Biotin
Also known as: Vitamin B7, Vitamin H, D-Biotin, Coenzyme R, Biopeiderm, Hair vitamin
This ingredient is classified as unclassified risk (GIRI score: 3.0/10).
Safety Profile
Known Safety Concerns
- CRITICAL: High-dose Biotin (≥5,000 mcg) falsifies TSH/T3/T4 thyroid tests and Troponin cardiac tests (FDA safety communication 2017/2019) — stop 3–7 days before bloodwork
Contraindications
- CRITICAL: High-dose Biotin (≥5,000 mcg) falsifies TSH/T3/T4 thyroid tests and Troponin cardiac tests (FDA safety communication 2017/2019) — stop 3–7 days before bloodwork
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Biotin (Vitamin B7) is a water-soluble B vitamin functioning as a covalently bound cofactor for five carboxylase enzymes: Pyruvate carboxylase (gluconeogenesis), Acetyl-CoA carboxylase 1 and 2 (fatty acid synthesis and oxidation), Propionyl-CoA carboxylase (branched-chain amino acid catabolism), 3-Methylcrotonyl-CoA carboxylase (leucine catabolism), and 3-Methylglutaconyl-CoA carboxylase. Supports keratin protein synthesis in hair follicles, nail matrix, and skin barrier. Biotin deficiency causes alopecia, brittle nails, and dermatitis — however, true dietary deficiency is rare. Clinical benefit of supplementation is best documented in biotin-deficient individuals; evidence for hair/nail improvement in biotin-replete individuals is limited. Beauty gummy products typically contain 2,500–10,000 mcg (2.5–10 mg). CRITICAL SAFETY — LABORATORY TEST INTERFERENCE: High-dose Biotin (≥5,000 mcg / 5 mg) saturates streptavidin used in competitive and sandwich immunoassay systems, causing: (1) FALSELY NORMAL or LOW TSH — masked hypothyroidism; (2) FALSELY ELEVATED free T3 and free T4 — misdiagnosis of hyperthyroidism or Graves’ disease; (3) FALSELY NEGATIVE Troponin I and Troponin T — missed acute myocardial infarction (LIFE-THREATENING); (4) FALSE Prolactin, Parathyroid hormone (PTH), Folate, Ferritin results. The FDA issued a safety communication in 2017 (updated 2019). RECOMMENDATION: Stop Biotin supplementation minimum 3 days (preferably 7 days) before any thyroid function test or cardiac enzyme panel. Inform requesting physician and laboratory. Biotin is otherwise very safe — no established UL; no toxicity at doses up to 200 mg/day in clinical studies.
Biological and Chemical Classification
Information not yet available for this ingredient profile.
Mechanism of Action
Information not yet available for this ingredient profile.
Clinical Evidence of Effectiveness
Information not yet available for this ingredient profile.
Pharmacokinetics
Information not yet available for this ingredient profile.
Recommended Dosage
Information not yet available for this ingredient profile.
SETI — Scientific Evidence Transparency Index
Executive Summary — Ingredient Assessment
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or RCT)
- Main clinical benefit observed: Vitamins & Minerals
- Evidence consistency: High consistency across studies (100%)
- CRITICAL: High-dose Biotin (≥5,000 mcg) falsifies TSH/T3/T4 thyroid tests and Troponin cardiac tests (FDA safety communication 2017/2019) — stop 3–7 days before bloodwork
The available scientific evidence for Biotin indicates notable safety signals that warrant caution. Use should be considered carefully and monitored, particularly in sensitive populations or alongside other medications.
Total SETI Score
High risk| Evidence quality | 10/40 |
| Evidence consistency | 20/20 |
| Safety signals | 0/20 |
| Study recency | 10/10 |
| Evidence transparency | 10/10 |
Evidence Summary
- 10 studies reviewed
- 0 high-quality studies (meta-analysis or systematic review)
- 0 studies identified benefits or no safety concern (GREEN)
- 10 studies reported limited or advisory safety evidence (YELLOW)
Evidence Policy
Only peer-reviewed scientific literature indexed in PubMed or comparable databases is included in this evaluation. Commercial websites, blogs, and marketing materials are excluded. All references include direct traceable links to source documents.
