Theanine
L-theanine has multiple GRAS notices on file with FDA (e.g., GRN 209, 251, 459) for use in beverages and foods up to 250 mg/serving. Toxicology studies show no genotoxicity or significant adverse effects.
What it is
L-theanine — a non-protein amino acid (γ-glutamylethylamide) naturally found in tea (Camellia sinensis).
Functional ingredient associated with relaxation and cognitive effects; flavor contributor.
What regulators actually say
"FDA had no questions regarding the GRAS notice for L-theanine for use as an ingredient in beverages... at levels up to 250 mg per serving."
Regulatory status
United States — FDA
GRAS via multiple GRAS Notices (e.g., GRN 209) for beverage and food use up to 250 mg/serving.
European Union — EFSA
Not authorized as a novel food in the EU for general food use; permitted in some food supplements per national rules.
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