Health Canada, the federal department that regulates the products that help the people of Canada maintain and improve their health, has reviewed and approved Sabinsa’s shelf-stable probiotic LactoSpore® ingredient for sale in Canada. This pre-market safety approval is required prior to natural health products being offered for sale in Canada.
Sabinsa’s LactoSpore Masterfile has been substantiated with the required safety profile, paving the way for customers to request a Letter of Access from Sabinsa, with which the customer can apply for a Product License Application (PLA) with the Natural and Non-Prescription Health Products Directorate (NNHPD). Thereafter, manufacturers can obtain NPN number for their formulations containing LactoSpore® for purpose of sales in Canada as a Natural Health Product.
Although LactoSpore® has been on the market for over 20 years, with emerging clinical evidence on LactoSpore® the focus goes beyond maintaining gut health into sports nutrition, IBS and related gut health conditions. Since obtaining GRAS status in the US, LactoSpore’s market reach has grown tremendously in the past five years to include a variety of foods, beverages, chocolate, gummies, candies, yogurts and soups. Beyond the digestive health market, LactoSpore® has also found applications in whey protein supplements, a big seller in the sports nutrition market.
“Our investment in and commitment to LactoSpore® runs deep,” said Shaheen Majeed, Sabinsa’s Marketing Director. “Realizing in the late 1990’s the potential of this ingredient, we invested in our own dedicated manufacturing facility to ensure ample and consistent supply of material meeting our quality standards. We made it a strong candidate for inclusion in functional foods by having it GRAS affirmed. We have now cleared the way for customers to sell products with our LactoSpore strain in Canada. These are exciting times for this brand and there’s more to come this year."
A number of other Masterfiles on Sabinsa ingredients, such as BioPerine®, Curcumin C3 Complex®, Curcumin C3 Reduct® and ForsLean® are available for Letter of Access requests.
About Health Canada:
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations, which came into force on January 1, 2004. The Regulations help give Canadians access to a wide range of natural health products that are safe, effective and of high quality. Through the Natural Health Products Directorate, Health Canada assures that all Canadians have ready access to a wide range of natural health products that are safe, effective and of high quality.
The safety and efficacy of NHPs and their health claims must be supported by proper evidence so that consumers and Health Canada know the products are indeed safe and effective. Evidence may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources. The type and amount of supporting evidence required depends on the proposed health claim of the product and its overall risks.
As part of the Health Products and Food Branch of Health Canada, the Natural and Non-prescription Health Products Directorate (NNHPD) is the regulating authority for natural health products for sale in Canada. Our role is to ensure that Canadians have ready access to natural health products that are safe, effective and of high quality while respecting freedom of choice and philosophical and cultural diversity.
The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs).
Fast fact: 71% of Canadians have used natural health products like vitamins and minerals, herbal products, and homeopathic medicines. Source: http://www.hc-sc.gc.ca/ahc-asc/branch-dirgen/hpfb-dgpsa/nhpd-dpsn/index-eng.php