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Market Updates, Products & Ingredients, Regulations

BLIS M18 Probiotic Granted GRAS ‘No Objection’ Status

FDA reviewed supporting scientific data on the probiotic and has no questions or objections, allowing it to be considered ‘Generally Recognized As Safe.’

Blis Technologies Limited and Stratum Nutrition, the exclusive North American distributor for the Blis Technologies’ ingredients, have received issuance of a U.S. Food and Drug Administration ‘Letter of No Objection’ for the probiotic strain BLIS M18. This follows the BLIS K12 ‘Letter of No Objection’ in 2016. 
 
Through the GRAS program, companies may submit their determination supported by research and expert review that a specific ingredient is Generally Recognized As Safe. The Letter of No Objection means that the FDA has reviewed the data and has no questions or objections regarding the submitted BLIS M18 GRAS notice. This milestone is further recognition of the robust safety data supporting the BLIS oral-cavity probiotics.
 
GRAS status adds a new level of credibility for BLIS M18 and has the potential to open up opportunities with larger consumer food and beverage companies in the U.S., but also is recognized as a relevant and credible safety assessment by other countries and multinational companies. 
 
Chris Haynes, director of global sales for Stratum Nutrition commented, “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.” 

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