Submission To The TGA On Proposed Poisons Standard Amendments

The NHAA recently made a submission to the TGA on proposed amendments to the Poisons Standard concerning two compounds commonly found in herbal medicine.

The Advisory Committee on Medicines Scheduling is considering whether to list Sanguinarine as a Schedule 10 substance (prohibited). The Joint Advisory Committee on Medicines and Chemicals Scheduling will be considering whether to amend the entry on Arbutin currently as Schedule 4 (prescription only).

Sanguinarine is the compound found in Black Salve, which has been inappropriately marketed as an alternative treatment for skin cancer.

While the NHAA supports moves to limit the misleading use of Sanguinarine, listing it as Schedule 10 could have the unintended consequence of banning two approved herbal medicine ingredients that contain Sanguinarine in amounts greater than 0.1% – Chelidonium majus and Eschscholzia californica. While these herbs may not always contain more than 0.1% Sanguinarine, literature suggests it is possible. For these reasons the NHAA would like to see further consultation on the amendment to avoid unintended consequences.

In the case of Arbutin, last year the TGA published an update stating that herbs which contain Arbutin in a concentration exceeding 10 ppm are not eligible to be included in Listed complementary medicines in Australia due to scheduling of Hydroquinone in Schedule 4 of the Poisons Standard. This has subsequently had an effect on the availability of medicines and extracts used extemporaneously by practitioners. Of concern is the loss of medicinal herbs with important therapeutic benefits that are commonly used in therapeutic goods or in extemporaneously dispensed preparations, such as Bearberry (Arctostaphylos uva-ursi) and Damiana (Turnera diffusa). Since the announcement last year we have lobbied that the understanding of the metabolism of Arbutin and clinical use of the herbs affected should be more closely considered, and an amendment to the Poisons Standard recommended.

This proposed amendment for the Arbutin entry in the Poisons Standard would thankfully see an exception for oral herbal preparations containing 500mg or less of Arbutin. The proposal is also to remove the cross reference of Arbutin to Hydroquinone. We have written in support of this amendment.

See the submission: