🇺🇸 FDA
GRAS · qualified health claim (calcium + vitamin D and osteoporosis · docket 2008Q-0317)
Vitamin D3 (Cholecalciferol)
Also known as: Cholecalciferol · 25-hydroxyvitamin D3 precursor
Mechanism of action
- VDR (vitamin D receptor) ligand
- Calcium/phosphate homeostasis
- Immune modulation
- Antimicrobial peptide induction (cathelicidin)
Molecular + tissue targets
- VDR transcription factor
- Calcium-phosphate axis
- Innate immunity
Dosage range
600-2000 IU/day general adult; up to 4000 IU/day UL (FNB); testing for 25(OH)D status before initiating supplementation (deficiency threshold 25(OH)D < 20 ng/mL)
Safety notes
Hypercalcemia risk at sustained > 10,000 IU/day; VITAL primary endpoint negative (cardiovascular + cancer primary prevention) — secondary endpoints + subgroups disclose honestly
Cross-market regulatory status
🇪🇺 EFSA
Authorized claims for bone, muscle, immune, calcium absorption
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V 6 alegações funcionais (formação ossos+dentes · absorção Ca/P · sistema imune · funcionamento muscular · manutenção Ca sangue · divisão celular) · Anexo III ≥ 3 µg/dia adultos ≥ 19 anos (= ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized claims · verbatim (12)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇺🇸 FDA · 1 claim
21 CFR 101.72(f) Authorized Health Claim (SSA standard · docket 2008Q-0317 final rule)
Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.
Conditions: Significant Scientific Agreement (SSA) standard · authorized health claim (not qualified) · Conditions per § 101.72 + § 101.54(b) "high" nutrient level: food must contain ≥ 20% DV calcium per RACC + be assimilable + phosphorus ≤ calcium by weight; when vitamin D included ≥ 20% DV vitamin D per RACC; § 101.72(f) provides two model wordings (this is one of two authorized verbatim options)
Authorized 2008
🇪🇺 EFSA · 5 claims
Commission Regulation (EU) 1228/2014 art 14 (disease risk reduction claim)
Calcium and vitamin D help to reduce the loss of bone mineral in post-menopausal women. Low bone mineral density is a risk factor for osteoporotic bone fractures.
Conditions: Two-tier: Tier 1 food product composition ≥ 400 mg calcium + 15 µg (600 IU) vitamin D per daily portion; Tier 2 consumer disclosure ≥ 1200 mg calcium + 20 µg (800 IU) vitamin D per day from all dietary sources combined; target population: women aged 50 years and older
Authorized 2014
Reg 432/2012
Vitamin D contributes to the maintenance of normal bones.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin D" — ≥ 15% of NRV per 100 g/100 ml/portion (NRV vitamin D = 5 µg/day · Reg 1169/2011 Annex XIII)
Authorized 2012
Reg 432/2012
Vitamin D contributes to the maintenance of normal muscle function.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin D" — ≥ 15% of NRV per 100 g/100 ml/portion (NRV vitamin D = 5 µg/day · Reg 1169/2011 Annex XIII)
Authorized 2012
Reg 432/2012
Vitamin D contributes to the normal function of the immune system.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin D" — ≥ 15% of NRV per 100 g/100 ml/portion (NRV vitamin D = 5 µg/day · Reg 1169/2011 Annex XIII)
Authorized 2012
Reg 432/2012
Vitamin D contributes to normal absorption/utilisation of calcium and phosphorus.
Conditions: Reg 1924/2006 art 10(2) + Annex: claim may only be used for food which is at least a "source of vitamin D" — ≥ 15% of NRV per 100 g/100 ml/portion (NRV vitamin D = 5 µg/day · Reg 1169/2011 Annex XIII)
Authorized 2012
🇧🇷 ANVISA · 6 claims
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia na formação de ossos e dentes.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI · 0-11 meses 1,5 µg · 1-3 anos 2,25 µg · 4-18 anos 2,25 µg · gestantes 2,25 µg · lactantes 2,25 µg)
Authorized 2018
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia na absorção de cálcio e fósforo.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized 2018
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia no funcionamento do sistema imune.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized 2018
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia no funcionamento muscular.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized 2018
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia na manutenção de níveis de cálcio no sangue.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized 2018
IN 28/2018 Anexo V alegação funcional
A vitamina D auxilia no processo de divisão celular.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de vitamina D atenda aos valores mínimos do Anexo III (≥ 3 µg/dia adultos ≥ 19 anos = ≥ 120 UI/dia · 1 µg colecalciferol = 40 UI)
Authorized 2018
Common use cases
- bone health
- skeletal mineralization
- immune support adequacy
- fall prevention older adults
Cross-reference
Health goals: joint bone menopause support inflammation relief
Lifestyles: pregnancy menopause senior 60 plus plant based
Full dossier: /ingredients/vitamin-d3/
Machine-readable JSON: /api/nc/vitamin-d3.json