Provisional scaffold. This page was created automatically on 2026-05-19 so that an ingested source could route to it. The HMTc taxonomy row, clean/contaminated pairing, primary metals of concern, and detailed scope have not yet been locked. Content below is minimal until a synthesis pass or taxonomy review consolidates the literature for this product class.
Reason: heal-gaps: routing_unresolved entry from source su2020-infant-formula-china-toxic-elements declared product/infant-formula-powder-soy, no close-slug match
Triggering source: Content and Dietary Exposure Assessment of Toxic Elements in Infant Formulas from the Chinese Market
Literature scope
Reported measurements from source notes are below. Sections that are still empty have not been synthesized into a population estimate. HMTc certification thresholds for products in this row continue to be developed under the certification program at heavymetalcertified.com, not on this public page.
Who this page is for
This provisional page is for readers separating soy-based powdered formula from dairy powder and ready-to-feed formula. The current routed evidence is useful for broad powder-basis toxic-element context and Mn formulation context, but row fit remains provisional because one major source covers infant formulas broadly rather than only soy formula.
Evidence summary
Evidence summary
The table below summarizes what the peer-reviewed and government literature cited on this page reports for heavy-metal concentrations in powder infant formula. Values are pulled directly from cited sources without re-aggregation. This page publishes literature evidence only, not certification thresholds.
Methodology rules for speciation, basis preservation, non-detect handling, and source pooling are stated in the Methodology section above and apply to every row below.
| Analyte | Subcategory | Reported concentration range | Detection rate | Applicable regulatory cap | Sources | Confidence | Basis |
|---|---|---|---|---|---|---|---|
| lead (Pb) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| cadmium (Cd) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| inorganic arsenic (iAs) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| total arsenic (tAs) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| methylmercury (MeHg) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| total mercury (tHg) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| nickel (Ni) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| aluminum (Al) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| hexavalent chromium (Cr-VI) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
| tin (Sn) | powder (no contributing evidence loaded) | No concentration data loaded for this analyte | Sample-level detection rate not reported | No applicable cap loaded | 0 | data gap | Basis not reported |
Source Evidence Inventory
Content and Dietary Exposure Assessment of Toxic Elements in Infant Formulas from the Chinese Market routes here as a China-market infant-formula powder survey reporting lead (Pb), cadmium (Cd), total arsenic (As), and total chromium (Cr) across 93 products stratified by feeding stage. The source reports low means relative to its cited regulatory comparators, but it does not speciate arsenic or chromium and does not by itself isolate a soy-only distribution.
Manganese Levels in Infant Formula and Young Child Nutritional Beverages in the United States and France contributes Mn context for formula powders and related child nutrition beverages in US and French markets. Its role on this page is formulation and product-form context, not a complete contaminant screen.
Supporting evidence and scope
Pending: regenerated by tools/evidence/apply-product-broad-context.mjs once broad-scope sources route to this page.
Federal/Regulatory Limits vs Field Findings
Pending: regenerated by tools/apply-product-crosswalk-sections.mjs once applicable_regulations are identified and field-finding evidence is pooled.
Controls and mitigation
The current evidence supports soy-specific finished-powder testing rather than extrapolating from all-formula averages. QA panels should preserve total As and total Cr labels while adding inorganic arsenic and Cr(VI) only when methods actually speciate them. Mn should be reviewed as both an ingredient/fortification contribution and a finished-product result.
Reported measurements
The FDA special-survey note reports soy-based infant formula powder as prepared for feeding, in ppb. The lower-bound summary sets results below the limit of detection to 0. It is not a dry-powder-as-sold figure. Total arsenic, n=38, detected 38: 50th percentile 1.1 ppb, 90th percentile 1.5 ppb, 95th percentile 1.9 ppb, maximum 2.2 ppb. The arsenic characterization table prints the same soy-powder percentiles. Lead, n=38, detected 38: 50th percentile 0.3 ppb, 90th percentile 0.5 ppb, 95th percentile 0.5 ppb, maximum 1.1 ppb. Cadmium, n=38, detected 38: 50th percentile 0.8 ppb, 90th percentile 1.2 ppb, 95th percentile 1.3 ppb, maximum 1.4 ppb. Total mercury, n=38, detected 4: 50th percentile 0 ppb, 90th percentile 0.08 ppb, 95th percentile 0.2 ppb, maximum 0.3 ppb. Arsenic in this note is total arsenic, not inorganic arsenic. Mercury in this note is total mercury, not methylmercury. Inorganic arsenic was not measured. Methylmercury was not measured. Cow-milk powder, ready-to-feed, concentrated-liquid, and amino-acid powder rows in the same note are not soy powder and are not repeated here. Analytical Results for Toxic Elements in Infant Formula, FY2023-FY2025 Special Survey
Cantoral and colleagues report soy infant formula lead as 0.035 mg/kg (standard deviation 0.008) for the note’s Brand 2 sample, and the note’s Brand 1 soy infant formula as below the limit of quantification, with no numeric concentration printed for that sample. This page repeats both and does not choose one. The study limit of quantification is 0.0025 mg/kg. The note’s product list assigns the row to soy powder, and the result line says soy infant formula. This page repeats that result line and does not add a powder or liquid word the line does not use. The note’s cited FAO/WHO maximum of 0.01 mg/kg for infant formula is the authors’ comparator. Whole-milk infant formula rows in the same note are not soy formula and are not repeated here. Lead Levels in the Most Consumed Mexican Foods: First Monitoring Effort
Soy infant formula powder and early-life studies that did not name a lot
Soy infant formula powder is an early diet with its own protein source. The studies below did not test a soy powder lot. Hexavalent chromium gavage is omitted so total chromium in the powder is not paired with a dichromate dose. Colonization evidence that compares formula feeding with breastfeeding does not print a soy-powder concentration.
