Natural health products

Information on the regulation of natural health products.

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What are natural health products?

Natural health products support health and wellness, and are made from natural ingredients, or synthetic equivalents such as synthetic vitamins. 

Natural health products include herbal remedies (in the form of capsules, tonics, and skin creams), vitamin and mineral supplements, traditional Māori remedies, traditional Chinese medicine, homeopathic remedies, and some remedies based on animal products, such as deer velvet and fish oil capsules.

Supplemented foods, such as bread or juice fortified with vitamins and minerals, are not considered natural health products. They are regulated by the Ministry for Primary Industries. Read more on the regulation of supplemented foods.

Why we need to regulate natural health products

It’s important consumers have the information they need to make informed decisions about the products they use, and have access to safe and high-quality products. Natural health products are not risk-free. They are generally lower risk products than medicines and higher risk than foods. Regulations can help ensure:

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  • products contain safe ingredients at a safe dose
  • high quality manufacturing processes are in place to provide assurance that products are not contaminated
  • product information is clear on the use and recommended dose
  • health claims are based on evidence
  • New Zealand producers are in a positive position in the global marketplace.

How natural health products currently regulated

There is currently no legislation specific to natural health products in New Zealand. Natural health products are regulated in the following ways: 

  • dietary supplements such as vitamin and mineral tablets are regulated under the Dietary Supplements Regulations 1985. The Food Act 2014 enables the regulations to stay in effect until 1 March 2026, when we intend to have a new regulatory regime well in place. The Ministry for Primary Industries regulates manufacture of dietary supplements, while Medsafe administers the Regulations. Read more on the regulation of dietary supplements.
  • beauty products that support health and wellbeing through the addition of certain active ingredients are regulated by the Environmental Protection Authority through the Cosmetic Products Group Standard 2017, under the Hazardous Substances and New Organisms Act 2017. Read more on the regulation of cosmetics
  • some products derived from animals are regulated by the Ministry for Primary Industries, under the Animal Products Act 1999. Read more on the Animal Products Act
  • a natural health product will be a medicine under the Medicines Act 1981 if its main purpose is therapeutic, as defined in Section 4 of the Medicines Act. If a product contains an ingredient listed in Schedule 1 of the Medicines Regulations 1984, this implies the product has a therapeutic purpose. Read more about medicines regulation
  • the commercial sale and promotion of natural health products are also regulated under general consumer legislation (Fair Trading Act 1986 and Consumer Guarantees Act 1993). Read more on business obligations under consumer legislation

 


Regulating natural health products under the Therapeutic Products Bill

In 2021, Cabinet decided to regulate natural health products under the Therapeutic Products Bill. However, they won’t be regulated as therapeutic products or as foods, and will have their own regulations under the Bill.

The Therapeutic Products Bill will introduce modern, fit-for-purpose legislation to protect New Zealanders by ensuring acceptable safety, quality and efficacy or performance of therapeutic products across their lifecycle, and acceptable safety and quality of natural health products.

The draft Bill’s principles will include that the likely benefits should outweigh the likely risks, and regulation should be proportionate to the risks posed by the products. These are critical factors for regulating natural health products, medicines and medical devices alike. The regulatory scheme will provide for a regulator that is independent, transparent, accountable, able to sustain regulatory capability and capacity, and is responsive and flexible.

Read more on the therapeutic products regulatory regime [link Therapeutic products regulatory regime | Ministry of Health NZ]

Why was this decision made?

Natural health products are being included as there are similarities between natural health products and therapeutic products, even though there are also differences.

Regulatory scheme similarities include, for example:

  • supporting consumer safety
  • supporting an open, well-functioning market, including innovation and exports
  • applying a risk-proportionate approach to regulation that includes market authorisation of products
  • aligning with international regulatory best-practice
  • recognising and protecting rongoā Māori traditional healing
  • providing for clear definitions, labelling, and product and consumer information
  • establishing one regulator that is independent, transparent, accountable and cost effective.

The differences are accounted for in the Bill, along with the different regulations. While the Bill will provide a comprehensive approach to both, it will be clear that natural health products are not therapeutic products and will not be regulated as such.

Having a single Bill will help clarify the nature of interfaces with other products in the Bill and other pieces of legislation such as the Food Act and the Cosmetic Group Standard.

It will also provide a timely approach to put robust, modern regulation for natural health products in place.

In developing the new regime, the Ministry of Health is drawing on previous work on natural health products, which included several rounds of consultation and significant input from stakeholders. The aim is to: 

  • support consumer safety by helping to provide for natural health products that are safe and of high quality, and that users can make an informed choice about whether to use them 
  • support the natural health products industry and exports by making clear and fair rules, and assuring other countries that New Zealand products are safe.

The scheme will include:

  • a risk proportionate approach to the manufacture of natural health products
  • requirements that support exports, taking relevant international standards and practice into account, and meeting New Zealand’s international obligations (including those under the World Trade Organisation agreement on technical barriers to trade)
  • a definition for natural health products that differentiates them from food and therapeutic products
  • the ability to make health benefit claims that can be substantiated by robust scientific or traditional evidence
  • recognition and protection of rongoā Māori
  • labelling to support consumers to make informed choices about their own health and wellbeing
  • enforcement provisions that include the recall of products where necessary.

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If you would like more information or to get in touch with the team, please contact us at: [email protected].

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