Health Canada Approves KSM-66 Ashwagandha Health Claims

Finished products that include KSM-66 at a 300-mg dose can use the claims for stress and anxiety, athletic support, and healthy testosterone production.

Ashwagandha products using the KSM-66 ashwagandha brand can now boast a number of functional health claims in the Canadian market. In January, Health Canada issued KSM-66 ashwagandha a Natural Product Number (NPN) and approval three claims, for stress and anxiety, athletic support, and healthy testosterone production.

Finished products that include KSM-66 at a 300-mg dose can use the following claims:

Helps increase resistance to stress/anxiety in individuals with a history of chronic stress, thereby improving their overall quality of life

Athletic support or workout/exercise supplement

Helps promote healthy testosterone production in males

An NPN license indicates that Health Canada has reviewed a product-including clinical study evidence-and deemed it safe, effective, and of high quality.

Because KSM-66’s extract comes from the root of the ashwagandha plant (Withania somnifera), it meets specifications of Health Canada’s own ashwagandha monograph, as well as specifications of the U.S. Pharmacopeia and the British Pharmacopeia.

“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 [newly approved health] claims are over and above what is available to formulators who reference the generic Health Canada ashwagandha monograph,” said KSM-66’s supplier Ixoreal Biomed (Hyderabad, India), in a press release.

Also, because the root is what’s most often referenced in clinical ashwagandha studies, “this probably puts KSM-66 on more familiar ground in the minds of governmental regulators across the world,” adds Kartikeya Baldwa, director, Ixoreal.

KSM-66’s NPN is #80047973.

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine jennifer.grebow@ubm.com