The shelf-stable probiotic LactoSpore from Sabinsa Corporation, East Windsor, NJ, has received a “no questions” letter from the U.S. FDA on its Generally Recognized As Safe (GRAS) status.
 
“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.
 
LactoSpore is currently featured in a variety of foods and beverages ranging from baked goods to milk products, jams and jellies, gelatins and puddings, soups, snacks, candy, sugar, non-alcoholic beverages and even instant tea and coffee. In any and all food categories, a maximum level of approximately 2×10⁹ 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 also 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.