Herbal medicine banned by the TGA

In Business and Environment, Health and Healing, Health and Nutrition by Martin OliverLeave a Comment

Herbal medicine arbutin (a.k.a bearberry) has been officially banned by the Therapeutic Goods Administration.

In May this year, the Therapeutic Goods Administration issued information governing the sale of herbal products containing the chemical substance arbutin. Certain to be affected is uva ursi, also known as bearberry. Arbutin is a known reliever of urinary tract infections. There is a possibility the TGA will continue banning other herbal drugs, such as yarrow, marjoram and damiana.

By the end of June 2018, products containing arbutin will have to be removed from the shelves. They will be available via prescription only. This change will exclude the possibility of consuming either the simple herb or tincture.   

Scheduled as a poison

This situation originated back in 2010, when arbutin was added to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), as an S4 poison. However, only in May 2018 was this followed up with a website update specifying the legal requirements affecting herbs.

The allowable level of arbutin is set at a low 10 parts per million (ppm.) Uva ursi, in comparison, is about six per cent arbutin, equivalent to 6,000 ppm, six hundred times higher than the allowable threshold. As a herb, it is widely used for tackling urinary tract infections.

No consumer has reported being harmed by arbutin

In addition to the loss of access to at least one of these herbs, some other concerns have been raised surrounding the process. Harm from consuming substances with arbutin is only theoretical. However, it has been labelled as potentually harmful because of its relationship to the chemical hydroquinone.

No consumers have complained about being harmed by herbs as a result of their arbutin content. Uva ursi has been classed as safe in the EU, to give an example. As a result of these decisions, Australia will become the only jurisdiction globally where it is prohibited.

TGA’s Poisons Scheduling Committee

The heavy-handed aspect of this decision has been acknowledged by the TGA’s Poisons Scheduling Committee, which is sympathetic to the damaging effects of decisions. Other issues include the relatively short notice given, and the potential setting of a precedent, where such a scenario could be repeated again, with further herbs removed.

Acknowledgements are due to the Health Australia Party for raising an alert and spreading it to a wide audience. Other valuable contributions have been from Complementary Medicines Australia and the Naturopaths and Herbalists Association of Australia, both of which have put out their own factsheets.

For the decision to reversed, arbutin would have to be removed or downscheduled by the Poisons Scheduling Committee, and any lobbying would need to be tailored to this outcome. Some practitioner peak bodies are working behind the scenes for a better outcome.

Meanwhile, actions worth taking include:

CMA factsheet

NHAA factsheet



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