New legislation for New Zealand dietary supplements industry

The New Zealand Therapeutic Products Bill (the Bill) passed its third reading in the Committee of the Whole House on 19 July 2023. The Bill establishes a scheme for supplements, currently known in NZ as ‘dietary supplements’ to become therapeutic Natural Health Products (NHPs), and a new Regulator for these products. This is similar to the national recognition in Australia of complementary medicines as therapeutic goods. As Parliament has now passed the Bill, it will go to the NZ Governor-General, Her Excellency the Rt Hon Dame Cindy Kiro, for her signature. At this point, the Bill will receive Royal assent, however, most of the Act will not commence until September 2026.

The passing of the Bill marks the most significant change to the regulation of medicines, medical devices and natural health products in New Zealand in nearly 40 years. There are currently around 20,000 natural health products in NZ representing around $NZ 2.3billion. Australia exports approximately AU$400 million annually, about 20 % of the total value of the NZ NHPs market. A therapeutic scheme for the natural health product sector has been sought in NZ for some time, to recognise the therapeutic use of these products and unlock important export opportunities. However, significant concern remains regarding the high level of bureaucracy implied, in particular, the Bill requires the individual authorisation of all products on the market, which is in contrast to Australia’s listing (notification) style system.

Secondary legislation around the practicalities of the regulatory regime such as allowable ingredients and product claims, are yet to be developed but will need to be in place by 1 September 2026. This will be the start of the transitional period for existing NHPs being imported, supplied in, or exported from NZ. The team at Manatū Hauora (Ministry of Health NZ) has started planning for these next steps and will publish further details on the timing for engagement and consultation in the coming months. Until late 2026, the existing Medicines Act 1981 (and Medicines Regulations) and Dietary Supplementary Regulations 1985 remain in force. Importantly, the transitional periods for current activities and existing products will only start once the Act commences in 2026. The date set for commencement for the majority of the Act is 1 September 2026. From commencement, most Natural Health Products that require market authorisation (low concentration products are excepted) and that were, immediately before commencement, lawfully being imported into, supplied in, or exported from New Zealand in the course of a business or undertaking; will have a temporary market authorisation.