Regulations – Latest News on the regulation of Natural Health Products

By /

CURRENT SITUATION

The Therapeutic Products Bill was introduced to Parliament on 30 November 2022. On Wednesday 14 December it passed first reading, and has now been sent to the Health Select Committee.  Submissions are due 15 February 2023 (extended from original deadline of 9 Feb). CLICK HERE for our very latest news. 

Whilst Natural Health Products NZ welcomes this progress, it’s important to note that the association is also reading it for the first time now and will provide further comment once the detail has been digested.

READ Natural Health Products NZ’s PRESS RELEASE

This Bill, when enacted, will replace the Medicines Act 1981 and Dietary Supplements Regulations 1985 and provide regulations for all natural health products.

Read/Download the Therapeutic Products Bill here:

NZ’s regulations for NHPs are decades out of date, broken and no longer fit for purpose.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Much of this legislation is outdated, difficult to interpret and the legal relationships are messy and broken.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 Therapeutic Products Bill which will regulate natural health products (the Bill also regulates medicines and medical devices) was introduced to parliament on 30 November 2022. Once the Bill has had it’s First Reading a date will be set for the Health Select Committee to meet, and a deadline will be notified for submissions.  

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. 

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 [email protected].

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

Fiona Ryan’s Summit 2022 presentation
To access a PDF version of the slide deck, click here.

WHAT IS NATURAL HEALTH PRODUCTS NZ DOING?

Our Regulatory/Technical team are reading through the fine print of the Bill now and we will be back in touch with Members with more information including what Members need to do next.

In the meantime, we urge you to read the Bill. 

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

 

How can you participate and have your say prior to the Select Committee process?

  • Read the Bill
  • Review and familiarize yourself with the documents listed below
  • This very recent news item from RNZ will also be useful in preparation for Select Committee submissions:
    ARTICLE/AUDIO:  Submitting to Parliament (but in a good way)
  • Contact the Ministry of Health directly at [email protected].
  • Participate in Natural Health Products NZ surveys and working groups

    As our Regulatory Sub-committee works through facets of the regulations, they will be reaching out to members to seek your input, ensuring that we best represent the interests of the industry.  

The following surveys are open for member feedback:

Thank you to all who have already contributed.

* Conditions list will likely be the next survey

RELEVANT DOCUMENTS, UPDATES & LINKS

Natural Health Products NZ regulatory updates to members

CURRENT LEGISLATION

CURRENT GOVERNMENT DOCUMENTS

PAST CONSULTATION & DOCUMENTS

The Ministry of Health have indicated their intention to use the previous Natural Health and Supplementary Products Bill and Draft Guidelines to inform the drafting of the Natural Health Products content of the Therapeutic Products Bill.

Natural Health and Supplementary Products Bill 324-2

In 2015 the Ministry of Health sought public feedback on proposals on natural health products regulations and notices under the Natural Health and Supplementary Products Bill (the Bill).

An archive of the documents from this period of consultation is available here which includes the following draft guidelines for manufacturing, evidence requirements and permitted ingredients:

In addition to the Ministry’s archive, the following are also of interest:

We recommend reviewing these documents.

 

International Comparisons

The Ministry of Health have also indicated that they are looking to the regulatory regimes of Australia and Canada to inform their thinking. 

Additionally for evidence requirements they are also referencing the evidence requirements for FSANZ Self Substantiated Health Claims

 

PROPOSED HEALTH BENEFIT CLAIMS FOR NHPS IN THE THERAPEUTIC PRODUCTS BILL

(Currently proposed by MOH) Health benefit claim means a claim of a health benefit.
Health benefit means any one of the following benefits:

  1. The maintenance or promotion of health or wellness
  2. Nutritional support
  3. Vitamin or mineral supplementation
  4. Affecting or maintaining the structure or function of the body
  5. Relief of symptoms of any condition that is not a serious condition

NHPNZ has determined that the points highlighted below are what would NOT be permitted within the proposed NZ Health Benefit Claim definition, but are permitted in CANADA and AUSTRALIA.  It is NHPNZ’s position that the Bill must enable all of these claims for Natural Health Products. We have made our position on this matter very clear to the Ministry.

CANADA – Natural Health Product
Natural health product means a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in

  1. The diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans
  2. Restoring or correcting organic functions in humans; or
  3. Modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health. However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.
    A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1 to the Act.

AUSTRALIA – Complementary Medicine (from TGA)
Traditional or scientific indications can be classified into two sub-types
Sub-type 1: Non-specific (general indications)
Non -specific indications refer to general health and wellbeing, such as:

  • Health maintenance
  • Relief of symptoms not related to a named condition; and
  • General vitamin, mineral or nutritional supplementation.

Sub-type 2: Specific indications
Specific indications refer to health benefits beyond general health and wellbeing, such as:

  • Health enhancement
  • Reduction of risk or frequency of a named condition or symptoms
  • Management or relief of symptoms linked to a named condition
  • Nutritional supplementation claims linked to a specific therapeutic benefit

WHO Traditional and Complementary Medicines Strategy

As a WHO member country our government has not fulfilled New Zealand’s obligation as per WHO resolution at the sixty-seventh world assembly that:

URGES Member States, in accordance with national capacities, priorities, relevant legislation and circumstances:

(1) To adapt, adopt and implement, where appropriate, the WHO traditional medicine strategy: 2014–2023 as a basis for national traditional and complementary medicine programmes or work plans; 1 Document A67/26. WHA67.18 2

(2) To develop and implement, as appropriate, working plans to integrate traditional medicine into health services particularly primary health care services

(3) to report to WHO, as appropriate, on progress in implementing the WHO traditional medicine strategy 2014–2023

We recommend members become familiar with the WHO Traditional and Complementary Medicines Strategy documents and reports on the governments lack of progress as regulatory reform for Natural Health Products must enable New Zealand to fulfil these obligations.    The government has not acted to meet these WHO Member State obligations to date.

Scroll to Top