The Therapeutic Products Act (TPA) (which was passed by the previous Government last July) has now been repealed – the Therapeutic Products Repeal Act 2024 (the Repeal Act) came into force yesterday. As we have previously written about, the repeal of the TPA is part of the Government's programme of work to reform the regulation of medicines, medical devices and natural health products.
Welcome clarification for dietary supplement exporters
Along with repealing the TPA, the Government has taken the opportunity to clarify the exemptions process for dietary supplements. The Repeal Act states that the Dietary Supplements Regulations 1985 (the Regulations) are to be treated as if they were made under the Food Act 2014 (unlike in many other countries, dietary supplements are regulated as a type of food in New Zealand).
The Regulations set out the labelling and composition requirements (ie permitted ingredients and maximum daily doses) that dietary supplements must comply with, and were made under a statute that is no longer in force. By expressly reissuing the Regulations under the current Food Act, the Repeal Act has clarified a long-standing question in the sector - whether exemptions are available under the Food Act from the labelling and composition requirements under the Regulations.
This clarification is important for New Zealand businesses that produce export-only dietary supplements. The labelling and composition requirements that apply in many of our export markets (for example, the United Kingdom) are different from those that apply in New Zealand. If exemptions from domestic labelling and composition requirements were not available, then dietary supplements produced in New Zealand only for export would have to comply with those domestic requirements (even though they are not intended to be sold here) in addition to the requirements imposed by the export markets. By expressly reissuing the Regulations under the current Food Act, the Repeal Act provides certainty that the exemption mechanism does apply to dietary supplements (albeit on a product-by-product basis).
The amendment is part of the Government's plan to make it easier for exporters to deliver New Zealand food to more export markets, and we are likely to see more law changes of this kind soon. In a recent media release, Food Safety Minister Andrew Hoggart announced that a new exemption from domestic labelling requirements will be implemented across all food products intended for export, including dietary supplements, by mid-2025. The media release suggests that this exemption will apply generally, which we expect will eliminate the need for exporters to apply on a product-by-product basis.
The Repeal Act also clarifies two other key points. First, it provides that the Australia New Zealand Food Standards Code does not apply to dietary supplements, clarifying that dietary supplements do not need to comply with the labelling and composition requirements imposed by the Food Standards Code (ie in addition to the Regulations). Second, it confirms that the offence/penalty provisions in the Food Act apply to the Regulations.
In terms of its longer-term objectives, the Government is working on a standalone bill to regulate natural health products including dietary supplements. It is not clear yet what the bill will contain or how it will differ from current regulations. We will be watching for developments in this space.
This article was co-authored by Aisling Weir (special counsel), Diana Thomas (senior associate) , Emily Tyler (senior solicitor), and Josh Kemp Whimp (summer clerk).
