Consultation is now open for proposed Green Tea scheduling:
Consultation closes 29th September 2022. If you would like help with a response to the consultation, or help understanding if the proposed change will impact your products please don’t hesitate to get in contact with MKK Consulting Services for a regulatory review.
Green Tea has been proposed for Schedule 2 entry in the Poisons Standard under the following conditions:
GREEN TEA EXTRACT (Camellia sinensis) for internal use except:
a) when present as an excipient in preparations containing 5 per cent or less of green tea extract; or
b) when labelled with the warnings: “Take with food.”; and “WARNING: Green tea extract (Camellia sinensis) may harm the liver in some people. If you experience yellowing of the skin/eyes, dark urine, discoloured stool, nausea, vomiting, unusual tiredness weakness, abdominal pain, and/or loss of appetite, stop using this product and see your doctor.”
The consultation document states “Reviews have found evidence that green tea extracts in products such as sports supplements (some of which may in law be medicines despite not being included in the Australian Register of Therapeutic Goods (ARTG)) pose a risk for hepatotoxicity in consumers.
The proposed Poisons Standard amendment will raise awareness of early warning signs for liver damage to mitigate the hepatotoxicity risk for certain preparations purchased by general sale. The warning statements included in the proposal are to be included in the Poisons Standard rather than the Required Advisory Statements of Medicines Labels (RASML). This is to ensure clarity that the warning statements will capture all products for internal use containing this substance (except products that are, in law, food) whether or not they are entered in the ARTG.
If the proposal is to be accepted and green tea extract were to be included in the Poisons Standard, several supplements would subsequently be regulated as therapeutic goods as per the Therapeutic Goods (Declared Goods) Order 2019 Schedule 1, part 2. Products containing green tea extract usually make low-level claims and risks of overuse can be mitigated with the relevant labels and safety warnings. The label statements proposed alerts consumers to the early warning signs of hepatotoxicity and can reduce the risk and severity of potential harm, which is usually reversible with early cessation of use or medical intervention.”
For more information, please click below:
https://lnkd.in/gprumh_i