Following the announcement of the new Medical Products Bill late last year, the government has now officially repealed the Therapeutic Products Act 2023 (TP Act).

The repeal paves the way for a new regulatory framework for medicines and medical devices under the Medical Products Bill which is currently being developed. While we are still awaiting a draft Bill, the Modernising regulation of medicines and medical devices Cabinet paper sets out the proposed programme and scope that the Bill is expected to cover. 

Changes for dietary supplements

With the confirmation that the new Medical Products Bill will exclude natural health products (including dietary supplements), such products will continue to be regulated under the Dietary Supplement Regulations 1985 (DSRs) until new standalone legislation is put in place.

In the meantime, the repeal of the TP Act has brought about some changes to the regulation of dietary supplements. The DSRs are now deemed to be made under the Food Act 2014. This means that the powers under the Food Act also apply to dietary supplements. For example, exemption powers for exports will enable exporters to apply for New Zealand labelling and composition requirements for their exported products. 

There have also been changes to the DSRs themselves, including a new clause clarifying the adopted joint food standards do not apply to dietary supplements. This does not, however, prevent future changes under the DSRs to adopt joint food standards where necessary.

In addition, the offences and penalties provision under the DSRs have been revoked, meaning that the offences, penalties and defences under the Food Act now apply to dietary supplements in the same way as for food. This means a 1,000% increase in the maximum fines that could result from committing an offence in relation to dietary supplements, from a modest sum of $500 under the DSRs to $500,000 under the Food Act. Not only this, being regulated under the food regime also means managers and directors could also be personally liable for the offences committed by the company in certain circumstances. 

The changes mark the first of a series of reforms to the export of dietary supplements and other natural health products to better enable exporters to compete in international markets, as announced by the government in a media release late last year.

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If you have any questions relating to how your products are affected by current and upcoming changes, please contact our team.