Natural products regulation – Getting the balance right. The case of arbutin

Recently, 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 Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (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). This article briefly discusses the history of arbutin scheduling and the chemistry and metabolism of arbutin. It suggests that the understanding of the metabolism of arbutin and clinical use of the herbs affected should be more closely considered, and amendments to the Poisons Standard is recommended for the oral use of herbal medicines containing arbutin, such that continued use of Bearberry and Damiana can be achieved.