#Taiwan #Taipei #Glac Biotech #FDA GRAS #CP-9 Probiotic

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

Taipei-based Glac Biotech has recently announced an important milestone in its journey to enhance gut health through its probiotic products. The company received the Generally Recognized as Safe (GRAS) status from the U.S. Food and Drug Administration (FDA) for its prominent probiotic strain, CP-9 (Bifidobacterium lactis CCTCC M 2014588). This decision marks a significant achievement, as Glac Biotech now becomes the only manufacturer of probiotic raw materials in Taiwan to hold multiple GRAS approvals from the FDA, following the earlier recognition of Lactobacillus rhamnosus MP108 in 2023.

The GRAS designation underscores the safety and quality of CP-9, making it suitable for incorporation into various foods and beverages. According to the FDA’s approval, CP-9 is approved for use at a level of up to 10⁹ colony-forming units (CFUs) per serving in a range of products, including:

• - Sports and energy drinks
• - Fortified waters
• - Bottled teas
• - Cereals
• - Dairy and non-dairy products
• - Nutritional bars
• - Candies
• - Fruit juices
• - Soy and plant-based protein products
• - Infant formula

The approval of CP-9 was a notable moment for Glac Biotech, especially since the strain was a finalist at the NutraIngredients Awards 2023. The research into CP-9 highlighted its positive effects on gut health and its role in immune regulation. With the GRAS status granted, the company anticipates expanding its portfolio, serving markets focused on infant and family nutrition, alongside established strains like Bifidobacterium lactis BB-12.

Growing Portfolio of Probiotic Solutions

Glac Biotech is not a newcomer when it comes to obtaining GRAS recognition. The company’s first GRAS notified strain, MP108, was recognized in 2021 and received FDA approval in 2023, becoming the first probiotic strain in Asia approved for use in infants. Backed by clinical and safety data, MP108 is also approved for use at 10⁹ CFUs in various products, similarly spanning sports and dietary areas.

In addition to these remarkable probiotics, Glac Biotech is making significant strides in postbiotics as well. Their flagship product, Totipro®, currently available in Europe, Southeast Asia, and North America, is set to be submitted for FDA GRAS approval in the near future. Totipro® is distinguished as the only publicly declared raw material fulfilling 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).

Shin-Yu Tsai, the head of the product and marketing department at Glac Biotech, stated, “The FDA GRAS approval sets a significant standard for quality and safety. By approving CP-9, alongside the earlier recognition of MP108 and the upcoming submission of Totipro®, Glac Biotech is consistently advancing its research in probiotics and postbiotics with a clear international focus. We will continue to base our work on scientific insights and collaborate with partners globally to develop reliable health solutions.”

For further information about Glac Biotech and their innovative products, you can visit glacbiotech.com or follow them on LinkedIn and Facebook.

About Glac Biotech

Founded in 2008, Glac Biotech is a subsidiary of Center Laboratories Inc., the largest manufacturer of liquid pharmaceuticals in Taiwan. The company focuses on developing probiotics (PRONULIFE®) and postbiotics (Totipro®), supported by a dedicated team of over 30 researchers and 30 quality specialists who work on strain development, patents, clinical validation, and international certifications.