Blis K12 FDA certification opens way for global launch

Barry Richardson
Barry Richardson
Dunedin-based biotechnology company Blis Technologies plans to launch its probiotic Blis K12 on the global food-manufacturing market.

The company recently obtained GRAS (generally recognised as safe) status from the United States Food and Drug Administration (FDA), having worked towards obtaining it for two years.

The FDA requires all ingredients used in food manufacturing to obtain a standard for safety.

Until now, the company's Blis K12 probiotic had been limited to sale as a dietary supplement, which was a small market compared with the "massive" food industry in the US, Blis Technologies chief executive Dr Barry Richardson said in a statement.

Blis K12 is a natural bacteria, promoted as a probiotic prevention of upper-airways infection, bacterial sore throats, tooth and gum disease and chronic bad breath.

While having GRAS status was expected to rapidly expand market opportunities for the company and enable Blis K12 to be sold to many major food manufacturers in the US, it also had major international consequences.

Dr Richardson believed it would make it "far easier" for the company to market K12 in other countries because GRAS status was well recognised internationally as a "gold standard" for food-ingredient safety.

The company has plans to immediately start promotion to food manufacturers such as ice cream, yoghurt and other dairy producers in the US. Blis K12 is already approved as a food ingredient in both Australia and New Zealand.

The company's development scientists have been preparing new food-product applications, including delivery systems such as lozenges, powder formulations, chewable soft gels, mouthwashes, chewing gum and wafer melts.

The company's market development group has also been busy with several market development initiatives associated with dietary supplements or foods containing Blis K12 or Blis M18, now in 13 countries around the world, including Russia.

Two recent developments involved a presentation of Blis K12 to a major meeting of Eastern European dentists and dental professionals in Russia, and the announcement of a major launch of a Blis K12 jelly bean product to protect children from upper respiratory tract infection by an Israel-based biopharmaceutical company, Anlit Advanced Nutrition, at the pharmaceutical networking event Cphl Worldwide 2011 in October.

While the slow global economy and tough regulatory environment still meant it would be a challenging period for the company over the next one to two years, "at least it is an even playing field for all participants within the industry", Dr Richardson said.

The immune health category had been forecast to grow over the next few years, and he was "cautiously optimistic" for the future.

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