09.21.20
Ixoreal Biomed Inc., the manufacturer of KSM-66 Ashwagandha has been granted approval to use a number of additional functional claims by Health Canada, the regulatory agency responsible for authorizing marketing claims for dietary supplements throughout the Canadian market.
Under Health Canada’s Natural Product Number 80102381, and its accompanying license, formulators using KSM-66 can now make new claims related to memory enhancement, sleep, energy, libido, testosterone, and thyroid function. In total, KSM-66 is now approved for a total of 14 claims, more than any other Ashwagandha extract in the Canadian market, Ixoreal claimed. The issuance of an NPN involves a process in which the government regulatory body has reviewed the ingredient and its clinical evidence, and has deemed it to be safe, effective, and of high quality under the recommended conditions of use.
“We are very pleased with this new set of claims,” said Kartikeya Baldwa, CEO of Ixoreal Biomed. “These health claims are a testament to high-quality clinical research backing KSM-66, which Health Canada has recognized. We thank our partner CK Nutraceuticals for their continued strong performance in the Canadian market with respect to KSM-66’s market development.”
Health Canada’s ashwagandha monograph specifies only the root, while leaves and other aerial parts of the plant are not recognized for functional claims in the Canadian market. Because KSM-66 uses only the root, the claims which are approved for the ingredient go above and beyond what is available to formulators who reference the generic Health Canada ashwagandha monograph, Baldwa added.
The clinical trials to date evaluating KSM-66 have shown that the ingredient was able to significantly reduce stress and anxiety, decrease serum cortisol and stress-related food cravings, enhance memory and cognition, increase endurance and strength, support healthy sexual function, and, in males, increase the endogenous production of testosterone, the company reports. The Health Canada claims represent the most recent in a line of government and third-party certifications attributed to the ingredient, which also include a number of GMP (good manufacturing practices) certifications, USDA Organic, non-GMO, gluten-free, BSCG-drug free, Kosher, Halal, HACCP, and more.
The recommended use for KSM-66, in addition to risk information and other pertinent consumer-level information can be found on Health Canada’s website.
Under Health Canada’s Natural Product Number 80102381, and its accompanying license, formulators using KSM-66 can now make new claims related to memory enhancement, sleep, energy, libido, testosterone, and thyroid function. In total, KSM-66 is now approved for a total of 14 claims, more than any other Ashwagandha extract in the Canadian market, Ixoreal claimed. The issuance of an NPN involves a process in which the government regulatory body has reviewed the ingredient and its clinical evidence, and has deemed it to be safe, effective, and of high quality under the recommended conditions of use.
“We are very pleased with this new set of claims,” said Kartikeya Baldwa, CEO of Ixoreal Biomed. “These health claims are a testament to high-quality clinical research backing KSM-66, which Health Canada has recognized. We thank our partner CK Nutraceuticals for their continued strong performance in the Canadian market with respect to KSM-66’s market development.”
Health Canada’s ashwagandha monograph specifies only the root, while leaves and other aerial parts of the plant are not recognized for functional claims in the Canadian market. Because KSM-66 uses only the root, the claims which are approved for the ingredient go above and beyond what is available to formulators who reference the generic Health Canada ashwagandha monograph, Baldwa added.
The clinical trials to date evaluating KSM-66 have shown that the ingredient was able to significantly reduce stress and anxiety, decrease serum cortisol and stress-related food cravings, enhance memory and cognition, increase endurance and strength, support healthy sexual function, and, in males, increase the endogenous production of testosterone, the company reports. The Health Canada claims represent the most recent in a line of government and third-party certifications attributed to the ingredient, which also include a number of GMP (good manufacturing practices) certifications, USDA Organic, non-GMO, gluten-free, BSCG-drug free, Kosher, Halal, HACCP, and more.
The recommended use for KSM-66, in addition to risk information and other pertinent consumer-level information can be found on Health Canada’s website.
