Inbiose receives FDA No Question letter for GRAS notices on five Human Milk Oligosaccharides

Ghent Belgium – 6 December, 2023

Inbiose, a leading biotech company active in the development of Human Milk Oligosaccharides (HMOs), is pleased to announce that it has received a no question letter from the United States’ Food and Drug Administration (FDA) regarding its Generally Recognized as Safe Substances (GRAS) notices for five human milk oligosaccharides (HMOs). This FDA no question letter permits the use of Inbiose’s 2'-Fucosyllactose (2'-FL), 3'-Sialyllactose sodium salt (3’-SL), 6'-Sialyllactose sodium salt (6’-SL), Lacto-N-tetraose (LNT) and Lacto-N-neotetraose (LNnT) in non-exempt infant formula and various conventional foods (GRN 1091, GRN 1074, GRN 1075, GRN 1068 and GRN 1067, respectively).

“Over the years, Inbiose has earned itself a solid reputation of technological leadership in the development of HMOs. I am very proud of our team that has allowed us to achieve this big milestone” said Prof. Soetaert, executive chairman of Inbiose.

Inbiose has been developing a wide range of Human Milk Oligosaccharides that are structurally identical to the ones from human milk and can be industrially produced by sustainable fermentation processes at low cost. Inbiose is currently developing its next generation HMOs that will permit infant formula milk with an HMO composition that is close to breast milk. HMOs are the newest ingredients for premium infant formula and industry watchers expect the HMO market to reach €500m by 2025 with an annual growth of 20 to 30%, growing further to well over € 1bn. The markets for HMOs go beyond infant nutrition as recent scientific studies have demonstrated that HMOs may play an important role as bio-active health ingredients for improved immunity, gut and brain health of the general population.

About Inbiose

Inbiose is a Belgium-based biotech company focused on the research, development and commercialization of specialty carbohydrates, including human milk oligosaccharides (HMOs). Inbiose’s unique proprietary technology platform “GlycoActives^®” enables cost-effective manufacturing of a wide range of specialty carbohydrates by sustainable fermentation processes. Since its establishment in 2013, Inbiose has grown to a dedicated team of over 50 people, unlocking the vast potential of specialty carbohydrates for a wide range of human and animal health applications.

For more information, please visit www.inbiose.com or send an e-mail to busdev@inbiose.com