REGULATION REPORT
Submission to the TGA on Prunus Serotina
Christine Pope | Director , Australian Traditional Medicine Society
The Australian Traditional Medicine Society ( ATMS ) and a number of other industry representatives have taken the opportunity to support a change to the scheduling of Prunus serotina ( Wild Cherry Bark ). The submission supports the inclusion of Wild Cherry Bark for traditional use in natural medicines subject to appropriate labelling .
Key Points of Submission ATMS made the following points in support of this submission :
• There is no evidence to suggest that amygdalin , at a maximum daily dose of less than 5 mg , or hydrocyanic acid , at the equivalent dose of less than 0.28 mg , is toxic or likely to induce adverse events .
• Wild Cherry Bark , containing amygdalin as a naturally occurring constituent , has been extensively used for over a century in both traditional and mainstream medicine , with no reported instances of toxicity or adverse events .
• Any potential risks to vulnerable groups ( children , pregnant women ) can be effectively mitigated through clear and explicit label statements to discourage use in these groups .
• A label statement can effectively deter long-term use .
• Intentional misuse of medicines containing Wild Cherry Bark as an unverified ‘ alternative ’ cancer therapy is extremely unlikely due to the very low dose of amygdalin . The TGA cites five case reports of toxicity in adults consuming daily oral amygdalin / laetrile doses ranging from approximately 420mg to 1.5g1 , which is up to 300 times higher than the proposed use .
Proposed Amendments In line with our commitment to safe and effective natural medicine practices , ATMS recommends that preparations of Wild Cherry Bark be excluded from the Schedule 10 entry for amygdalin and the Schedule 4 entry for Hydrocyanic Acid ( HCN ). This recommendation is based on the longstanding history of safe usage of Wild Cherry Bark , its low toxicity at recommended doses , and the potential benefits it brings to patients when used appropriately .
Implementing these recommendations would ensure that natural medicine practitioners can continue to provide their patients with access to this traditional medicine , supporting patient choice and the continuity of care . It would also safeguard against potential misuse or adverse effects through the recommended maximum daily doses and additional labelling requirements , and offer a more nuanced approach to the scheduling of naturally occurring substances like amygdalin and HCN .
We believe these recommendations strike a balance between ensuring the safe use of natural medicines and preserving access to these important therapeutic options . We look forward to a favourable outcome that supports the safe and effective use of natural medicines in Australia .
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