The outbreak of the SARS-CoV-2 virus has brought prominence to the concept of immune health for individuals. A common means of attempting to do so is by incorporating immune supplements into everyday life. While immune supplements generally contain well-documented traditional herbs, knowledge about the quality and safety of these commercial products is minimal. In Australia, the Therapeutic Goods Administration (TGA) regulates and enforces advertising, labelling and compositional consistency of immune supplements; however, minimal pre-market assessment omits the potential harm and adulteration regularly cited in the literature.
A multifaceted approach to these products’ overall safety and quality is essential in safeguarding human health. Following TGA guidelines, seventeen immune supplements were investigated for their labelling compliance with the Therapeutic Goods Order No. 92 for non-prescription medicines. Although systemic labelling non-compliance was observed throughout the products, this was not associated with their potential to cause harm. Thus, stringency in this area is not necessarily applicable to protecting consumers. More focus should be put on high throughput pharmacovigilance methods that examine immune supplements' compositional integrity and consistency. For this study, the composition of immune supplements was analysed via nuclear magnetic resonance (NMR) spectroscopy using metabolomics. NMR provides detailed ‘snap shots’ into the chemical profile of immune supplements that can be interpreted via multivariate statistics to indicate the consistency of products across numerous batches. Therefore, this thesis aims to provide an overview of the quality and safety of Australian immune supplements. At the same time, it is recognising the place of metabolomics in regulatory environments as a high throughput mechanism of quality assurance
