Safety Profile
Known Safety Concerns
- Increased lung cancer risk in smokers at high doses (CARET, ATBC trials)
- Skin yellowing (carotenodermia) at very high doses -- harmless
- Contraindicated in current smokers at supplemental doses
- Much safer than preformed retinol but not risk-free
Contraindications
- Increased lung cancer risk in smokers at high doses (CARET, ATBC trials)
- Skin yellowing (carotenodermia) at very high doses -- harmless
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Beta-carotene as a vitamin A source is converted to retinol only as needed, making overdose far less likely than preformed retinol. However high-dose supplementation significantly increased lung cancer risk in smokers in the CARET and ATBC trials. Commonly listed on labels as the vitamin A source in multivitamins.
Biological and Chemical Classification
- Scientific Name
- Beta-carotene (provitamin A)
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: Vitamin
- Evidence consistency: High consistency across studies (100%)
- Increased lung cancer risk in smokers at high doses (CARET, ATBC trials)
- Skin yellowing (carotenodermia) at very high doses -- harmless
- Contraindicated in current smokers at supplemental doses
- Much safer than preformed retinol but not risk-free
The available scientific evidence for Vitamin A (Beta-Carotene) 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: 24 მარ 2026, 10:59
Evidence Distribution
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Observational / other LOW evidence YELLOW[Extraction of protective dietary pattern for remnant cholesterol among adult in China in 2015-2017]. ↗Li F et al.. [Extraction of protective dietary pattern for remnant cholesterol among adult in China in 2015-2017].. Wei Sheng Yan Jiu. 2026. PMID:41819995.PMID 41819995 ↗Journal Wei Sheng Yan JiuYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41819995/
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Observational / other LOW evidence YELLOWAssociation between pro-inflammatory diet and fecal incontinence: a large population-based study. ↗Wang H et al.. Association between pro-inflammatory diet and fecal incontinence: a large population-based study.. Front Nutr. 2025. PMID:40474896.PMID 40474896 ↗Journal Front NutrYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40474896/
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Observational / other LOW evidence YELLOWA Mendelian randomized study of circulating antioxidants in the diet and risk of cardiovascular disease. ↗Yang R et al.. A Mendelian randomized study of circulating antioxidants in the diet and risk of cardiovascular disease.. Sci Rep. 2025. PMID:40133449.PMID 40133449 ↗Journal Sci RepYear 2025Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/40133449/
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Observational / other LOW evidence YELLOWResveratrol Modulates Diabetes-Induced Neuropathic Pain, Apoptosis, and Oxidative Neurotoxicity in Mice Through TRPV4 Channel Inhibition. ↗Osmanlu0131ou011flu Hu00d6 et al.. Resveratrol Modulates Diabetes-Induced Neuropathic Pain, Apoptosis, and Oxidative Neurotoxicity in Mice Through TRPV4 Channel Inhibition.. Mol Neurobiol. 2024. PMID:38976129.PMID 38976129 ↗Journal Mol NeurobiolYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38976129/
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Observational / other LOW evidence YELLOWThe Association between Dietary Nutrient Intake and Acceleration of Aging: Evidence from NHANES. ↗Ma J et al.. The Association between Dietary Nutrient Intake and Acceleration of Aging: Evidence from NHANES.. Nutrients. 2024. PMID:38892569.PMID 38892569 ↗Journal NutrientsYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38892569/
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Observational / other LOW evidence YELLOWAssociation between Dietary Total Vitamin A, u03b2-carotene, and Retinol Intake and Risk of cardiometabolic multimorbidity: Results from the China Health and Nutrition… ↗Tang Y et al.. Association between Dietary Total Vitamin A, u03b2-carotene, and Retinol Intake and Risk of cardiometabolic multimorbidity: Results from the China Health and Nutrition Survey, 1997-2015.. Res Sq. 2024. PMID:38853914.PMID 38853914 ↗Journal Res SqYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38853914/
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Observational / other LOW evidence YELLOWImpact of antioxidants on PM(2.5) oxidative potential, radical level, and cytotoxicity. ↗Wang Y et al.. Impact of antioxidants on PM(2.5) oxidative potential, radical level, and cytotoxicity.. Sci Total Environ. 2024. PMID:38157913.PMID 38157913 ↗Journal Sci Total EnvironYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38157913/
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Observational / other LOW evidence YELLOWProtective effect of dietary micronutrients on gastric cancer risk among Jordanians. ↗Allehdan S et al.. Protective effect of dietary micronutrients on gastric cancer risk among Jordanians.. Nutr Hosp. 2024. PMID:37705441.PMID 37705441 ↗Journal Nutr HospYear 2024Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37705441/
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Observational / other LOW evidence YELLOWAssociation between dietary inflammatory index and body fat percentage among newly diagnosed breast cancer patients. ↗Ng WH et al.. Association between dietary inflammatory index and body fat percentage among newly diagnosed breast cancer patients.. Ann Med. 2023. PMID:38242100.PMID 38242100 ↗Journal Ann MedYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/38242100/
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Observational / other LOW evidence YELLOW5'-UTR allelic variants and expression of the lycopene-u025b-cyclase LCYE gene in maize (Zea mays L.) inbred lines of Russian selection. ↗Arkhestova DK et al.. 5'-UTR allelic variants and expression of the lycopene-u025b-cyclase LCYE gene in maize (Zea mays L.) inbred lines of Russian selection.. Vavilovskii Zhurnal Genet Selektsii. 2023. PMID:37808214.PMID 37808214 ↗Journal Vavilovskii Zhurnal Genet SelektsiiYear 2023Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/37808214/
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 Vitamin A (Beta-Carotene). 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 Vitamin A (Beta-Carotene)
A score of 4.5 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.