The company recently announced that its ashwagandha (Withania somnifera) extract, branded as Shoden, has been approved as a natural health product (NHP) by Health Canada, a process that took up to 270 business days.
All NHPs must be approved by the authority before they are allowed to be legally sold in Canada. To achieve this, a product is required to undergo a rigorous review process that involves testing the ingredients for purity and potency, and evaluation of published scientific research and clinical studies.
These measures ensure that the product meets stringent safety and efficacy standards before it is licensed and brought to market.
“There are numerous unregulated ashwagandha extracts on the market that are failing to deliver what they promise. This recognition by Health Canada validates Shoden as a reliable, science-backed source of ashwagandha extract that delivers its distinct benefits. It underscores Arjuna Natural’s commitment to supplying regulatory-compliant, high-quality ingredients that consumers in Canada and around the world can trust.
“Ashwagandha is the fastest-growing supplement worldwide, including Canada, thanks to its wide-ranging benefits for stress and sleep. Having obtained the Natural Product Number (NPN) for Shoden, it enables manufacturers to make a variety of health claims while saving them time and effort by eliminating the need to apply for NPN themselves,” Benny Antony, Joint Managing Director of Arjuna Natural, told NutraIngredients-Asia.
The company believes this ability to make health claims will potentially open new doors.
“It will also allow supplement manufacturers to make label recommendations pertaining to Shoden’s specific health benefits on their end products.”
The long-term benefits include helping to improve sleep onset, duration and quality; increase resistance to stress and reduce symptoms of mild anxiety in individuals with a history of chronic stress; decrease symptoms of stress; and alleviate fatigue and boost energy.
It is also said to help promote testosterone production in males and reduce “stress hormone” cortisol, when consumed over time.
“We are excited to bring Shoden to the Canadian nutraceutical space and look forward to collaborating with researchers and product developers, not only in Canada but internationally, helping them to create innovative solutions for stress management and overall well-being.
“The US, as well as countries in Europe and Asia view Health Canada’s approval as a highly reliable benchmark for quality, which will fast-track Shoden’s expansion into those markets.”
According to Antony, Shoden is the only ashwagandha extract that has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS) on the functionality of improving sleep quality.
Low-dose capabilities widen application possibilities
Shoden is distinguished for its standardisation to more than 35% withanolide glycosides, the key active compounds in the ashwagandha extract.
Also called Indian ginseng, the adaptogen is noted for its antioxidant and anti-inflammatory properties, and is considered a rejuvenating herb in traditional Ayurvedic medicine due to its studied capacity to enhance overall resilience and vitality.
“Our potent ashwagandha extract of the whole plant is derived from carefully chosen and validated sources using a proprietary extraction process. This ensures exceptional absorption and maximum utilisation of the full spectrum of withanolide compounds, even at an unusually low dose of 60 to 120mg.”
Currently, Shoden holds 23 patents for its formulation and manufacturing methods, and is backed by 11 clinical studies and 4 animal studies that support its positive role in mitigating stress and anxiety and improving sleep quality, even at low doses.
The studies have linked its stress-relieving effects to its ability to regulate the hypothalamus-pituitary-adrenal axis, reducing cortisol and increasing GABA neurotransmitters for relaxation.
Another clinical study has highlighted its immunomodulating benefits, demonstrating improvements in immune cell markers, including natural killer and T-cell activity. These suggest its potential for diminishing infection risks and boosting immunity.
The ingredient is available in three dosage levels and can be applied in various supplement formats, including pill, capsule, and powder.
“With the rising popularity of functional foods, Shoden’s low-dosing capabilities allow it to be integrated seamlessly into food and beverage applications, including soft drinks, energy shots, and other sports nutrition products.”
