About
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
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
| 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
Research citations
- 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
