Regulatory

Current Situation

NZ’s regulations for NHPs are decades out of date, broken and no longer fit for purpose. Over many years various attempts at regulatory reform have failed, the most recent being the Labour / NZ First Government’s removal of the Natural Health and Supplementary Products Bill from the order paper despite it having passed the Second Reading stage and with years of consultation and public submissions.

Natural Health Products are currently regulated as dietary supplements, foods and cosmetics. Minimum manufacturing standards are prescribed in the Food Act. Therapeutic purpose claims are prohibited by the Medicines Act. Composition and labelling are regulated by the dietary supplements regulations, food standards codes and cosmetics group standards. The Fair Trading Act applies and consumer law applies.

Much of this legislation is outdated, difficult to interpret and the legal relationships are messy and broken. For example, Medsafe are only the administrator of the Dietary Supplements Regulations, not the regulator.

This has resulted in:

  • NZ Consumers are unable to be fully informed about the evidence-based health benefits of products
  • Traditional medicines including those as part of Rongoā Māori are not recognised by Medsafe as being natural health products
  • Some products being blocked from export to overseas markets
  • Inadequate policing by the regulator of non-compliant products in the New Zealand market
 

What is the Government doing?

In 2021 Cabinet decided to incorporate regulatory reform for natural health products within the Therapeutic Products Bill. The Government is drafting the Therapeutic Products Bill which will regulate natural health products (the Bill also regulates medicines and medical devices). They anticipate the Bill being introduced to parliament in the latter part of 2022. They have indicated that the Bill will not be released as a draft, nor public consultation sought prior to the Bill being introduced to Parliament.

The latest statements from the Ministry of Health are here:

The Ministry of Health have advised the following:

When can I provide feedback?
When the Bill reaches Select Committee stage, expected to be early next year, there will be an opportunity for people to have their say. By this stage you’ll have the updated Bill in its entirety.

There will also be further opportunities during the consultation on the regulations.

Contacting the team
If you’d like to get in touch, please email therapeuticproducts@health.govt.nz.

If you, or someone you know would be interested in receiving these MOH updates, you can subscribe via the Ministry of Health website.

 

What is Natural Health Products NZ doing?

Natural Health Products NZ’s Government Affairs team have been working intensively with officials and ministers over the past year, with our primary objectives being to achieve a modern, fit-for-purpose regulatory regime that:

  • Assures safety and quality in a risk proportionate manner
  • Enables appropriate, evidence-based health claims that fully inform consumers about the function of products
  • Removes export barriers by demonstrating New Zealand has world-class regulatory, compliance and audit systems
  • Enables the industry to expand faster, innovate, employ more people and contribute more to the economy, especially in the regions
  • Makes it harder for non-compliant products to be marketed and sold here