Last updated: 06 აპრ 2026, 12:09
Evidence Distribution
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Observational / other LOW evidence YELLOWDual-Receptor Targeted Imaging of Cancer Cells with a Bioorthogonal Iridium(III)-Based Probe. ↗Jing S et al.. Dual-Receptor Targeted Imaging of Cancer Cells with a Bioorthogonal Iridium(III)-Based Probe.. Inorg Chem. 2026. PMID:41937303.PMID 41937303 ↗Journal Inorg ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41937303/
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Observational / other LOW evidence YELLOWGeraniol induces apoptosis in gastric cancer cells by inhibiting the Wnt/u03b2-catenin pathway. ↗Yu XL et al.. Geraniol induces apoptosis in gastric cancer cells by inhibiting the Wnt/u03b2-catenin pathway.. J Pharm Pharmacol. 2026. PMID:41934234.PMID 41934234 ↗Journal J Pharm PharmacolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41934234/
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Observational / other LOW evidence YELLOWDevelopment of anti-IgA monoclonal and polyclonal reagents for detecting mucosal and systemic IgA in nonhuman primates. ↗Iacone Y et al.. Development of anti-IgA monoclonal and polyclonal reagents for detecting mucosal and systemic IgA in nonhuman primates.. J Immunol Methods. 2026. PMID:41933648.PMID 41933648 ↗Journal J Immunol MethodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41933648/
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Observational / other LOW evidence YELLOWMulti-omics integration identifies PGAP3 as a tumor-intrinsic factor associated with CD8(+) T-cell exclusion in prostate cancer. ↗Liu W et al.. Multi-omics integration identifies PGAP3 as a tumor-intrinsic factor associated with CD8(+) T-cell exclusion in prostate cancer.. Front Mol Biosci. 2026. PMID:41930249.PMID 41930249 ↗Journal Front Mol BiosciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41930249/
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Observational / other LOW evidence YELLOWA red/blue bicolor lateral flow immunoassay for simultaneous detection of two enteroviruses based on duplex RT-LAMP. ↗Zhou T et al.. A red/blue bicolor lateral flow immunoassay for simultaneous detection of two enteroviruses based on duplex RT-LAMP.. Front Microbiol. 2026. PMID:41929678.PMID 41929678 ↗Journal Front MicrobiolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41929678/
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Observational / other LOW evidence YELLOWAPEX-seq maps transcriptome-wide subcellular RNA localization in living cells. ↗Sharma S et al.. APEX-seq maps transcriptome-wide subcellular RNA localization in living cells.. Nat Protoc. 2026. PMID:41927971.PMID 41927971 ↗Journal Nat ProtocYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41927971/
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Observational / other LOW evidence YELLOWModular CuAAC-Based Synthesis of C-Functional Cyclam-Picolinate Chelators for Antibody Conjugation. ↗Ollier C et al.. Modular CuAAC-Based Synthesis of C-Functional Cyclam-Picolinate Chelators for Antibody Conjugation.. J Org Chem. 2026. PMID:41919943.PMID 41919943 ↗Journal J Org ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41919943/
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Observational / other LOW evidence YELLOWDroplet Microfluidics-Assisted Fabrication of Magnetite Nanoparticle Hybrid Microgels for Facile Protein Immobilization. ↗Neuendorf TA et al.. Droplet Microfluidics-Assisted Fabrication of Magnetite Nanoparticle Hybrid Microgels for Facile Protein Immobilization.. Chembiochem. 2026. PMID:41918213.PMID 41918213 ↗Journal ChembiochemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41918213/
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Observational / other LOW evidence YELLOWAutomated Generation of Supported Lipid Bilayer Arrays with Controlled Receptor Densities in Well Plates. ↗Schlicke J et al.. Automated Generation of Supported Lipid Bilayer Arrays with Controlled Receptor Densities in Well Plates.. ACS Appl Mater Interfaces. 2026. PMID:41910407.PMID 41910407 ↗Journal ACS Appl Mater InterfacesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41910407/
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Observational / other LOW evidence YELLOWQuantifying Spatially Resolved Hydration Thermodynamics Using Grid Inhomogeneous Solvation Theory [Article v1.0]. ↗Egger-Hoerschinger VJ et al.. Quantifying Spatially Resolved Hydration Thermodynamics Using Grid Inhomogeneous Solvation Theory [Article v1.0].. Living J Comput Mol Sci. 2025. PMID:41924489.PMID 41924489 ↗Journal Living J Comput Mol SciYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41924489/
Score Transparency
0 of 10 approved references (score saturates at 10). More peer-reviewed studies = stronger evidence base.
