Glac Biotech, a Taiwan-based developer of probiotics and postbiotics, today announced that its core probiotic strain CP-9 (Bifidobacterium lactis CCTCC M 2014588) has been recognised as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug Administration (FDA). With this recognition, Glac Biotech becomes the only probiotic raw-material manufacturer in Taiwan to hold multiple FDA GRAS acknowledgements, following the 2023 GRAS recognition of Lactobacillus rhamnosus MP108.

With CP-9 now joining MP108, Glac Biotech holds two FDA GRAS-recognised probiotics suitable for a broad array of food and beverage applications.

Approval highlights CP-9’s safety and quality

According to the FDA filing, CP-9 is authorised for use at levels up to 10⁹ CFU per serving across a wide range of categories, including:

• Sports and energy drinks; fortified waters; bottled teas

• Cereals; dairy and non-dairy items; cheeses; yoghurts; milk-based desserts

• Nutrition bars; candies

• Fruit juices; processed fruits and juices

• Soy and plant-based protein products

• Infant foods

CP-9 was a finalist at the 2023 NutraIngredients Awards and has been studied for roles in gut health and immune regulation. With FDA GRAS status, CP-9 expands Glac Biotech’s portfolio and is expected to serve infant and family nutrition markets alongside established strains such as Bifidobacterium lactis BB-12.

Growing portfolio in probiotics and postbiotics

Glac Biotech’s first GRAS-notified strain, MP108, was shortlisted for the NutraIngredients Awards in 2021 and recognised by the FDA as GRAS in 2023. It was the first probiotic strain in Asia to be approved for infant use and is permitted at up to 10⁹ CFU per serving across multiple food and beverage categories, including: sports/energy drinks, fortified waters, nutritional beverages, bottled teas, processed fruits and juices, cereals, cheeses, yoghurts, milk desserts, soy-based products, nutrition bars, candies, and infant foods.

In postbiotics, Glac’s flagship Totipro® is available in Europe, Southeast Asia, and North America, with an FDA GRAS submission planned. Totipro® is the only raw material publicly declared to meet all four postbiotic categories defined by the International Probiotics Association (IPA): intact cells (IC), cell fragments and cytoplasmic contents (FC), microbial metabolites (MM), and fermentation media containing microbial components (CX).

“FDA GRAS recognition represents an important benchmark for safety and quality,” said Shin-Yu Tsai, Product & Marketing Department Manager at Glac Biotech. “With CP-9 now recognised and MP108 already in market, plus Totipro® moving toward submission, we’re strengthening our leadership in scientifically grounded probiotic and postbiotic solutions. We’ll continue to collaborate globally and invest in rigorous research to deliver reliable health benefits to infants and families.”