Health Canada approves KSM-66 Ashwagandha

Health Canada approves KSM-66 Ashwagandha

Root-only extract gets clearance for broad set of functional claims.

Ixoreal Biomed, the developer of KSM-66 Ashwagandha—recipient of the "Best Botanical Ingredient" Award for 2013 at Natural Products Expo West—announced that Health Canada has granted approval to KSM-66 for a broad range of compelling functional claims. This issuance is based in part on KSM-66’s impressive set of clinical studies, which have been published in respected peer-reviewed journals indexed in the PubMed database of the U.S. Government’s National Institutes of Health.

Under Health Canada’s NPN (Natural Product Number) 80047973, formulators can make the following end-product claims using KSM-66 at the clinically-relevant dosage: (1) Helps increase resistance to stress/anxiety in individuals with a history of chronic stress, thereby improving their overall quality of life; (2) Athletic support or Workout/Exercise supplement; and (3) Helps promote healthy testosterone production in males. 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.

Kartikeya Baldwa, director at Ixoreal Biomed, said: “KSM-66 is the ashwagandha root's highest concentration full-spectrum extract available on the world market today. Being drawn from just the root, KSM-66 is in keeping with the specification of Ashwagandha in the leading natural supplements references, like the U.S Pharmacopeia and the British Pharmacopoeia. Indeed, the vast majority of the independent clinical studies on ashwagandha also use only the root. Therefore, this probably puts KSM-66 on more familiar ground in the minds of governmental regulators across the world. This is likely one of the factors that triggered issuance of the KSM-66 NPN in a prompt fashion.”

Ixoreal is represented in Canada by Toronto-based raw material supplier CK Ingredients. “Ixoreal is delighted to partner with the industry leader CK Ingredients in Canada. Ixoreal and CK share a strong belief and deep commitment to the philosophy of discovering and bringing to market the best science-based ingredients that nature has to offer,” said Mr. Baldwa.

Michael Chernyak, CK Ingredients president and CEO, added, “Having had extensive experience with ashwagandha in Canada, we can confidently state that KSM-66 is without doubt the finest ashwagandha ingredient available today. We are highly optimistic about KSM-66’s future prospects in Canada and we commend Ixoreal for its unwavering commitment to science and quality”

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