Health Canada, the federal department that regulates the products that help the people of Canada maintain and improve their health, has issued a Product License to Sabinsa for a significant health claim on LactoSpore® Balance: “Helps relieve abdominal pain associated with IBS (Irritable Bowel Syndrome).” The strain is LactoSpore® MTCC 5856.
“This health claim was based on the IBS clinical study we did for LactoSpore®,” said Shaheen Majeed, Sabinsa’s Marketing Director. “It gives us great validation for the clinical work we’re doing globally.”
While LactoSpore® has been on the market for over 20 years, emerging clinical evidence on LactoSpore® has moved the focus beyond maintaining gut health into sports nutrition, cognitive health, IBS and related gut health conditions. Sabinsa obtained self-affirmed GRAS status for LactoSpore® in the US in 2008, with LactoSpore®’s intended market reach clearly listed, and included foods, beverages, chocolate, confectionaries such as gummies and soft candies, yogurts and soups. LactoSpore® has also found applications in whey protein supplements, a staple of the sports nutrition market. Earlier in 2016, US-FDA submitted their no questions GRAS letter for Sabinsa’s LactoSpore® as well.
A number of Sabinsa ingredients have Canadian Masterfiles, such as BioPerine®, Curcumin C3 Complex®, Curcumin C3 Reduct®, LactoSpore® and ForsLean®, all available for Letter of Access requests.
Sabinsa Corporation received a Foreign Site Registration Number for its Payson, Utah finished product manufacturing facility from Health Canada’s Natural and Non Prescription Health Product Directorate (NNHPD) in August 2015.
About Health Canada:
All natural health products (NHPs) sold in Canada are subject to the Natural Health Products Regulations. 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, which may include clinical trial data or references to published studies, journals, pharmacopoeias and traditional resources.
