🇺🇸 FDA
GRAS (vitamin B3 acid form low dose) · Rx Niaspan for hyperlipidemia
Niacin (Nicotinic Acid · Vitamin B3 acid form)
Also known as: Nicotinic Acid · Vitamin B3 (acid form) · Vitamin PP (acid form) · Niaspan (Rx ER form)
Mechanism of action
- HM74A/GPR109A agonism
- NAD+ precursor
- Lipid management (HDL+ / TG-)
- Adiponectin-mediated insulin sensitivity
Molecular + tissue targets
- GPR109A receptor
- NAD+ pool
- Liver lipoprotein metabolism
Dosage range
14-18 mg/day RDA (B3 deficiency prevention) · 500-2000 mg/day Rx ER Niaspan (Tier C · prescription only)
Safety notes
Flushing common at > 50 mg/day acute · hepatotoxicity at sustained > 3 g/day · UL 35 mg/day (NIH-ODS) for non-prescription · Rx Niaspan AIM-HIGH 2011 (PMID 22085343) + HPS2-THRIVE 2014 (PMID 25014686) showed no incremental benefit + adverse signal on statin background
Cross-market regulatory status
🇪🇺 EFSA
Reg 432/2012 authorized health claims · 6 niacin claims (vitamin B3 family)
🇧🇷 ANVISA
IN 28/2018 Anexo V "niacina" · 4 functional claims (pele · mucosas · metabolismo energético · metabolismo de proteínas/carboidratos/gorduras) · UL 35 mg/day non-prescription
Authorized claims · verbatim (10)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇪🇺 EFSA · 6 claims
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224
Niacin contributes to normal energy-yielding metabolism
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim "SOURCE OF [VITAMIN/S]" threshold (15% of NRV per 100 g/ml or per portion; niacin NRV = 16 mg)
Authorized 2012
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224
Niacin contributes to normal functioning of the nervous system
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim threshold
Authorized 2012
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757
Niacin contributes to normal psychological function
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim threshold
Authorized 2012
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224
Niacin contributes to the maintenance of normal mucous membranes
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim threshold
Authorized 2012
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2009;7(9):1224 + 2010;8(10):1757
Niacin contributes to the maintenance of normal skin
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim threshold
Authorized 2012
Reg 432/2012 Annex · authorized health claim · EFSA Journal 2010;8(10):1757
Niacin contributes to the reduction of tiredness and fatigue
Conditions: Food must be at least a source of niacin per Reg 1924/2006 nutrition claim threshold
Authorized 2012
🇧🇷 ANVISA · 4 claims
IN 28/2018 Anexo V · alegação funcional autorizada
A niacina auxilia no metabolismo energético.
Conditions: Alegação restrita aos suplementos alimentares cuja quantidade de niacina atenda aos valores mínimos estabelecidos no Anexo III (≥ 2.4 mg/dia adultos ≥ 19 anos)
Authorized 2018
IN 28/2018 Anexo V · alegação funcional autorizada
A niacina auxilia no metabolismo de proteínas, carboidratos e gorduras.
Conditions: Alegação restrita aos suplementos alimentares cuja quantidade de niacina atenda aos valores mínimos estabelecidos no Anexo III (≥ 2.4 mg/dia adultos ≥ 19 anos)
Authorized 2018
IN 28/2018 Anexo V · alegação funcional autorizada
A niacina contribui para a manutenção da pele.
Conditions: Alegação restrita aos suplementos alimentares cuja quantidade de niacina atenda aos valores mínimos estabelecidos no Anexo III (≥ 2.4 mg/dia adultos ≥ 19 anos)
Authorized 2018
IN 28/2018 Anexo V · alegação funcional autorizada
A niacina auxilia na manutenção de mucosas.
Conditions: Alegação restrita aos suplementos alimentares cuja quantidade de niacina atenda aos valores mínimos estabelecidos no Anexo III (≥ 2.4 mg/dia adultos ≥ 19 anos)
Authorized 2018
Common use cases
- cardiovascular lipid management (Rx prescription only)
- NAD+ precursor (low dose RDA)
- pellagra treatment
Cross-reference
Health goals: heart health longevity stack
Lifestyles: senior 60 plus
Full dossier: /ingredients/niacin/
Machine-readable JSON: /api/nc/niacin.json