{
  "slug": "biotin",
  "name": "Biotin (Vitamin B7)",
  "alternate_names": [
    "Vitamin B7",
    "Vitamin H",
    "D-Biotin",
    "Coenzyme R"
  ],
  "mechanism": [
    "Cofactor for the four biotin-dependent carboxylases (PC, ACC, PCC, MCC) in gluconeogenesis, fatty-acid synthesis and amino-acid catabolism",
    "Pyruvate carboxylase (PC) cofactor — key gluconeogenesis step",
    "Acetyl-CoA carboxylase (ACC) cofactor — rate-limiting step of fatty-acid synthesis",
    "Propionyl-CoA carboxylase (PCC) and β-methylcrotonyl-CoA carboxylase (MCC) cofactors — branched-chain/odd-chain and leucine catabolism",
    "Studied for keratin-synthesis regulation in hair and nail structural proteins",
    "Studied for epigenetic gene-expression regulation via histone biotinylation"
  ],
  "target": [
    "Pyruvate carboxylase (PC)",
    "Acetyl-CoA carboxylase (ACC)",
    "Propionyl-CoA carboxylase (PCC)",
    "β-Methylcrotonyl-CoA carboxylase (MCC)",
    "Keratin structural proteins (hair/nail)"
  ],
  "use_case": [
    "normal hair maintenance (EFSA authorized)",
    "normal skin and mucous-membrane maintenance (EFSA authorized)",
    "normal energy-yielding metabolism (EFSA authorized)",
    "nutritional B-vitamin supplementation",
    "marginal-deficiency states (pregnancy, prolonged antibiotics, raw egg-white intake, biotinidase deficiency)"
  ],
  "body_system": [
    "HAIR",
    "SKIN",
    "ENDO",
    "NEURO",
    "METABOLISM"
  ],
  "evidence_tier": "B",
  "evidence_anchor_pmid_count": 3,
  "dosage_range": "30-100 µg/day adequate-intake (general nutritional supplementation; no IOM upper limit set) · 2.5-10 mg/day used in hair/skin/nail research contexts (clinical trials to 10 mg/day showed no adverse events) · ⚠️ 100-300 mg/day = pharmaceutical-grade MS research dose, far above supplement range and NOT a supplement reference",
  "safety_notes": "Orally very well tolerated; adverse events rare even at 10 mg/day. CRITICAL ASSAY INTERFERENCE: intake ≥1 mg/day can interfere with streptavidin-biotin immunoassays (troponin, TSH, BNP and others), producing falsely high or low results — FDA issued 2017/2019 safety communications and at least one death has been linked to biotin-confounded troponin testing. Patients on high-dose biotin should inform their clinician and consider stopping ≥72 h before laboratory testing. Marginal deficiency may occur in pregnancy; supplementation in pregnancy is a matter for medical supervision. Long-term high-dose safety data are limited.",
  "regulatory": {
    "fda": "GRAS · lawful dietary-supplement ingredient · structure/function claims (hair/skin/nails/energy metabolism) permissible. ⚠️ FDA 2017/2019 Safety Communications: high-dose biotin interferes with immunoassays (troponin/TSH/BNP) — high-dose products should carry a warning.",
    "efsa": "Listed in Directive 2002/46/EC Annex I permitted vitamins. Reg 432/2012 Art.13(1) authorizes 7 biotin health claims: normal energy-yielding metabolism · normal macronutrient metabolism · normal functioning of the nervous system · normal psychological function · maintenance of normal hair · maintenance of normal skin · maintenance of normal mucous membranes. Claims may be used only for food that is at least a SOURCE OF biotin per Reg 1924/2006 (≥15% of the 50 µg NRV per 100 g/ml or per portion).",
    "anvisa": "Listed in RDC 269/2005 permitted-vitamins list (biotina). ANVISA functional-claim framework (IN 28/2018) available subject to minimum-quantity thresholds."
  },
  "authorized_claims": [
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to normal energy-yielding metabolism"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to normal macronutrient metabolism"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to the normal functioning of the nervous system"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to normal psychological function"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to the maintenance of normal hair"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to the maintenance of normal skin"
    },
    {
      "market": "EFSA",
      "framework_reference": "Reg 432/2012",
      "claim_verbatim": "Biotin contributes to the maintenance of normal mucous membranes"
    }
  ],
  "ingredient_hub_url": "https://asxan.ai/ingredients/biotin/",
  "related_goal_slugs": [
    "hair-nail",
    "skin-beauty"
  ],
  "related_lifestyle_slugs": [
    "senior-60-plus"
  ],
  "last_evidence_review": "2026-06-13",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-13",
    "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",
        "rnd_pipeline_compounds",
        "supplier_specific_grade_specifications",
        "unpublished_endpoint_data"
      ],
      "rationale": "asxan.ai surfaces the educational, evidence-tier-disclosed slice. Formula composition, clinical-protocol internals, and RnD pipeline data are intentionally outside this public surface."
    }
  }
}