Method: Q = number of approved references ÷ 10 (capped at 1.0)
Limited — mostly case reports or animal studies
Method: L = mean study-level weight across approved references. Level 1 (meta-analysis / systematic review) = 1.0; Level 2 (RCT) = 0.8; Level 3 (cohort/case-control) = 0.6; Level 4 (case report) = 0.4; Level 5 (animal / in-vitro) = 0.2.
Mixed or neutral — roughly equal benefit and risk signals
Method: D = (sum of risk-scored references − sum of benefit-scored references) ÷ total evidence score, then scaled from [−1, 1] to [0, 1]. 0.0 = pure benefit; 0.5 = neutral; 1.0 = pure risk.
One or more monitoring-level safety signals active
Method: S = 0.5 (neutral baseline) + sum of active signal severity deltas ÷ 10. Severity deltas: Critical = +2.0, High = +1.5, Moderate = +1.0, Low = +0.5. Capped at 1.0.
Final GIRI Score for Biotin. Risk level thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
Full methodology & data sources
The GIRI Score is computed entirely from structured data — no editorial scoring or subjective weighting is applied at any step.
- References: Only approved references are counted. Each reference is assigned an evidence level (L1–L5) and a direction (risk / neutral / benefit) by the reference manager or AI classifier.
- Safety Signals: Sourced from regulatory agencies (FDA, EMA, Health Canada, TGA, and others) and pharmacovigilance databases. Only active signals count toward the score.
- Formula version: GIRI Score v3.7.0 — Q × L × D × S × 10.
- Limitations: The score reflects published evidence and recorded signals as of the last update date. It is not a clinical risk assessment and should not replace advice from a qualified healthcare professional.
Risk Level Classification
Based on available regulatory signals and scientific evidence, this ingredient presents a moderate safety concern. Caution is advised, particularly at high doses or in sensitive populations.
0–3.0
3.0–5.5
5.5–7.5
7.5–10
The score pin shows exactly where this ingredient falls on the fixed risk scale.
What drove the Moderate classification for Biotin
A score of 3.0 places this ingredient in the Moderate band. Thresholds: Low 0–3.0 · Moderate 3.0–5.5 · High 5.5–7.5 · Critical 7.5–10.
0 approved references.
Limited — mostly case reports or animal studies (Level 4–5).
Neutral or mixed — benefit and risk signals roughly balanced.
No active signals — S component is at neutral baseline (0.5), contributing no extra risk weight.
No major regulatory restrictions or advisories recorded across monitored jurisdictions (FDA, EMA, Health Canada, TGA, and others).
How are the Low / Moderate / High / Critical thresholds defined?
The four risk levels are fixed score bands. A score is assigned to exactly one level based on where it falls:
| Level | Score | Meaning |
|---|---|---|
| LOW | 0.0 – 2.9 | Sparse or predominantly beneficial evidence. No active safety alerts. |
| MODERATE | 3.0 – 5.4 | Mixed signals — some risk alongside benefit. Caution at high doses or in sensitive groups. |
| HIGH | 5.5 – 7.4 | Multiple studies or regulatory alerts documenting adverse effects. Professional oversight recommended. |
| CRITICAL | 7.5 – 10 | Regulatory restrictions in one or more major jurisdictions. Serious documented harm. Avoid without specialist supervision. |
Thresholds are fixed constants (GIRI_Score_Utils::LEVEL_THRESHOLDS). They do not change per ingredient and are never subject to editorial adjustment.