Consumer Reports investigation finds heavy metals in brands of baby formula

An important investigation into infant formula: Exclusive new testing by Consumer Reports highlights safer formulas while also identifying some that contain potentially harmful levels of heavy metals, including lead and arsenic. Here’s what parents need to know to make the best choice for their baby.

About 1 in 5 newborns in the U.S. rely solely on formula and by six months, 3 out of 4 babies are using it as part of their diet.

Consumer Reports analyzed 41 types of powdered formula. 21 of the formulas tested had little to no detectable heavy metals, including Enfamil Gentleease, Similac Advance, and Kirkland Signature ProCare from Costco.

But there were also worrisome results – Consumer Reports detected inorganic arsenic, a known carcinogen, in seven baby formulas and harmful levels of lead in 18 of the formulas tested. – Lead exposure in babies can hurt their brain development.

Recent studies have shown that heavy metals like lead and arsenic are present throughout our food supply, and formula is no exception. In fact, all the contaminants in CR's tests have also been previously detected in breast milk, food, and water.

But that doesn't mean the industry can't do better. James Rogers, Ph.D., Director of Product Safety Consumer Reports, says, “The fact that some levels in our tests are lower than others – and many are non-detectable – just shows that it is possible to produce baby formula that doesn’t contain worrisome contaminants and chemicals.” Consumer Reports urges manufacturers to test their raw ingredients, packaging, and final products to minimize risks.

CR reached out to all the infant formula manufacturers with questions about their own testing for contaminants. Those that responded said that they test their formulas and that their products are safe.

Two major formula manufacturers, Abbott Nutrition, which makes Similac and EleCare, and Mead Johnson, which makes Enfamil, both challenged the results and stressed that heavy metals and chemicals are never intentionally added to their products. They also pointed out that trace amounts of heavy metals are not a problem that is unique to infant formula.

In the meantime, parents should always consult their pediatrician with any concerns and should never try to make their own baby formula. 

CR’s investigation is part of its Toxic-Free Kids Food campaign, which encourages policymakers and manufacturers to protect children from harmful dyes, heavy metals, and chemicals in their food.

Full test results can be seen here and here.

Companies contacted in the investigation released the following statements:

Mead Johnson

Mead Johnson Nutrition (MJN) 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.
We employ stringent testing protocols for potential contaminants and are proud of our efforts to date to reduce the levels of unintended materials in our products, which are lower than the levels set by the U.S. Food and Drug Administration (FDA) and other regulatory bodies.

We understand parents and caregivers may be concerned by these results and we remain confident in the safety our infant formula products. We recognize your efforts to support parental education and empower informed decision-making. However, we are concerned that a singular report of this type, without the scientific, regulatory and environmental context setting limits for contaminants in infant formula, can lead to oversimplified statements, not representative of the product category or industry.

This may unnecessarily scare parents and caregivers about the food they feed their babies and children leading them to seek alternatives much less safe than commercial infant formulas. The BPA and acrylamide findings in your report are inconsistent with our own testing results.

Heavy metals and PFAS are not ingredients in infant formula, nor are they added to any infant formula formulation. It is important to note heavy metals are commonly found in the environment, drinking water, the food supply chain, and cannot be completely avoided.

The FDA acknowledges this and last month released its final guidance for lead in processed food for infant and toddlers and the FDA acceptable levels ranged from 10 to 20ppb and, our internal limits are well below these levels, as indicated in the CR report. The complete absence of these elements is unattainable and any suggestion that zero is the only acceptable level would be irresponsible to parents and caregivers."

Mead Johnson uses the same methods of testing that Consumer Reports is reporting to have used and therefore detection levels would not be a way to explain the discrepancy. To reiterate, your single result on a finished product 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. Again, while we recognize your efforts to support parental education and empower informed decision-making, we remain concerned that reporting a single set of results that is inconsistent with any other findings may unnecessarily scare parents and caregivers.

The BPA and acrylamide findings in your report are inconsistent with our own testing
results. A review of three years of testing data for acrylamide across our full product portfolio, including Nutramigen, found no test results for acrylamide at any detectable level. We suspect either a false positive or a lab error and suggest you investigate the possibility with your lab."

