Regulation of Nutraceuticals in Australia and New Zealand

Abstract

In the Australian and New Zealand regulatory landscape, nutraceuticals fall at the potentially very complex human food-medicine interface. Both countries have a very complex set of legislation, legislative instruments, regulations, and guidance documents. In addition, multiple different regulatory bodies and agencies may be involved. In Australia, nutraceuticals may also be subjected to various state and territorial legislation and regulatory processes in addition to the Federal system. For the most part, three main regulatory agencies are likely to be involved: the Australian Therapeutic Goods Administration which is part of the Australian Commonwealth Department of Health, the transnational agency Food Standards Australia New Zealand, and Medsafe New Zealand. To organizations that are unused to the Australian and New Zealand systems, the requirements and processes can seem like a Gordian knot. Thus, this chapter hopes to provide an introduction to these regulatory ecosystems and to demystify some of the important concepts.