Table 5.

Regulatory status of nutrients marketed as creatine supplements in the United States of America.

FDA Generally Recognized As Safe (GRAS)
Purported Creatine Source Submitted	FDA Report Number	Submission Year	Intended Dosage	FDA Response
Creatine Monohydrate (Creapure®)	GRN 931	2020	1 g creatine (1.12 g creatine monohydrate) as an ingredient in “energy” drinks, protein bars and powders, milk shakes, meal replacement powders and bars, meat analogs, and powdered drink mixes (excluding infant formula.	FDA has no questions at this time.
Self-Affirmed Generally Recognized As Safe (GRAS)
Purported Creatine Source Submitted	FDA Report Number	Submission Year	Intended Dosage	FDA Response
Creatine chelated with Mg (Creatine MagnaPower®)		2013
New Dietary Ingredient Notifications (NDIN) *
Purported Creatine Source Submitted	FDA Report Number	Submission Year	Intended Dosage	FDA Response
Creatine Pyruvate	RPT28	1998	5–10 g/day in 2 equal doses	Filed by FDA without substantive comments.
Creatine Ethylesters [Brand: Cre-Ester™]	RPT154	2002	Maximum daily dose of 30 g	Objected by the FDA.
Creatine Ethylesters [Brand: Cre-Ester™]	RPT190	2002	0.5–5.0 g/day	Objected by the FDA.
Tricreatine Orotate	RTP201	2003	1–2 g 3 ×/day (3–6 g/day)	Objected by the FDA.
Creatine ethyl ester HCL [Brand: CE2™]	RTP249	2004	500 mg–5 g/day	Objected by the FDA.
Creatine from creatine ethyl ester HCL [Brand: CE2™]	RTP264	2004	500 mg–3 g/day	Objected by the FDA.
Beta Creatine	RPT660	2010	4.5–7.5 g/day creatine 3–6 g/day beta-alanine	Objected by the FDA.
Creatine Nitrate	RTP696	2011	1.5 g serving, maximum dose 3 g/day	Objected by the FDA.
Creatine Nitrate	RPT993	2017	750 mg per day	Acknowledged with no objections by FDA.
Creatine acesulfame	RPT1064	2018	10 g per day	Objected by the FDA.

FDA = Food and Drug Administration. * Data retrieved from AHPA NDI Database http://ndi.ahpa.org/ (accessed on 1 January 2022).