🇺🇸 FDA
GRAS · DSHEA dietary supplement · NOT subject to a specific authorized health claim · FDA + IOM tolerable upper intake levels not formally set for β-carotene (vitamin A precursor pathway is regulated)
β-Carotene (Provitamin A · Mixed Carotene)
Also known as: Beta-carotene · Provitamin A · All-trans-β-carotene
Mechanism of action
- Provitamin A converted to retinol via β-carotene-15,15-monooxygenase
- Singlet oxygen quenching (carotenoid antioxidant)
- Cleavage products with potential pro-oxidant effects in high-pO2 lung tissue (mechanism behind smoker lung-cancer signal)
Molecular + tissue targets
- Retinoid pathway (skin / vision / immunity)
- Lipid peroxidation buffers in low-oxygen tissues
Dosage range
Diet-derived β-carotene is generally safe at any intake. Isolated supplemental β-carotene at ≥ 20 mg/day in current and former smokers significantly increased lung cancer incidence in the ATBC study (Middha 2019 PMID 29889248 Nicotine Tob Res follow-up confirmed the effect was independent of tar / nicotine level). CARET (β-carotene 30 mg + retinol) was stopped early in 1996 for a 28% increased lung cancer incidence in smokers and asbestos-exposed workers. Supplement is contraindicated in current or former smokers
Safety notes
CONTRAINDICATED in current and former smokers (ATBC + CARET hard evidence). Excess preformed vitamin A pathway concerns at very high cumulative intake; β-carotene per se does not cause vitamin A toxicity due to regulated cleavage. Skin yellowing (carotenodermia) at high doses is reversible and harmless
Cross-market regulatory status
🇪🇺 EFSA
Authorized claim Reg 432/2012 vitamin A contributes to maintenance of normal vision / iron metabolism / immune system / skin / mucous membranes — applies via retinol equivalents (12 µg β-carotene = 1 µg retinol activity equivalent); no separate β-carotene-specific claim
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 vitamin A claims applicable when β-carotene contributes to retinol activity equivalents · no β-carotene-specific separate Anexo V claim
Common use cases
- vitamin A precursor for plant-based diets (with safe upper-limit awareness)
- mixed-carotenoid antioxidant adjunct in non-smoker populations
Cross-reference
Health goals: eye protection skin beauty
Lifestyles: plant based
Full dossier: /ingredients/beta-carotene/
Machine-readable JSON: /api/nc/beta-carotene.json