As reported in recent weeks media coverage, the Vaping Regulatory Authority (VRA) has raised concerns related to the level of nicotine within vaping products sold in New Zealand. 

The following covers: 

1. How were the New Zealand vaping regulations on maximum nicotine levels formed?
2. What is the maximum nicotine concentration specified in the final regulations?
3. What is the VRA ?
4. Are the VRA changing vaping regulations?

How were the New Zealand Vaping Regulations for maximum nicotine levels created?

Decision to regulate vaping and the formation of the TEAG

The decision to regulate vaping products in New Zealand was made in 2018 following a High Court decision that they could be legally imported sold and distributed in New Zealand (Ministry to consider risk-proportionate regulation for vaping and heated tobacco products, 2018). In recognition of the Tobacco Harm Reduction benefits vaping can have, a commitment to create risk proportionate regulations was made by the Government.

To help create fit for purpose vaping regulations the Ministry of Health established a Technical Expert Advisory Group (TEAG) on Electronic Cigarettes consisting of leading Tobacco Harm Reduction experts, smoking cessation providers and key vaping industry representatives (Electronic Cigarette Technical Expert Advisory Group).

Within the TEAG meeting minutes, it documents discussion on the maximum limit of nicotine.  

Limit on nicotine strength

Discussion on maximum nicotine strength in free-base e-liquids and nicotine salt e-liquids. The document needs to be clearer about the rationale for the two different proposed nicotine strengths, particularly the 60 mg/mL limit for nicotine in vaping liquids made using nicotine salts, as compared to the 36 mg limit for nicotine in vaping liquids made using free-base nicotine.

Its clear from the work completed by the TEAG that there was an intent to differentiate the nicotine concentration between eliquids made using freebase nicotine and eliquid made using nicotine salts.

The minutes specify:

• 60mg/mL limit for nicotine in vaping liquids made using nicotine salts
• 36mg/mL limit for nicotine in vaping liquids made using freebase nicotine

The original intent of nicotine limits in vaping safety standards was to regulate the nicotine concentration.

Proposed vaping regulations public consultation.

In January 2021 the Ministry of Health released proposed vaping product regulations for public consultation (Vaping regulations consultation opens today, 2021). A copy of the proposed regulations the public consulted on can be found here.

To help provide context to contributors of the consultation, the Ministry of Health also included an appendix related to the rationale of for proposed product safety requirements which can be found here.

Public Consultation Document – Nicotine Concentration

On page 27 of the consultation document are the proposed nicotine strength limits for free-base nicotine and nicotine salts.

“Nicotine strength. We propose limiting the strength of nicotine allowed in vaping substances to not exceed 20mg/mL for free-base nicotine and 50mg/mL for nicotine salt. We also propose restricting the total amount of nicotine that may be present in a single container to 500mg.”

The proposed regulations specify:

• Limiting the strength of nicotine allowed in vaping substances to not exceed 20mg/mL for freebase nicotine.
• Limiting the strength of nicotine allowed in vaping substances to not exceed 50mg/mL for nicotine salt.

In addition, it is proposed that the total amount of nicotine that may be present in a single container should be limited to 500mg, meaning a maximum bottle size of 10mL for most nicotine salt eliquids (which is aligned to the UK legislation).

Product Safety Standards Appendix – Nicotine Strength

The supplementary information contained in the product safety standards appendix helps provide context on reduced nicotine concentration previously recommended by the TEAG (Page 5-6).

Based on the product safety standards appendix;

• The strength of free-base nicotine in vaping substances is set at 20mg/mL because it aligned with UK Legislation.
• The strength of nicotine salt in vaping substances is set at 50mg/mL which is higher than the UK Legislation but in line with other international vaping markets.  
• In the UK legislation there is no differentiation between nicotine salts and free-base nicotine because nicotine salts were not commercially sold during the time UK legislation was created. As such, the same nicotine concentration limit of 20mg/mL applies to nicotine salts in the UK.

Because nicotine salts are less alkaline than free-base nicotine, it allows for higher concentrations that provide nicotine absorption levels closer to those from smoking nicotine and confirms there is no current evidence that products containing nicotine salts are any more harmful than those with freebase nicotine.  

Outcome from consultation on vaping regulations

In August 2021 the Ministry of Health released the final vaping regulations (Vaping regulations released today) and a report summarising the results from public consultation on the vaping regulations, including any changes to the regulations based on public consultation feedback (Smokefree Environments and Regulated Product Act 1990 Proposals for regulations: Summary of submissions 2021). A copy of the report can be obtained here.  

