Sabinsa’s LactoSpore Probiotic Receives FDA “No Questions” GRAS Letter for Food, Drink

Photo © iStockphoto.com/Agnieszka Kirinicjanow

FDA has issued a “no questions” letter in response to a Generally Recognized as Safe (GRAS) submission for Sabinsa Corp.’s (East Windsor, NJ) LactoSpore probiotic ingredient. LactoSpore is a hardy, shelf-stable Bacillus coagulans probiotic strain suited for use in a variety of foods and beverages and that studies have associated with digestive health and other health benefits.

LactoSpore is already featured in a variety of foods and beverages on the shelf, including baked goods, milk products, jams and jellies, gelatins and puddings, soups, snacks, candy, sugar, non-alcoholic beverages, and even hot drinks like instant tea and coffee. The GRAS affirmation declares safe a maximum level of approximately 2x10⁹ colony forming units per serving of a food or beverage.

FDA’s response provides another layer of confirmation of the ingredient’s safe use in the food and beverage format. “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 Sabinsa founder Muhammed Majeed, PhD, in a press release.

“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,” adds Shaheen Majeed, the company’s marketing director.

Jennifer Grebow
Editor-in-Chief
Nutritional Outlook magazine
jennifer.grebow@ubm.com

Also read:

A 2016 Update: Promising New Science on Probiotics

2016 Ingredient Trends to Watch for Food, Drinks, and Dietary Supplements: Probiotics

Are Probiotics Moving Beyond Gut Health?