Manufacturers, importers and distributors of nutraceuticals, herbal or homeopathic remedies, traditional treatments and dietary supplements will be subject to much tighter regulation with the passage of the Natural Health Products Bill.
The Bill, which was introduced into the House recently, follows a Ministry of Health consultation process and appears to enjoy broad cross-party support. We expect that it will be passed next year without significant amendment.
What are natural health products?
The Bill proposes that a natural health product:
- be intended for administration to humans for the purpose of achieving a “health benefit” (which excludes relief of symptoms of serious conditions)
- be in a form normally used for therapeutic products (tablets, powders, liquids, creams, etc.)
- contain only ingredients from a published list of low-risk ingredients
- not contain ingredients from a published list of prohibited ingredients, and
- not be intended for administration to the eye or ear, or by injection.
Food and drink (including ingredients, nutrients and additives for food and drink), prescription and pharmacy-only medicines and controlled drugs are excluded.
Why greater regulation?
Natural health products are currently covered (if at all) by the Dietary Supplements Regulations 1985 or, if used for a therapeutic purpose, the Medicines Act 1981. This framework is now seen as out of date (the list of allowable additives in the Dietary Supplements Regulations has not been updated for 20 years), piecemeal and inadequate to manage safety risks. In addition, claims of therapeutic benefits cannot legally be made unless the costly and prescriptive Medicines Act approval process is followed.
The Ministry considered the regulatory schemes in various OECD countries with an objective of imposing the level of regulatory control “commensurate with the risks associated with [the use of natural health products]”. While the Regulatory Impact Statement claims the Bill is moderate regulation by OECD standards, we consider the proposals to be at the more heavy-handed end of the spectrum.
New regulator: a Natural Health Products Regulatory Authority, separate to Medsafe, will be established within the Ministry of Health. This Authority may be rolled into the proposed joint Australia-New Zealand therapeutic products regulator, once that entity comes into being, because of the potential cost-savings and to reflect the ongoing desire for harmonisation with Australia.
Product notification: sponsors, being New Zealand resident importers or manufacturers, or those who arrange the import or manufacture of a natural health product, must complete a “product notification” to distribute in New Zealand. Export-only products, products prepared by a practitioner for a patient and certain declared products (aromatherapy and homeopathic remedies are possible examples) will be exempt.
Self-certification: product notifications are completed via an online self-certification process. The sponsor must provide details about itself, the manufacturer, the product (including its ingredients and health benefit claims) and must certify compliance with aspects of the scheme.
Ingredients – prohibited, permitted, new: the Authority is to develop and maintain both a list of prohibited ingredients and an open-ended list of permitted ingredients (initially based on those approved by overseas regulators as well as those accepted in traditional medicine). New ingredients (i.e. those not on the permitted list) would need to be notified to the Authority so a safety assessment can be carried out and the ingredient added to the permitted list.
These ingredient requirements are one of the more onerous and potentially unwieldy aspects of the Bill. A number of submitters to the consultation paper preferred a list of prohibited ingredients only or a non-exclusive white list (i.e. new ingredients can be used without assessment provided they are not on the prohibited list).
Manufacturers must be licensed: the Authority will issue licences if an audit demonstrates compliance with a code of practice (yet to be developed but intended to be less onerous than pharmaceutical GMP). Sponsors of a natural health product manufactured overseas must provide evidence to satisfy the Authority that the manufacturer complies with the code, e.g. certification from a trusted foreign regulator.
Substantiation of claims: contrary to what was originally proposed by the Ministry, there will be no restrictions on the nature of the therapeutic claims that may be made. But standards will set out the levels of substantiation required for different types of claims and sponsors must certify that the requisite evidence is held to support the claims made.
Mandatory labelling requirements: these will be set out in regulations.
Advertising: regulations will also set out minimum advertising requirements but the Advertising Standards Authority will continue to set the detail through its codes of practice and be the preferred route for complaints. The Natural Health Products Authority will have back-up powers of enforcement.
Bedding in period: a generous transitional regime is proposed – one year to complete product notifications, two years to comply with labelling requirements and three years to meet manufacturing standards.
Chapman Tripp will follow the progress of this legislation with interest.