#Taipei #United States #Glac Biotech #Probiotic CP-9 #FDA GRAS

Glac Biotech Achieves FDA GRAS Approval for Probiotic Strain CP-9

Glac Biotech, a prominent developer of probiotics and postbiotics from Taiwan, recently announced a significant milestone in its journey towards enhancing gut health. The company has received the Generally Recognized as Safe (GRAS) status from the U.S. Food and Drug Administration (FDA) for its flagship probiotic strain CP-9, recognized scientifically as Bifidobacterium lactis CCTCC M 2014588. This achievement positions Glac Biotech uniquely within the Taiwanese probiotic sector as it becomes the only manufacturer with multiple FDA GRAS approvals.

Significance of GRAS Approval

The GRAS approval from the FDA symbolizes a rigorous assessment of safety and quality, affirming that CP-9 can be utilized in a diverse range of food and beverage products. According to the FDA's notification, CP-9 is cleared for use at levels reaching up to 10⁹ colony-forming units (CFUs) per serving, extending its applicability to a variety of products. These include:

• - Sports and energy drinks
• - Fortified waters
• - Bottled teas
• - Cereals
• - Dairy and non-dairy products
• - Nutrition bars
• - Candies
• - Fruit juices
• - Soy and plant-based proteins
• - Infant foods

Innovation in Probiotics

The introduction of CP-9 follows Glac Biotech’s previous success with Lactobacillus rhamnosus MP108, which was the first probiotic strain in Asia approved for infant use and secured its own GRAS status in 2023. MP108 was recognized as a finalist at the NutraIngredients Awards and has set a high standard for safety, thus paving the way for innovation in the sector.

The CP-9 strain not only offers extensive usability across various products but has also been a finalist at the NutraIngredients Awards in 2023, solidifying its reputation in the industry for promoting gut health and supporting immune regulation.

A Comprehensive Portfolio of Solutions

Glac Biotech continues to broaden its portfolio of probiotic and postbiotic solutions. The company’s first GRAS-notified strain, MP108, already holds its approval for numerous applications spanning products such as fortified beverages, yogurts, cheeses, and a selection of infant foods. With the recent inclusion of CP-9 in its offerings, Glac Biotech positions itself strategically to cater to both infant and family nutrition sectors, alongside its established strains including the renowned Bifidobacterium lactis BB-12.

Additionally, Glac Biotech is making strides in postbiotics with their flagship product, Totipro®. This innovative postbiotic product is available in key markets including Europe, Southeast Asia, and North America, with plans underway for FDA GRAS submission in the near future. Remarkably, Totipro® stands as the only raw material acknowledged to meet all four postbiotic categories as defined by the International Probiotics Association, which include intact cells, cell fragments and cytoplasmic contents, microbial metabolites, and fermentation media containing microbial components.

Future Outlook

Shin-Yu Tsai, the Product and Marketing Department Manager at Glac Biotech, emphasized the importance of FDA GRAS approval in ensuring the safety and quality of probiotics used globally. With CP-9 now approved, and MP108 already recognized, Glac Biotech is reinforcing its commitment to advancing probiotics and postbiotics research aligned with international standards. The company plans to continue relying on scientific evidence while collaborating with partners worldwide to deliver reliable health solutions.

Founded in 2008 as a subsidiary of Center Laboratories Inc., Taiwan's largest liquid pharmaceutical manufacturer, Glac Biotech boasts a dedicated team of over 30 researchers and quality specialists, focused on developing innovative probiotic solutions through clinical validation and international certification. By harnessing cutting-edge technology and consistently working to improve gut health, Glac Biotech stands poised to further elevate its industry stature and promise of health solutions.

For more information, visit glacbiotech.com and follow Glac Biotech on LinkedIn and Facebook for the latest updates.