🇺🇸 FDA
GRAS · DSHEA dietary supplement · NO authorized cancer-risk-reduction claim (2005 FDA QHC petition denied for lycopene-cancer); structure/function claims permitted
Lycopene (Tomato Carotenoid)
Also known as: All-trans-lycopene · Tomato lycopene · Synthetic lycopene
Mechanism of action
- Acyclic carotenoid with strongest singlet oxygen quenching among the carotenoid family
- Modulates oxidative stress markers in serum (varies by study)
- Heat-processed tomato matrices increase bioavailability vs raw tomato
Molecular + tissue targets
- Serum oxidative stress markers
- Prostate tissue carotenoid pool (mechanism interest only · no QHC support)
Dosage range
Typical commercial product 10-30 mg/day from tomato extract. Kavanaugh 2007 PMID 17623802 JNCI summarises the FDA evidence-based review of qualified health claim petitions for tomatoes / lycopene + cancer (prostate / lung / colorectal / gastric / breast / ovarian / endometrial / pancreatic) — FDA concluded there is no credible evidence to support a lycopene-cancer association and only very limited evidence for tomato consumption + a narrow set of cancer sites
Safety notes
Excellent safety profile within typical supplement doses. Very-high-dose lycopene can produce orange-tinted skin (lycopenodermia) — reversible and not harmful
Cross-market regulatory status
🇪🇺 EFSA
No EFSA Reg 432/2012 authorized health claim adopted for lycopene; some opinions remain inconclusive
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · no IN 28/2018 Anexo V alegação funcional for licopeno
Common use cases
- general carotenoid dietary diversity
- tomato-derived antioxidant adjunct
Cross-reference
Health goals: heart health longevity stack
Lifestyles: plant based
Full dossier: /ingredients/lycopene/
Machine-readable JSON: /api/nc/lycopene.json