GRAS Associates - Nutrasource company - has partnered with OraTicx (formerly OraPharm), to receive a “no questions” letter from FDA for the GRAS notification, for the use of Weissella cibaria CMU as an ingredient at levels up to 8 x 109 colony forming units per serving in yogurt, frozen desserts (dairy, ices, sorbets, and sherbets) and mixes, hard candy, mints, and chewing gum.
OraTicx, a company based in South Korea, established the OraTicx branch in the US and determined that GRAS with FDA notification was essential to grow oraCMU into a global strain.
The GRAS for oraCMUwas based on scientific procedures and supported by published literature, including genetic toxicity studies and a repeat dose oral toxicity study on the strain. Six published clinical trials in healthy subjects that consumed oraCMU provide additional safety support for the GRAS conclusion.
Working with OraTicx with support from Nutrasource Asia, was a successful partnership
Dr Mi-Sun Kang, Head of Department/R&D Center OraTicx noted that GRAS Associates was selected to prepare the GRAS dossier and notification to FDA due to having a higher than industry average success rate along with the expectation of smooth communication through Nutrasource Asia, which is based in Korea Dr Kang also noted that: “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. We believe this lays the foundation for entering the global market.”
Amy Mozingo, VP of US Nutra Regulatory Sciences for Nutrasource, noted: “OraTicx provided a robust dataset characterising the strain and establishing the safety profile for oraCMU resulting in a conclusion of GRAS status and no questions from FDA notification. Working with OraTicx, with support from Nutrasource Asia, was a successful partnership, we value them as a client and look forward to supporting them in future efforts.”
OraTicx plans to proceed with another GRAS program for another Weissella cibaria strain (oraCMS1) and plans to conduct additional efficacy studies so that oraCMU and oraCMS1 can be referred to as the most representative oral probiotics, not only in Korea but also globally, to help people around the world who are concerned about oral health.