Glac Biotech Achieves GRAS Approval for CP-9 Probiotic Strain
Glac Biotech, a notable name in the probiotic and postbiotic sectors, proudly announced its recent achievement of the Generally Recognized as Safe (GRAS) status by the U.S. Food and Drug Administration (FDA) for its core probiotic strain CP-9, scientifically known as Bifidobacterium lactis CCTCC M 2014588.
With this prestigious recognition, Glac Biotech has positioned itself as a leader in probiotic innovations within Taiwan, being the only manufacturer in the region with multiple FDA GRAS approvals. This follows its earlier recognition of Lactobacillus rhamnosus MP108 in 2023, solidifying the company's commitment to quality and safety in its probiotic offerings.
Significance of CP-9’s Approval
The approval of CP-9 allows its incorporation at levels up to 10? colony-forming units (CFUs) per serving across a diverse array of food and beverage 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 protein items
- Infant foods
CP-9's safety and efficacy are backed by extensive research, particularly in gut health and immune support. Its GRAS designation not only boosts Glac Biotech's product lineup but also fills an important gap in the market for infant and family nutrition, complementing established strains like Bifidobacterium lactis BB-12.
A Growing Portfolio of Probiotic Innovations
Previously, Glac Biotech introduced its first GRAS-approved strain, MP108, which gained attention at the NutraIngredients Awards in 2021. This strain, recognized for its suitability for infant use, further cements the company’s role as a pioneer in the probiotic field, with its approval obtained in 2023. MP108 is likewise deployed at levels up to 10? CFUs per serving in diverse applications such as:
- Sports and energy drinks
- Fortified waters
- Nutritional beverages
- Bottled teas
- Processed fruits and juices
- Cereals
- Cheeses and yogurts
- Milk-based desserts
- Soy-based products
- Nutrition bars
- Candies
- Infant foods
Advancements in Postbiotics with Totipro
Glac Biotech is not stopping at probiotics; it is also advancing its postbiotic offerings. Totipro, the company’s flagship postbiotic product, is now available in several markets including Europe, Southeast Asia, and North America, with plans for FDA GRAS submission on the horizon. Notably, Totipro is distinct as the only raw material recognized to meet all four postbiotic categories established by the International Probiotics Association, covering intact cells, cell fragments, microbial metabolites, and fermentation media containing microbial components.
As stated by Shin-Yu Tsai, the Product and Marketing Department Manager, "Achieving FDA GRAS approval is a significant milestone for ensuring the quality and safety of our products. With CP-9 approved and MP108 recognized, alongside our upcoming Totipro submission, Glac Biotech is at the forefront of probiotics and postbiotics research. We are dedicated to leveraging scientific evidence while collaborating globally to devise reliable health solutions for consumers."
For interested parties seeking further information about Glac Biotech's offerings, resources, and innovations in health and nutrition, please explore their official website.
About Glac Biotech
Founded in 2008, Glac Biotech operates as a subsidiary under Center Laboratories Inc., Taiwan's leading liquid pharmaceutical manufacturer. The company specializes in the development of probiotics, known as PRONULIFE, and postbiotics like Totipro, supported by a team of over 30 researchers and quality specialists focused on strain development, patents, clinical validation, and international certification.
Frequently Asked Questions
What is the significance of GRAS approval?
GRAS approval indicates that the U.S. FDA has recognized a substance as safe for consumption in specified amounts and applications.
How does CP-9 benefit consumer health?
CP-9 has been shown to support gut health and enhance immune regulation, making it an effective addition to various food and beverage products.
What other products does Glac Biotech offer?
Besides CP-9, Glac Biotech offers a range of probiotic and postbiotic solutions, including MP108 and Totipro, scientifically formulated for health benefits.
Where can I learn more about Glac Biotech's products?
Visit Glac Biotech's official website for detailed information on their product offerings and ongoing research initiatives.
Is Glac Biotech involved in international markets?
Yes, Glac Biotech has established a presence in various international markets including Europe, Southeast Asia, and North America.
