CMA Submission to TGA on Amygdalin, hydrocyanic acid, Wild Cherry Bark, and Green Tea

On 1 March, the TGA amended a public consultation on amygdalin and hydrocyanic acid, which affects 22 herbs used by complementary medicine practitioners and/or are permitted to be included on the ARTG, including Wild Cherry Bark.

The amendment to the consultation, which closed on 12 April, proposed an increased allowance to amygdalin and hydrocyanic acid in therapeutic preparations. This amended proposal was based on an advocacy appeal by CMA to the TGA to consider that the total ban on amygdalin and the restrictive ban on hydrocyanic acid, which are both naturally occurring in some plant materials, was too restrictive to allow supply of particular herbs. Despite this,  the TGA consultation also proposed a new Schedule 10 entry in the Poisons Standard for Wild Cherry Bark (Prunus serotina) which, if adopted, will result in a total ban on Wild Cherry Bark. The newly proposed Schedule 10 entry is due to TGA concern about high levels of amygdalin and hydrocyanic acid occurring in Wild Cherry Bark, and the potential for misuse.

In summary, CMA’s submission:

Supported the proposed limit of 10mg/kg hydrocyanic acid. CMA proposed that the 10mg/kg limit is specified in the Poisons Standard to apply only to plant preparations for therapeutic use rather, than all preparations for therapeutic use.

Partially supported the proposal to increase the limit of amygdalin in therapeutic preparations however, CMA did not support the TGA proposed limit of 10mg/kg. CMA’s submission proposed a permissible daily exposure per medicine of up to 1mg (without further controls) or up to 2.5mg (with additional regulatory controls such as a requirement for the preparation to be on the ARTG, a child resistant closure and a limited duration of use). This proposal is supported by intake levels determined to be safe by comparable scientific bodies, including the WHO/JECFA and FSANZ for both chronic and acute exposure, and takes into account any additional dietary consumption of foods and beverages that contain amygdalin and hydrocyanic acid.

Did not support the proposal to include Wild Cherry Bark in Schedule 10 of the Poisons Standard, as the substance is not subject to misuse and may be appropriately controlled according to the same proposals above for amygdalin and hydrocyanic acid .

Did not support the proposal to schedule Green Tea extract (GTE) (Camellia sinensis), as the proposal did not appear to support any functional outcome other than redirecting sports supplements with GTE in dosage forms such as powders, liquids and gummies onto the ARTG by way of the Therapeutic Goods (Declared Goods Order) 2019.

Please read CMA’s submission in full here.



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