REGULATION REPORT
Practitioner information : Issue affecting practitioner only liquid herbs – Amygdalin scheduling
Summary
• On December 2021 the Therapeutic Goods Administration ( TGA ) published a Notice of final decisions confirming that amygdalin will remain in Schedule 10 of the Poisons Standard without a lower limit allowance - Amygdalin is a naturally occurring component of many medicinal herbs such as wild cherry bark , sour cherry and many traditional Chinese medicines , and can be hydrolysed in the gut to produce hydrocyanic acid ( which is a poison ).
• This means that amygdalin-containing herbs ( provided in a list below ) ( whether in complementary medicines available over the counter , or in compounded medicines by practitioners ) remain classified as “ Substances of such danger to health as to warrant prohibition of sale , supply and use ” and are not able to be supplied ( including sale or gift of ) by practitioners for therapeutic use .
• Practitioners should be aware of this issue , particularly when dispensing liquid herbal formulations to clients , and are encouraged to contact their respective professional association for any available guidelines , procedures and / or State and Territory legislation related to supply of a scheduled substance , which may be illegal depending on your State / Territory .
• More detailed information and background is provided below for practitioner ’ s information .
Background
Amygdalin is a naturally occurring component of approximately 1000 species of plants , several of which are consumed in the diet or in herbal medicines . These include plants including cassava ( tapioca , manioc ), sweet potato , corn , cabbage , linseed , millet , almonds , in kernels of stone fruits , such as cherries , peaches , and apricots , apple seeds and seeds of other plants in the Malus and Prunus genus .( 1 )
Amygdalin is a glycoside , which may be hydrolysed in the gut to produce hydrocyanic acid ( HCN ), although this may be affected by several interindividual factors including enzyme activity and gut microbiota . Amygdalin can be present in low levels in foods as well as some herbs used in Traditional Chinese ( TCM ) and Western Herbal Medicine ( WHM ).
Many Traditional Chinese Medicines ( TCMs ) are formulated to include one or more members of the Prunus spp . and Malus spp . and medicinal plants used in Western Herbal medicine which belong to the Prunus genus include Prunus cerasus (‘ sour cherry ’) and Prunus serotina (‘ wild cherry bark ’). Amygdalin has , at times , been attempted for use in higher quantities as alternative cancer treatment ( or for other conditions ) and has been associated with toxic consequences . Consequently , it is banned as a medicinal treatment in many countries with restrictions placed on content of foods and medicines . Preparations containing amygdalin have also been called ‘ laetrile ’ or ‘ Vitamin B17 ’ however it is not recognised as a vitamin .
Amygdalin is included as a Schedule 10 substance in the Poisons Standard ( substances of such danger to health as to warrant prohibition of sale , supply and use ); and HCN is included as a Schedule 4 substance when for therapeutic use in the Poisons Standard ( Prescription Only Medicine ). More information about Scheduling is available on the TGA website .
Issue
In April 2021 the Traditional Chinese Medicine ( TCM ) community submitted an application to the TGA proposing to amend the Poisons Standard entries for amygdalin and HCN to permit TCMs that naturally contain low levels of amygdalin .
Specifically , it was proposed that :
• the amygdalin Schedule 10 entry should be amended to allow for unscheduled oral use as a natural component in traditional Chinese medicines in adults with a maximum daily dose not exceeding 5 mg amygdalin ; and
• an equivalent change to the Schedule 4 entry for hydrocyanic acid not exceeding 0.3 mg .
This application underwent two rounds of public consultation , which are required in advance of a decision to amend the Poisons Standard . This consultation process is designed to provide members of the public and other stakeholders an opportunity to express their views ; and respond to an ‘ interim decision ’ on the proposal which is provided by the TGA .
On December 2021 the TGA published a Notice of final decisions to not amend the current Poisons Standard in relation to amygdalin and hydrocyanic acid .
40 | vol28 | no1 | JATMS