The proposed vaping regulations specified:

• Limiting the strength of nicotine allowed in vaping substances to not exceed 20mg/mL for freebase nicotine.
• Limiting the strength of nicotine allowed in vaping substances to not exceed 50mg/mL for nicotine salt.
• Limiting the total amount of nicotine that may be present in a single container to 500mg

Changes resulting from the public consultation (Released 10th August 2021):

Based on the consultation results report (p15), the following changes to the proposed regulations were outlined

“The Ministry proposes to amend the product safety requirements to increase container sizes, restrict the ban on sweeteners to those known to be harmful and remove requirements covered in other legislation (such as the Health and Safety at Work Act).”

Based on the consultation results report, there is no mention from the Ministry of Health noting their decision to change "Limiting the strength of nicotine allowed in vaping substances to not exceed 50mg/mL for nicotine salt." 

Final vaping regulations (Released 10th August 2021)

The final regulations reflect the amended container size (increased to 1800mg) which allows for a maximum bottle size of 30ml (for both free-base nicotine or nicotine salts).

Wording for nicotine levels under Schedule 5 Part 1 in the regulations:

Nicotine Strengths

14. The strength of free-base nicotine in a vaping substance must not exceed 20 mg/mL.

15. The strength of nicotine salt in a vaping substance must not exceed 50 mg/mL.

16. The total nicotine content in a container of vaping substance sold at retail must not exceed 1,800 mg, whether it is present as free-base nicotine or nicotine salts.

In our view we believe it is "reasonable" to expect that if a conscious decision had been made by the Vaping Regulatory Authority to half the originally proposed maximum nicotine limit in a vaping substance; the time to communicate this change to all relevant stakeholders would have been on August 10th 2021 when releasing final regulations.  

What is the VRA?

The Vaping Regulatory Authority (VRA) is a department within the Ministry of Health created to implement and embed vaping regulations, including the premarket notification process required for all vaping products distributed within New Zealand, and the processing of applications for Specialty Vape Retail stores (SVRs). (New Zealand Ministry of Health)

How many staff are employed by the Vaping Regulatory Authority?

 The VRA has 3.5 full time staff whose responsibilities also include the functions of the Medicinal Cannabis Agency, the Psychoactive Substances Regulatory Authority, as well as the VRA. (Responses to Official Information Act requests, 2022)

Who does the VRA Report to?

The VRA is part of the Regulatory Practice and Analysis Team which is part of Medsafe. Medsafe is currently part of the Health System Improvement and Innovation Directorate led by the Deputy Director-General. (Responses to Official Information Act requests, 2022)

How many product notifications and SVR applications are the VRA responsible for?

• Based on the notified products register, there are currently 15,476 notified vaping products (Dec 12th 2022).
• The approved Specialty Vape Retail register shows there are currently 950 approved vaping premises (vape stores)

Are the VRA changing vaping regulations?

To date it remains unclear what the VRA is doing. The VRA have indicated they “do not consider a meeting strictly necessary for effective regulation” so have declined to have meetings / interact with notifiers which means all communication has been in the form of industry wide emails and various media statements.

Email 1, 27 Oct 2022

 Dear notifier,

 The Vaping Regulatory Authority have received reports that a number of nicotine salt vaping substances are being sold in New Zealand that do not comply with concentration limit for nicotine salts set out in the product safety requirements for vaping substances. At least some of this seems to be based on a misinterpretation of the maximum permitted concentration of nicotine salts in the by the product safety requirements in Schedule 5 of the Smokefree Environments and Regulated Products Regulations 2021 (the Regulations).

 However, in some cases, notifiers appear to have provided false or misleading information in their product notifications with regards to the quantity of nicotine in a product, as product labelling differs from their product notification.

 During our investigation into this issue, we also found some product notifications showing products with unreacted benzoic acid. Benzoic acid is classified as a STOT-RE 1 substance, and it is therefore prohibited in the product safety requirements. If benzoic acid is used in the manufacture of a vaping substance, all of the acid must be reacted to form nicotine benzoate – the final product must not contain unreacted benzoic acid.

