About
What it is and where it shows up.
Creatine monohydrate is a naturally occurring nitrogenous organic compound (creatine crystallised with one water molecule) found in meat and fish, and also synthesised endogenously in the liver and kidneys from amino acids. It is added to functional foods and dietary supplements to replenish phosphocreatine stores in skeletal muscle, supporting high-intensity exercise performance and lean mass.
Safety summary
The regulatory and scientific consensus.
Over 1,000 human studies show no clinically significant adverse effects at doses up to 30 g/day for up to 5 years in healthy individuals; the only consistently reported effect is transient body-weight gain attributed to intramuscular water retention. FDA granted GRAS status at ≤1.12 g creatine monohydrate per serving and noted that doses up to 3 g/day are unlikely to cause harm. Individuals with pre-existing renal impairment should use caution, as creatine catabolism elevates serum creatinine and may confound kidney-function tests.
Regulatory landscape
What food-safety regulators have decided.
| Jurisdiction | Status | Note |
|---|---|---|
| FSSAI (Food Safety and Standards Authority of India) (India) | Restricted | FSSAI issued a December 2017 advisory noting that creatine monohydrate was not listed as a permitted ingredient under the FSS Act and its sale was considered illegal. Subsequent FSSAI guidance on supplements for sportspersons (2018–2019) and the FSS (Health Supplements, Nutraceuticals, FSDU) Regulations 2016/2021 created a potential pathway for approval under Food for Special Dietary Use (FSDU) for sportspersons, but manufacturers must comply with all labelling, licensing, and prior-approval requirements. Not permitted in products for infants under 24 months.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | EFSA AFC Scientific Panel (2004) approved creatine monohydrate for use in foods for particular nutritional uses. EFSA NDA Panel (2016, EFSA Journal 14(2):4400) substantiated the Article 13(5) health claim for improvement in muscle strength when combined with resistance training at ≥3 g/day. A 2024 EFSA NDA opinion found insufficient evidence to substantiate a separate claim for cognitive function improvement. No formal ADI has been established.source |
| FDA (Food and Drug Administration) (United States) | Approved | GRAS GRN 000931 (AlzChem/Creapure®). Approved at a maximum of 1.12 g creatine monohydrate per serving (equivalent to 1 g creatine) in energy drinks, protein bars, milkshakes, protein powders, meal-replacement products, meat analogues, and dry-mix drinks. FDA response letter states consumption of doses up to 3 g/day is unlikely to cause harm. Use in infant formula is explicitly excluded from GRAS scope.source |
Who should approach with care
Whose guidance would steer them away.
Kidney Disease — Creatine catabolism raises serum creatinine, which can confound renal function tests, and safety has not been established in individuals with pre-existing kidney impairment, as noted in the FDA GRAS dossier review of case reports.
Liver Disease — Although human studies in the FDA GRAS dossier show no liver toxicity at doses up to 7 g/day in healthy adults, individuals with existing hepatic conditions should seek medical advice before use.
Infants — The FDA GRAS notice explicitly excludes infant formula from its scope, and FSSAI nutraceutical regulations do not permit unapproved ingredients in products for children under 24 months.
Pregnancy — Controlled safety data in pregnant women are limited; the ISSN position stand and clinical guidance recommend medical consultation before supplementation during pregnancy or lactation.
Lactation — Insufficient human data exist on creatine transfer into breast milk or its safety for nursing infants, warranting medical consultation before use during lactation.
Research citations
The sources behind this verdict.
- 1FDA. FDA Response Letter to GRN 000931 (Creatine Monohydrate). fda.gov
- 2FDA. GRAS Notice No. GRN 931: Creatine Monohydrate (Creapure®) — AlzChem Trostberg GmbH. fda.gov
- 3PubMed. Common questions and misconceptions about creatine supplementation: what does the scientific evidence really show?, 2021. pmc.ncbi.nlm.nih.gov
- 4FSSAI. FSSAI Advisory Letter on Illegal Sale of Creatine Monohydrate, 2017. fssai.gov.in
- 5PubMed. International Society of Sports Nutrition position stand: safety and efficacy of creatine supplementation in exercise, sport, and medicine, 2017. pmc.ncbi.nlm.nih.gov
- 6EFSA. Creatine in combination with resistance training and improvement in muscle strength: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006, 2016. efsa.europa.eu
Independently researched7 citations