Sitarik et al. 2020 measured tooth lead and stool microbiota at 1 month and 6 months in 146 maternal-child pairs in the Detroit-area WHEALS cohort. In utero tooth lead was associated with fungal community composition at 1 month. Lead was not associated with overall bacterial community structure. Taxon-level bacterial shifts were higher Collinsella at 1 month, higher Bilophila at 6 months, and lower Bacteroides. The direction is lead exposure toward microbiota composition. Tooth lead is a biomarker, not a concentration in this product.
Eggers et al. 2023, per WikiBiome source summary, DOI 10.3389/fmicb.2023.1193919, followed 123 children in the Mexico City PROGRESS cohort. Maternal blood lead means were 33.6 µg/L in the second trimester and 34.9 µg/L in the third. Stool metagenomes at ages 9 to 11 showed lower Bacteroides caccae with lead exposure. Weighted quantile sum regression gave a negative overall mixture effect (beta = -0.17) in both trimesters. The direction is prenatal lead toward the childhood gut microbiota. The summary does not support a lead concentration in food.
Liu et al. 2023, per WikiBiome source summary, DOI 10.3389/fvets.2023.1219729, exposed Sprague-Dawley rats to cadmium chloride for 30 days. The note states lower intestinal ZO-1, higher TNF-alpha and IL-6 in intestine and blood, and Muribaculaceae in blood that was absent in the unexposed group. The note does not print the dose or the number of rats. The direction is cadmium toward gut and blood microbiota and barrier markers.
Zhang et al. 2015, per WikiBiome source summary, DOI 10.1021/acs.chemrestox.5b00237, gave mice 10 mg/L cadmium in drinking water for 10 weeks. Firmicutes and gamma-proteobacteria decreased in feces after 4 weeks, and Firmicutes decreased in cecum contents after 10 weeks. The direction is cadmium toward gut microbiota, alongside hepatic energy-metabolism changes in the same animals. The summary does not name a food.
Hoen et al. 2018 related urinary total arsenic at 6 weeks to stool microbiota in 204 infants in the New Hampshire Birth Cohort Study. Urinary total arsenic had median 0.4 µg/L and mean 0.63 µg/L. Feeding-stratified means were 0.5 µg/L in exclusively breastfed infants, 0.9 µg/L in mixed-fed infants, and 1.2 µg/L in formula-only infants. Overall composition was marginally associated with natural-log urinary arsenic after adjustment for feeding and urine specific gravity (pseudo-F 1.85, p = 0.05). The clearest association was in formula-fed males (n = 33, pseudo-F 2.30, p = 0.008). Formula-fed females (n = 23) did not show that association. The direction is an early-life arsenic biomarker toward infant gut microbiota. Urinary arsenic is not a concentration in this product.
Soto-Ocana et al. 2024 report that formula-fed infants had higher gastrointestinal metal levels than breastfed infants, and that the higher-metal pattern tracked with a different early community. In culture, Lactobacillus was highly susceptible to zinc and manganese restriction, while Enterococcus, Enterobacteriaceae, and Bacteroides were resistant. The direction is metal availability toward which taxa colonize. The source page does not print a metal concentration in formula.
Dahan et al. 2018, per WikiBiome source summary, DOI 10.3389/fmicb.2018.01323, exposed larval zebrafish to 10, 50, and 100 ppb arsenic in water for 20 days. Arsenic exposure explained 54.7 percent of the variance in overall bacterial composition. The class 1 integron relative copy number at the highest concentration was 9 times the control value. The note does not state whether the dissolved arsenic was inorganic or total, and it does not give the number of larvae. The direction is arsenic in water toward the larval microbiome. The model is not a human gut, and the summary does not support an arsenic concentration in food.
Giambo et al. 2021, per WikiBiome source summary, DOI 10.3892/wasj.2021.90, screened 600 articles and included 97. For mercury, the note states that methylation and demethylation are a core process in methylmercury metabolism and that microbiota changes have been linked to neurodevelopmental effects in rat offspring. The note does not assign a new sample size to that mercury summary. The direction summarized is microbiota toward methylmercury metabolism, and exposure toward microbiota in the offspring studies. The review does not test this product.