Bobbie, Baby's Only Organic

"As a market leader in high quality baby formula, we pride ourselves on being test obsessed -- our infant formula undergoes over 2,000 quality checks to ensure it meets safety standards before it reaches any of our customers (the most vulnerable population). We take pride in the controls we have put in place to prevent any contaminants from entering our supply chain and consistently see excellent test results.

As parents first and formula innovators second, we hold ourselves and our suppliers to the highest standards for ingredient quality and manufacturing transparency. We extend our quality procedures and standards all the way through our upstream supply chain via extensive supplier screening and quality evaluations including auditing and testing.

While our testing details are confidential, all Bobbie products meet not just regulatory standards but our own, internal higher standards that go above and beyond what’s required by the FDA.

By thoroughly testing our ingredients, batches, and shelved product, we ensure every ounce meets our stringent purity standards. After canning, each batch is tested for contaminants, microorganisms, or naturally occurring heavy metal residue—as well as ensuring the vitamin and mineral levels match our recipe. Not a single batch leaves the facility until it goes through all 2,000 quality checkpoints. We voluntarily put our products through independent third-party testing with Clean Label Certification so we can ensure our products are as safe and clean as possible – above and beyond FDA standards. All Bobbie infant formulas are Clean Label Certified.

Our sampling and testing plans are confidential and proprietary. We test every one of our products through certified third party labs that work within globally recognized testing standards and limits applicable to the infant formula industry.

We are continually seeking to improve the quality and safety of our products by collaborating with suppliers to improve the quality and purity of ingredients. We engage with academia and research organizations, such as CR and Clean Label, to identify and improve contaminant levels in our ingredients and products.

Unfortunately PFAS is a global environmental issue that impacts every part of the food chain and is even detected in breastmilk. We have historically and will continue to explore every opportunity that exists to reduce or remove any trace of environmental contaminants."

Perrigo

"Perrigo routinely screens for arsenic, lead, and other heavy metals as part of its contaminant testing program. Perrigo-manufactured infant formulas meet all stringent U.S. Food and Drug Administration (FDA) standards.

Heavy metals originate from the Earth’s crust, occurring naturally in soil and many ingredients across the food supply chain. These compounds and PFAS are also found in breast milk. Their levels in infant formula are insignificant and well below
regulations in the United States and around the world. Infant Nutrition Council of America (INCA) members test their products for these compounds, and our industry is actively working to limit their occurrence."

ByHeart

"At ByHeart, we take quality and food safety very seriously. We are pleased to see that Consumer Reports’ testing of ByHeart Whole Nutrition Infant Formula is non-detect for acrylamide, BPA, BPF, BPS, aluminum, and mercury. All detection levels reported by the Consumer Reports data are below all applicable thresholds for the Clean Label Project, European Union (EU) and Codex Alimentarius Commission (Codex) for infant formula.

ByHeart Whole Nutrition Infant Formula was the first infant formula to be certified through the Clean Label Project, and now has three accreditations: the Purity Award, the Pesticide Free Award, and the First 1,000 Days Promise. The Clean
Label Project tests for approximately 300 contaminants including industrial and environmental toxins, arsenic, cadmium, mercury, lead, BPA, antibiotic, BPS, mycotoxin and pesticide residues, acrylamide, and melamine.

ByHeart tests for over 700 contaminants in addition to heavy metals - including pesticides, veterinary drugs, environmental, and process contaminants.
Contaminants including heavy metals are widely present in all types of consumer products due to their ubiquitous presence in the environment. It is ByHeart’s goal to limit these to the lowest levels reasonably achievable. By Heart’s comprehensive quality program is built on a foundation of careful supplier selection, rigorous testing of ingredients, and an unwavering commitment to delivering quality, safety, and purity for the customers we serve.

As a leader in quality and innovation, we invest in scientific R&D and strive to continuously evolve our products in line with the latest advancements, including through ongoing efforts to limit heavy metals and other unavoidable contaminants."

Happy Baby

"The safety and quality of our formula is of the utmost importance and we can say with confidence that our Happy Baby formula is safe for babies to consume.
The formula that Consumer Reports conducted their tests on – Happy Baby Organics Sensitive – is no longer on shelves in the U.S. market and has been replaced with a reformulated line of Happy Baby infant formulas, the first and only USDA
and EU-Certified Organic formulas made in Europe with a patented probiotic and prebiotic blend.

