A number of people and organisations have contacted the Ministry with questions about the Bill, in particular the proposal to regulate natural health products (NHPs).
On this page:
- Prohibited/permitted natural health products (NHP) ingredients
- Risk of harm of NHPs
- Access to NHPs
- Costs
- Rongoā/Te Tiriti
- WHO report
Prohibited/permitted NHP ingredients
Does the Ministry of Health have a list of prohibited or restricted herbal ingredients?
The Ministry does not have a specific list of prohibited or restricted herbal ingredients, although some herbal ingredients are restricted under the Medicines Act for safety reasons (e.g., Atropa belladonna and Datura species).
The Bill does not have a proposed list of prohibited or restricted herbal ingredients in it. If the Bill is passed, a list of recognised NHP ingredients would be developed as secondary legislation, in consultation with stakeholders.
What about the previous Permitted Substances list developed between 2013-2017?
There was an old draft Permitted Substances list for natural health products from 2013 to 2017, which was not finalised and never used. It is now of historical note only and has no legal standing.
Did the previous Permitted Substances list prohibit cinnamon, neem, coconut or tamarind?
No, it did not prohibit those substances.
Some reports on social media have referred to the draft Permitted Substances list as a ‘list of 300 prohibited or restricted herbal ingredients.’ Based on reports we have seen, the examples used of supposed prohibited ingredients are misleading and/or inaccurate. For example, the draft Permitted Substances list only proposed to limit the amount of cinnamon oil present in a natural health product due to established toxicity at high levels. It is similar for neem.
Statements made about the previous, draft Permitted Substances list are misleading, in that they imply that the plant, herb or spice itself would be prohibited. Likewise, these statements usually omit that, where an ingredient was on the list, it was usually with reference to a specific form (e.g., oil) and concentration.
There was no proposal to prohibit tamarind or to prohibit coconut from being included as part of a natural health product.
Risk of harm
Aren’t NHPs risk free?
While overall the risks associated with NHPs are generally lower compared to medicines, NHPs are not risk-free.
NHPs can be safe to use if they contain safe ingredients, are made appropriately, and are accompanied by accurate information that helps consumers make informed choices, including information on possible risks.
When these conditions are not met, the risk of harm increases. Consumers have experienced a range of harms from NHPs – from mild discomfort to severe adverse reactions or dangerous interactions with medicines.
Inaccurate or unsubstantiated (i.e., unsupported) information about NHPs (e.g., health claims) may also delay people seeking treatment for serious conditions that are best treated with conventional medicines.
What evidence of harm does the Ministry hold on natural health products?
In New Zealand, the Centre for Adverse Reaction Monitoring (CARM) collects, evaluates, and analyses spontaneous reports of adverse reactions to medicines and vaccines, herbal products and dietary supplements used in New Zealand. Further information about CARM.
Evidence of harm is not the same as reports of suspected adverse reactions. The word ‘harm’ implies some kind of injury and that someone has less of something (eg, health). In contrast, a report to CARM relates only to a suspicion of an adverse reaction. It may not actually be related to the product taken and may be for something that doesn’t cause ‘harm’, such as a headache from which the person recovers completely.
Reports received by CARM are submitted voluntarily. As such, the use or interpretation of these data holdings is subject to significant limitations such as incomplete or biased reporting of adverse events and the extent to which the clinical details provided in reports are complete. All data that is extracted for external use is provided in the context of a caveat document explaining the limitations of the CARM dataset. Read the caveat document
The CARM database reports are received largely from health professionals and are therefore limited if patients do not tell their healthcare providers if they are taking natural health products. Additionally, many natural health products are bought online or at retail shops without a natural health practitioner consultation. This can result in adverse reactions that may go unreported, particularly as consumers are generally unaware of CARM and may not recognise that NHPs can cause adverse reactions.
Detecting the cause of adverse reactions is difficult. For example, there have been media reports on the difficulty in diagnosing vitamin B6 toxicity due to overconsumption of supplements, leading to misdiagnosis and considerable ill-health, including hospitalisation.
Data on adverse reactions to dietary supplements and herbal products from 2013-2021 can be found in a proactively released OIA response letter.
What is an example of harm caused by a natural health product?
In 2018, Medsafe issued an alert communication in relation to Arthrem, a product which was linked to serious cases of liver harm.
Further information: Artemisia annua (Sweet wormwood, Sweet Annie, Qing hao) extract marketed as Arthrem: risk of harm to the liver – statement under section 98 of the Medicines Act 1981 (medsafe.govt.nz)
Access to NHPs
Will the Bill control/limit the availability and access to NHPs?
The Bill is not intended to stop people buying NHPs, unless there is robust scientific evidence to justify restricting it (e.g., certain parts of a plant may be toxic while other parts are fine, or the concentration of a product is too risky to be available for general sale).
Won’t NHPs be regulated the same as medicines? Will people need a prescription to access NHPs?
