Heavy Metal Index

FDA Closer to Zero — Program Overview

5 min read

FDA Closer to Zero — Program Overview

Closer to Zero is the US Food and Drug Administration’s program to reduce childhood dietary exposure to lead, cadmium, inorganic arsenic, and mercury by setting action levels for foods commonly consumed by babies and young children under two years of age (FDA CTZ Pb 2025). The program launched in April 2021 and is iterative by design: FDA collects occurrence data through its Toxic Elements Program and Total Diet Study, publishes draft action levels for industry comment, finalizes guidance, then uses the finalized levels in enforcement decisions under 21 CFR 109.6(d) and section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (FDA CTZ Pb 2025).

The program frames its thresholds against FDA’s Interim Reference Levels for dietary exposure, which are themselves derived from the underlying public-health reference values each metal has accumulated (for lead, the CDC blood lead reference value of 3.5 µg/dL (CDC BLRV); cadmium, inorganic arsenic, and mercury reference values are pending ingest of the corresponding FDA CTZ documents). Action levels are chosen such that industry achievability, defined as the share of samples in FDA’s combined Toxic Elements Program and targeted-survey data at or below the level, lands in the 90th to 95th percentile range (FDA CTZ Pb 2025). This achievability framing is consistent with the approach the Codex Committee on Contaminants in Foods uses to recommend reductions in maximum levels when samples traded internationally have contaminant concentrations at or below proposed new MLs (Codex CCCF17 2024).

Scope

The program addresses processed foods (packaged foods in jars, pouches, tubs, or boxes) intended for babies and young children less than two years of age. It does not cover raw agricultural commodities, homemade foods, snack foods (arrowroot cookies, puffs, rusks, teething biscuits, grain-based or freeze-dried snacks), infant formula, beverages including toddler drinks, or juices. Juices and grain-based snacks are addressed through separate guidance tracks. The USDA Food Safety Inspection Service is consulted on single-ingredient meats and meat-containing mixtures (FDA CTZ Pb 2025).

Rules established under this program

Finalized action levels ingested to date:

  • fda2025-lead-processed-baby-foods — canonical hub for FDA’s January 2025 final guidance action levels for lead in processed foods intended for babies and young children. Use this hub for product-page regulatory crosswalks and legal/HMTc interpretation of the nonbinding guidance status.
  • fda-ctz-Pb-babyfood-10ppb — 10 ppb lead, for fruits, non-root vegetables, mixtures, yogurts, custards and puddings, and single-ingredient meats. Finalized January 2025.
  • fda-ctz-Pb-rootveg-20ppb — 20 ppb lead, for single-ingredient root vegetables (carrots and sweet potatoes). Finalized January 2025.
  • fda-ctz-Pb-cereal-20ppb — 20 ppb lead, for dry infant cereals. Finalized January 2025.

Cadmium action levels under CTZ are expected in a separate FDA guidance document not yet ingested. Inorganic arsenic action levels under CTZ (including the finalized 100 ppb in infant rice cereal) and mercury levels are also in separate guidance documents pending ingest.

History

The Closer to Zero program was initiated in April 2021 as FDA’s formal framework for reducing childhood dietary exposure to toxic elements (FDA CTZ Pb 2025). FDA’s Interim Reference Level for dietary lead was first established in 2018 at 3 µg/day for children and 12.5 µg/day for women of childbearing age, replacing earlier provisional tolerable total daily intakes developed in the early 1990s. The IRLs were updated in 2022 to 2.2 µg/day for children and 8.8 µg/day for women of childbearing age, tracking a 2021 update to the CDC blood lead reference value (FDA CTZ Pb 2025; CDC BLRV). The Joint FAO/WHO Expert Committee on Food Additives withdrew its provisional tolerable weekly intake for lead in 2011, concluding that no PTWI could be considered health protective (JECFA 72nd 2010); the FDA IRL framework is the current operational reference for US federal action on dietary lead (FDA CTZ Pb 2025).

The first set of finalized lead action levels under the program was issued in January 2025 under docket FDA-2022-D-0278 (FDA CTZ Pb 2025). Additional rules for cadmium, inorganic arsenic, and mercury are issued under the same program but through separate guidance documents.

Reference values underlying the program

For lead, the operative reference is FDA’s 2.2 µg/day IRL for children and 8.8 µg/day IRL for women of childbearing age (FDA CTZ Pb 2025), derived from the CDC blood lead reference value of 3.5 µg/dL and dietary-to-blood-lead conversion factors with a 10x safety factor for conversion variability (CDC BLRV; FDA CTZ Pb 2025). Reference values for cadmium, inorganic arsenic, and mercury under the CTZ framework will be recorded here when the respective guidance documents are ingested.

Comparison to EU, Codex, and state rules

Each per-rule page carries its own jurisdictional comparison for the specific threshold it sets; this section will expand to include the program-level comparative posture relative to EU Regulation 2023/915, Codex Alimentarius contaminant standards, and California Proposition 65 once the relevant ingests are complete.

Sources

  • FDA CTZ Pb 2025 — FDA, 2025. Action Levels for Lead in Processed Food Intended for Babies and Young Children: Guidance for Industry (evidence tier A, US government work).