FDA Closer to Zero — 10 ppb Lead Action Level for Processed Baby Food (Fruits, Non-Root Vegetables, Mixtures, Yogurts, Custards/Puddings, Single-Ingredient Meats)
Under the Closer to Zero program, the US Food and Drug Administration has established a 10 ppb action level for lead in a consolidated category of processed foods intended for babies and young children less than two years of age (FDA CTZ Pb 2025). The category covers fruits (single-ingredient or combination), vegetables excluding single-ingredient root vegetables (single-ingredient or combination), mixtures including grain-based and meat-based mixtures, yogurts, custards and puddings, and single-ingredient meats. Root vegetables and dry infant cereals are addressed by separate action levels under the same program, because the occurrence data supported neither a tighter uniform level across all matrices nor equivalent achievability at 10 ppb for those two categories (FDA CTZ Pb 2025).
Scope
The action level applies to packaged foods (in jars, pouches, tubs, or boxes) that are represented or purported to be for babies and young children less than two years old. This includes ready-to-eat foods such as purees and semi-prepared foods. The guidance does not apply to raw agricultural commodities, homemade foods prepared from fruit purees or other ingredients, snack foods for this age group (including arrowroot cookies, puffs, rusks, teething biscuits, and grain-based or freeze-dried snacks), infant formula, beverages including toddler drinks, or juices, which are addressed in a separate draft guidance (FDA CTZ Pb 2025).
Exact limit and units
Limit parameters from FDA CTZ Pb 2025:
| Parameter | Value |
|---|---|
| Action level | 10 ppb |
| Unit definition | Parts per billion equals micrograms per kilogram (µg/kg) |
| Basis | Whole sample, as sold |
| Analytical method | Inductively coupled plasma mass spectrometry (ICP-MS) |
| Sample composition | 12 randomly selected subsamples from a single lot, per Toxic Elements Program protocol |
Enforcement posture
The action level is non-binding guidance. Consistent with 21 CFR 109.6(d), it defines a lead concentration at which FDA may regard a food as adulterated within the meaning of section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act. When considering whether to bring an enforcement action in a particular case, FDA states it will consider the action level alongside other factors including the agency’s confidence in a measured analytical value. The guidance does not establish a legally enforceable responsibility on any person and is not binding on FDA or the public; alternative approaches that satisfy applicable statutes and regulations are permitted (FDA CTZ Pb 2025).
The USDA Food Safety Inspection Service was consulted on the inclusion of single-ingredient meats and meat-containing mixtures, and supports the action level; FSIS intends to consider this level alongside other factors when determining appropriate FSIS actions (FDA CTZ Pb 2025).
Achievability assessment
Achievability is defined by FDA as the percentage of samples in the combined Toxic Elements Program and FDA survey dataset (FY 2009-2024, n = 1,452 samples) that fall at or below the action level. For this matrix category, 97 percent of samples are at or below 10 ppb (FDA CTZ Pb 2025). The occurrence statistics underlying this determination, by matrix component:
| Matrix component | n | Mean ± SD (ppb) | 90th percentile (ppb) | 95th percentile (ppb) |
|---|---|---|---|---|
| Fruits (single-ingredient or combination) | 215 | 1.2 ± 1.4 | 2.4 | 4.1 |
| Mixtures | 551 | 2.7 ± 4.0 | 6.0 | 9.1 |
| Yogurts, custards, puddings, single-ingredient meats | 55 | 1.1 ± 1.0 | 2.6 | 2.9 |
| Vegetables excluding single-ingredient root vegetables | 130 | 2.1 ± 2.6 | 4.2 | 7.0 |
Occurrence data drawn from FDA’s Toxic Elements Program (FY 2009-2024), three targeted FDA surveys (FY 2013-14, FY 2021, FY 2023), with Total Diet Study data (FY 2014-2020) used as a complementary analysis (FDA CTZ Pb 2025).
Exposure reduction
FDA estimated dietary lead exposure for babies and young children 0 to 23 months at the 90th percentile consumption level, using What We Eat in America (WWEIA) intake data from NHANES 2003-2018 and occurrence data before and after removing samples with lead concentrations greater than the action level (FDA CTZ Pb 2025):
| Scenario | Mean Pb concentration (ppb) | 90th percentile dietary exposure (µg/day) |
|---|---|---|
| Status quo (no action level) | 2.2 | 0.78 |
| With 10 ppb action level | 1.7 | 0.61 |
Exposure reduction: 19 percent (FDA CTZ Pb 2025). The 90th percentile 2-day average consumption by eaters only, 0 to 23 months, for this combined category is 354 g/day (FDA CTZ Pb 2025).
Reference value context
The action level was selected to ensure dietary exposure from the covered foods does not cause consumers to exceed FDA’s Interim Reference Level for dietary lead. The IRL is 2.2 µg/day for children, updated in 2022 from an earlier 2018 value of 3 µg/day (FDA CTZ Pb 2025). It is derived from the CDC blood lead reference value of 3.5 µg/dL (CDC BLRV) and dietary conversion factors, with an additional 10x safety factor to account for variability in the conversion of dietary lead to blood lead (FDA CTZ Pb 2025). FDA notes that no safe level of lead exposure has been identified for children’s health; the IRL serves as a benchmark for evaluating the potential for adverse effects of dietary lead exposure, including neurodevelopmental effects (FDA CTZ Pb 2025).
History
The Closer to Zero program was initiated in April 2021. FDA’s IRLs for dietary lead were first established in 2018 (3 µg/day for children, 12.5 µg/day for women of childbearing age) and updated in 2022 (2.2 µg/day and 8.8 µg/day respectively) (FDA CTZ Pb 2025). This final guidance was issued in January 2025; an earlier draft was issued under the same docket, FDA-2022-D-0278 (FDA CTZ Pb 2025). 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); since then, FDA and other authorities have operated against the IRL or analogous benchmarks rather than a single international lead reference value.
Comparison to EU, Codex, and state rules
For the Category 1 lead comparison layer, see lead-benchmark-context. EU Regulation 2023/915 generally maps covered baby food and processed cereal-based food for infants and young children to 20 ppb lead as placed on the market, while California Proposition 65 operates as a daily-exposure screen rather than a food-category ppb limit. The gap between a federal non-binding action level under 21 CFR 109.6(d), an EU enforceable maximum level, and a Prop 65 exposure threshold is a durable structural difference to preserve in the synthesis.
Parent program
Sources
- FDA CTZ Pb 2025 (evidence tier A, US government work)