Dietary Supplements
Regulation of Dietary Supplements
Legislation
Regulation of dietary supplements
Guidance on whether a product is
a dietary supplement
Dietary supplements containing folic acid
Importing dietary supplements
Manufacturing and packing dietary supplements
Requirements under the Biosecurity Act
Export certification
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@health.govt.nz.
Legislation
Dietary supplements are regulated under the Dietary Supplements Regulations 1985, which fall under the Food Act 2014. Medsafe is responsible for administering the dietary supplement regulations and the Ministry for Primary Industries (MPI) the Food Act.
Dietary supplements containing ingredients from animals and animal products also need to comply with the Animal Products Act 1999 or the Food Act 2014.
Dietary supplements are also subject to legislation set forth by the Biosecurity Act 1993. The Biosecurity Act Legislation was enacted to protect New Zealand’s environment, plants and animals from unwanted pests and diseases.
The legislation described above is available from New Zealand Legislation.
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.
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:
- contain controlled drugs – dietary supplements cannot contain ingredients scheduled as controlled drugs under the Misuse of Drugs Act 1975
- contain substances listed in the First Schedule to the Medicines Regulations 1984 – dietary supplements cannot contain ingredients that are scheduled as prescription medicines, restricted (pharmacist-only) medicines or pharmacy-only medicines under the Medicines Act 1981
- have a stated or implied therapeutic purpose - the definition of a therapeutic purpose is given in the Medicines Act 1981.
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 specified in the Guideline for Therapeutic Products in New Zealand: Manufacture of Medicines (PDF 136 KB, 9 pages).
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:
- 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 (Microsoft Word document 50KB, 1 page)
- Attach evidence of Good Manufacturing Practice compliance for the manufacturing site that is current, less than three years old and meets the requirements specified in the Guideline for Therapeutic products in New Zealand: Manufacture of Medicine (PDF 136 KB, 9 pages).
- Send the completed declaration and Good Manufacturing Practice
evidence to:
dietarysupplements@health.govt.nz.
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):
- sponsor details
- product name
- maximum daily dose
- manufacturing site
- packing site.
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 dietarysupplements@health.govt.nz.
Requirements under the Food Act
Importing dietary supplements
Dietary supplements fall under the Food Act 2014. The Food Act requires import of all food for sale to be via a Registered Food Importer. If you are importing dietary supplements you must register as an importer with the Ministry for Primary Industries which has responsibility for administering the Food Act 2014.
MPI lists registered food importers in a public database: See http://www.foodsafety.govt.nz/registers-lists/food-act-2014-registered-food-importers/index.htm
Information on how to register with the Ministry for Primary Industries is available on their website . There is a charge for registering as an importer.
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 environment, plants and animals from unwanted pests and diseases.
Manufacturing and packing dietary supplements
As the Dietary Supplements Regulations 1985 fall under the Food Act 2014, dietary supplements should be manufactured, packed and sold in a manner that complies with the Food Act 2014 and the Food Regulations 2015.
Most businesses handling dietary supplements whether manufacturing, packaging or selling will need to register their business either under a National Programme or with a Food Control plan. To find out more about this and other obligations under the Food Act 2014 visit the MPI website at: http://www.mpi.govt.nz/food-safety/food-act-2014/overview/
Step-by-step guides to registering a National Programme or Food Control Plan can be found on the relevant pages at: https://www.mpi.govt.nz/food-safety/food-act-2014/
Requirements under the Biosecurity Act
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 dietary supplements and medical preparations is to set Import Health Standards for both private and commercial imports from overseas.
MPI has import standards relevant to some dietary supplements and medical preparations. These are published on the MPI website.
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.
The fee for each application for a certificate is $186 (GST inclusive). If a copy of the original certificate is requested at the same time, then a $26 (GST inclusive) fee is charged for each additional copy. Requests should be emailed to dietarysupplements@health.govt.nz.
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.’
Applicants are responsible for checking that their product complies with the Dietary Supplement Regulations 1985. Specifically:
- The product is not intended for a therapeutic purpose (refer to section 4 of the Medicines Act 1981
- The product does not contain a substance which is scheduled as a medicine (https://www.medsafe.govt.nz/profs/class/classintro.asp)
- The product does not exceed maximum daily doses as defined in regulation 3 of the Dietary Supplement Regulations 1985.
- Labelling and marketing of this product does not include therapeutic claims (refer to regulation 11 of the Dietary Supplement Regulations 1985).
- The labelling of this product includes the words ‘Dietary Supplement’
Once payment for export certificate applications has been received by Medsafe, the application will be checked to determine whether there are any clear compliance issues, for example that the product is not in breach of the Medicines Act 1981. Please note that if any compliance issues arise, applicants will be given the opportunity to bring the products into compliance, where appropriate. If this cannot be done, Medsafe will not issue an export certificate and the fee for the application will not be refunded. It is important to note that the check completed by Medsafe should not be seen as a comprehensive pre-market evaluation to check for compliance. The applicant is responsible for ensuring that their product fully complies with all applicable legislation. Medsafe is not able to act in a consultatory role.
To obtain an export certificate, please complete the Application Form for an Export Certificate for Dietary Supplements (Word document 46KB, 3 pages)
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 Act 2014) 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 Act 2014.
Or contact the Ministry for Primary Industries at AucklandCertification@mpi.govt.nz
Information about our Regulatory Statements for Foreign Governments
- Medsafe administers the New Zealand Dietary Supplements Regulations 1985 (https://legislation.govt.nz/regulation/public/1985/0208/latest/DLM102109.html)
- These regulations prescribe minimal requirements for dietary supplements supplied in New Zealand
- Dietary supplements are not assessed for compliance with these regulations and there is no approval process before they can be placed on the market in New Zealand
- There is no statutory provision requiring export certification to be issued by Medsafe
- Medsafe requires applicants for certification to make a declaration of compliance with the dietary supplements legislation
- Medsafe does not verify whether the declaration is true in all respects
- Medsafe advises that foreign regulators should ensure that the products referred to meet their own regulatory requirements
