Children's exposures to lead and cadmium: FDA total diet study 2014-16

Overview

This Food Additives & Contaminants: Part A paper by Judith Spungen of the FDA Center for Food Safety and Applied Nutrition uses the FDA Total Diet Study FY2014-FY2016 dataset to estimate children’s dietary exposure to Pb and Cd by age group (6-11 months, 1 year, 2 years, 6 years, and adolescents). The paper is the canonical FDA-authored child-focused exposure assessment for the 2014-2016 TDS window and is the immediate predecessor to the FDA 2025 final guidance for industry on lead in processed food intended for babies and young children. The companion paper Gavelek et al. 2019 extends the same TDS assessment to older children, women of childbearing age, and adults.

Key conclusions

Spungen 2019 reports per-age-group estimated daily Pb and Cd intake from the FDA TDS 2014-2016 sampling, with comparison to the FDA Interim Reference Levels (IRLs) for Pb U.S. Food and Drug Administration's interim reference levels for dietary lead exposure in children and women of childbearing age and to JECFA / EFSA dietary Cd reference values. The paper documents that infant and young-child age groups consume Pb and Cd at higher per-kilogram-body-weight rates than older age groups due to the combination of higher food intake per kilogram body weight and higher concentration in baby-and-toddler-targeted matrices (rice-based cereals, root-vegetable purees, fruit purees). The findings supported the 2020-2025 FDA Closer-to-Zero rulemaking that produced the final action levels for Pb in processed baby food and for iAs in apple juice and infant rice cereal.

Implications

• Certification: Authoritative FDA-internal exposure assessment supporting the case for tight HMTc thresholds on baby-and-toddler product rows. Spungen’s age-stratified intake estimates are the operational FDA evidence base for child-vulnerable-population HMTc thresholds.
• Courses: Standard FDA exposure-assessment reference.

Wiki pages updated on ingest

• Lead
• Cadmium
• FDA 2025 Lead Action Levels for Processed Food Intended for Babies and Young Children

Update history

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