The testing results are not reflective of this new line of formulas.
The U.S. Food and Drug Administration has not yet set safety levels for heavy metals in baby formula. Happy Baby sets strict internal goals, relying on guidance from European food safety governing bodies, and our formula is within levels set
forth as safe in EU guidance documents."

Aptamil

"The safety and quality of our formula is of the utmost importance and we can say with confidence that our Happy Baby formula is safe for babies to consume.
The formula that Consumer Reports conducted their tests on – Happy Baby Organics Sensitive – is no longer on shelves in the U.S. market and has been replaced with a reformulated line of Happy Baby infant formulas, the first and only USDA
and EU-Certified Organic formulas made in Europe with a patented probiotic and prebiotic blend.

The testing results are not reflective of this new line of formulas. The U.S. Food and Drug Administration has not yet set safety levels for heavy metals in baby formula. Happy Baby sets strict internal goals, relying on guidance from European food safety governing bodies, and our formula is within levels set forth as safe in EU guidance documents."

Abbott

Upon reviewing the data and information you provided, we have concerns that the proposed article relies on questionable data that could unintentionally mislead consumers and cause confusion. We provide more detail about certain scientific concerns at later points in the letter; but overall, we would suggest that any proposed article on this topic should:

• Educate the reader with substantial context about these substances, which are
  commonly found in the environment.
• Be careful of language that gives the consumer a false sense that infant formula is unsafe or deliberately adulterated.
• Rely on data that is accurate (much of the methodology and testing information that Consumer Reports relied on for this analysis is irregular and may not be accurate).
• Conduct a risk assessment based on health-based guidance values, not a standard (California Proposition 65 MADL) where exposure to a substance at a level 1,000 times greater than the MADL is expected to have no observable effect. For all Abbott products Consumer Reports tested, the average reported test results were below European Union limits for inorganic arsenic, lead, and cadmium as well as Canadian limits for lead.

Testing Criteria

We believe there are several concerns and irregularities with the methods by which Consumer Reports conducted its testing. If published as is, we believe that the proposed article will lead to an inappropriate reliance by consumers on results that in some instances may not be accurate or valid.

First, analytical methods cannot be validated in the abstract. They must be specifically validated for use with infant formula to prove they yield accurate results when used to test infant formula. As discussed below, at least some of the analytical methods used in Consumer Reports’ testing do not appear to have been specifically validated for use with infant formula. To the extent that is the case, the reported results are unreliable.

Second, Consumer Reports indicated that “[i]f a contaminant was detected or measurable in any of the samples in the product, the samples that had test results below the method reporting limit…were assumed to have a concentration of half the MRL for that contaminant.” This is not a reliable interpretation of the test results. The MRL, or method reporting limit, is the smallest concentration of an analyte that a laboratory can reliably report. By definition, any result below the MRL is unreliable.

Third, the heavy metals and BPA testing raises concerns about the validity of the methodology used: The BPA method used is validated for testing fish, not infant formula. There are different compounds in infant formula, which may require different measurement than what's applicable for fish. One cannot know if the reported results are accurate if the method is not validated for infant formula.

The method used to test for heavy metals was apparently a “mod[ified]” version of
AOAC 2015.01, described as “Lab’s internal methodology.” While AOAC 2015.01 is a
standard method of testing for total arsenic, lead, and cadmium, your methodology does not identify any modifications or how it was determined that such modification(s) did not impact the validity of the test results.

There is no information provided on the method that was used for testing inorganic
arsenic, beyond the generic descriptor “IC-ICP-MS — Lab’s Internal Methodology.”
“ICP-MS” is not a standardized methodology, but rather, a general technique that can
be applied in numerous ways. We cannot assess whether the method is validated for
testing infant formula, and therefore we do not know if the results are accurate.

Potassium is not classified as a heavy metal and is required by regulation to be in infant formula, as it is an essential nutrient. Including potassium in your analysis risks causing confusion to parents, and we suggest that Consumer Reports consider omitting potassium entirely. On a technical level, it is also unclear how one would achieve accurate quantitation for single digit ppb levels of heavy metals, while simultaneously reporting potassium at 7 orders of magnitude higher. Most analytical methods are only linear over 2-3 orders of magnitude.

