ADM’s spore-forming probiotic DE111^TM receives approval from the Therapeutic Goods Administration in Australia

ADM, a global leader in innovatve solutions from nature, announced that spore-forming probiotic DE111^™* (Bacillus subtilis) has received official approval from the Therapeutic Goods Administration (TGA), a part of the Australian Department of Health. This extends DE111^™’s availability into new regions^**, following the recent approval from the Naonal Health Commission (NHC) in China.

“This is an important milestone for ADM, as it marks the first Bacillus subtilis strain to be approved by the TGA in Australia,” said Helen Hu, president of health & wellness APAC at ADM. “By expanding access to DE111^™, we’re facilitating new innovation possibilies for our Australian customers, enabling the development of pioneering gut health-supporting products. Additionally, the continued approval of DE111^™ by important government authorities demonstrates its high quality, safety and alignment with strict regulatory standards.”

Clinically documented results show that DE111^™: Supports digestive health1 and helps support healthy immune function^2,3. Can survive through the stomach and germinate in the small intestine⁴. Can support a healthy gastrointesnal (GI) tract, gut function and microbiome diversity. “DE111^™ is a spore-forming probiotic, which means it can withstand harsh formulation environments that may otherwise damage conventional probiotics. This robustness is paving the way for new, convenient and enjoyable foods, beverages and dietary supplements that meet people where they are on their wellness journeys, especially as more consumers make the connection between their gut and digestive health and other aspects of well-being,” continued Hu.

In Australia, 81 % of consumers recognize a link between digestive health and overall well-being, and 76 % specifically see a connection between their digestive health and immune function⁵. Plus, 64 % of Australian consumers state that they have used probiotics/cultures to address digestive health concerns over the past 12 months⁵. Simultaneously, the Australian probiotic supplement market is anticipated to grow, with Euromonitor reporting a forecasted CAGR of 2.7 % between 2023 and 2028⁶.

^*DE111^® is a trademark of Deerland Probiotics & Enzymes, Inc. in the US and other countries.
^**Local regulations must be reviewed to confirm permissibility of ingredients for each food category.
¹Labellarte, G., et al. (2019) Food and Nutrition Sciences, 10, 626-634
²Freedman, K.E., et al. (2021) Int. J. Mol. Sci. 2021, 22, 2453
³Townsend, J., et al. (2018) Sports, 6(3), 70
⁴Colom J.; et al. (2021) Front. Microbiol., 12:715863
⁵FMCG Gurus, Digestive Health Global Study, 2022
⁶Euromonitor Passport Data, Retail RSP Values, USD Millions, Fixed 2023 ex Rates, Constant 2023 Prices