Immune system (lymphocyte proliferation, cytokine production)
Dosage range
US IOM RDA: 1.3 mg/day adults 19-50y, 1.5 mg/day women 51+, 1.7 mg/day men 51+ (1.9 mg/day pregnancy, 2.0 mg/day lactation). EFSA NDA AI: 1.6 mg/day adult men, 1.6 mg/day adult women (1.8 mg/day pregnancy, 1.7 mg/day lactation). EFSA NRV (labelling): 1.4 mg. Common supplemental doses: 1.4-25 mg/day. US IOM Tolerable Upper Intake Level (UL): 100 mg/day adults. EFSA UL: 25 mg/day adults. Higher doses (50-100 mg/day) in clinical use for hyperhomocysteinemia or premenstrual symptoms must be time-limited under clinical supervision.
Safety notes
Vitamin B6 is generally well-tolerated at supplemental doses up to the UL. Chronic high-dose B6 supplementation (>200 mg/day for months to years) is associated with sensory peripheral neuropathy that is usually reversible upon discontinuation but may be persistent in severe cases. The EFSA UL of 25 mg/day is more conservative than the US UL of 100 mg/day and reflects this neurotoxicity concern. Drug interactions: B6 reduces effectiveness of levodopa (when taken without carbidopa); may reduce phenytoin and phenobarbital serum levels; potentiates effects of altretamine. Patients on isoniazid, hydralazine, cycloserine, penicillamine, or oral contraceptives may have increased B6 requirements. Pregnancy/lactation: stay within RDA unless clinically directed; pyridoxine has been used safely for nausea of pregnancy at 10-25 mg doses.
Cross-market regulatory status
🇺🇸 FDA
United States (FDA): NO 21 CFR Part 101 Subpart E SSA health claim exists for vitamin B6. Vitamin B6 is not among the 12 SSA-authorized nutrient-disease pairs. No FDA Qualified Health Claim (QHC) under 21 CFR 101.93 has been authorized for vitamin B6 either. Vitamin B6 is regulated as an essential nutrient under 21 CFR 101.9 (Nutrition Facts) with a Daily Value of 1.7 mg, and may bear DSHEA structure/function claims under 21 CFR 101.93 (e.g., "supports nervous system function", "supports energy metabolism") provided the disclaimer "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." is included.
🇪🇺 EFSA
European Union (EFSA / Reg 432/2012): Ten authorized Article 13(1) function health claims for vitamin B6 in the Annex to Commission Regulation (EU) No 432/2012 (CELEX:32012R0432), covering cysteine synthesis, energy-yielding metabolism, nervous system functioning, homocysteine metabolism, protein and glycogen metabolism, psychological function, red blood cell formation, immune system function, reduction of tiredness and fatigue, and regulation of hormonal activity. All ten share the standard condition: claim may be used only for food which is at least a source of vitamin B6 per the SOURCE OF reference in the Annex to Regulation (EC) No 1924/2006 (>=15% NRV per 100 g/100 mL or per portion; NRV = 1.4 mg per Regulation (EU) No 1169/2011 Annex XIII). Character-level second-pass framing applied per [[feedback-websearch-second-pass-ab-framing-for-char-audit]] confirmed article placement on the four ambiguous rows. No Article 14 disease-risk-reduction claim authorized for vitamin B6.
🇧🇷 ANVISA
Brasil (ANVISA): A vitamina B6 (piridoxina) é constituinte autorizado para suplementos alimentares conforme Instrução Normativa DC/ANVISA IN nº 28/2018 (com atualizações em IN 76/2020 e seguintes), Anexos I/II (constituintes), III/IV (limites mínimos e máximos) e V (alegações autorizadas). As alegações funcionais autorizadas seguem o padrão verbatim oficial "A vitamina B6 auxilia ..." cobrindo metabolismo de proteínas / carboidratos / gorduras, formação de células vermelhas do sangue, síntese de cisteína, funcionamento do sistema imune, sistema nervoso, função psicológica, redução do cansaço e fadiga, e regulação da atividade hormonal. Verbatim character-for-character requer consulta direta ao PDF oficial do BVSMS — authorized_claims ANVISA deste card intencionalmente ausentes até confirmação manual via leitura do PDF oficial.
B-vitamins in patients with recent transient ischaemic attack or stroke in the VITAmins TO Prevent Stroke (VITATOPS) trial: a randomised, double-blind, parallel, placebo-controlled trial
Folate intake, MTHFR genotype, and sex modulate the association between methylenetetrahydrofolate reductase and homocysteine in the Leiden 85-plus Study
B12/folate-centric Leiden 85-plus cohort · NOT B6-centric (Workflow critique self-flag · candidate for replacement with HOPE-2 or NORVIT in future revision)
Authorized claims · verbatim (10)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇪🇺 EFSA · 10 claims
Reg 432/2012
Vitamin B6 contributes to normal cysteine synthesis
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal energy-yielding metabolism
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal functioning of the nervous system
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal homocysteine metabolism
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal protein and glycogen metabolism
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal psychological function
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to normal red blood cell formation
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to the normal function of the immune system
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to the reduction of tiredness and fatigue
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Reg 432/2012
Vitamin B6 contributes to the regulation of hormonal activity
Conditions: The claim may be used only for food which is at least a source of vitamin B6 as referred to in the claim SOURCE OF [NAME OF VITAMIN/S] AND/OR [NAME OF MINERAL/S] as listed in the Annex to Regulation (EC) No 1924/2006.
Common use cases
Daily nutritional support for energy metabolism and nervous system function
