Monk Fruit Extract
Monk fruit extract has been the subject of multiple FDA GRAS notices to which the agency has not objected. It contributes no calories or sugars and has not raised safety concerns at intended use levels.
What it is
High-intensity natural sweetener obtained from Siraitia grosvenorii (luo han guo) fruit; primary sweet compounds are mogrosides.
Non-nutritive sweetener; 100-250x sweeter than sucrose.
What regulators actually say
"FDA has not questioned the notifiers' GRAS determinations under the intended conditions of use described in the GRAS notices submitted to FDA for monk fruit extracts."
Regulatory status
United States — FDA
FDA has issued no-questions GRAS letters for monk fruit extracts (e.g., GRN 301, GRN 522, GRN 556, GRN 627).
European Union — EFSA
Not authorised as a food additive in the EU; requires novel food authorisation.
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