Oral Probiotic BLIS K12 gets FDA GRAS ‘Letter of No Objection’

By Stephen Daniells

- Last updated on GMT

Image: iStockPhoto
Image: iStockPhoto

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The US Food and Drug Administration has issued a ‘Letter of No Objection’ over the generally recognized as safe (GRAS) status of oral probiotic BLIS K12.

BLIS K12 was developed by scientists at the University of Otago in New Zealand. It is a specific strain of Streptococcus salivarius​ , which secretes powerful antimicrobial molecules called BLIS: Bacteriocin-Like-Inhibitory Substances.

The ingredient is said to support healthy bacteria in the mouth for long-term fresh breath and immune support.

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,”​ said Fennessy.

“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.”

Jeremy Moore, Managing Director of Blis Technologies’ North American distributor, Stratum Nutrition, added: “Very few ingredients in this space go to this level, so it is a definite feather in the cap for Blis.”

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