FDA has no objections over BLIS M18 Probiotic GRAS status

By Stephen Daniells contact

- Last updated on GMT

© Getty Images / AaronAmat
© Getty Images / AaronAmat
The US Food and Drug Administration has no objections around the GRAS (Generally Recognized As Safe) status of BLIS M18, a probiotic strain for oral health.

The GRAS notification​ related to use of the ingredient in a range of food and beverage products, including baby, infant, and toddler foods (but excluding infant formula), baked goods and baking mixes, beverages, breakfast cereals, hard candy, milk and milk products, and many, many more.

The notification relates to a level of 20 mg per serving, providing a minimum of 1x109 CFU/serving.

Chris Haynes, Director of Global Sales for Stratum Nutrition, the exclusive North American distributor for the Blis Technologies’ ingredients, said: “This is great news and confirmation on an incredible ingredient.  BLIS M18 is the type of ingredient that should be on the Continuing Education Unit agenda for every Dentist and Dental Hygienist practicing today. It’s that good.”

BLIS is one of the best-known probiotics for oral health, and was developed by scientists at the University of Otago in New Zealand. It is a specific strain of Streptococcus salivarius​ (S. salivarius​), which secretes powerful antimicrobial molecules called BLIS: Bacteriocin-Like-Inhibitory Substances.

There are different BLIS ingredients available, including K12 and M18: K12 supports ENT/immune health and M18 supports teeth and gum health.

BLIS K12 obtained a GRAS ‘Letter of No Objection’ in 2016​.  

Related topics: Regulation & Policy

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