Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. 
Clinical Pharmacist and Master’s student in Clinical Pharmacy with research interests in pharmacovigilance, behavioral interventions in mental health, and AI applications in clinical decision support. Experience includes digital health research with Bloomsbury Health (London) and pharmacovigilance practice in patient support programs. Published work covers drug awareness among healthcare providers, postpartum depression management, and patient safety reporting. What was reviewed?
This review examines the FDA Closer to Zero initiative as articulated on the agency’s program page, with a focus on how FDA Closer to Zero heavy metal limits are generated, staged, and enforced for foods commonly consumed by babies and young children. The page explains the scientific and regulatory basis for reducing arsenic, lead, cadmium, and mercury exposures; defines action levels; and outlines a four-stage, iterative cycle from scientific evaluation through finalization and reassessment. It emphasizes interim reference levels, stakeholder consultation, targeted compliance, and continual improvement while balancing nutritional access and unintended trade-offs, all of which are core for setting FDA Closer to Zero heavy metal limits in an HTMC context.
Who was reviewed?
The principal subjects are vulnerable pediatric consumers—infants and young children—whose smaller bodies and metabolism elevate risk from dietary contaminants. The page also addresses industry manufacturers and processors obligated under the Federal Food, Drug, and Cosmetic Act to implement preventive controls, as well as federal partners (EPA, USDA, CDC, NIH), scientific advisors, and public stakeholders engaged through workshops and webinars. The program prioritizes baby foods and other foods commonly eaten by children and explicitly connects enforcement discretion, action levels, and monitoring to industry performance over defined timeframes.
Most important findings
| Critical point | Details |
|---|---|
| Contaminants and rationale | The initiative targets arsenic, lead, cadmium, and mercury because these elements occur naturally and from human activity, vary geographically, and are taken up by crops and animals; babies and young children are prioritized due to heightened vulnerability. |
| Definition and legal status of “action levels” | Action levels are a regulatory tool indicating contamination levels at which a food may be deemed adulterated under section 402(a)(1); they are not permissive limits but guide enforcement decisions alongside other scientific factors. |
| Four-stage iterative approach | 1) Evaluate science and set interim reference levels; 2) Propose draft action levels; 3) Consult stakeholders on feasibility/achievability; 4) Finalize action levels, then reassess progress and data for potential downward adjustments. |
| Sequencing by element | FDA began with lead due to data availability and will progress to arsenic and cadmium, while mercury is addressed uniquely via seafood exposure and existing fish-consumption advice co-issued with EPA. |
| Timeline and milestones | Lead in juices: draft guidance issued April 2022; target 2025 for finalization. Lead in baby foods: draft January 2023; final guidance issued January 2025. Arsenic and cadmium in baby foods: action levels to be developed and draft guidance issued in 2025, with a goal to finalize one year thereafter. |
| Enforcement without action levels | FDA may take action on unsafe foods even absent an action level; manufacturers must employ preventive controls to significantly minimize or prevent exposure to chemical hazards, including the four metals. |
| Research and monitoring backbone | Activities include toxicology reassessments, predictive toxicology, seafood methylmercury sampling, and method development, plus ongoing publication of analytical results for infant/young child foods (e.g., January 2025 datasets). |
| Public engagement | Over 130 stakeholder engagements since 2021, including webinars on lead action levels and NASEM meetings on seafood and child development. |
| Ongoing work | Continued method validation, toxicological modeling for infant sub-populations, agronomic mitigation research with USDA, and reassessment of risk as levels decline. |
| Relevance to HTMC | The structure provides measurable benchmarks (IRLs, action levels), transparent timelines, and public data streams that can be mapped to certification thresholds, audit protocols, and corrective-action expectations within HTMC. |
Key implications
For primary regulatory impacts, the program operationalizes FDA Closer to Zero heavy metal limits via staged guidance, IRLs, and enforceable adulteration standards. Certification requirements should align with announced action levels, interim reference levels, and preventive controls. Industry applications require validated analytical methods, supplier controls, and reformulation timelines. Research gaps include dose–response for arsenic and cadmium and mercury exposure modeling. Practical recommendations include adopting agronomic and processing mitigations, tracking FDA datasets, and pre-aligning product specs with forthcoming 2025 drafts.
Citation
U.S. Food & Drug Administration. Closer to Zero: Reducing Childhood Exposure to Contaminants from Foods.
