BLIS Technologies, Dunedin, New Zealand, and Stratum Nutrition, Saint Charles, MO, have received a ‘Letter of No Objection’ from the U.S. Food and Drug Administration (FDA) for oral probiotic BLIS K12. A ‘Letter of No Objection’ refers to the letter sent by the FDA confirming that they do not question the basis for the GRAS self-affirmation notification submitted by BLIS Technologies.
 
BLIS Technologies Board Chairman Peter Fennessy said the Letter of No Objection is another step on the strategic pathway to opening markets through regulatory approval. “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,” he said.
 
“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.”
 
Through the GRAS notification program, companies voluntarily submit their self-affirmation dossier, substantiated by extensive research and expert peer review, that a specific ingredient is Generally Recognized As Safe. The ‘Letter of No Objection’ means that FDA has reviewed all of the scientific data on BLIS K12 and has no questions or concerns regarding its safety.
 
BLIS K12 is an oral cavity probiotic that has been shown in multiple published clinical trials to provide benefits for supporting ear and throat health in both children and adults.