Clasado Biosciences' gut health-boosting prebiotic ingredient, Bimuno GOS, is now available for use in Therapeutic Goods Administration (TGA)-listed products in Australia.
This means that the nutraceutical can be incorporated into dietary supplements intended for therapeutic purposes within the country.
This also means that supplements containing Bimuno GOS marketed under the TGA framework can reference a range of permitted health claims.
Clasado's move into the TGA category bolsters the company's existing success with the FSANZ category, where 29 self-substantiated food-health relationship claims are available.
This further strenghtens the company's regulatory position within Oceania, which is now considered one of the "world's mot progressive supplement markets," valued at USD $13.74bn in 2023.
Prebiotics are also seein a strong growth curve in particular according to Grand View Research data, with the category expected to triple in value to $708m by 2030.
"This is a major step forward for Bimuno GOS in Australia. Formulators now have the opportunity to include the most studied GOS on the market, in therapeutic products that align with consumer demand for credible, gut-focused health solutions," noted David Mharakurwa, Regional Director APAC at Clasado.
"And with permitted claims available under TGA regulation for products containing Bimuno GOS, it makes it easier to communicate those benefits clearly and confidently to consumers."
With a clinically proven low dose starting from just 1.37g, Bimuno GOS combines formulation flexibility with a strong scientific profile backed by more than 125 publications and over 20 clinical trials.
Lucie Nagy, General Counsel at Clasado, said: “Entering the TGA category is a key milestone for Bimuno GOS in the APAC region. This reinforces the trusted safety and quality of Bimuno GOS, while creating new opportunities for our partners to innovate in the growing therapeutic product space.”
“This development supports our broader ambition – to make better gut health accessible to more people, in more markets, through scientifically validated ingredients that are easy to formulate and trusted by the industry," added Mharakurwa.
"With Bimuno now available for use within TGA-listed products now, we're proud to be giving Australian formulators the tools to deliver next-generation prebiotic gut health products that meet the highest consumer and regulatory expectations”.
