. I’m going to get you that power.’” Laskin laughs: “At which point, he hung up on me because he thought I was a crazy person.”

Laskin soon connected with Lynne Pilot, after their sons were seen by the same pediatric kidney specialist; together they made a plan. The two of them and their families spoke to reporters and appeared on TV to spread their story. They asked other parents with similar experiences or questions to write to a post office box they set up; she said they got 50,000 letters. They relentlessly lobbied members of Congress. Eventually, their efforts succeeded. In 1980, the Infant Formula Act became law, giving the FDA the authority to make sure all formulas meet certain nutritional requirements.

Learning that there are heavy metals, PFAS, and other toxins in baby formula may be alarming, and CR’s experts and advocates believe that the industry and regulators could be doing more to keep formula safe. But formula provides vital nutrients, and is the best (in fact, only) option for parents who can’t or don’t want to breastfeed. 

CR’s tests also revealed that there are many accessible, less expensive options available for formula-feeding families. This is important because finding the right formula can be a slow—and sometimes expensive—process of trial and error. Your baby may need a particular formulation for allergies or reflux, or your baby may simply not like the way a formula tastes, and reject it. 

“Something that I didn’t think about—and I don’t think a lot of first-time parents think about ahead of time—was, of course you as the parent are choosing the formula, but you also have to see what your baby will tolerate,” said Hannah Stoppelman, a CR staffer and mother who went through several brands of formula samples from her pediatrician before she found one that her newborn daughter could eat and keep down. “It’s just not totally in your control.”