ADM receives TGA Australia approval for spore-forming probiotic DE111

Published: 20-Jun-2024

The approval allows for the distribution and marketing of the spore-forming probiotic in Australia

ADM, a global natural solutions specialist, has received approval from the Australian Therapeutic Goods Administration (TGA) for its spore-forming Bacillus subtilis probiotic, DE111. 

This follows the recent approval from the National Health Commission (NHC) in China.


DE111 for better gut health

Clinically documented results show that DE111:

  • Supports digestive health1 whilst also supporting immune function2,3
  • Survives in the stomach, allowing it to reach the small intestine4
  • Support gastrointestinal health, gut function and microbiome diversity

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

“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,”

Consumer knowledge on gut health expanding

In Australia, 81% of consumers recognise a link between digestive health and overall well-being, and 76% specifically see a connection between their digestive health and immune function.5

Plus, 64% of Australian consumers state that they have used probiotics/cultures to address digestive health concerns over the past 12 months.5
Simultaneously, the Australian probiotic supplement market is anticipated to grow, with Euromonitor reporting a forecasted CAGR of 2.7% between 2023 and 2028.6




1  Labellarte, G., et al. (2019) Food and Nutrition Sciences, 10, 626-634

2   Freedman, K.E., et al. (2021) Int. J. Mol. Sci. 2021, 22, 2453

3  Townsend, J., et al. (2018) Sports, 6(3), 70

4  Colom J.; et al. (2021) Front. Microbiol., 12:715863

5  FMCG Gurus, Digestive Health Global Study, 2022

 Euromonitor Passport Data, Retail RSP Values, USD Millions, Fixed 2023 ex Rates, Constant 2023 Prices


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