Potential Contaminants in
Human Milk and Infant Formula
Page last updated on June 1, 2026
Funder: U.S. Food and Drug Administration (FDA)
Status: Complete
Contract Start: September 2023
Project Description: Infant exposure to environmental contaminants has the potential to interfere with healthy development. Human milk and infant formula are the main foods consumed across infancy and infants develop rapidly, requiring high intakes of foods relative to their body size. Understanding concentrations of potential contaminants in human milk and infant formula and their bioavailability inform estimates of how these foods potentially contribute to overall contaminant exposure from all sources for infants in the U.S.
The FDA commissioned the Evidence Center to conduct a series of systematic reviews of the peer-reviewed literature about U.S. infant exposure to arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyl substances (PFAS) from human milk and infant formula, describe knowledge gaps, and identify types of research studies that could address gaps. This series of systematic reviews evaluated the peer-reviewed literature for specific research questions on:
- Potential concentrations of arsenic, cadmium, lead, mercury, and PFAS in human milk and infant formula.
- Associations between exposures to these contaminants during pregnancy and lactation and human milk concentrations.
- Bioavailability of these contaminants from human milk and infant formula when consumed by infants.
- Concentrations of these contaminants in biological samples from infants living in the U.S. in relation to consumption of human milk and infant formula.
Research Topics
Research Question: What are the concentrations of contaminants in human milk and infant formula in the U.S.?
Approach: Systematic Review
Publication: Assessment of arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyl substances concentrations in human milk and infant formula in the United States: A systematic review. DOI: 10.1016/j.ajcnut.2025.07.039
Background:
- This systematic review describes the concentrations of arsenic, cadmium, lead, mercury, and PFAS in human milk and infant formula from studies from the U.S.
- This systematic review did not assess outcomes associated with exposure to heavy metals and PFAS.
Key Findings:
- 14 studies on human milk and 16 studies on infant formula from the U.S. met the inclusion criteria.
- For both human milk and infant formula, studies for arsenic, cadmium, lead, and mercury had small and unrepresentative samples, and most were published before 2000. Those studies published prior to 2000 were outdated and would not be considered representative of current infant formula supply or maternal exposure to these contaminants.
- The peer-reviewed evidence indicated that specific types of PFAS (perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS)) were detected in human milk samples assessed in U.S. studies, which aligns with findings from other countries.
- For context, no established reference values for PFAS in human milk exist that would allow for comparison to the amounts identified in the peer-reviewed literature.
- Based on evidence from peer-reviewed publications, PFAS were not detected in infant formula products assessed in U.S. studies.
- Though PFAS were not detected in infant formula in the studies included in the systematic review, other possible sources of exposure from at-home formula preparation can occur, for example, through the home water supply, storage containers, feeding bottles, or cleaning products.
Addressing Research Gaps:
- Evidence outside of the peer-reviewed literature was not in the scope of this study, though if available, could provide additional context to evaluate heavy metals and PFAS in infant formula products in the U.S.
- The scope of this systematic review was U.S. studies. The Evidence Center identified evidence from other countries that could be further examined in future systematic reviews to help address these research gaps for the U.S.
- National biomonitoring of environmental contaminant exposure prior to or during pregnancy and lactation (e.g. blood, human milk) and routine infant formula composition analysis and data-sharing in the U.S. would provide data for analysis through new research and directly inform decision-makers who are aiming to mitigate infant exposure and/or effects of potential contaminants in human milk and/or infant formula.
Citation:
Thoerig RC, O’Connor LE, Spill MK, Balalian AA, Trivedi R, Advani SM, Uffelman CN, Bosse T, Foster MJ, Holland KM, Dewey KG, Fisher MM, Galusha AL, Huset CA, MacFarlane AJ. Assessment of arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyl substances concentrations in human milk and infant formula in the United States: a systematic review. Am J Clin Nutr. 2025 Oct;122(4):1006-1026. doi: 10.1016/j.ajcnut.2025.07.039. PMID: 41043870.
Accompanying Editorial:
Domingo JL. Protecting infants from environmental contaminants in milk and formula: addressing assessment gaps and advancing next steps. Am J Clin Nutr. 2025 Oct;122(4):911-912. doi: 10.1016/j.ajcnut.2025.08.009. PMID: 41043875.
Research Question: What is the relationship between exposure to a) contaminants and b) contaminants specifically from foods during pregnancy and lactation and contaminant concentration in human milk?
Approach: Systematic Review
Publication: Arsenic, cadmium, lead, mercury, and PFAS exposure during pregnancy or lactation and respective concentrations in human milk: Systematic review. DOI: 10.1016/j.envres.2025.123433
Graphical Abstract:

Background:
- This systematic review synthesizes the peer-reviewed literature on relationships between arsenic, cadmium, lead, mercury, and PFAS exposure during pregnancy or lactation and respective concentrations in human milk.
- Contaminant exposure was measured as the concentration in biological samples collected during pregnancy or lactation.
Key Findings:
- 46 studies conducted in 25 countries met the inclusion criteria.
- Higher exposure to lead, mercury, and specific PFAS chemicals (PFOA and PFOS) during pregnancy or lactation correlated with higher concentrations of each respective contaminant in human milk. Certainty of evidence was moderate for lead, PFOA, and PFOS, and low for mercury. Evidence for arsenic and cadmium was limited and inconclusive.
