{
  "slug": "saw-palmetto",
  "name": "Saw Palmetto (Serenoa repens)",
  "alternate_names": [
    "Saw Palmetto",
    "Serenoa repens",
    "Sabal serrulata",
    "Saw palmetto berry extract"
  ],
  "mechanism": [
    "5-alpha-reductase inhibition (reduces DHT conversion · research context)",
    "Anti-androgenic activity on prostate tissue (preclinical/biomarker research)",
    "Anti-inflammatory and anti-edematous effects on prostatic tissue (research-stage)",
    "Alpha-1 adrenoceptor modulation relevant to lower-urinary-tract smooth muscle (mechanistic research)"
  ],
  "target": [
    "5-alpha-reductase",
    "Androgen receptor / DHT pathway",
    "Prostatic inflammation",
    "Lower urinary tract smooth muscle"
  ],
  "use_case": [
    "lower-urinary-tract / prostate comfort research context (BPH symptom endpoints · evidence mixed)",
    "androgen-pathway / DHT modulation mechanism research",
    "men's reproductive-health support research-context only (not a claim)"
  ],
  "body_system": [
    "HORMONE",
    "URINARY"
  ],
  "evidence_tier": "B",
  "evidence_anchor_pmid_count": 3,
  "dosage_range": "Commercial/RCT doses 320 mg/day standardized lipophilic extract (85-95% fatty acids/sterols), usually 1x320 mg or 2x160 mg with food. Educational reference, not a dosing recommendation.",
  "safety_notes": "Anti-androgenic activity: not recommended in pregnancy, breastfeeding, or children (theoretical anti-androgenic / feminization concern for a male fetus); women who are or may become pregnant should consult a clinician before use. Per NCCIH, saw palmetto does not appear to meaningfully alter PSA readings, but disclose any supplement use to your physician before prostate screening. Generally well tolerated; mild GI upset most common. Cochrane evidence is inconsistent and the rigorous STEP/CAMUS trial did not meet its primary endpoint, so BPH framing must stay conservative. Must NOT claim equivalence/superiority to finasteride or that it treats hair loss / BPH. This describes scientific evidence, not medical advice.",
  "regulatory": {
    "fda": "Legal DSHEA dietary-supplement ingredient; prostate-health category bestseller (~320 mg/day). Structure/function claims with FDA disclaimer permitted; disease claims (treats BPH / treats hair loss / replaces finasteride) prohibited. No FDA-authorized health claim.",
    "efsa": "Marketable as food supplement (Directive 2002/46/EC) in several member states; EMA has a traditional-herbal monograph (BPH well-established use) and Permixon is registered as a medicine in some member states. EFSA has authorized no health claim.",
    "anvisa": "Legal food supplement under ANVISA RDC 243/2018 + IN 28/2018 (Serenoa repens extract permitted); daily-amount and use-warning labeling required. No IN 28/2018 Anexo V authorized functional claim.",
    "cn": "China NMPA: not listed in health-food raw-material catalogue or medicine-food homology list; no clear market-access pathway; market entry restricted."
  },
  "regulatory_markets": [
    {
      "market": "US",
      "status": "DSHEA",
      "tier": "permitted"
    },
    {
      "market": "EU",
      "status": "2002/46/EC",
      "tier": "permitted"
    },
    {
      "market": "BR",
      "status": "ANVISA",
      "tier": "permitted"
    }
  ],
  "authorized_claims": [],
  "ingredient_hub_url": "https://asxan.ai/ingredients/saw-palmetto/",
  "related_goal_slugs": [
    "reproductive-health"
  ],
  "related_lifestyle_slugs": [
    "senior-60-plus"
  ],
  "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."
    }
  }
}