The Natural Health and Supplementary Products Bill sets up a new regulatory regime to manage the risks associated with natural products manufactured and imported into New Zealand.
The main focus of the Bill is consumer protection. However, the Bill also seeks to uphold the industry’s integrity, and maintain New Zealand’s reputation as a quality producer and supplier of natural health products.
The Bill was developed to provide regulation to a rapidly expanding multi-million dollar enterprise. It was introduced as a standalone scheme on 7 September 2011 and is currently awaiting its third reading. The commencement date is expected to be some time in early 2015. Although, there will be a three year transitional period with the full regulatory scheme phased in gradually following enactment.
The new regime seeks to ensure that natural health and supplementary products are:
- safe and fit for human use; and
- that the health claims are true and supported by scientific or traditional evidence; and
- that they are manufactured safely, true to label, and contain the ingredients specified.
A fundamental principle of the regime is that regulation should be proportionate to the low risk generally associated with natural health products. Higher risk products will require approval under the Medicines Act.
What is a Natural Health and Supplementary Product (NHSP)?
A NHSP is defined as any product manufactured for the primary purpose of bringing about a health benefit in humans.
It must only contain permitted ingredients or new ingredients where approval has been granted. Specifically excluded under the definition of an NHSP are food products, cosmetics, medicines and any related medical device. This definition also explicitly excludes anything used wholly or principally for a therapeutic purpose or used to treat named conditions.
How will the new scheme work?
A Natural Health and Supplementary Product’s Authority is being established as part of the Ministry of Health to oversee and manage the new legislation.
The new regulatory system is to be web-based. All communication with the Authority will be electronic via the Natural Health and Supplementary Products website.
Any NHSPs being distributed and sold in New Zealand must have a “Product Notifier”. This will be either the manufacturer (if based in New Zealand), or the importer.
The Product Notifier is obliged to provide the Authority with details of the NHSP, including manufacturer details, health benefit claims and any other information required under the Regulations.
Products that are exempt from notification are those made by a practitioner for an individual patient on request of that person, where an active ingredient is in a very low concentration (<20 PPM), export-only NHSPs (unless export certification is sought from the Authority), or where the Authority deems compliance impractical or unfeasible.
Regulation of Ingredients
The Authority will prepare and maintain a list of all the permitted ingredients. There are approximately 5500 permitted ingredients on the draft list .
All ingredients contained in a NHSP must be accepted by the Authority. If a Product Notifier wants to use an ingredient that is not on the list of approved ingredients, the Notifier must apply to the Authority. If no objection is raised within 90 days of this application, the new ingredient may be used in the NHSP.
Regulation of Health Benefits and Product Claims
Health benefit claims will be regulated using a list of ‘allowable’ claims. If the Product Notifier wishes to make a health benefit claim on their NHSP, it must be an allowable claim as deemed by the Bill.
The Bill allows health benefits to be claimed for NHSPs as long as there is sufficient evidence that supports a claim in relation to that particular condition. The Authority will be charged with deciding what claims are allowable in relation to which conditions.
Claims to particular conditions may only be made if the Authority is satisfied that substantial evidence exists to make that claim in relation to that condition. The list of conditions has been taken from the “International Statistical Classification of Diseases and Related Health Problems”, published by the World Health Organisation.
The Authority is also charged with considering the nature and quality of the supporting evidence, as well as being satisfied that the risk of the NHSP is low. To make a health claim, the Product Notifier will need to submit a summary of the evidence relied upon to support the health claim. The Product Notifier must also declare that it is able to provide the remaining substantive evidence to support the health benefit claim on request by the Authority.
Product Notifiers that wish to make a health claim relating to a particular condition that is not included on the list of conditions, will need to submit an application to the Authority. The Authority will then decide whether the claims will be permitted.
Regulation of Labels and Advertising
The Regulations will contain the minimum information requirements for NHSP labelling. Product Notifiers will have two years from the commencement date to comply with these requirements. NHSPs may contain additional information on their labels provided that it is not misleading. There are similar requirements and minimum information requirements for advertising on NHSPs.
Regulation of Manufacturing
All manufacturers must obtain a licence to manufacture NHSPs, including those manufacturers outside of New Zealand.
A code of practice will be established by the Authority for manufacturing NHSPs. This will set certain standards that be will proportionate to the risk associated with a particular product. The manufacturer will be granted a licence provided that the facilities meet the code’s requirements and the licence holder is deemed a fit and proper person.
A key principle of the new Bill is that the regulation should be proportionate to the risk posed by NHSPs which is generally low.
The Bill seeks to protect consumers by requiring the licensing of manufacturing facilities, establishing a code of manufacturing practice, requiring NHSPs to be manufactured from a list of permitted ingredients, regulating health claims as well as providing minimum information standards for labelling and advertising requirements.
The greater transparency of an open database and the flexibility afforded to the Authority in regulating allowable health claims and permitted ingredients, should go a long way to ensuring the adequate protection of consumers, as well as maintaining the reputation of New Zealand as a quality provider of NHSPs.