South Korean probiotic strain gains “no questions” letter from FDA for use in food in U.S.


The GRAS notification was compiled by South Korean firm OraTicx and regulatory services company GRAS Associates, a Nutrasource company.

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A probiotic strain under the trade name oraCMU has received a “no questions” letter from U.S. FDA for use in food. The probiotic strain, Weissella cibaria CMU, comes from a South Korea company called OraTicx Inc., previously known as OraPharm Inc. OraTicx partnered with regulatory services firm GRAS Associates, a Nutrasource company (Guelph, ON, Canada), to prepare the GRAS notification (GRN 1063).

The GRAS notification covers use of the probiotic strain oraCMU as an ingredient at levels up to 8 X 109 colony forming units per serving in foods like yogurt, frozen desserts, hard candy, mints, and chewing gum. The GRAS notification was supported by published literature, including genetic toxicity studies and a repeat-dose oral toxicity study on the strain. In addition, there were six published clinical trials in healthy subjects who consumed oraCMU.

In the press release, Mi-Sun Kang, PhD, head of the department/R&D center at OraTicx, stated that the firm chose to work with GRAS Associates and through Nutrasource Asia due to the companies’ success rate for FDA notifications that is higher than the industry average. “Our expectations were correct, and we are pleased to say that this is the first GRAS-notified strain to FDA as an oral probiotic in Korea,” Kang said. “We believe this lays the foundation for entering the global market.”

OraTicx says that it plans to start GRAS proceedings for another one of its Weisella cibaria probiotic strains called oraCMS1.

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