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Dietary Supplements

Regulation of Dietary Supplements

This section of the website provides an overview of the regulation of dietary supplements in New Zealand:

If you have a query that is not answered by the information in this section please contact us at dietarysupplements@moh.govt.nz.


Legislation

Dietary supplements are regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 1981. Medsafe is responsible for administering the dietary supplement legislation.

Dietary supplements containing ingredients from animals and animal products also need to comply with the Animal Products Act 1999 or the Food Hygiene Regulations 1974. Dietary supplements containing ingredients from animals and animal products are also subject to legislation set forth by the Biosecurity Act 1993. The Biosecurity Act Legislation was enacted to protect New Zealand’s biosecurity from unwanted pests and diseases.

The legislation described above is available from New Zealand Legislation.


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Regulation of dietary supplements

Dietary supplements must comply with the Dietary Supplements Regulations 1985. The regulations describe a number of requirements including, but not limited to, labelling and maximum permitted daily doses for several vitamins and minerals.

Specific regulations apply to dietary supplements containing folic acid.

There is no pre-approval process for dietary supplements. It remains the responsibility of the sponsor (the person legally responsible for placing the product on the market) to ensure the product is made to an acceptable quality, is safe to use and complies with the law.


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Guidance on whether a product is a dietary supplement

The Dietary Supplements Regulations 1985 give a definition of dietary supplements and specify requirements for some ingredients.

In general, dietary supplements are substance(s) for oral use that are packed in a controlled dosage form and are intended to supplement the intake of that substance(s) normally derived from food.

Dietary supplements cannot:

The Medsafe guideline on the Categorisation of Products can be used to determine whether a product is a dietary supplement.

The Ministry for Primary Industries New Zealand Supplemented Food Standard – User Guide has a flow chart in chapter 4 which can help you decide whether your product is a dietary supplement or supplemented food.


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Dietary Supplements containing Folic Acid

The maximum daily dose for a dietary supplement is 300 micrograms folic acid per day.

However, the maximum daily dose of folic acid may be increased to 500 micrograms per day if the sponsor has demonstrated to Medsafe that the dietary supplement is manufactured in a Good Manufacturing Practice certified facility.

Note that the Good Manufacturing Practice certification must meet the requirements of New Zealand Regulatory Guidelines for Medicines, Part D: Guides to Preparing the Content of your Application, Section 5: Good Manufacturing Practice Documentation (page 23).

To demonstrate that your product is manufactured in a Good Manufacturing Practice certified facility and to appropriate Good Manufacturing Practice standards you will need to:

  1. Complete a declaration that the product is manufactured in a way that accords with the New Zealand Code of Good Manufacturing Practice using the Sponsor declaration form (Word 50KB, 1 page).
  2. Attach evidence of Good Manufacturing Practice compliance for the manufacturing site that is current, less than three years old and meets the requirements of New Zealand Regulatory Guidelines for Medicines, Part D: Guides to Preparing the Content of your Application, Section 5: Good Manufacturing Practice Documentation (page 23).
  3. Send the completed declaration and Good Manufacturing Practice evidence to:

    Manager, Compliance Management
    Medsafe
    PO Box 5013
    WELLINGTON 6145

You cannot legally supply dietary supplements containing more than 300 micrograms folic acid per daily dose until the Medsafe verified declaration has been returned to the sponsor. The verified declaration should be retained by the sponsor for at least one year after the expiry of the last batch supplied.

If Medsafe is not satisfied that all requirements are met the sponsor will be contacted.

Sponsor declarations are subject to audit. Medsafe reserves the right to request further details regarding the manufacturing arrangements and Good Manufacturing Practice compliance of the product while it remains on the market.

A verified sponsor declaration remains valid if all details of the sponsor declaration remain unchanged. If changes are planned, the sponsor must submit an updated declaration and receive verification in advance of supplying the product to the New Zealand market.

Changes that require a new declaration include (but are not limited to):

If the site manufacturing your product does not have acceptable Good Manufacturing Practice certification, you can contact the Compliance Management Branch of Medsafe to arrange a Good Manufacturing Practice audit. A service fee will apply to such audits in order to recover the time and travel costs associated with the audit.

