Ethical Naturals' AlphaWave L-Theanine earns TGA approval for sale in Australian market

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According to Ethical Naturals, the approval was the result of 18 months of work by the company and Transchem, its Australian partner and exclusive distributor of AlphaWave in the country.

Photo © AdobeStock.com/Thomas Pajot

Photo © AdobeStock.com/Thomas Pajot

Ethical Naturals Inc. (ENI; Novato, CA) has announced that its Alpha Wave L-Theanine has been approved by the Australian Therapeutic Goods Administration (TGA) for sale in the country. According to Ethical Naturals, the approval was the result of 18 months of work by the company and Transchem, its Australian partner and exclusive distributor of AlphaWave in the country.

“The application process through TGA is extremely vigorous in respect to both safety and efficacy,” said Cal Bewicke, CEO of ENI, in a press release. “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.”

ENI’s AlphaWave L-Theanine has been available in the U.S.for over ten years, and is GRAS (generally recognized as safe) for use in food and beverage products. ENI states in a press release that the product’s stress-support and cognitive health benefits have been supported by two clinical studies, with a third nearing completion. The most recent study found that a 200 mg dose of the product significantly increased frontal region alpha power and reduced the salivary cortisol.1

Reference

  1. Evans, M.; McDonald, A.C.; Xiong, L.; Crowley, D.C.; Guthrie, N. A Randomized, Triple-Blind, Placebo-Controlled, Crossover Study to Investigate the Efficacy of a Single Dose of AlphaWave® L-Theanine on Stress in a Healthy Adult Population. Neurology and Therapy, 2021, 10: 1061-1078. DOI: 10.1007%2Fs40120-021-00284-x
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