Safety Profile
Known Safety Concerns
- Skin yellowing at very high doses -- harmless but visible
- No established UL -- no documented serious adverse effects
- May compete with beta-carotene absorption at very high doses
- One of the safest supplement ingredients available
Contraindications
- Skin yellowing at very high doses -- harmless but visible
- No established UL -- no documented serious adverse effects
Interactions
Information not yet available for this ingredient profile.
Evidence and Scientific Findings
Ingredient Overview
Lutein is a carotenoid antioxidant concentrated in the macula of the eye and in the brain. Clinical evidence supports its role in reducing age-related macular degeneration risk (AREDS2 trial). Excellent safety profile with no established UL. Very high doses cause skin yellowing (carotenodermia) — harmless.
Biological and Chemical Classification
- Scientific Name
- Lutein from Tagetes erecta (marigold)
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: Botanical
- Evidence consistency: High consistency across studies (100%)
- Skin yellowing at very high doses -- harmless but visible
- No established UL -- no documented serious adverse effects
- May compete with beta-carotene absorption at very high doses
- One of the safest supplement ingredients available
The available scientific evidence for Lutein 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 | 9/10 |
| 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: 25 მარ 2026, 17:34
Evidence Distribution
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Observational / other LOW evidence YELLOWSkin wound healing effects of Pectinodesmus javanensis extract through activation of TGF-u03b2/SMAD signaling pathway. ↗Oh JH et al.. Skin wound healing effects of Pectinodesmus javanensis extract through activation of TGF-u03b2/SMAD signaling pathway.. Mol Biol Rep. 2026. PMID:41874813.PMID 41874813 ↗Journal Mol Biol RepYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41874813/
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Observational / other LOW evidence YELLOWThe Role of Antioxidants in Child Eye Health with a Focus on Myopia. ↗Didara Y et al.. The Role of Antioxidants in Child Eye Health with a Focus on Myopia.. Curr Med Chem. 2026. PMID:41863175.PMID 41863175 ↗Journal Curr Med ChemYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41863175/
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Observational / other LOW evidence YELLOWConsuming primarily egg dishes and eggs as ingredients among U.S. adolescents is associated with greater usual nutrient intakes compared with not consuming… ↗Morales-Juu00e1rez A et al.. Consuming primarily egg dishes and eggs as ingredients among U.S. adolescents is associated with greater usual nutrient intakes compared with not consuming eggs.. J Nutr. 2026. PMID:41861914.PMID 41861914 ↗Journal J NutrYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41861914/
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Observational / other LOW evidence YELLOWPermeable nanoreactor eye drop for enzymatic cascade-mediated treatment for acute retinal injury model mimicking geographic atrophy. ↗Shen J et al.. Permeable nanoreactor eye drop for enzymatic cascade-mediated treatment for acute retinal injury model mimicking geographic atrophy.. Nat Commun. 2026. PMID:41844666.PMID 41844666 ↗Journal Nat CommunYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41844666/
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Observational / other LOW evidence YELLOWThe Cu2082Hu2082-type zinc finger transcription factor PpZAT10 mediates abscisic acid-induced carotenoid accumulation in yellow peach. ↗Xiao X et al.. The Cu2082Hu2082-type zinc finger transcription factor PpZAT10 mediates abscisic acid-induced carotenoid accumulation in yellow peach.. Int J Biol Macromol. 2026. PMID:41833679.PMID 41833679 ↗Journal Int J Biol MacromolYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41833679/
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Observational / other LOW evidence YELLOWHow plasma activated water promotes plant root growth through interfacial modulation of nitrogen uptake. ↗Panja S et al.. How plasma activated water promotes plant root growth through interfacial modulation of nitrogen uptake.. J Colloid Interface Sci. 2026. PMID:41832826.PMID 41832826 ↗Journal J Colloid Interface SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41832826/
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Observational / other LOW evidence YELLOWFabrication of COS-Modified Corn Peptide-Lutein Nanoparticles: Enhancement of Stability and Bioactivity. ↗Chang Y et al.. Fabrication of COS-Modified Corn Peptide-Lutein Nanoparticles: Enhancement of Stability and Bioactivity.. J Food Sci. 2026. PMID:41830449.PMID 41830449 ↗Journal J Food SciYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41830449/
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Observational / other LOW evidence YELLOWDietary Effects of Carotenoid-Biofortified Wheat on Feed Conversion and Tissue Antioxidant Concentrations in Broiler Chickens. ↗Szmek J et al.. Dietary Effects of Carotenoid-Biofortified Wheat on Feed Conversion and Tissue Antioxidant Concentrations in Broiler Chickens.. Foods. 2026. PMID:41829130.PMID 41829130 ↗Journal FoodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829130/
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Observational / other LOW evidence YELLOWGene-Editing-Mediated Enhancement of Carotenoid Compound Accumulation in Common Wheat Grains. ↗Guo Y et al.. Gene-Editing-Mediated Enhancement of Carotenoid Compound Accumulation in Common Wheat Grains.. Foods. 2026. PMID:41829090.PMID 41829090 ↗Journal FoodsYear 2026Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/41829090/
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Observational / other LOW evidence YELLOWCarrot. ↗Carrot.. 2006. PMID:30000953.PMID 30000953 ↗Year 2006Study type Observational / otherEvidence strength LOW evidencePubMed link https://pubmed.ncbi.nlm.nih.gov/30000953/
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 Lutein. 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 Lutein
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.