Nutraceutical company Arjuna Natural's ashwagandha extract, Shoden, has been approved as a Natural Health Product by Health Canada.
This move enforces Canada's stance on ashwagandha safety when used as a calming, antioxidant dietary supplement ingredient.
However, this isn't every nation's stance, as Denmark has chosen to ban the Ayurvedic ingredient in fear of potential thyroid and liver toxicity risks.
To discuss the approval, as well as how Arjuna ensures its ashwagandha product is high-quality, safe and efficacious, NBR caught up with the company's co-founder, Benny Antony.
The Ayurvedic extract can reduce stress and anxiety, while enhancing sleep quality at a low dose
Achieving Health Canada approval
To achieve approval from the Canadian regulatory body, Antony notes that Arjuna was required to present safety data backing Shoden's use as a functional ingredient.
"By submitting comprehensive safety data for Shoden, we can demonstrate the ingredient's research-backed efficacy and provide assurance to consumers, as well as ensuring compliance with stringent global regulations," he comments.
"We currently have animal toxicology studies that demonstrate ashwagandha's safety across various applications, and we're hoping to publish another clinical study in 2025 surrounding the herb's use in humans."
To attain Health Canada's approval, Shoden was also tested for purity and potency — a measure used to make sure that only dietary supplements of a high quality are licensed.
On top of this, the company has conducted 11 clinical studies and four animal trials, which suggest that the Ayurvedic extract can reduce stress and anxiety, while enhancing sleep quality at a low dose.
Researchers believe it exhibits its effects by reducing the prevalence of the stress hormone cortisol, while also boosting the release of GABA neurotransmitters for relaxation.
Arjuna Natural's Shoden is a bioactive ashwagandha extract standardised to more than 35% withanolide glycosides; the key active ingredient within the herb.
Addressing the recent ashwagandha controversy
After the ban on ashwagandha in Denmark, France issued warnings against the use of ashwagandha in certain populations, while Poland set an upper limit of 3g and advises that pregnant women and children don't ingest the ingredient.
The UK is currently investigating the use of ashwagandha in dietary supplements, while Sweden and Finland are considering banning it.
However, Antony notes that "the recent ban on ashwagandha by authorities in countries such as Denmark seems to contradict the scientific and traditional evidence supporting its safety and benefits."
"Considering ashwagandha’s long history of safe use and global acceptance, we respectfully disagree with these allegations and believe that such bans may not be justified," he states.
"Regulatory decisions should be based on a comprehensive review of modern scientific research and traditional knowledge to ensure they accurately reflect the herb’s safety and benefits."
The impact of regulations on the ashwagandha market
Although Denmark has banned the herb, Antony believes that these changes aren't all bad.
"The increased legal scrutiny of ashwagandha will significantly impact market development and innovation — driving the industry towards higher standards of safety and quality."
"It pushes market players to innovate more responsibly, focusing on rigorous scientific validation and transparency."
"In the long run, this can strengthen the market, leading to more credible and high-quality ashwagandha products that meet global regulatory standards," he concludes.
