Tier C

Niacinamide (Nicotinamide · Vitamin B3 amide form)

Also known as: Nicotinamide · Vitamin B3 (amide form) · Nicotinic Acid Amide · Vitamin PP (amide form)

2 PMID anchor · SKIN · METABOLISM · MITO · Last reviewed 2026-06-08

Mechanism of action

  • NAD+ salvage substrate
  • PARP inhibition (high dose)
  • Sirtuin modulation
  • Topical skin barrier support

Molecular + tissue targets

  • NAD+ pool
  • PARP1/2
  • Skin keratinocytes

Dosage range

14-18 mg/day RDA (B3 deficiency prevention) · 500-1500 mg/day NAD+ precursor (Tier C · caution hepatotoxicity > 3 g/day) · 5% topical (Bissett 2005 PMID 16029679 skin RCT)

Safety notes

Hepatotoxicity reported at sustained > 3 g/day systemic intake (UL guidance threshold) · pregnancy generally safe at RDA · topical 5% well-tolerated in 12-week trial

Cross-market regulatory status

🇺🇸 FDA

GRAS (vitamin B3 amide form)

🇪🇺 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) · threshold ≥ 2.4 mg/dia adultos ≥ 19 anos per Anexo III

Evidence anchors (PubMed) · 2

  • PMID 34882669 Review review
    Hołubiec P et al. (2021) Folia Med Cracov
    Pathophysiology and clinical management of pellagra - a review
    Pellagra clinical management review · "therapy is causal and based on administering niacinamide" verbatim · verified 2026-06-07 · official PDF https://www.journals.pan.pl/Content/122089/PDF/2021-03-FMC-09-Halubiec.pdf
  • PMID 34439563 Review review
    Boo YC (2021) Antioxidants (Basel)
    Mechanistic Basis and Clinical Evidence for the Applications of Nicotinamide (Niacinamide) to Control Skin Aging and Pigmentation
    Mechanistic + clinical evidence niacinamide for skin aging/pigmentation · also covers B3 deficiency causes pellagra context + B3 supports NAD+ coenzymes · verified 2026-06-07 · official MDPI https://www.mdpi.com/2076-3921/10/8/1315

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 (15% of NRV per 100 g/ml or per portion)

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

  • NAD+ precursor
  • topical skin appearance
  • pellagra treatment (historical)
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