GRAS Status of Suntheanine® Affirmed

Taiyo has received official “letter of no objection” from the Food and Drug Administration (FDA) regarding the self-affirmed Generally Recognized as Safe (GRAS) status of its enantiomerically pure L-theanine, marketed as Suntheanine, produced via a patented enzymatic fermentation method.

The GRAS affirmation, as determined by an independent panel of scientific experts, affirms the safe use of Suntheanine in food and beverage categories up to 250 mg per serving, with no limitations on the maximum number of servings.

“The FDA’s confirmation paves the way for Suntheanine to be used in a wide range of food and beverages, including juices, teas, sports beverages, specialty bottled waters, confections and candies”, says Scott Smith, Vice President, Taiyo International.

As protected by numerous U.S. and international patents, Suntheanine has been clinically shown to reduce stress. promote relaxation without drowsiness, improve quality of sleep, diminish normal PMS symptoms, improve concentration and reduce the negative side effects of caffeine (i.e. the jitters).

After reviewing Taiyo’s extensive documentation, the FDA concluded that the agency has no questions regarding Taiyo’s conclusion that L-theanine produced via an enzymatic fermentation processes is GRAS under the intended conditions of use.

“Taiyo strives to develop highly functional and safe ingredients, while working closely with regulatory agencies across the globe to assure total safety and compliance for its global client base,” says Dr. Lekh Juneja, Vice President, Taiyo Kagaku. “This achievement is based on Taiyo’s dedication to science, technology and safety.”


Taiyo International is the North American sales office for Taiyo Kagaku Japan, a leading manufacturer of functional ingredients for the food, beverage and dietary supplement industries. Taiyo focuses on the development of innovative ingredients, derived from natural sources, to further develop the body’s ability to protect and manage one’s health.

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