ATMS Journal Autumn 2022 (Public Version) | Page 41

REGULATION REPORT

The TGA ’ s final decision confirms that amygdalin and hydrocyanic acid ( HCN ) remain in Schedule 10 of the Poisons Standard , without any lower limits permitted in herbal medicine ingredients for either listed medicines ( available from health food shops or pharmacies etc .) or compounded practitioner medicines ( in which a practitioner may prescribe and supply a customised herbal formula ).

The reasons for the final decision reflect concerns about the risks associated with the presence of amygdalin in traditional Chinese medicines ; and the potential for toxic effects even at low doses of amygdalin , coupled with the hazards presented to children and the evidence that this substance is misused in the treatment of cancer and other serious health conditions .

Whilst amygdalin for therapeutic use has been prohibited via Scheduling in the Poisons Standard for many years , it can be a substance found in low or trace amounts in a range of foods and herbal medicines from the Prunus ( such as almond , cherry ) and Malus ( apple ) species . Some examples of foods that may contain amygdalin include almond milk , confectionary , almond biscuits , marzipan and prune juice . However , Food Standards do permit low level allowances of HCN glycosides ( such as amygdalin ) in food and as such , foods are exempt from the Poisons Standard .

This current TGA decision effectively confirms that practitioners are not able to supply ( including sale or gift of ) the affected herbs ( listed below ) for therapeutic use , and further could be committing an offence by doing so under federal TGA and ( or ) State and Territory legislation , unless compliance with the Poisons Standard can be demonstrated via an absence of amygdalin ( 0 %) in herbs ; and conformance with the HCN restriction of maximum 1 microgram per litre or kilogram is demonstrated . This is generally considered extremely difficult to achieve .

This means that amygdalin-containing herbs such as Wild Cherry Bark ( Prunus serotina ) and other herbal medicines ( whether in complementary medicines available over the counter , or in extemporaneously compounded medicines by practitioners ) remain in Schedule 10 if they contain amygdalin , as no lower limit is permitted for amygdalin .

Therefore , these medicines are not permitted for supply according to the following legislation ( these are examples and may not represent a comprehensive list ) if amygdalin is present :

• Medicines are not eligible to be listed or registered onto the ARTG if they contain substances in Schedule 10 .

• States and Territories also have controls on Schedule 10 substances , for example : - The NSW Poisons List adopts the ten Schedules of the Standard for the Uniform Scheduling of Medicines and Poisons ( SUSMP or Poisons Standard ) as in force at any time . www . health . nsw . gov . au / pharmaceutical / Pages / legislation . aspx ; and

- Controls on poisons are defined in Victorian Drugs , Poisons and Controlled Substances legislation . This legislation is applicable to substances that are listed in the Australian Standard for the Uniform Scheduling of Medicines and Poisons . www . health . vic . gov . au / drugs-and-poisons / drugs-poisons-and-controlledsubstances-act-1981-andregulations-2017

Affected ingredients include ( but are not limited to ):

OneCAM , in strategic collaboration with partnered organisations , particularly Complementary Medicines Australia , is considering further steps in relation to this issue for practitioners . In the meantime , we ask practitioners to be aware of the issue , particularly when dispensing liquid herbal formulations to clients . Practitioners are also encouraged to contact their respective professional association for any available guidelines , procedures and / or State and Territory legislation related to Scheduling matters .

This article was prepared with contribution of information by Complementary Medicines Australia .

OneCAM is an alliance of natural medicine organisations that represents the complementary medicine and natural therapies industry and its practitioners . Our member-base includes practitioners and associations from both ingestive modalities ( such as herbal medicine ), as well as non-ingestive modalities ( such as clinical Pilates ). A desire to see complementary medicine and natural therapies modalities unified and represented as one has long been expressed by Government , industry and practitioners alike , which has driven the development of strategies by OneCAM that represent the common needs of practitioners and industry .

REFERENCE

1 . Simeonova FP , Fishbein L . World Health Organization & International Programme on Chemical Safety . Hydrogen cyanide and cyanides : human health aspects . 2004 World Health Organization . https :// apps . who . int / iris / handle / 10665 / 42942

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