Under the Bill, NHPs are not medicines. If the Bill passes, separate regulations will be developed for medicines and NHPs, and will be publicly consulted on.
People will not need a prescription to access a NHP. In some instances though, some products that people may think of as a NHP may need a prescription, For example, Atropa belladonna (commonly known as deadly nightshade) is a prescription medicine in some circumstances. In other circumstances, where the risk is lower, it is a pharmacy-only medicine. This is to protect people from consuming too much of the toxic alkaloids in the plant that can cause serious illness or death.
Costs
Will consumers see an increase in the costs of NHPs?
One of the principles of the Bill is that regulation should be proportionate to the risks posed by the products. That will apply to NHPs and will generally be reflected in costs. Lower-risk products requiring less regulatory oversight will incur lower costs.
The Regulator will be able to recover costs from businesses and it will be up to the businesses to determine whether they pass on or absorb the costs. It is fair that businesses that stand to gain financially from having their products on the market contribute to the cost of the system that keeps everyone safe.
The types of activities businesses will likely be charged for, include:
- obtaining a ‘market authorisation’ for an NHP.
- seeking a licence to manufacture, import, or export a NHP in the course of business.
These fees are intended to support a range of activities including the regulator’s assessment of applications for market authorisation, maintaining a public register of therapeutic products and licence holders, and post-market surveillance activities, such as investigating whether there is a problem with a specific product and issuing a recall.
Fees and charges will be set out in secondary legislation (regulations) and the Bill requires consultation on the regulations.
Won’t extra red tape and increased costs have a big impact on small businesses already struggling?
Fees, charges, and levies will be determined after the Bill is passed, following further consultation with the sector. In setting fees and charges, the Regulator will need to consider whether costs are equitable, efficient, justifiable, and transparent. We will be working to ensure all regulatory requirements are proportionate to keeping products safe and high quality.
The new scheme includes a market authorisation pathway for NHPs where products are registered by self-registration, rather than requiring an evaluation by the Regulator. This should result in lower costs for NHP manufacturers than for manufacturers of medicines and some medical devices. There will be some exceptions to registration, such as products that have extremely low concentrations and natural health practitioners who manufacture their own products during or following consultations.
Manufacturing requirements will also be risk proportionate and lower risk products such as NHPs may not always need to meet the same manufacturing standards as medicines. All exported products, however, will likely need to meet the internationally recognised Good Manufacturing Practice standards, as it is difficult to meet an importing countries’ requirements without it.
All businesses, small and larger, will be able to make health benefit claims, provided they can substantiate their claims with sound evidence. Some higher-level claims may also be provided for by the Regulator, and applications will be able to be made to include further claims.
By being able to provide consumers with a greater understanding of what their products can do for them, they will be able to boost product viability and in turn, boost sales.
Rongoā/Te Tiriti
Is rongoā being regulated by the Bill?
‘Rongoā’ is not mentioned explicitly in the Bill. However, because the regulation of NHPs operates through a permitted ingredients list – and some plants and animals that are used in the practice of rongoā will likely be on that list – products manufactured by rongoā practitioners, or used in the practice of rongoā, will be captured by the Bill.
What is the rongoā workstream?
A new rongoā work stream has been established to consider how rongoā might be appropriately recognised and protected, including through legislation. As part of this work, Manatū Hauora is engaging with Māori, rongoā practitioners and stakeholder groups.
What engagement has there been on rongoā?
Manatū Hauora conducted targeted engagement with stakeholders during 2022, including a number of online hui and face to face meetings, including with Māori practitioners and health providers, where rongoā Māori issues were raised and discussed.
What about Te Tiriti?
The approach adopted in the Bill reflects a similar approach used in the Pae Ora Act to reflect the principles of Te Tiriti throughout the Bill.
The Bill includes a number of provisions which reflect the Crown’s intention to uphold Te Tiriti, for example in clauses around the functions and capabilities of the Regulator, principles to be applied by decision makers, consultation and the use of advisory committees. Further details will be provided in subsequent legislation if the Bill passes.
WHO report
Why does the WHO Global Report on Traditional and Complementary Medicine 2019 state that some NHPs are regulated in New Zealand under the Medicines Act?
The wording in the WHO report is potentially misleading without additional context. This report was published in 2019 and includes information from surveys taken back as far as 2005. The reference in the report to ‘natural health product’ may be to the product category as proposed in the Natural Health and Supplementary Products Bill which lapsed in 2017.
Under the Medicines Act, there is currently no legislative provision for a product to be marketed in New Zealand as a ‘natural health product’. However, as per the WHO report, some products that may be considered ‘natural health products’ in other jurisdictions are currently being supplied in New Zealand as dietary supplements, related products, or medicines.
There is legislative provision for products that meet the definition of ‘dietary supplement’, as per the Dietary Supplements Regulations 1985, and which comply with the requirements specified in the Regulations, to be marketed in New Zealand. There is no pre-market assessment or approval of dietary supplements. It is the responsibility of the supplier to the market to ensure compliance.