Systematic Reviews of Potential Contaminants in Human Milk and Infant Formula

Reducing child exposure to contaminants

Funded by the U.S. Food and Drug Administration

The U.S. Food and Drug Administration’s Closer to Zero initiative aims to reduce child exposure to specific environmental contaminants found in food that are prioritized based on the relative toxicity, prevalence in the food supply, and the relative contribution of food as a source of exposure to these contaminants. Young children are prioritized because of the impact exposure to these contaminants can have on development, particularly neurodevelopment.

Systematic Review of Composition, Variability, and Bioavailability of Potential Contaminants in Human Milk and Infant Formula

Role of the Evidence Center

The Agriculture, Food, and Nutrition Evidence Center (Evidence Center) conducts research to inform policy makers but does not make recommendations for applying the findings to policy, programs, or regulations. The Evidence Center was commissioned to conduct a series of systematic reviews of the peer-reviewed literature related to contaminants in human milk and infant formula. The systematic reviews evaluated the peer-reviewed literature on the potential:

  • concentrations in human milk and infant formula;  
  • exposures during pregnancy and lactation on human milk concentrations; and  
  • concentrations in infant biospecimens and bioavailability. 

In addition, knowledge gaps are articulated and types of research studies capable of addressing gaps are described.  

Systematic Reviews

This project will result in a suite of systematic reviews. The first in the suite is below.

A suite of systematic reviews on heavy metals and PFAS in human milk and infant formula. 

Now available: Concentrations in human milk and infant formula

Additional publications are anticipated on exposures during pregnancy and lactation on human milk concentrations and concentrations in infant biospecimens and bioavailability. 

Assessment of arsenic, cadmium, lead, mercury, and PFAS concentrations in human milk and infant formula in the US: A systematic review

American Journal of Clinical Nutrition (AJCN)

Accompanying editorial by Jose L. Domingo: Protecting infants from environmental contaminants in milk and formula: addressing assessment gaps and advancing next steps

Key Findings

  • Fourteen studies on human milk and 16 studies on infant formula from the U.S. met the inclusion criteria.  
  • For studies on heavy metal concentrations, for both human milk and infant formula, only small and unrepresentative samples were available, and most were published before 2000. We mapped available data from other countries that could be systematically reviewed to potentially help address these research gaps. 
  • For studies on PFAS concentrations, specific types of PFAS (PFOA and PFOS) were detected in human milk samples, which aligns with findings from other countries. PFAS were not detected in infant formula products tested in the U.S. studies, which may reflect attention to ingredients sourcing by manufacturers for this highly regulated product.  
  • National biomonitoring of human milk and routine data collected on infant formula composition could help fill these knowledge gaps in the U.S.   
  • Surveillance of environmental contaminant exposures during pregnancy and lactation in the U.S. would advance understanding of how best to limit transfer of potential contaminants into human milk to mitigate infant exposures.