Taiwan’s Glac Biotech probiotic gains US GRAS approval

Taiwanese probiotic and postbiotic developer Glac Biotech has secured regulatory approval in the US for its core probiotic strain CP-9 (Bifidobacterium lactis CCTCC M 2014588), scientifically backed for its role in gut health and immune regulation. The US FDA deems the ingredient Generally Recognized as Safe (GRAS). 

Glac Biotech is the only probiotic raw material manufacturer in Taiwan to hold multiple FDA GRAS approvals, following the recognition of its Lactobacillus rhamnosus MP108 in 2023.

According to the FDA filing, CP-9 is authorized for use at levels up to 1 billion colony-forming units (CFUs) per serving in a wide range of food and beverage products.

These include sports and energy drinks, infant foods, fortified waters, bottled teas, cereals, dairy and non-dairy items, nutrition bars, candies, fruit juices, and plant-based protein products.

With FDA GRAS status, CP-9 expands Glac Biotech’s portfolio and is expected to serve the infant and family nutrition markets alongside established strains such as Bifidobacterium lactis BB-12.

Expanding probiotic and postbiotic solutions

Glac Biotech’s first GRAS-notified strain, MP108, was approved by the FDA in 2023. It was the first probiotic strain in Asia to be approved for infant use.

MP108 is supported by clinical and safety data and permitted for use at up to 1 billion colony-forming unit per serving.

In postbiotic advances, Glac Biotech reveals its flagship product, Totipro, is slated for FDA GRAS submission in the future. It is currently available in Europe, Southeast Asia, and North America.

The company markets Totipro as the only raw material publicly declared to meet all four postbiotic categories defined by the International Probiotics Association: intact cells, cell fragments and cytoplasmic contents, microbial metabolites, and fermentation media containing microbial components.

“FDA GRAS approval represents an important standard of quality and safety. With CP-9 now approved, MP108 already recognized, and Totipro to be submitted soon, Glac Biotech is advancing its probiotics and postbiotics research with consistency and international alignment,” says Shin-Yu Tsai, product and marketing department manager of Glac Biotech.

“We will continue to base our work on scientific evidence while cooperating with partners worldwide to develop reliable health solutions.”

In other probiotic headlines, Nutrition Insight recently connected with BioGrowing on its targeted biotic innovations like its Flora-Focus strains to aid in Helicobacter pylori infections and support the vaginal microbiome, immune health, and weight management.