Member Alert TGA Enforces Methyl Salicylate Scheduling Impacting Filipendula/Meadowsweet

In 2019 the TGA announced they would be amending the requirements for menthol and methyl salicylate in the Therapeutic Goods (Permissible Ingredients) Determination. Under the current (2022) revised permissible ingredient standard announced by the TGA, the concentration of methyl salicylate in medicines (ingestible) must not be more than 0.0001% (10ppm).
Methyl salicylate (high in winter greens/oil of wintergreen) is only a small fraction of the phytochemical profile of Meadowsweet. However, many Meadowsweet extracts naturally exceed the permissible level of 0.0001% and has affected our access to further supply, unless the extract meets the requirement. Note: Meadowsweet of itself is not scheduled, but the component methyl salicylate is scheduled (requirements in schedule 4, 5 and 6 of the Poisons Schedule).