For further information, contact the Compliance Management Branch on 04 819 6800.

Questions and answers on requesting confirmation of GMP status for the manufacture of a dietary supplement containing folic acid with a daily dose of more than 300 mcg


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Manufacturing and packing dietary supplements

Excluding products that contain more than 300 micrograms of folic acid, there is no requirement for dietary supplements to be manufactured to Good Manufacturing Practice.

As the Dietary Supplements Regulations 1985 fall under the Food Act 1981, dietary supplements should be manufactured / packed in a manner that complies with the Food Hygiene Regulations 1974 and Food Act 1981. This may involve, for instance, registration with a local council under the Food Hygiene Regulations 1974 or registration with the Ministry for Primary Industries through a Food Safety Programme.

For further information on the registration process via a local council, contact the environmental health section of that local council.

Further information on Food Safety Programmes can be found on the Ministry for Primary Industries website.


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Export certification

Export certification, in the form of a Statement to Foreign Governments that explains the regulatory setting for dietary supplements, can be obtained from Medsafe on request.

Export certification can only be issued for dietary supplements manufactured in New Zealand. Export certification can be issued for products exported in bulk, for packaging and labelling overseas, and this will be included in the certificate.

A service fee of $135 (GST inclusive) is charged for the first certificate and then $22.50 (GST inclusive) is charged for every additional certificate issued at the same time. Requests should be addressed to the:

Manager, Product Regulation

Medsafe

PO Box 5013

WELLINGTON 6145

Exporters should note that, due to the nature of dietary supplement regulation, it is not possible to attest to the safety or quality of products or their compliance with New Zealand law. Export certificates will therefore include the following statement:

‘Under New Zealand law, dietary supplements are not assessed by a Government agency. This statement cannot therefore provide any assurance that the product(s) listed meet any quality or safety standards, are of New Zealand origin, or meet the regulatory requirements of the importing country.

If the product(s) listed comply with the requirements of the New Zealand Dietary Supplements Regulations (and any other applicable legislation) the product(s) are legally able to be sold in New Zealand.’

To obtain an export certificate, please complete the Application Form for an Export Certificate for Dietary Supplements (Microsoft Word document 55kb, 1 page).

Any requests for certification that attests to aspects of regulation administered by the Ministry for Primary Industries (such as the Animal Products Act 1999 or the Food Hygiene Regulations 1974) should continue to be sent to the Ministry for Primary Industries. For instance, any animal materials or animal products in a dietary supplement need to comply with the requirements of the Animal Products Act 1999 or the Food Hygiene Regulations 1974.

Information on how to acquire the animal component certification is available on the Ministry for Primary Industries website.

Or contact the Ministry for Primary Industries at dairycerts@mpi.govt.nz.


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Importing dietary supplements

As dietary supplements fall under the Food Act 1981, an importer should list their details with the Ministry for Primary Industries which has responsibility for administering the Food Act 1981.

Information on how to list with the Ministry for Primary Industries is available on their website. There is no charge for this.

The New Zealand Customs Service is able to advise on the requirements (eg, taxes, paperwork) for commercial importation into New Zealand.

Dietary supplements containing ingredients from animals and animal products are also subject to legislation set forth by the Biosecurity Act 1993. The biosecurity act legislation was enacted to protect New Zealand's biosecurity from unwanted pests and diseases.

The Ministry for Primary Industries is responsible for enforcing the Biosecurity Act 1993. The role of the Ministry for Primary Industries in managing potential biosecurity risks in health supplements is to set Import Health Standards for both private and commercial imports from overseas.

The Ministry for Primary Industries has three Import Health Standards relevant to dietary supplements:

  1. Beeproic.all (section 7.4 – dietary supplements and medical preparations containing honey and bee products).
  2. Ediproic.all (sections 7.5 – velvet from cervine animals, 7.20 – muscle protein powders containing dairy and egg ingredients, and 7.21 – gelatine capsules.
  3. Ineprioc.all (sections 6.1 through 6.14).