The proposed regulation of natural health products (NHPs) under the Therapeutic Products Bill has sparked wide debate and concern in some quarters. Many of those concerns appear to be based on myths and misconceptions of what NHPs actually are, and how they will be regulated. This article sets out the key provisions in the Bill relating to NHPs and dispels some of those common myths and misconceptions.
What are natural health products under the Bill?
NHPs are the products you tend to find in the 'health' section of the supermarket. The Bill defines them as products that:
- Are intended for use in, on, or in relation to humans for a therapeutic purpose - such as maintaining or promoting human health
- Consist only of NHP ingredients (that do not exceed specified concentrations). These include:
- plants, algae, fungi, non-human animal materials (or extracts)
- vitamins and provitamins, including salts and other compounds
- minerals and mineral compounds
- amino acids
- microorganisms
(Plus additives and formulation aids).
The Bill distinguishes between NHPs and 'low concentration NHPs', which are essentially NHPs where the concentration of every ingredient in it (other than an additive or formulation aid) is 20 parts per million or less. Another difference between the two categories is that low concentration NHPs are allowed to contain ingredients other than NHP ingredients, additives and formulation aids.
How will NHPs be regulated?
The Bill seeks to protect, promote and improve the health of New Zealanders by providing for the safety and quality of NHPs. The key ways that the Bill achieves this aim is as follows:
- NHPs will generally be required to have a market authorisation before they can be imported into, supplied in, or exported from New Zealand in the course of a business or undertaking. Applications for market authorisations will require a declaration to be made on the Regulator's website that the NHP meets specified criteria. Market authorisations are not required for low concentration NHPs
- A licence or permit will generally be required to manufacture or export an NHP in the course of a business or undertaking, or to import a low concentration NHP in the course of a business or undertaking
- The administration of NHPs to a person by injection or parenteral infusion will be prohibited
- Sponsors can only make 'permitted' health benefit claims in relation to NHPs. A permitted health benefit claim is one that is specified:
- in rules (standard health benefit claims), or
- in a market authorisation (a custom health benefit claim)
- Health benefit claims will need to be substantiated by scientific evidence, evidence of traditional use, or both.
Myths and misconceptions
NHPs are currently regulated under a patchwork of legislation (including the outdated Dietary Supplements Regulations 1985), and there is no doubt that the proposed regulation of NHPs will have a range of impacts on the natural health product industry. However, some of the misconceptions currently circulating about how the Bill will regulate NHPs makes it harder to understand those impacts. We dispel some key misconceptions below.
Misconception: The Bill regulates food products, and will stop me from eating fruit from my citrus trees.
A product intended for human consumption as a food will not be regulated under the Bill, even if the food has incidental therapeutic purpose. For example, flour intended for human consumption will be food and not a therapeutic product, even if it is fortified with folic acid.
The Bill will not restrict individuals from growing citrus trees or eating fruit from them.
Misconception: As a naturopath, I won't be able to manufacture and use NHPs on my patients.
NHP practitioners (eg naturopaths) will be permitted to manufacture and supply any NHPs directly to clients during consultations, provided that specified criteria are met. NHPs provided in those circumstances do not require market authorisations. However, the Regulator may regulate how consultations are carried out, and how NHPs can be manufactured and supplied by the practitioner.
Misconception: NHPs do not cause any harm, and therefore should not be regulated.
While the Ministry of Health has noted that the overall risks associated with NHPs are generally lower compared to medicines and medical devices, the Ministry has advised that NHPs are not risk free. For example:
-
NHPs can cause a range of harms from mild discomfort to severe adverse reactions or dangerous interactions when taken with medicines (for example, if they contain unsafe ingredients, are contaminated, are not made appropriately, or are accompanied by inaccurate information)
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Inaccurate or unsubstantiated information about NHPs may delay people seeking treatment for serious conditions that are best treated with conventional medicines.
Misconception: You will need a prescription to obtain NHPs.
People will not need a prescription to access NHPs. The confusion on this point seems to have come from the fact some products that people may think of as NHPs are actually medicines and therefore require prescriptions.
Misconception: I will no longer be able to purchase NHPs.
The Bill will not stop people buying NHPs. However, some NHPs may cease being available if, for whatever reason, an NHP importer or manufacturer decides not to obtain the required market authorisations or licences or permits to import or manufacture those NHPs, or there is clear evidence that justifies restricting those NHPs.
Misconception: Cinnamon will be a prohibited NHP ingredient.
The Bill does not prohibit cinnamon (or any other spice), nor does it contain a list of prohibited or restricted herbal ingredients. If the Bill is passed, a list of recognised NHP ingredients would be developed as secondary legislation, in consultation with stakeholders.
Next steps
The Bill is currently being considered by the Health Select Committee. The Select Committee is due to report back on the Bill on 14 June 2023.
Given the large number of submissions on the NHP part of the Bill, it will be interesting to see what changes the Select Committee makes to it.
Please subscribe to Buddle Findlay's Health insights if you are interested in hearing more about how the Bill progresses.