- While causality cannot be determined from these correlations, evidence suggests exposure to certain contaminants during pregnancy or lactation may result in contaminant transfer to human milk and subsequent ingestion by the infant.
Addressing Research Gaps:
- Future research may consider alternative and indirect approaches to assess contaminant exposure specifically from food, such as:
- Measuring contaminants in foods reported in diets during pregnancy or lactation and assessing those associations with concentrations in milk. Additionally, to reduce measurement error in self-reported dietary data, prospective research studies that use “-omics” technologies can identify objective markers of food exposures for pregnant and lactating individuals. For example, metabolomics – the study of how cell processes result in various substances – can be used to identify how those substances could be measured in human samples, like blood or urine.
- Standardizing how related data sets are structured and strengthening the linkages between them, such as national food, nutrient, and contaminant datasets. Examples of data sets include dietary data collected from the National Health and Nutrition Examination Survey, nutrient composition, manufacturer data from FoodData Central, and contaminant data from the Total Diet Study.
- Intervention studies targeting reduction of contaminant exposures before or during pregnancy or lactation could potentially reduce concentrations in human milk, subsequently potentially reducing infant exposure to contaminants.
- Studies assessing relationships between exposure to total and speciated forms of contaminants, such as inorganic arsenic and methylmercury and emerging PFAS isomers, during pregnancy or lactation can contribute to a more robust understanding about their respective concentrations in human milk.
Citation:
O’Connor LE, Uffelman CN, Thoerig RC, Balalian AA, Trivedi R, Bosse T, Foster MJ, Holland KM, Dewey KG, Fisher MM, Galusha AL, Huset CA, Spill MK, MacFarlane AJ. Arsenic, Cadmium, Lead, Mercury, and PFAS Exposure During Pregnancy or Lactation and Respective Concentrations in Human Milk: Systematic Review. Environ Res. 2026 Feb:123433. doi: 10.1016/j.envres.2025.123433. PMID: 41314500.
Research Questions:
- What is the bioavailability of contaminants from human milk and infant formula when consumed by the infant?
- What factors impact the bioavailability of contaminants from human milk and infant formula when consumed by the infant?
- What is the relationship between contaminants and the bioavailability of other components in human milk and infant formula?
- What are the observed levels of contaminants in infants in the United States consuming human milk and/or infant formula?
Approach: Systematic Review
Publication: Bioavailability of and US infant exposure to arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyls from human milk and infant formula: Results from a series of systematic reviews. DOI: 10.1016/j.advnut.2026.100628
Background:
- This series of systematic reviews synthesizes the peer-reviewed literature on the observed levels of arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyls in biological samples from infants and the bioavailability of these contaminants from human milk or infant formula when consumed by the infant.
Key Findings:
- 7 articles from 4 studies met inclusion criteria.
- These studies measured concentrations of arsenic, cadmium, lead, and mercury in biological samples from infants in the U.S in relation to their consumption of human milk and/or infant formula. No studies measured PFAS in biological samples from infants in the U.S. in relation to their consumption of human milk and/or infant formula.
- Most evidence was from one cohort or published 30+ years ago and lacked demographic and geographic diversity. Therefore, conclusions could not be made about infants’ exposure to arsenic, cadmium, lead, or mercury from human milk and/or infant formula in the United States.
- No studies reported on the bioavailability of these contaminants from human milk or infant formula when consumed by the infant.
Addressing Research Gaps:
- Conduct biomonitoring in existing national surveillance systems (e.g., the U.S. Centers for Disease Control and Prevention’s NHANES and National Biomonitoring Program) in the U.S. to estimate infant contaminant exposure from all sources accounting for factors such as location, demographics, and socioeconomic status.
- These existing surveillance systems as well as research partnerships with pediatric practices and local health departments could also facilitate sample collection of human milk and infant formula to estimate bioavailability ratios.
- Nationally-representative surveillance studies of mother-infant pairs with maternal dietary data, human milk, and maternal and infant biological samples could inform how contaminants transfer from maternal food exposure to human milk and, finally, from human milk to the infant. Additional sample collection of home-prepared infant formula samples could inform how contaminants transfer from infant formula to the infant.
- Bioavailability experiments for infant populations are unlikely to be conducted because of the ethical considerations of conducting experiments on infants and practical challenges such as the amount of time and repeated measures that would be needed from the infant. Observational evidence may offer useful insight if the results can be corroborated by mechanistic study designs, such as animal or in vitro models.
- Systematic reviews to synthesize findings from animal or in vitro digestion models that indirectly assess bioavailability of contaminants from human milk or infant formula are needed.
Citation:
O’Connor LE, Thoerig RC, Leta CN, Balalian AA, Advani SM, Bosse T, Foster MJ, Holland KM, Dewey KG, Fisher MM, Galusha AL, Huset CA, MacFarlane AJ, Spill MK. Bioavailability of and US infant exposure to arsenic, cadmium, lead, mercury, and per- and polyfluoroalkyls from human milk and infant formula: Results from a series of systematic reviews. Adv Nutr. 2026 Apr:100628. doi: 10.1016/j.advnut.2026.100628. PMID: 41966405.




