Re: Suntheanine® GRAS - FDA Letter of no Objection
Taiyo is pleased to announce that on February 6, 2007 it received official notification from the FDA that the agency has no objection to the conclusion of an independent panel of scientific experts that Suntheanine®, as produced via a patented enzymatic fermentation method, resulting in an enantiomerically pure L-theanine, is safe and is GRAS for its intended use in foods.
Based on the human clinical studies for relaxation and stress, the recommended dosage for Suntheanine is between 50 200 mg per serving. As defined by the GRAS monograph, Suntheanine is intended to be added to foods in a number of different categories to provide up to 250 mg/serving of Suntheanine, with no limitation on the maximum servings.
In accordance with 21 CFR 170.36, a copy of the FDA Letter of No Objection for Suntheanine® produced via an enzymatic fermentation process (GRN 000209) is available on the homepage of the Office of Food Additive Safety.
Taiyo International, Inc.
5960 Golden Hills Drive
Minneapolis, MN 55416