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U.S. Department of Health and Human Services

GRAS Notices

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GRN No. 931

Creatine monohydrate

Intended Use: Intended for use as an ingredient in energy drinks, protein bars and powders, milk shakes, meal replacement bars and powders, meat analogs, and dry powdered drink mixes at a level of 1.2 grams (g)/serving (equivalent to 1.0 g creatine/ serving).
Basis: Scientific procedures
Notifier: AlzChem Trostberg GmbH
Notifier Address: Dr. Albert_Frank_Str. 32
D-83308 Trostbreg
GRAS Notice (releasable information): GRN 931 with amendments (in PDF) (3.1 MB)
Date of closure: Nov 12, 2020
Date of FDA’s corrected letter: Dec 3, 2020
FDA's Letter: FDA has no questions (in PDF) (437 kB)