🇺🇸 FDA
Self-affirmed GRAS (AlzChem Creapure · GRN 144 · 2003) · DSHEA dietary supplement framework
Creatine Monohydrate
Also known as: α-methyl guanidinoacetic acid · Creatine monohydrate (Cr-H2O) · Creapure
Mechanism of action
- Phosphocreatine system ATP regeneration
- Muscle cell water retention (cell volumization)
- mTOR signaling potentiation
- Brain creatine pool augmentation
Molecular + tissue targets
- Skeletal muscle phosphocreatine reserve
- Brain creatine kinase axis
- Mitochondrial bioenergetics
Dosage range
3-5 g/day maintenance; optional 20 g/day × 5-7 day loading (4 × 5 g); higher dose (10 g/day) explored for cognitive endpoints
Safety notes
Most studied performance supplement; no harm in healthy kidneys (Kreider 2017 ISSN position); creatinine elevation is metabolite (not kidney injury marker in creatine users); hydration recommended
Cross-market regulatory status
🇪🇺 EFSA
Authorized claim for creatine + increased physical performance in repeated short-term high-intensity exercise (3 g/day)
🇧🇷 ANVISA
RDC 243/2018 dietary supplement · IN 28/2018 Anexo V alegação funcional verbatim: "A creatina auxilia no aumento do desempenho físico durante exercícios repetidos de curta duração e alta intensidade." (Anexo III ≥ 3.000 mg/dia adultos ≥ 19 anos)
Authorized claims · verbatim (4)
Direct quotes from each jurisdiction's framework · never paraphrased · with framework reference and conditions of use.
🇺🇸 FDA · 1 claim
Self-affirmed GRAS (multiple GRN submissions including AlzChem Creapure GRN 144 · 2003) + DSHEA dietary supplement framework
Creatine monohydrate is Generally Recognized As Safe (GRAS) under specified conditions of use.
Authorized 2003
🇪🇺 EFSA · 2 claims
Reg 432/2012
Creatine increases physical performance in successive bursts of short-term, high intensity exercise.
Conditions: 3 g/day · adult population doing high-intensity exercise
Authorized 2012
Reg 432/2012
Daily creatine consumption can enhance the effect of resistance training on muscle strength in adults over the age of 55.
Conditions: 3 g/day creatine + resistance training
Authorized 2017
🇧🇷 ANVISA · 1 claim
IN 28/2018 Anexo V alegação funcional
A creatina auxilia no aumento do desempenho físico durante exercícios repetidos de curta duração e alta intensidade.
Conditions: IN 28/2018 Anexo V: alegação restrita aos suplementos cuja quantidade de creatina atenda aos valores mínimos do Anexo III (≥ 3.000 mg/dia = ≥ 3 g/dia para adultos ≥ 19 anos · NA para outros grupos populacionais)
Authorized 2018
Common use cases
- athletic performance (resistance training)
- sarcopenia prevention (older adults)
- cognitive support (sleep deprivation · vegetarian baseline)
Cross-reference
Health goals: athletic performance longevity stack cognitive support
Lifestyles: athletic performance senior 60 plus plant based
Full dossier: /ingredients/creatine/
Machine-readable JSON: /api/nc/creatine.json