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AlphaWave L-Theanine earns approval for Australian market in addition to US GRAS affirmation
Alpha brainwaves have the potential to unlock a state of relaxed wakefulness.
Alpha brainwaves – as measured by electroencephalogram (EEG) – are associated with a state of relaxed wakefulness, typically observed when a person is awake but in a relaxed state, such as during meditation.1 Research has shown that alpha brainwaves play a role in a variety of cognitive processes, including attention, memory, and creativity.2 Higher levels of frontal region alpha activity have also been linked to reduced anxiety and stress.
Clinical studies have demonstrated AlphaWave L-Theanine's ability to increase alpha brainwave activity.
AlphaWave L-Theanine, a key stress-relief ingredient, now available for use in Australia
AlphaWave L-Theanine has been available for over 10 years in the US, where it has grown to become one of the most popular ingredients for stress-relief in both supplements and beverages. However, AlphaWave had not been permitted for use in Australia until it received approval from the Australian Therapeutic Goods Administration (TGA) for inclusion in the Permissible Ingredients Determination (PID) for use as an ingredient in listed medicines in Australia. This approval was received after 18 months of work by Ethical Naturals Inc. (ENI).
The application process for approval of a new ingredient for use in listed medicines in Australia is an essential step to the ingredient's use in supplements and foods, and it requires the submission to TGA of extensive data for assessment. The process examines aspects such as quality through the manufacturing systems, analytical methods used and data relating to safe usage and dosage. AlphaWave is the only source of L-Theanine to receive this approval that now allows its use in the manufacture of supplements in Australia.
The market potential of AlphaWave through Australia
The potential for AlphaWave in the Australian and Asia-Pacific market is substantial now that TGA approval for its use has been granted. Strong interest has been shown by several leading brands that market products both in Australia, New Zealand and throughout the Asia-Pacific region. It's expected that a retail and practitioner launch will take place in the first quarter (Q1) of 2024.
Clinical studies show significant increase in alpha brainwave levels
The efficacy of AlphaWave L-Theanine has been validated by two clinical studies that confirm its ability to increase alpha brainwave activity and deliver significant relaxation benefits.
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 2021.3
In this study a 200mg dose of AlphaWave L-Theanine was shown to promote significant increases in both whole-scalp and frontal region alpha power, and reductions in salivary cortisol (both are objective measurement of reduced levels of stress). These changes were not observed when the participants received placebo.
The summary of this study concluded: 'A single dose of AlphaWave® L-Theanine had significant positive effects on brainwaves, salivary cortisol, and self-reported state anxiety compared to the placebo in response to an acute stress challenge. These changes are indicative of relaxation in the brain and suggest a calming response in a moderately stressed but otherwise healthy population. AlphaWave® L-Theanine was found to be safe and well tolerated by participants.'
AlphaWave: The only source of L-Theanine for supplement use in Australia
Highlighting the complex application through TGA, Cal Bewicke, CEO of Ethical Naturals, says: “The application process through TGA is detailed and rigorous. It examines in-depth the manufacturing system, the analytical methods used and clinical data. Though this work took us a year and a half, we consider it a privilege to have our product put under this detailed examination.
“The fact that AlphaWave is now the only L-Theanine approved for use in Australia is a real bonus for us. We look forward to supplying Australian companies with AlphaWave and this will certainly bring this key stress-relief ingredient into wider use in the Asia-Pacific region.”
The Asia Pacific region is considered a key growth area for supplement demand and is expected to grow at a compound annual growth rate (CAGR) of over 12% 2023 - 2030.4 There are a number of factors driving this trend including an increasing focus on personal health and well-being.4 Among the leaders in this growth trend are key Australian brands and manufacturers. The TGA approval will allow these brands to bring AlphaWave L-Theanine to this market.
Ethical Naturals Inc. (ENI)
Since 2005 Ethical Naturals (ENI) has been a key supplier of standardized and proprietary botanical ingredients in US and international supplement markets. ENI’s distribution, testing laboratory and finished product manufacturing operations are all Current Good Manufacturing Practice (cGMP) certified by National Sanitation Foundation (NSF), and the company operates out of its solar powered facility in Redwood City, California.
References
1. Lee, D.J.; Kulubya, E.; Goldin, P.; et al. (2018). Review of the neural oscillations underlying meditation. Front Neurosci. 2018;12:178.
2. Lustenberger, C.; Boyle, M. R.; Foulser, A. A.; et al. (2015). Functional role of frontal alpha oscillations in creativity. Cortex. 67, 74–82.
3. Study conducted by KGK Science Inc. Neurology and Health. 2021. 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.
4. Grand View Research. Asia Pacific Dietary Supplements Market Size, Share & Trends Analysis Report By Ingredient (Vitamins, Minerals, Botanicals) 2023-2030.
