{
  "slug": "lactoferrin",
  "name": "Lactoferrin (bovine bLF · recombinant rhLF)",
  "alternate_names": [
    "bLF (bovine lactoferrin)",
    "rhLF (recombinant human lactoferrin)",
    "Lactoferricin (derived peptide)"
  ],
  "mechanism": [
    "Iron sequestration broad-spectrum bacteriostasis (binds 2 Fe3+ per molecule, ~300x transferrin affinity, depriving pathogens of iron)",
    "Direct LPS / Lipid A binding and endotoxin neutralization",
    "HSPG binding blocking initial viral adhesion (in vitro)",
    "NF-kB (p65/p50) pathway inhibition, downregulating TNF-a / IL-6 / IL-8",
    "Immune-cell modulation (NK-cell activity, T-cell proliferation, phagocyte activation)",
    "Gut-microbiota modulation (selective Bifidobacterium growth promotion) and tight-junction (ZO-1, occludin) barrier support",
    "Receptor-mediated (LRP1 / TfR) enteral iron transcytosis supporting iron uptake",
    "Osteoblast differentiation promotion / osteoclast inhibition (preliminary)"
  ],
  "target": [
    "Fe3+ ion",
    "LPS / Lipid A",
    "HSPG (viral binding)",
    "NF-kB",
    "TfR / LRP1 receptors",
    "Bifidobacterium spp.",
    "Osteoblast"
  ],
  "use_case": [
    "immune-function and respiratory-tract-infection markers (research context)",
    "dietary iron absorption / serum-ferritin support (pregnancy, infants — research context)",
    "gut health / intestinal-barrier and microbiota balance",
    "skin / acne-prone skin oral-adjunct markers (research context)",
    "oral microbiota / gum-health maintenance (emerging, weak)",
    "preterm-infant enteral nutrition (clinical setting only)"
  ],
  "body_system": [
    "IMMUNE",
    "GUT",
    "BLOOD",
    "SKIN",
    "ORAL",
    "MUSCULO",
    "VISION",
    "MITO",
    "CELL"
  ],
  "evidence_tier": "S",
  "evidence_anchor_pmid_count": 436,
  "evidence_breakdown": {
    "meta_sr": 30,
    "human_rct": 101,
    "total_indexed": 436
  },
  "dosage_range": "100-600 mg/day bLF in human studies (immune/microbiota); 100-250 mg/day for iron-status outcomes (pregnancy/infant trials); 200 mg/day x 8-12 weeks in the acne RCT; EFSA assessed no safety concern up to 1000 mg/day adult supplement. Educational reference only — acid/heat-sensitive protein, enteric coating / microencapsulation used to preserve activity.",
  "safety_notes": "EFSA found no safety concern for bLF up to 1000 mg/day (adult) and 100 mg/100 kcal (infant formula); long-term RCTs at 200-600 mg/day reported no serious adverse events; occasional mild bloating/loose stools. IMPORTANT: bovine lactoferrin may contain residual milk-protein allergens (notably beta-lactoglobulin) — caution in cow's-milk-protein-allergic individuals. rhLF (precision-fermented) theoretically avoids bovine allergens. rhLF/recombinant variants are regulatorily lagging (no EU Novel Food / no CN approval) and their human evidence is sparse; bLF clinical data must not be attributed to rhLF products. Pregnancy/lactation/infant use is documented in trials but a clinical/educational context only — not self-medication guidance.",
  "regulatory": {
    "fda": "GRAS — bovine lactoferrin (Morinaga GRN 000077; multiple GRAS notices incl. GRN 130/423/464/465/669). Lawful as a dietary-supplement ingredient under DSHEA; structure/function claims only (FDA disclaimer required). rhLF: some firms hold FDA No Objection Letter / self-affirmed GRAS (Helaina Effera 2023; TurtleTree LF+ 2024; precision-fermented rhLF GRN 1284 no questions). 'GRAS' is not 'FDA approval'.",
    "efsa": "bLF authorized as a Novel Food — Commission Implementing Decisions 2012/725/EU (Morinaga) + 2012/727/EU (FrieslandCampina), Reg (EU) 2017/2470 Union List. EFSA 2012 safety opinion passed (≤1000 mg/day adult). Max concentrations set by product category (infant formula 100 mg/100g; sports drinks 300 mg/100g; etc.). NO authorized health claim under Reg 432/2012. Precision-fermented rhLF: NOT authorized as a Novel Food.",
    "anvisa": "bLF authorized — IN 28/2018 authorized constituent (bovine lactoferrin); permitted in infant formula (RDC 43/2011) and dietary supplements (RDC 243/2018). Colostrum products permitted (≥19 yrs, ≤4 g/day). No disease-reduction claims. rhLF: assessed as a novel constituent, no approval to date."
  },
  "regulatory_markets": [
    {
      "market": "US",
      "status": "GRAS",
      "tier": "permitted"
    },
    {
      "market": "EU",
      "status": "Authorized claim",
      "tier": "authorized"
    },
    {
      "market": "CN",
      "status": "Supplement (CBEC)",
      "tier": "permitted"
    },
    {
      "market": "BR",
      "status": "ANVISA supplement",
      "tier": "permitted"
    }
  ],
  "ingredient_hub_url": "https://asxan.ai/ingredients/lactoferrin/",
  "related_goal_slugs": [],
  "related_lifestyle_slugs": [],
  "last_evidence_review": "2026-06-27",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-27",
    "ip_axes_disclosed": {
      "public_axes": [
        "mechanism",
        "target",
        "use_case",
        "body_system",
        "evidence_tier",
        "dosage_range",
        "safety_notes",
        "regulatory",
        "authorized_claims"
      ],
      "ip_axes_not_exposed": [
        "proprietary_formula_ratios",
        "clinical_protocol_internals",
        "proprietary_research_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition and clinical-protocol internals are intentionally outside this public surface."
    }
  }
}