This TGA approval was received after 18 months of work by Ethical Naturals Inc. (ENI) and Transchem, their Australian partner in this venture and the exclusive distributor of AlphaWave into Australia.
“The application process through TGA is extremely vigorous in respect to both safety and efficacy,” said Cal Bewicke, CEO of ENI.
“It examines the manufacturing system, the analytical methods used and clinical data. When it comes down to it, though, although it took us a year and a half, we consider it a privilege to have our product put under a detailed microscope by an organisation so informed as TGA.”
AlphaWave L-Theanine, available for more than 10 years in the US, has become one of the most popular products for stress-relief. In addition to use in dietary supplements, Alpha Wave, which is GRAS affirmed in the US, is widely used in beverage products due to high solubility and neutral taste.
AlphaWave L-Theanine, which is ENI’s key product in the stress relief category, is supported by two clinical studies that showed significant increase in alpha brainwave activity and resulting relaxation and cognitive benefits. A third study is near completion.
The most recent study, A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single 200 mg Dose of Alphawave L-Theanine On Stress in a Healthy Adult Population, was published in Neurology and Health.
In this study, a 200 mg dose of AlphaWave L-Theanine showed significant increases in both whole-scalp and frontal region alpha power, and reductions in salivary cortisol (an objective measurement of stress). These changes were not observed when the participants received the placebo.