🇺🇸 FDA
GRAS · DSHEA dietary supplement · 21 CFR 101.79 authorized health claim: folate + neural tube defect risk reduction (food + supplement label); 21 CFR 184.1492 folic acid food additive
Folate · Vitamin B9 (Folic Acid · 5-MTHF)
Also known as: Folic acid · 5-methyltetrahydrofolate · 5-MTHF · Vitamin B9 · L-methylfolate calcium
Mechanism of action
- One-carbon metabolism cofactor (DNA synthesis, methylation, amino acid metabolism)
- Co-cofactor with B12 in methionine synthase reaction
- Required for neural tube closure in early embryogenesis (closure window day 21-28 post-conception)
Molecular + tissue targets
- Erythropoiesis
- Homocysteine metabolism
- Embryonic neural tube closure
- DNA synthesis in dividing cells
Dosage range
400 μg/day periconceptional for first-occurrence NTD prevention (Czeizel 1992 PMID 1307234 NEJM RCT n = 4,156 multivitamin + 0.8 mg folic acid vs trace-element · 0 NTD vs 6 NTD); 4 mg/day for recurrence prevention in women with a prior NTD pregnancy (MRC Vitamin Study 1991 PMID 1677062 Lancet n = 1,195 completed pregnancies · 72% protective effect, RR 0.28, 95% CI 0.12-0.71); RDA 400 μg DFE for adults
Safety notes
Folate supplementation can mask the haematological signs of B12 deficiency while neuropathy progresses — measure or supplement B12 alongside folate in adults > 50 or with malabsorption risk; upper limit 1000 μg/day folic acid from fortified food + supplement (excluding food folate)
Cross-market regulatory status
🇪🇺 EFSA
Authorized claims Reg 432/2012 (blood formation, homocysteine, maternal tissue growth, etc.) + Commission Reg 1135/2014 implementing Reg 1924/2006 Article 14(1)(a) reduction of disease risk claim for periconceptional 400 µg folic acid lowering NTD risk; NRV 200 μg
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "O ácido fólico auxilia na formação das células vermelhas do sangue." + additional homocysteine / cell division 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
Folate contributes to normal blood formation.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of folate"
Authorized 2012
Reg 432/2012
Folate contributes to maternal tissue growth during pregnancy.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of folate" + the claim must be accompanied by information that a balanced and varied diet plus a healthy lifestyle is important
Authorized 2012
Reg 432/2012
Folate contributes to normal homocysteine metabolism.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of folate"
Authorized 2012
Commission Reg 1135/2014 (Reg 1924/2006 Article 14(1)(a) reduction of disease risk authorization)
Supplemental folic acid intake increases maternal folate status. Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus.
Conditions: Commission Reg 1135/2014 implementing Reg 1924/2006 Article 14(1)(a): target population is women of childbearing age; daily supplemental intake of folic acid 400 µg for at least one month before and up to three months after conception
Authorized 2014
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
O ácido fólico auxilia na formação das 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 (240 μg para adultos)
Authorized 2018
Common use cases
- periconceptional supplementation for neural tube defect prevention
- maternal nutrition in pregnancy
- megaloblastic anaemia adjunct (with B12 confirmed)
- homocysteine reduction
Cross-reference
Health goals: reproductive health cognitive support longevity stack
Lifestyles: pregnancy plant based
Full dossier: /ingredients/folate/
Machine-readable JSON: /api/nc/folate.json