Sabinsa Corporation has hit another important milestone for the shelf-stable probiotic LactoSpore® with receipt of a "no questions" letter on Generally Recognized As Safe (GRAS) status from the US FDA.
"Hearing from FDA that ‘the agency has no questions at this time regarding Sabinsa Corporation’s conclusion that B. coagulans spore preparation is GRAS under the intended conditions of use’ underscores Sabinsa’s commitment to demonstrating the safety of LactoSpore®," said Dr. Muhammed Majeed, founder of Sabinsa.
Soni & Associates (Vero Beach, Florida) worked with Sabinsa on LactoSpore®’s self-affirmed GRAS status in 2009 and again on this next important step.
While many manufacturers of functional foods are comfortable enough with self-affirmed GRAS status to have included LactoSpore® in a variety of foods and beverages ranging from baked goods to milk products, jams & jellies, gelatins & puddings, soups, snacks, candy, sugar, non-alcoholic beverages and even instant tea and coffee, having the FDA’s notification that they have reviewed information on LactoSpore® and have no questions about the product’s safety opens many more doors. In any and all food categories, a maximum level of approximately 2x109 colony forming units per serving (cfu/serv) is generally recognized as safe.
"This is yet another accolade for Sabinsa’s probiotic and our support for this ingredient from its use in pharma, in dietary supplements, in cosmetics, and now more than ever, in functional foods,” said Shaheen Majeed, Sabinsa’s Marketing Director. “I commend our scientists for this achievement, as well as the production team at our dedicated world-class probiotic factory in India for producing this fine probiotic."
LactoSpore® was cleared by Health Canada as approved for sale in that country in January 2015, and has recently been the subject of several recently published clinical studies.