REGULATORY INFORMATION

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Dietary Supplements

Regulation of Dietary Supplements

Legislation

Dietary supplements are regulated under the Dietary Supplements Regulations 1985 (the DSR), promulgated under the Food Act 1981.

On 31 March 2010 the DSR were amended by the Dietary Supplements Amendment Regulations 2010 (SR 2010/5) which introduced the following changes:

• A new definition of dietary supplement. This change has the effect of narrowing the scope of the DSR so they now cover only therapeutic-type products. The food-type supplements previously also regulated under the DSR are now regulated as Supplemented Foods under a new standard (the New Zealand Food (Supplemented Food) Standard 2010) issued under the Food Act 1981 and administered by the Ministry of Agriculture and Forestry (MAF).
• A permission for a supplement to contain more than a maximum daily dose of 300mcg of folic acid (but not more than a maximum daily dose of 500mcg) if the Director-General of Health has confirmed that the supplement has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods (New Zealand Code of GMP).
• A transfer of responsibility for administration of the DSR from the New Zealand Food Safety Authority (NZFSA, which has now merged with MAF) to the Ministry of Health (Medsafe).

The DSR and the Dietary Supplements Amendment Regulations 2010 are available from http://www.legislation.govt.nz

Guidance on whether a product is a dietary supplement

The categorisation of a product is determined by its ingredients, its purpose for use and the manner in which it is presented in the market. The Medsafe guideline Is my product regulated under the Medicines Act or the Food Act can be used to determine whether a product is a dietary supplement.

Dietary Supplements containing more than 300mcg of Folic Acid

It is only lawful for a dietary supplement to contain more than a maximum daily dose of 300mcg (but not more than a maximum daily dose of 500mcg) if the Director-General of Health has confirmed that the dietary supplement has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice (GMP).

Confirmation of compliance with GMP is not required for dietary supplements containing up to a maximum daily dose of 300mcg folic acid. It is not permissible to supply a product containing more than a maximum daily dose of 500mcg folic acid as a dietary supplement.

To obtain confirmation from the Director-General that a dietary supplement has been prepared in a way that accords with the New Zealand Code of GMP, a prospective supplier must make an application to Medsafe using the Request for confirmation of GMP status form (Microsoft Word document 50kb). Refer to the question and answer for further information on completing the form.

The application must be accompanied by copies of:

1. Good manufacturing practice certification relating to the manufacture of the dietary supplement, that is current and may be any of the following:

• a Licence to Manufacture Medicines issued by Medsafe
• a Licence to Manufacture Therapeutic Goods issued by the Australian Therapeutic Goods Administration
• a GMP Certificate issued by Medsafe or by any of the recognised regulators listed in Part D Section 5 of the New Zealand Regulatory Guidelines for Medicines and that is less than 3 years old

AND

2. Where the dietary supplement is presented as a tablet but is not a chewable, effervescent, dispersible or modified-release tablet or is presented as a capsule but is not a soft or modified-release capsule, the finished product specification for the dietary supplement must include a dissolution test for folic acid that either:

• meets the requirements of the USP

OR

• meets the requirements of TG078
  http://www.comlaw.gov.au/Details/F2008L04287

The completed application form and supporting documentation should be sent to:

Manager, Compliance Management
Medsafe
P O Box 5013
WELLINGTON 6145

Following receipt of a completed application form and supporting documentation, Medsafe will check the information supplied. When Medsafe is able to confirm the acceptability of the manufacturing arrangements, a signed confirmation certificate will be issued and sent to the prospective supplier, together with a copy of the original submission. This documentation should be retained by the supplier as evidence that supply of the supplement described on the form is lawful. The product cannot lawfully be supplied as a dietary supplement in New Zealand until the Medsafe confirmation has been received.

If not satisfied Medsafe will contact the supplier to discuss the reason(s) the documentation supplied is inadequate.

A prospective supplier who does not hold acceptable GMP certification should contact Medsafe's Compliance Management Branch if they wish to arrange a GMP 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.

Export certification

Export certification in the form of a Statement to Foreign Governments that explains the regulatory setting for dietary supplements can be obtained 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, P O Box 5013, Wellington.

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.

Any requests for certification that attests to aspects of regulation administered by MAF (such as the Animal Products Act 1999 or the Food Hygiene Regulations 1974) should continue to be sent to MAF.

Please click here for the Application Form for an Export Certificate for Dietary Supplements (Microsoft Word document 55kb)

General Enquiries

Please e-mail general enquiries to Medsafe at dietarysupplements@moh.govt.nz.