Study table
| Study | Model | Metal and dose | Main finding | Limitation |
|---|---|---|---|---|
| Sitarik et al. 2020 | Human infants; tooth lead and stool; n = 146 | Lead; tooth biomarker, not a food dose | Fungal composition at 1 month shifted; overall bacterial structure did not | Not this product |
| Eggers et al. 2023 | Human children, ages 9 to 11; n = 123 | Maternal blood lead; means 33.6 and 34.9 µg/L | Lower Bacteroides caccae; mixture beta = -0.17 | Per WikiBiome source summary; not this product |
| Liu et al. 2023 | Rats; cadmium chloride; 30 days | Cadmium; dose not printed in the source note | Lower intestinal ZO-1; Muribaculaceae appeared in blood | Per WikiBiome source summary; n and dose unstated |
| Zhang et al. 2015 | Mice; drinking water; 10 weeks | Cadmium; 10 mg/L | Lower fecal Firmicutes and gamma-proteobacteria by 4 weeks | Per WikiBiome source summary; not this product |
| Hoen et al. 2018 | Human infants at 6 weeks; n = 204 | Urinary total arsenic; mean 0.63 µg/L | Composition associated with urinary arsenic; strongest in formula-fed males (n = 33) | Biomarker study; not a lot concentration |
| Soto-Ocana et al. 2024 | Human infants and bacterial culture | Zinc and manganese availability; formula versus breast milk; concentrations not printed | Higher gut metals in formula-fed infants tracked with community differences; Lactobacillus was metal-restriction sensitive | Not a named-lot assay |
| Dahan et al. 2018 | Larval zebrafish; water; 20 days | Arsenic; 10, 50, and 100 ppb; species not stated | 54.7 percent of composition variance; class 1 integron 9 times controls at the high dose | Per WikiBiome source summary; not a human gut and not this product |
| Giambo et al. 2021 | Review; 97 of 600 articles | Mercury; no new dose | Methylation and demethylation described as core to methylmercury metabolism; offspring microbiota changes noted | Per WikiBiome source summary; review, not this product |
What remains uncertain
Hoen and colleagues did not split soy formula from other formula. Soto-Ocana and colleagues do not print a metal concentration. Dahan and colleagues used larval zebrafish. Liu and colleagues do not print the cadmium dose. The mercury review does not speciate formula mercury.
How standards math uses this page
This page reports what the peer-reviewed and government literature says about heavy-metal concentrations in this product category; it publishes no certification thresholds of its own. Certification criteria are set separately under the Heavy Metal Tested & Certified program at heavymetalcertified.com, which reads this page as its literature baseline. The two are kept apart by design, so this page remains an independent record of the evidence rather than a justification for any threshold.
Historical recalls and enforcement
No soy powdered formula recall or enforcement source is currently routed to this provisional page. Future entries should summarize public regulatory records without turning the section into a brand-comparison surface.
Methodology
Powdered soy formula evidence stays powder-basis unless a source reports prepared formula directly. Broad infant-formula surveys can stay visible here as context, but standards use requires soy-specific row fit. Total arsenic and total chromium must remain labeled as total arsenic (tAs) and total Cr; they do not substitute for inorganic arsenic or Cr(VI).
References
Works cited in this page’s text, in first-appearance order. See Sources for this page’s source inventory. Each title links to a source record with bibliographic details, reported findings, and document provenance.
- Content and Dietary Exposure Assessment of Toxic Elements in Infant Formulas from the Chinese MarketPeer-reviewed
- Analytical Results for Toxic Elements in Infant Formula, FY2023-FY2025 Special SurveyDataset
- Lead Levels in the Most Consumed Mexican Foods: First Monitoring EffortPeer-reviewed
- Fetal and early postnatal lead exposure measured in teeth associates with infant gut microbiotaPeer-reviewed
- Prenatal lead exposure is negatively associated with the gut microbiome in childhoodPeer-reviewed
- Environmental cadmium exposure alters the internal microbiota and metabolome of Sprague-Dawley ratsPeer-reviewed
- Subchronic Exposure of Mice to Cadmium Perturbs Their Hepatic Energy Metabolism and Gut MicrobiomePeer-reviewed
- Sex-specific associations of infants’ gut microbiome with arsenic exposurePeer-reviewed
- Metal availability shapes early life microbial ecology and community successionPeer-reviewed
- Exposure to arsenic alters the microbiome of larval zebrafishPeer-reviewed
- Influence of toxic metal exposure on the gut microbiotaPeer-reviewed
- Manganese Levels in Infant Formula and Young Child Nutritional Beverages in the United States and FrancePeer-reviewed
Sources
Source records associated with this topic. Inclusion does not establish that every finding applies to this product or ingredient. References above identify works cited in the text.
| # | Citation | Year | Type | Used on this page for |
|---|---|---|---|---|
| 1 | Editor 2019. Manganese Levels in Infant Formula and Young Child Nutritional Beverages in the United States and France, Unknown | 2019 | Journal article | US/FR Mn occurrence in Commercial infant formulas and nutritional beverages marketed in the United States and France (n=Unknown) |
Update history
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