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. This begins with only working with suppliers that pass our supplier qualification program. In addition, individual ingredients that have the possibility of containing trace heavy metals (due to absorption from the natural environment) are tested before we approve them for use in our products. We also have an ongoing surveillance testing program designed to periodically retest ingredients and test a sample of finished products to ensure that our supplier and ingredient qualification process is working as intended.

Finally, there are significant concerns with the validity of the PFAS testing methods and results:

• There is currently not an established method to accurately identify and quantify PFAS in infant formula.
• The method used by Consumer Reports appears to be a modification of a method used to detect PFAS in drinking water. It is not clear whether the method used for detection of PFAS in this report is applicable to infant formula.
• There are several known, common food interferences in PFAS determination. As an example, cholic acids in milk and other foods are known to give false positives and bias results for several PFAS isomers.
• The method is also not proven to give accurate results without bias (e.g. higher results) from interference with normal food compounds.
• Also, the suspected presence of perfluorobuanoic acid (PFBA), perflucropentanoic acid (PFPeA), and N-ethyl perfluorooctanesulfonamidoethanol (EtFOSE) cannot be confirmed directly with the drinking water method, yet they are included in this analysis. High-resolution mass spectrometry is required to confirm these three compounds, which does not appear to have been used in this analysis. In other words, presence of these three compounds was reported, but likely was not adequately confirmed.

Risk Assessment

To conduct its “Risk Assessment,” Consumer Reports indicates that it “compared the intake estimates” from its testing to certain specified “exposure limits” listed in Table 1 of its methodology description. We are concerned that using California’s Proposition 65 MADLs for purposes of a self-described “risk assessment” is misleading to consumers. Proposition 65 MADLs are expressly not intended to be “exposure limits” or “cutoffs indicating the point where [a substance] becomes a health risk.” Under the Proposition 65 statute, MADLs are intentionally set one thousand times below the lowest level at which any health effect would be expected.? By describing Proposition 65 MADLs as “exposure limits,” using those levels in a “risk assessment,” or suggesting that exceeding a Proposition 65 MADL by a factor of less than
1,000 entails a threat to health, Consumer Reports would mislead and potentially unnecessarily alarm its readership.

If Consumer Reports intends to compare levels of these substances in
infant formula to Proposition 65 MADLs—something Abbott finds inherently confusing and misleading—it should clearly disclose to readers that MADLs are not intended to serve as “exposure limits” or safety thresholds, and that “[e}xposure [to a substance] at a level 1,000 times greater than the MADL is expected to have no observable effect."

Alternatively, the risk assessment should consider established limits specific to heavy metals in infant formula set by regulators in the European Union and Canada. The European Union has adopted such limits for inorganic arsenic (20 ppb), lead (20 ppb), and cadmium (20 ppb in soy-based formulas, 10 ppb in non-soy-based formulas),4 while Canada has adopted limits for lead (10 ppb in the formula as consumed, i.e., as prepared). For all Abbott products Consumer Reports tested, the average reported test results were below each of these limits—often by a wide margin. A balanced and non-misleading discussion of these test results should report this important information.

Context

We recognize that Consumer Reports seeks to inform the public and give objective advice to consumers. In order to preserve that objectivity, we would suggest that Consumer Reports consider the following suggestions on wording and the need for additional context:

• Consumer Reports’ use of the term “contaminants” implies that infant formula is unsafe and/or deliberately adulterated. Additionally, to avoid consumer confusion, it would be prudent to remind parents that infant formulas have been safely fed to babies when breast milk is not available for over 100 years.
• Abbott fully supports breastfeeding and believes that breastfeeding provides the best nutrition for babies, but in the absence of breast milk, infant formula is a well-known safe and suitable alternative.
• Heavy metals and PFAS exist in the environment and may be absorbed by plants from the soil and ingested by animals from which food ingredients are sourced. As a result, these substances may be present in trace amounts in food products, including all brands of infant formula and even human breast milk. Thus, it is important to provide context in discussion of these substances to avoid any mistaken conclusion that this topic is somehow unique to infant formula.

Consumer Reports uses “parts per billion” (ppb) as its testing measurement. This unit
of measurement is likely not understood by the average consumer, so adding context
would be helpful and important, especially as analytical methods continue to evolve to
be able to detect substances at lower levels.

