Australia: New Zealand Natural Health Products Bill – Implications for Supplies of Dietary Supplements – What Could This Mean For Your Business? – Increased Compliance Requirements and Costs?

Last Updated: 16 June 2012
Article by Jamie Nettleton and Cate Sendall

On 15 September 2011, the Natural Health Products Bill was read for the first time in the New Zealand Parliament. If passed, the new legislation will cover most natural therapeutic-type products which are currently regulated as dietary supplements under the Dietary Supplement Regulations 1985.1

What Does the Bill Propose?

  • A new category of products, "natural health products" (NHP). An NHP is a product that is intended by the Sponsor 2 of the product (i.e. those who import or manufacturer or arrange for the import or manufacture), to be administered to a person, to bring about a health benefit to that person. NHPs must contain only natural health product ingredients and no prohibited ingredients. Further, NHPs must be administered by the following means only:
    • oral ingestion;
    • application to the skin, scalp or nails;
    • application to the teeth, throat, anal canal or vagina; or
    • application to the mucosa of the mouth or nose.
  • A new Natural Health Products Regulatory Authority (the Authority) within the Ministry of Health, to administer the regime. This Authority will be required to establish an NHP advisory committee, and a code of practice for the manufacture of NHPs. The Authority will also be responsible for the establishment and maintenance of the NHP database and have the power to set labelling requirements.
  • Before distributing the NHP, Sponsors will be required to submit to the Authority information about the NHP, themselves, the manufacturer and health benefit claims of the NHP. The Authority will have the power to accept, audit, suspend or cancel NHP notifications, as well as recall previously accepted NHPs. These notifications can be submitted online.
  • Product notifications will not be required for any "export-only natural health products." However, if a sponsor requires an export certificate, it must do so meeting the requirements of the Authority which includes providing a product notification.
  • All New Zealand manufacturers of NHPs will need to be licensed, unless exempted by the Authority.
  • Ingredients will need to fall within permitted ingredient classes, failing which ingredients cannot be used unless assessed and approved.
  • All NHPs distributed in New Zealand will need to comply with labelling requirements.
  • Heavy penalties for breaches: fines up to $500,000 for corporations and, in respect of individuals, fines up to $100,000 and imprisonment for up to 5 years.
  • A staggered transition period of 3 years.
  • The revocation of the Dietary Supplements Regulations 1985.

What Does This Mean?

Concern has been voiced as to how this new legislation will impact the implementation of the joint scheme with Australia for the uniform trans-Tasman regulation of therapeutic goods. Despite these concerns, the New Zealand Ministry of Health has expressed its intention to continue moving ahead with the joint scheme, while continuing to regulate natural health products under a New Zealandonly scheme. This is similar to the manner of operation of the New Zealand Dietary Supplements Regulations, which the new Bill will replace, and will result in inconsistent regulations in New Zealand and Australia.

There are concerns with regard to the cost of establishing a new regulatory authority; developing an online, automatic product notification system that has integrity and is free from abuse and maintaining the NHP database and prohibited lists. Sponsors can also expect higher compliance costs, as they will have to pay fees to obtain a licence for their products.

Sponsors can also expect a greater regulatory burden as a result of the new labelling requirements. In addition, they will have to comply with the new manufacturing code of practice and provide the necessary evidence to support claims relating to the health benefits of their products. A particularly onerous regulatory obligation is that Sponsors will be required to provide (and pay the cost of) a new product notification every time there is a change in the product's manufacturing arrangements, health benefit claims or ingredients – no matter how minor.

As the approval process in New Zealand will likely be more cost effective and time efficient, companies may continue to import New Zealand compliant products into Australia under the TransTasman Mutual Recognition Arrangement (subject to the risk inherent in relying on this Arrangement). 3 Further, as stated above, if the NHP is for export only, no product notification will be required.

Going Forward

Following the first reading of the Bill in September 2011, the Bill was referred to the Health Select Committee. Whilst public submissions closed on 24 February 2012, the Committee is not due to deliver its report until 31 July 2012. Watch this space!


1 Food-type dietary supplements are regulated by the New Zealand (Supplemented Food) Standard 2010.
2 A Sponsor of a NHP, within the context of the Bill, must be resident in New Zealand – s12 Natural Health Products Bill.
3 When relying on the Trans-Tasman Mutual Recognition Arrangement there is always a risk that the Australian Quarantine and Inspection Service (AQIS) may seize the products if AQIS considers the products are a therapeutic good (for example in pill form) and thus should be listed with the Therapeutic Goods Administration.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

Cate Sendall
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Mondaq Advice Centre (MACs)
Up-coming Events Search
Font Size:
Mondaq on Twitter
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
Email Address
Company Name
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at and we will use commercially reasonable efforts to determine and correct the problem promptly.