Shoden, an ashwagandha extract by Arjuna Natural, has been approved as a Natural Health Product by Health Canada, authorizing its sale in the country following a review of its safety and efficacy.

To receive a Natural Product Number from Health Canada, the Canadian regulatory agency in charge of the sale of natural health products, a product must undergo a pre-market review process involving testing the ingredient for purity and potency, and an evaluation of scientific research and clinical studies on the product.

Shoden is a bioactive extract of ashwagandha, distinguished by its standardization to more than 35% withanolide glycosides as measured by HPLC testing. Ashwagandha is noted for its antioxidant, inflammatory modulating properties, and is considered to be a rejuvenating herb in traditional Ayurvedic medicine.

“Our potent ashwagandha extract of the whole plant is derived from carefully chosen and validated sources using a proprietary extraction process,” says Benny Antony, PhD, joint managing director for Arjuna Natural. “This ensures exceptional absorption and maximum utilization of the full spectrum of withanolide compounds, even at an unusually low dose of 60-120mg. Shoden holds a string of 23 patents for its unique formulation and manufacturing methods.”

“Troublingly, there are numerous unregulated ashwagandha extracts on the market that are failing to deliver what they promise,” said Antony. “This recognition by Health Canada confirms Shoden as a reliable, scientifically backed source of the extract that delivers the distinct wellness benefits of ashwagandha. It underscores Arjuna Natural’s commitment to supplying regulatory compliant, high-quality ingredients that consumers in Canada and internationally can trust.”

Health Canada has approved the following health claims for Shoden:

• Helps improve sleep onset, duration, and quality when used over time.
• Helps increase resistance to stress and reduce symptoms of mild anxiety in individuals with a history of chronic stress.
• Helps reduce the symptoms of stress when used over time.
• May be used in herbal medicine as an adaptogen to help increase energy and resistance to stress over time (e.g., in case of mental and physical fatigue related to stress).
• Helps promote healthy testosterone production in males.
• Helps reduce cortisol, a biomarker of physical stress, when used over time.

Shoden is backed by 11 clinical studies and four animal studies, supporting its role in stress and sleep support at low doses. Studies have associated these benefits with markers of hypothalamus-pituitary-adrenal (HPA) axis regulation, reduction of cortisol, and increasing GABA.

Another clinical study found that Shoden may have immune support benefits, such as improvements in natural killer and T-cell activity, suggesting potential for reducing infection risks and boosting immunity.

A pharmacokinetics evaluation of Shoden found that, in blood serum samples, the ingredient had exceptional bioavailability of withanolides. Acute and subchronic toxicity studies on animals found the ingredient to be safe.

“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,” said Antony. “The US, and countries in Europe and Asia view Health Canada approval as a highly reliable benchmark for quality, which will fast-track Shoden ®’s expansion into those markets.”

Shoden is suitable for pills, capsules, and powders, and can be integrated into food and beverage applications like soft drinks, energy shots, and other sports nutrition products.