FDA 2024 - Toxic Elements Compliance Results For Baby And Young Child Foods

Summary

This FDA compliance-program table is an A-tier government dataset for arsenic, lead, cadmium, and mercury in foods intended for babies and young children from FY2009 through FY2024. It has been ingested as sample-level Category 1 evidence where the FDA baby-food category and product name can be mapped to locked HMTc product rows.

This source does not cover infant formula, fruit juice, fish-containing baby foods, or meat/poultry purees. It also does not report inorganic arsenic; the arsenic table is ingested as source-reported arsenic / total arsenic (tAs) until speciation evidence says otherwise.

Extracted Files

  • data/evidence/category1_fda_baby_food_compliance_samples.csv: 1,944 parsed sample/analyte rows.
  • data/evidence/category1_fda_baby_food_compliance_summary.csv: 39 row/product/analyte summary records.
  • data/evidence/values.jsonl: 39 machine-extracted value records with prefix category1-fda-baby-food-compliance-.
  • data/evidence/sources.jsonl: source metadata record for this PDF.

Source Tables

  • Arsenic table: 575 samples from FY2009-FY2024.
  • Lead table: 598 samples from FY2009-FY2024.
  • Cadmium table: 576 samples from FY2009-FY2024.
  • Mercury table: 195 samples from FY2009-FY2024.

FDA reports that arsenic, lead, cadmium, and most mercury analyses were conducted by ICP-MS. Three early mercury rows were reported by X-ray fluorescence as NDb under a 5 ppm LOQ.

Category 1 Mapping

Rows were mapped conservatively:

Summary Highlights

The summary values below are lower-bound nearest-rank percentiles in ppb with <LOD and NDb treated as 0. They are machine-extracted and require review before standards use.

Category 1 scopeEvidence FitnessKey lower-bound distribution signals
baby-cereals-dry-rice-basedEF-2tAs n=253, p50 115, p90 135, max 348; Pb n=256, p90 19.2, max 32; Cd n=252, p90 22, max 40.5; tHg n=64, p90 2.1, max 4.
baby-cereals-dry-non-riceEF-2 / EF-3tAs n=25, p90 37.8, max 54.8; Pb n=25, p90 8, max 9.9; Cd n=25, p90 27.4, max 62.9; tHg n=9, all lower-bound 0.
fruit-pureesEF-2tAs n=39, p90 5.2, max 8.7; Pb n=44, p90 2.4, max 8; Cd n=39, p90 2.2, max 4; tHg n=14, p90 0.5, max 0.6.
non-root-vegetable-pureesEF-2tAs n=20, p90 1, max 11; Pb n=29, p90 2, max 7.6; Cd n=22, p90 12.8, max 23.1; tHg n=13, p90 0, max 0.4.
root-vegetable-pureesEF-2tAs n=54, p90 6.4, max 10.3; Pb n=59, p90 15.9, max 27.3; Cd n=54, p90 31.5, max 42; tHg n=25, p90 0.3, max 1.1.
mixed-meals-non-riceEF-2tAs n=77, p90 5.6, max 13.6; Pb n=78, p90 6.8, max 13; Cd n=77, p90 5.2, max 44.4; tHg n=36, p90 0, max 0.4.
mixed-meals-rice-containingEF-3Small rice-named mixture subset: tAs n=9, p90/max 28.3; Pb n=9, p90/max 11.6; Cd n=9, p90/max 7; tHg n=3, p90/max 0.3.
teething-and-snacks-rice-basedEF-3Explicit rice-named snack subset: tAs n=2, p50 96.3, p90/max 171; Pb n=2, p90/max 6.5; Cd n=2, p90/max 3.5.
Broad FDA grain-based snacks, rice status not isolatedEF-4Context only: tAs n=91, p50 61, p90 224, p95 383, max 561; Pb n=91, p90 15, max 23.7; Cd n=91, p90 27, max 41; tHg n=28, p90 2.5, max 3.3.

LOD/LOQ Handling

The PDF gives analyte-level ranges for LOQ and LOD, not per-row usable censoring thresholds in the table text. The machine extraction therefore preserves the source-reported text (<LOD, NDb, or numeric value) and computes lower-bound distributions by substituting 0 for <LOD and NDb.

  • Arsenic LOQs ranged from 0.7 to 103 ppb; LODs ranged from 0.2 to 34.3 ppb.
  • Lead LOQs ranged from 0.2 to 100 ppb; LODs ranged from 0.1 to 33.3 ppb.
  • Cadmium LOQs ranged from 0.1 to 63 ppb; LODs ranged from 0.03 to 21 ppb.
  • Mercury LOQs ranged from 0.8 to 38.4 ppb; LODs ranged from 0.1 to 12.8 ppb for most mercury analyses.

Evidence Fitness

Direct row-fit subsets with at least 10 reconstructable sample rows are EF-2 pending review. Small rice-named subsets are EF-3. Broad grain-based snacks without isolated rice status and yogurt/custard/pudding rows are EF-4 context only.

These values do not publish or justify HMTc thresholds. They are occurrence evidence candidates for internal review and product-page synthesis under the shared evidence contract.

Limitations

  • Compliance-program sampling is not a market-share-weighted Total Diet Study.
  • As is retained as tAs / source-reported arsenic, not inorganic arsenic.
  • Hg is retained as total mercury, not methylmercury.
  • Grain-based snack product names are not enough to infer non-rice status.
  • The source does not cover infant formula, fruit juice, fish-containing baby foods, or meat/poultry purees.

Implications

Certification: priority A-tier occurrence dataset for Category 1 review, especially rice-based dry cereals, root-vegetable purees, and snack context.

Courses: strong example for teaching surveillance sampling, censoring, and why source analyte/speciation labels must travel with values.

App: useful for retrieval and row-specific evidence summaries after reviewed promotion; not sufficient by itself for brand ranking or ingredient-level inference.

Microbiome: no direct microbiome endpoint.

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