Health Canada grants additional functional claims to KSM-66 Ashwagandha

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Ixoreal Biomed’s root-only Ashwagandha extract has achieved additional claims in Canada relating to memory enhancement, sleep, energy, stress, libido, testosterone and thyroid function.

The recent approvals, which are registered under Health Canada’s NPN (Natural Product Number) 80102381, add to earlier approvals by the Agency and give KSM-66 a total of 14 claims.

In Canada, the issuance of an NPN means that the governmental regulatory body has reviewed the ingredient and its clinical evidence, and deemed it be safe, effective and of high quality under their recommended conditions of use.

“We are very pleased with these new set of claims. These health claims are a testament to high-quality clinical research backing KSM-66, which Health Canada has recognized,” said Kartikeya Baldwa, the CEO at KSM-66 Ashwagandha. “We thank our partner CK Nutraceuticals for their continued strong performance in the Canadian market with respect to KSM-66’s market development.

“Because KSM-66 uses only the root and no other part of the ashwagandha plant, and because Health Canada’s own ashwagandha monograph similarly specifies only the root, these claims are over and above what is available to formulators who reference the generic Health Canada ashwagandha monograph.”

According to a monograph from the American Herbal Pharmacopoeia (AHP), the herb has a history of use in ayurvedic medicine that dates back as much as 4,000 years to the teaching of renowned scholar Punarvasu Atreya, and in subsequent works that make up the ayurvedic tradition. The name of the herb derives from Sanskrit, and means “smells like a horse”, which refers to the strong smell of the root which is said to be redolent of horse sweat or urine.

Ashwagandha (Withania somnifera) has been gaining traction in the mainstream North American market over recent years with consumers embracing its wide-ranging body of health benefits, which include supporting stress, cognitive function, sleep, metabolic wellness, adrenal function, sports performance, and more.

In the US, sales of herbal supplements with Ashwagandha topped $10,835,737 in the US Mainstream Multi-Outlet Channel for 2019, an increase of 45% over the previous, according to HerbalGram’s 2019 Herb Market Report. An additional $13,661,462 in sales were reported from the Natural Channel (making the herb the number 5 top-seller in this channel).

Baldwa told NutraIngredients-USA that sales of KSM-66 this year are 220% more than what they were last year in Canada.

"A few of the top brands in Canada that use KSM-66 include Webber Naturals, Natural Factors, Canprev Natural Products, Magnum Nutraceuticals, St-Francis Herb Farm, 88Herbs, Flora and more," he said.