BLIS K12 Receives “No Objection” GRAS Letter From FDA
19 Feb 2016 --- Oral-health probiotic BLIS K12 has received a “Letter of No Objection” from the US Food and Drink Administration (FDA) for its self-affirmed notification of Generally Recognized As Safe (GRAS) status.
The patented probiotic strain of Streptococcus salivarius, BLIS K12, has been studied for benefits to ear and throat health in children and adults, including reducing incidence of halitosis and Streptococal pharyngitis.
BLIS K12 developer Blis Technologies (Dunedin, New Zealand) and North America distributor Stratum Nutrition (Saint Charles, MO) celebrated the “No Objection” GRAS status as key to opening more markets for the probiotic:
“It adds a new level of credibility for BLIS K12 and puts the conversations with larger consumer food and beverage companies in the US on a stronger footing,” said Peter Fennessy, board chairman, Blis Technologies.
“Many of those companies are, quite rightly, risk averse. Therefore, having the non-objection notification from the FDA offers an additional level of confidence and makes it clearer where BLIS K12 fits within the category,” Fennessy added.
Jeremy Moore, managing director of Stratum Nutrition, added, “Very few ingredients in this space go to this level, so it is a definite feather in the cap for Blis.”
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 regarding the notice submitted.
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