On 20 December 2021, the Therapeutic Goods Administration (TGA) were advised not to amend the scheduling for amygdalin and hydrocyanic acid in the current Poisons Standard, which was implemented on 1 February 2022. The final decision states that amygdalin will remain in Schedule 10 (substances of such danger to health as to warrant prohibition of sale, supply and use) of the Poisons Standard. Found in the seeds of some edible plants, such as bitter almonds and peaches, amygdalin is a naturally occurring cyanogenic glycoside compound converted into hydrocyanic acid (cyanide) in the gut. The toxicity of amygdalin is highly variable and influenced by numerous factors, including other ingested plants or nutrients (e.g. plant enzymes or ascorbic acid), vitamin B12 and individual gut flora.
Complementary Medicines Australia (CMA) opposed the interim decision and made a submission that the zero tolerance for amygdalin, established by its entry in the Poisons Standard, is “not practicable”. However the delegate responsible for the decision for the advisory committee said: “I remain unconvinced that the risks associated with the presence of amygdalin in traditional Chinese medicines (TCM) are outweighed by any health benefits…” It would seem the TGA were influenced by the history of persistent misuse of amygdalin for the treatment of cancer. “Amygdalin has been prohibited since 1974 when it was supplied as Laetrile or vitamin B17, a purported treatment for cancer with serious toxicity and no clear evidence of therapeutic benefit. I am concerned that the down-scheduling of amygdalin may contribute to excessive use of amygdalin, particularly where people who have or who have had cancer are seeking alternative treatments.”
Devotees of almond milk lattes, and almond croissants, will be relieved that this is at odds with the regulations for foods, which are exempt from the Poisons Standard (Appendix A), and are therefore permitted to contain low levels of amygdalin. The delegate said: “I also do not support the down-scheduling of amygdalin at 5mg or less to unscheduled, to align with the limits set by the Australian New Zealand Food Standards (FSANZ). The FSANZ food limits are based on the Acute Reference Dose (ARfD) for a safe level of one-off exposure, rather than regular and possibly chronic ingestion, which is the assumed practice for a TCM…”
Substitutes for Wild Cherry (Prunus serotina) include:
Because the TGA did not alter the Poisons Standard for the trace levels (very small amounts) of amygdalin that can be found in wild cherry bark we recently ceased sales of this product. To assist you in clinic we have provided you with some substitute herbs below.
Wild cherry bark is a notable example of an antitussive, a remedy that quells coughing. Its powerful sedative action on the cough reflex means its main indication is dry, unproductive cough and thus it has a role in the irritating and persistent cough of bronchitis and whooping cough. It is especially helpful for coughs that prevent someone from sleeping or for the persistent dry cough that lingers long after other symptoms of a cold or flu have abated.
Wild cherry is high in antioxidants that can cool inflammation. Practitioners reach for wild cherry when there are signs of heat and excess whether it is a spasmodic dry unproductive cough, excess uric acid deposits causing painful gout or an excessive immune system response like seasonal allergies. It is also a great ally for aiding digestion (the aromatic and bitter aspects) and supporting heart health (modulating inflammation), similar to its close relative hawthorn (Crataegus monogyna).
Note: Wild cherry is energetically cooling so the substitutes have been chosen for their cooling or neutral energetics. Respiratory herbs with warming energetics, such as angelica, elecampane, hyssop, ivy leaf, rue and thyme, have not been included for this reason.
References
Notice of final decisions to amend (or not amend) the current Poisons Standard - ACMS #34, Joint ACMS-ACCS #28, ACCS #31. Delegate’s final decisions and reasons for decisions (ACMS #34, Joint ACMS-ACCS #28, ACCS #31 - June 2021 meetings) Australian Government Department of Health Therapeutic Goods Administration Commonwealth of Australia c2021 (updated 20 Dec 2021; accessed 11 Mar 2022). p5-6. Available from https://www.tga.gov.au/sites/default/files/notice-final-decisions-amend-or-not-amend-current-poisons-standard-acms-34-joint-acms-accs-28-accs-31.pdf
Notice of interim decisions on proposed amendments to the Poisons Standard - ACMS, ACCS and Joint ACMS-ACCS meetings, November 2020. Australian Government Department of Health Therapeutic Goods Administration (updated 3 Feb 2021; accessed 11 Mar 2022). Available from https://www.tga.gov.au/book-page/21-amygdalin-and-hydrocyanic-acid
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