The FDA’s 2023 draft guidance sets lead limits for baby foods under Closer to Zero, aiming to cut infant lead exposure by 24–27%. The non-binding action levels of 10–20 ppb apply to cereals, fruits, root vegetables, and meats.
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The FDA’s 2023 draft guidance sets lead limits for baby foods under Closer to Zero, aiming to cut infant lead exposure by 24–27%. The non-binding action levels of 10–20 ppb apply to cereals, fruits, root vegetables, and meats.
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In January 2023, the U.S. Food and Drug Administration (FDA) issues draft lead limits in baby food for the industry titled Action Levels for Lead in Food Intended for Babies and Young Children. This guidance proposes specific, measurable action levels for lead contamination in categories of processed baby foods to reduce dietary exposure among children under two years of age. The guidance is part of the FDA’s broader Closer to Zero initiative, which outlines a science-based, phased approach to reducing toxic element exposure—including lead, arsenic, cadmium, and mercury—in food consumed by infants and young children. The guidance establishes provisional thresholds of 10–20 parts per billion (ppb) for lead in various baby food categories and encourages manufacturers to implement mitigation strategies to meet these levels. While non-binding, the FDA considers these action levels “achievable” under best practices and signals its intent to use them as benchmarks in enforcement decisions.
This regulatory guidance is primarily targeted at food manufacturers and processors producing packaged food for infants and toddlers, including purées, cereals, meat-based mixtures, and root vegetables. However, the ultimate population of concern is infants and young children under two years of age—a group recognized as especially vulnerable to the neurodevelopmental effects of lead exposure. The FDA also considers clinicians, toxicologists, food safety experts, and public health policymakers to be important stakeholders, as the guidance informs risk assessments, patient counseling, and future public health interventions. Additionally, the Closer to Zero strategy signals forthcoming changes to action levels for other toxic elements, affecting the broader food industry and clinical nutrition communities.
The draft guidance sets the following proposed action levels for lead:
| Food Category | Lead Action Level (ppb) |
|---|---|
| Fruits, vegetables (excluding single-ingredient root vegetables), mixtures, yogurts, custards/puddings, and single-ingredient meats | 10 ppb |
| Root vegetables (single ingredient) | 20 ppb |
| Dry cereals | 20 ppb |
These action levels are intended to be achievable when the industry implements best practices in sourcing, agriculture, and food processing. The FDA estimates that these limits could reduce lead exposure from food sources by 24–27% among the targeted age group. The agency emphasizes that these levels take into account both the Interim Reference Level (IRL) for lead exposure and the differential environmental uptake of lead among crop types—particularly in root vegetables and grains.
The FDA notes that while it is not possible to eliminate lead entirely from the food supply due to its natural and anthropogenic presence in soil, these action levels reflect the lowest achievable concentrations consistent with current science and agricultural feasibility.
This guidance represents a critical step forward in aligning food production practices with pediatric public health protection, particularly as emerging science links early toxicant exposures to lifelong developmental, cognitive, and metabolic consequences. For food manufacturers, the action levels create a regulatory pressure to adopt stricter sourcing, testing, and mitigation practices. For clinicians, especially pediatricians and integrative medicine practitioners, this underscores the importance of advising parents on dietary diversity and food sourcing to reduce cumulative toxicant exposures during early developmental windows.
From a microbiome perspective, early-life exposure to heavy metals such as lead has been associated with intestinal dysbiosis, barrier dysfunction, immune perturbations, and altered microbial metabolism, potentially establishing a trajectory of chronic inflammation or metabolic dysregulation. Therefore, this guidance supports parallel efforts in microbiome-safe dietary practices during infancy. Finally, this document sets a regulatory precedent for the introduction of future action levels for arsenic, cadmium, and mercury, positioning the FDA’s Closer to Zero initiative as a long-term structural shift in U.S. food safety policy.
U.S. Food and Drug Administration. FDA Announces Action Levels for Lead in Categories of Processed Baby Foods. January 24, 2023. Accessed September 23, 2025.
