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FDA confirms GRAS for Blue California's L-theanine

12-Nov-2010

The U.S Food and Drug Administration (FDA) has confirmed the GRAS (Generally Recognized as Safe) status of Blue California’s L-TeaActive-branded L-theanine ingredient for use in food and beverages.

The amino acid L-theanine (c-glutamylethylamide) is almost exclusively found in tea plants. The compound only exists in the free form, and is the principal free amino acid in tea – accounting for approximately 50 percent of the total free amino acids.

Various health effects have been associated with L-theanine, including relaxation, neuroprotective effects, and improved attention.

During rest, L-theanine increases alpha activity in EEG models - suggesting greater relaxation. Whilst the amino acid is known to induce changes in alpha activity that indicates increased attentional processing during tasks that require attention.

According to the GRAS application – prepared and submitted by Oregon-based GRAS Associates – “The proposed food uses are as a food ingredient – as a dietary source of theanine – in foods such as fruit juices and drinks, non-herbal teas, sports beverages, specialty bottled waters, chocolate bars and chews, hard candies and breath mints, and chewing gum,”

“The intended uses of L-theanine (98 percent) will result in an estimated 90th percentile daily intake of 1284 mg,” continues the GRAS application. “The background 90th percentile intake of L-theanine from its presence in tea has been estimated as 825 mg/day. The estimated daily intake is roughly similar to the levels of L-theanine currently consumed by the heaviest tea drinkers in the United States.”

The company’s ingredient is produced from green tea leaves and other natural ingredients using a proprietary manufacturing process, said Blue California, and the final product is standardized to 98 percent L-theanine.

Choice

“We are very pleased with the FDA’s GRAS confirmation for our product. Our goal was to set a new standard for purity for natural L-theanine derived from green tea and we have achieved it,” said Cecilia McCollum, Blue California’s executive vice president.

“Being able to offer a better choice, a safe and natural functional ingredient that can truly benefit the consumer is a great joy to all of us at Blue California,” she added.

The L-TeaActive ingredient is manufactured under GMP and ISO-9001:2000 quality certifications by NSF, and Blue California is Kosher-certified.

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