A Product License Application (PLA) referencing the Master File submitted by Stratum Nutrition and BLIS Technologies to the Natural and Non-Prescription Health Products Directorate (NNHPD) gained Health Canada approval.
The ingredient was then issued a Natural Product Number (NPN), allowing Canadian manufacturers and marketers to make substantial and specific label claims on their products which contain the BLIS K12 ingredient.
BLIS K12
BLIS K12 was developed by scientists at the University of Otago in New Zealand. It is a specific strain of Streptococcus salivarius (S. salivarius), which secretes powerful antimicrobial molecules called BLIS: Bacteriocin-Like-Inhibitory Substances.
BLIS K12 is an oral probiotic that is said to support healthy bacteria in the mouth for long-term fresh breath and immune support.
The ingredient is part of Stratum Nutrition’s portfolio of specialty bioactive ingredients, and is currently used in over 15 products in the US marketplace.
Claims
Health Canada has approved products containing BLIS K12 to bear claim language such as, the product “promotes oral health [through the re-colonisation of the oral cavity]”, that it is an “oral probiotic for re-colonization of the oral cavity after antibiotic treatment”, that “following oral antimicrobial rinsing Streptococcus salivarius K12 supplementation helps reduce volatile sulfur compound levels (halitosis)”, and that it “can help reduce the incidence of Streptococcal pharyngitis/tonsillitis (sore throats caused by pathogenic variants belonging to the Streptococcus genus)”.
“As arduous as the process is, each successful regulatory approval prepares the ground for the sales and marketing effort that follows,” said Barry Richardson, CEO of BLIS Technologies.
Kevin Ruff, PhD, Stratum’s director of scientific & regulatory affairs said that company was pleased to be able to use its regulatory expertise in North America to open up the Canadian market for BLIS K12. “We expect the strong efficacy claims that were approved to really resonate with Canadian consumers.”