Safety Profile
Known Safety Concerns
- Whole leaf stevia is NOT FDA-approved as food additive -- only purified glycosides are GRAS
- May lower blood pressure and blood sugar additively with medications
- GI bloating and digestive discomfort in some individuals
- Potential hormone disruption at very high doses in some animal studies
Contraindications
- Whole leaf stevia is NOT FDA-approved as food additive -- only purified glycosides are GRAS
- May lower blood pressure and blood sugar additively with medications
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Steviol glycosides (the active sweetening compounds from stevia leaf) are Generally Recognized as Safe (GRAS) by the FDA. The whole stevia leaf and crude stevia extracts are NOT approved as food additives. Purified steviol glycosides at ADI of 4 mg per kg per day (as steviol equivalents) are considered safe. Some individuals report GI bloating. Stevia may have mild blood pressure and blood sugar lowering effects.
Biological and Chemical Classification
- Scientific Name
- Steviol glycosides from Stevia rebaudiana
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: Excipient
- Evidence consistency: High consistency across studies (100%)
- Whole leaf stevia is NOT FDA-approved as food additive -- only purified glycosides are GRAS
- May lower blood pressure and blood sugar additively with medications
- GI bloating and digestive discomfort in some individuals
- Potential hormone disruption at very high doses in some animal studies
The available scientific evidence for Stevia Extract 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 | 9/10 |
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: 24 მარ 2026, 08:57
Evidence Distribution
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Observational / other LOW evidence YELLOWStevia Extract Improves Skeletal Muscle Metabolism and Mitochondrial Function While Attenuating Muscle Atrophy in Palmitate-Treated C2C12 Myotubes and db/db Mice. ↗Yoon JH et al.. Stevia Extract Improves Skeletal Muscle Metabolism and Mitochondrial Function While Attenuating Muscle Atrophy in Palmitate-Treated C2C12 Myotubes and db/db Mice.. Mol Nutr Food Res. 2026. PMID:41817289.PMID 41817289 ↗Journal Mol Nutr Food ResYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41817289/
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Observational / other LOW evidence YELLOWStructural Elucidation of Quinovose-Containing Steviol Glycosides from Enzymatic Biotransformation of Stevia rebaudiana. ↗Wong YY et al.. Structural Elucidation of Quinovose-Containing Steviol Glycosides from Enzymatic Biotransformation of Stevia rebaudiana.. Molecules. 2026. PMID:41752425.PMID 41752425 ↗Journal MoleculesYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41752425/
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Observational / other LOW evidence YELLOWEffect of alternative sweeteners on acrylamide, HMF and color formation in whole-grain wheat cookies. ↗u017diliu0107 S et al.. Effect of alternative sweeteners on acrylamide, HMF and color formation in whole-grain wheat cookies.. Food Chem X. 2026. PMID:41674685.PMID 41674685 ↗Journal Food Chem XYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41674685/
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Observational / other LOW evidence YELLOWComparison of the Cariogenic Potential of Two Sweeteners, Stevia and Aspartame, Based on Bacterial Inhibition and pH Reduction. ↗J R et al.. Comparison of the Cariogenic Potential of Two Sweeteners, Stevia and Aspartame, Based on Bacterial Inhibition and pH Reduction.. Cureus. 2025. PMID:41589156.PMID 41589156 ↗Journal CureusYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41589156/
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Observational / other LOW evidence YELLOWBiomarkers Characterizing the Onset of Dietary-Induced Hepatocellular Injury and Visceral Obesity in a Rat Experimental Model: Possible Anti-Inflammatory Effects of Steviol Glycosides. ↗Trifonova K et al.. Biomarkers Characterizing the Onset of Dietary-Induced Hepatocellular Injury and Visceral Obesity in a Rat Experimental Model: Possible Anti-Inflammatory Effects of Steviol Glycosides.. Metabolites. 2025. PMID:41149634.PMID 41149634 ↗Journal MetabolitesYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41149634/
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Observational / other LOW evidence YELLOWIn vitro metabolism study of u03b1-1,6-glucosylated steviol glycosides. ↗Park YL et al.. In vitro metabolism study of u03b1-1,6-glucosylated steviol glycosides.. Food Sci Biotechnol. 2025. PMID:41113275.PMID 41113275 ↗Journal Food Sci BiotechnolYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41113275/
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Observational / other LOW evidence YELLOWCorrection to: Effects of dietary stevia extract supplementation on growth performance, serum biochemical indices, and intestinal health of yellow-feathered broilers. ↗Correction to: Effects of dietary stevia extract supplementation on growth performance, serum biochemical indices, and intestinal health of yellow-feathered broilers.. J Anim Sci. 2025. PMID:40580047.PMID 40580047 ↗Journal J Anim SciYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40580047/
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Observational / other LOW evidence YELLOWOrdered mesoporous core-shell silica microspheres for the stationary phase of supercritical fluid chromatography. ↗Feng J et al.. Ordered mesoporous core-shell silica microspheres for the stationary phase of supercritical fluid chromatography.. J Chromatogr A. 2025. PMID:40540895.PMID 40540895 ↗Journal J Chromatogr AYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40540895/
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Observational / other LOW evidence YELLOWAssessing the temporal profile and liking of sugar-free spicy dark chocolates with different concentrations of Capsicum baccatum pepper and rebaudioside A. ↗Martins GAR et al.. Assessing the temporal profile and liking of sugar-free spicy dark chocolates with different concentrations of Capsicum baccatum pepper and rebaudioside A.. J Sci Food Agric. 2025. PMID:40320588.PMID 40320588 ↗Journal J Sci Food AgricYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40320588/
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Observational / other LOW evidence YELLOWThe effect of garlic and stevia extract with aerobic exercise on hypothalamic leptin and ghrelin receptor mRNA expression and insulin resistance in… ↗Amirkhani Z et al.. The effect of garlic and stevia extract with aerobic exercise on hypothalamic leptin and ghrelin receptor mRNA expression and insulin resistance in obese rats.. BMC Complement Med Ther. 2025. PMID:40087612.PMID 40087612 ↗Journal BMC Complement Med TherYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40087612/
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 Stevia Extract. 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 low safety concern under normal conditions of use.
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 Low classification for Stevia Extract
A score of 2.0 places this ingredient in the Low 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.