For example, Consumer Reports could explain that a single ppb equals a single grain of sand in 730 pounds of sandé or that 1 ppb is approximately the width of 1 human hair in a span of 68 miles.”

We also recommend that Consumer Reports avoid: {a) any suggestion that Abbott
intentionally adds such substances to its nutrition products; or (b) implying that
commercially available infant formulas are not the only safe and suitable alternative to breast milk; as neither of these is true.

Conclusion

As stated above, Abbott appreciates the valuable role Consumer Reports plays in educating the public and working with stakeholders to answer questions in the public’s interest, especially on sensitive topics such as infant formula. We are grateful for the invitation to provide input into this proposed article. After our review, we think Consumer Reports should revisit its testing protocols, risk assessment, scope, and add additional context for consumers.

We believe that without these changes, any possible publication presents unintentional risk of misleading the consumer and causing unnecessary confusion.

Ausnutria-Kabrita

We appreciate Consumer Reports' commitment to product safety and thank you for sharing your test results. At Kabrita, we prioritize the safety and quality of our infant formula products. We have carefully reviewed your test results and compared them against several benchmarks, including FDA guidelines, EU regulations, and our own internal Kabrita standards and testing records.

We're pleased to confirm that all of Consumer Reports' results fall well below our compliance standards, as well as regulatory limits. It's important to note that trace amounts of the contaminants you detected can be naturally occurring in soil and water, and may therefore be present in agricultural products used in infant formula. While varying methodologies in testing can sometimes yield slightly different results, we maintain full confidence in our third-party testing partners and the rigor of our methodologies.

These comprehensive testing protocols are in place to ensure that our products consistently meet our high safety and quality standards. Furthermore, we're proud to be the first and only infant formula company to proactively make heavy metal testing data publicly available to our customers, who can trace the results for their specific can of infant formula on our website. This commitment to transparency reflects our unwavering dedication to providing safe, high-quality nutrition for infants.

Additionally, Kabrita was mentioned in this Food Processing article, “Kabrita, an infant formula manufacturer, voluntarily reports results for Heavy Metals in its infant formula, which is exempt from the California’s AB 899 law requirements as a commitment to transparency for all parents.”

The trace levels of contaminants found are likely due to their natural occurrence in the environment. These elements can be present in soil and water, which may then be absorbed by plants or animals in the food chain. Concentrated powdered formula, due to manufacturing processes, will show a higher concentration of contaminants per billion part than what will be indigested by baby once the powder is diluted for consumption. We continuously work with our suppliers to ensure the highest quality ingredients and monitor for potential sources of contamination.

We have a comprehensive testing program for our ingredients. Our suppliers must meet agreed-upon specifications for contaminants, which are based on final product requirements and align with or exceed regulatory safety standards both in the U.S. and E.U. We test for heavy metals including arsenic, cadmium, lead, and mercury, as well as other potential contaminants relevant to each ingredient.

We test every batch of our finished products to ensure that the product meets all our standards and is safe for consumption. Our testing protocols adhere to and often exceed both US FDA and EU regulations. We use both European Standards and our own, often stricter, Kabrita Standards for heavy metal testing. It's worth noting that while the FDA doesn't currently have a standard for heavy metals in infant formula, we proactively test against European standards, which are among the strictest globally.

Our strict internal limits for contaminants are based on our Corporate Standards and regulatory requirements. For heavy metals (arsenic, lead, mercury, cadmium), we test every batch to ensure that the product meets all our standards, which often exceed
regulatory requirements to ensure the utmost safety for infants. All Kabrita products must meet these internal limits before being released for sale.

In addition to our rigorous testing protocols, we maintain active monitoring programs to enforce our strict limits on contaminants. We're constantly evaluating and improving our processes to minimize contamination risks. Our commitment to transparency is unparalleled in the industry – we provide customers with access to heavy metal testing data for their specific can of formula via our website. In addition to our current rigorous testing and monitoring programs, Kabrita is the first and only goat milk-based formula to achieve Clean Label Project's three strict certifications: Purity Award, Pesticide-Free Certification, and First 1,000 Day Promise Certification. These certifications further validate our commitment to transparency, ensuring parents can trust the safety and quality of our products."