Novato, California (January 11, 2024) –Ethical Naturals Inc. (ENI)’s Alpha Wave® L-Theanine, which provides clinically supported stress-relief, has now passed the rigorous safety and efficacy standards required for approval by the Australian Therapeutic Goods Administration (TGA). With TGA approval AlphaWave will be permitted for use in Australia.
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 in-depth the manufacturing system, the analytical methods used and clinical data. When it comes down to it, though it took us a year and a half, we consider it a privilege to have our product put under a detailed microscope by an organization so informed as TGA.”
AlphaWave L-Theanine, available for over ten 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 200mg dose of AlphaWave L-Theanine on stress in a healthy adult population’ was published in Neurology and Health, September 2021[1]. In this study a 200mg 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 placebo.
About Ethical Naturals
Since 2005 Ethical Naturals (ENI) has been a key supplier of standardized and proprietary botanical ingredients to the US and international supplement markets. ENI’s distribution, testing laboratory and finished product manufacturing operations are all cGMP certified by NSF, and the company operates out of their solar powered facility in Redwood City, California. Ethicalnaturals.com