Ingredients supplier Taiyo International said it has received a 'letter of no objection' from the US Food and Drug Administration (FDA) for the self-affirmed GRAS status of its L-theanine brand Suntheanine.
The amino acid ingredient is produced via a patented enzymatic fermentation method and the company said it is enantiomerically pure. The GRAS (Generally Recognized as Safe) status 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," said Scott Smith, Taiyo vice president.
Taiyo International is the sales office for Japanese firm Taiyo Kagaku. Suntheanine is protected by both United States and international patents. The company claims the ingredient has been clinically shown to reduce stress, promote relaxation without drowsiness, improve the quality of sleep, diminish normal PMS symptoms, improve concentration and reduce the negative side effects of caffeine.
According to Taiyo, after reviewing the company's documentation, FDA concluded it has no objection to Taiyo's conclusion 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," said Dr. Lekh Juneja, vice president, Taiyo Kagaku.