{
  "slug": "soy-isoflavones",
  "name": "Soy Isoflavones (Genistein · Daidzein · Glycitein)",
  "alternate_names": [
    "Soy Isoflavones",
    "Genistein",
    "Daidzein",
    "Glycitein",
    "Soy phytoestrogens"
  ],
  "mechanism": [
    "Selective estrogen-receptor modulation (phytoestrogen · preferential ER-beta binding · SERM-like research context)",
    "Equol metabolism: ~50-70% of consumers are non-equol-producers, affecting bioactivity (gut-microbiome dependent)",
    "Antioxidant / anti-inflammatory effects (research-stage biomarkers)",
    "Bone metabolism modulation: influence on osteoblast/osteoclast balance (research context, basis of CN bone-density function)"
  ],
  "target": [
    "Estrogen receptor beta (ER-beta)",
    "Bone remodeling (osteoblast/osteoclast)",
    "Lipid metabolism",
    "Vasomotor pathway (research context)"
  ],
  "use_case": [
    "bone-density support research context (basis of the CN bone-mineral-density health function)",
    "menopausal vasomotor / quality-of-life research context (not a claim; evidence mixed)",
    "cardiometabolic / LDL research context (EFSA claim rejected)",
    "skin / estrogen-pathway research context"
  ],
  "body_system": [
    "HORMONE",
    "MUSCULO",
    "CARDIO"
  ],
  "evidence_tier": "B",
  "evidence_anchor_pmid_count": 4,
  "dosage_range": "RCT/commercial doses 40-100 mg/day isoflavone aglycone-equivalent (DSLD median ~80 mg, range 40-750 mg). EFSA 2015 safety review: postmenopausal women <=100 mg/day isoflavone aglycone-equivalent shows no adverse effect on breast, thyroid, uterus. Educational reference, not a dosing recommendation.",
  "safety_notes": "Soy allergy = absolute contraindication; all packaging/content must carry allergen warning. Equol non-producer variability (~50-70%) means responses differ — avoid over-promising. Must NOT claim it treats menopause syndrome, prevents breast cancer, or replaces hormone-replacement therapy; must NOT be recommended in content aimed at breast-cancer patients. High-dose genistein may affect TPO activity in iodine-deficient individuals (thyroid caution). This describes scientific evidence, not medical advice.",
  "regulatory": {
    "fda": "Legal dietary-supplement ingredient sold freely under DSHEA (structure/function claims with disclaimer). GRN 1 (1998) was a ceased/withdrawn notification — NOT a valid GRAS. The 1999 soy-protein cardiovascular qualified health claim (25 g/day) is for soy protein, not isolated isoflavones, and FDA proposed to revoke it in 2017 (not finalized). No FDA-authorized health claim for soy isoflavones.",
    "efsa": "Marketable as food supplement under Directive 2002/46/EC. EFSA has authorized 0 health claims — 6 Art.13(1) applications (incl. hair growth EFSA 2011;9(7):2264, LDL cholesterol, joint maintenance EFSA 2010;8(2):1493) were all rejected. EFSA 2015 safety review confirmed postmenopausal use <=100 mg/day aglycone-equivalent has no adverse effect on breast/thyroid/uterus.",
    "anvisa": "Legal food-supplement ingredient under ANVISA RDC 243/2018 + IN 28/2018; any claim must conform to the ANVISA positive list. No specific IN 28/2018 Anexo V authorized functional claim asserted for soy isoflavones.",
    "cn": "China NMPA: listed in health-food raw-material catalogue; authorized health-food function limited to increasing bone density. Other directions (menopause/skin/cardiovascular) not permitted on labels."
  },
  "regulatory_markets": [
    {
      "market": "US",
      "status": "DSHEA",
      "tier": "permitted"
    },
    {
      "market": "EU",
      "status": "2002/46/EC",
      "tier": "permitted"
    },
    {
      "market": "CN",
      "status": "NMPA",
      "tier": "authorized"
    },
    {
      "market": "BR",
      "status": "ANVISA",
      "tier": "permitted"
    }
  ],
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/soy-isoflavones/",
  "related_goal_slugs": [
    "menopause-support",
    "heart-health",
    "joint-bone"
  ],
  "related_lifestyle_slugs": [
    "menopause",
    "plant-based"
  ],
  "last_evidence_review": "2026-06-22",
  "schema_version": "nc-public-v0.2",
  "api_version": "nc-public-v0.3",
  "_meta": {
    "last_evidence_review": "2026-06-22",
    "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."
    }
  }
}