Current Issues in the Authentication and Quality Control of Botanicals – An Australian Perspective

In Australia, botanicals and nutritional supplements are regulated as medicines and must meet pharmaceutical GMP standards. The most fundamental aspect of quality assurance of botanicals concerns the authenticity of the raw material. Despite ongoing advances in pharmacognosy, issues relating to authentication and quality control persist for many botanicals, and such issues directly affect the safety and efficacy of products. Intraspecific genetic variability, the many environmental factors that can influence the production of secondary metabolites, the often complex supply chain for botanical raw materials, taxonomic and nomenclatural uncertainties and the challenges of identifying crude botanical drugs are all factors that contribute to making this a challenging area. In addition, adulteration and substitution remains a serious issue for botanical raw materials.

This presentation will draw mostly on recent work in our laboratory, highlighting current issues in the authentication and quality control of botanicals in the Australian marketplace. However, as many botanical raw materials are sold on the international market, most of these issues are not confined to Australia. Cases to be discussed will include the increasingly common adulteration of ginkgo extracts, authentication issues affecting Scutellaria species, and safety concerns about Australian tea tree oil. The need for ongoing vigilance in the quality control of botanicals will be demonstrated.