🇺🇸 FDA
GRAS · DSHEA dietary supplement · multiple structure/function claims permitted; DV 6 μg (current label)
Vitamin B12 · Cobalamin (Cyanocobalamin · Methylcobalamin · Hydroxocobalamin · Adenosylcobalamin)
Also known as: Cobalamin · Cyanocobalamin · Methylcobalamin · Hydroxocobalamin
Mechanism of action
- Cofactor for methionine synthase (homocysteine → methionine remethylation)
- Cofactor for methylmalonyl-CoA mutase (odd-chain fatty acid metabolism)
- Supports myelin synthesis via methylation pathways
Molecular + tissue targets
- Erythropoiesis (red blood cell formation)
- Homocysteine metabolism
- Myelin / peripheral nerve maintenance
Dosage range
RDA 2.4 μg/day (adults); high-dose oral replacement 1000 μg/day can be effective in food-cobalamin malabsorption, but is not always sufficient at 4 months follow-up (Favrat 2011 PMID 21232119 BMC Family Practice pragmatic RCT n = 50, 1000 μg/day x 4 weeks · MMA partially normalised vs placebo but markers not sustained at 4 months); higher doses (5000 μg/day) may be required for sustained correction
Safety notes
Very wide safety margin in healthy adults — no Tolerable Upper Intake Level established by NIH ODS; rare allergic reactions to cyanocobalamin reported; methylcobalamin or hydroxocobalamin alternatives available for cyanide-sensitive individuals
Cross-market regulatory status
🇪🇺 EFSA
Authorized claims Reg 432/2012 cover red blood cell formation, energy metabolism, fatigue, nervous system, homocysteine metabolism, psychological function, immune system, cell division; NRV 2.5 μg
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegações funcionais verbatim: "A vitamina B12 auxilia na formação de células vermelhas do sangue." + additional energy / nervous system claims available when nutrient threshold met
Authorized claims · verbatim (5)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇪🇺 EFSA · 4 claims
Reg 432/2012
Vitamin B12 contributes to normal red blood cell formation.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin B12" as referred to in the Annex to Reg 1924/2006
Authorized 2012
Reg 432/2012
Vitamin B12 contributes to the reduction of tiredness and fatigue.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin B12"
Authorized 2012
Reg 432/2012
Vitamin B12 contributes to normal energy-yielding metabolism.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin B12"
Authorized 2012
Reg 432/2012
Vitamin B12 contributes to normal functioning of the nervous system.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin B12"
Authorized 2012
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
A vitamina B12 auxilia na formação de células vermelhas do sangue.
Conditions: IN 28/2018 Anexo V: alegação restrita a suplementos cujo aporte diário do nutriente atenda à quantidade mínima do Anexo II (2,4 μg para adultos)
Authorized 2018
Common use cases
- plant-based diet adequacy (B12 is exclusively animal-source in nature)
- food-cobalamin malabsorption in adults > 50
- pernicious anaemia replacement (with clinician oversight)
- fatigue reduction with confirmed deficiency
Cross-reference
Health goals: cognitive support longevity stack
Lifestyles: plant based senior 60 plus
Full dossier: /ingredients/vitamin-b12/
Machine-readable JSON: /api/nc/vitamin-b12.json