 We have also found some products that only show nicotine concentrations as a % value rather than in mg/mL as required by the Regulations. Our view is that only having a % figure is likely to be confusing for consumers, and a % figure is not an appropriate substitute for the concentration in mg/mL. The Regulations require the concentration of nicotine to be displayed but it is acceptable to display the concentration of nicotine salts, provided the label clearly states which is shown.

 Regulations

 Schedule 5, Part 1, section 15 of the Regulations states that “the strength of nicotine salt in a vaping substance must not exceed 50 mg/mL”.

 This 50 mg/mL limit in vaping substances refers to the permitted concentration of nicotine salt in a substance, not the concentration of nicotine. The quantity of nicotine (the specific chemical compound rather than the salt chemical compound) allowed in a vaping substance must be substantially lower than 50 mg/mL. For example, the maximum permitted nicotine concentration in a vaping substance containing fully dissolved nicotine benzoate would be 28.5 mg/mL.

 Schedule 5, Part 1, section 12(b) of the Regulations states that a vaping substance must not contain specific target organ toxicity (STOT-RE) Category 1 substances other than benzoic acid-nicotine salts.

 Schedule 5, Part 1, section 1(i) of the Regulations states that the labels of vaping substance containers must include the nicotine concentration in mg/mL, for substances containing nicotine.

 Notifying Products

 Section 60 of the Smokefree Environments and Regulated Products Act 1990 (the Act) states that a notifier of a notifiable product must not sell the product in New Zealand unless it complies with product safety requirements. A notifier that sells a notifiable product that does not meet the product safety requirements commits an offence and is liable to prosecution. Upon conviction, the courts can impose a fine of up to $400,000.

 Section 63 of the Act states that a notifier must notify the notifiable product by entering on the database:

• the notifiers contact details; and
• a description of the product and its parts (including its substances) in accordance with regulations; and
• a declaration by the notifier that the product complies with the requirements referred to in section 62.

 When submitting product notifications, all notifiers declare that the product being notified complies with the product safety requirements, which includes the above mentioned restriction on nicotine salt concentration and the prohibition on STOT RE 1 substances.

 Under section 63(2) of the Act, a person who, without reasonable excuse, provides false or misleading information in notifying a notifiable product commits an offence and is liable to a fine not exceeding $50,000.

 Action Required

 The Vaping Regulatory Authority requests all notifiers who have notified products under the product type ‘nicotine salt vaping substance’ to take the following actions:

• In your HARP portal, review all your current notifications under this product type and ensure that all products comply with the above mentioned nicotine limit, and the prohibition on STOT RE 1 ingredients.
• If any product does not comply with the product safety requirements, you must withdraw the product notification and cease selling the product in New Zealand immediately.
• All distributors and retailers who sell the product should also be advised to cease selling the product in New Zealand immediately as the product does not have a current notification and does not comply with the product safety requirements.
•  In order to withdraw a product notification through your HARP portal:

1.  Select ‘My Submissions’
2. Select ‘My Products’
3. Under the heading ‘VRA Products History’, click on the ellipses (three dots) next to the relevant product and select ‘withdraw’

• Review the labelling of all nicotine-containing products which have current notifications under this product type and ensure that the concentration of nicotine in the product (as its own chemical compound) is provided in mg/mL, and that it is clear whether the concentration is for nicotine or for nicotine salts in the product.

• If the labelling of any nicotine-containing product does not meet the requirements in Regulations, you should cease selling the product in New Zealand immediately as the product does not have a current notification and it does not comply with the product safety requirements. All distributors and retailers whom sell the product should also be advised to cease selling the product in New Zealand immediately.
•  The labels of the product must be amended to correctly display the concentration of nicotine or nicotine salts before the product can be re-notified. If only a product’s labelling is non-compliant, it would be acceptable for a new label to be stuck over the non-compliant label, provided the previous label underneath could not be seen. This would allow all existing stock to still be sold.

The Ministry will take enforcement action against notifiers and retailers of non-compliant vaping substances.

 If you have any questions, please email vaping@health.govt.nz.

 Kind regards,

Vaping Regulatory Authority

Press Release 1:

Vaping retailers, manufacturers and importers ask to check products are compliant

October 28th 2022

Source: https://www.health.govt.nz/news-media/news-items/vaping-retailers-manufacturers-and-importers-ask-check-products-are-compliant

The Vaping Regulatory Authority has requested all vaping retailers, and importers review all their products to ensure they are complying with the law.

Vaping products are regulated under the Smokefree Environments and Regulated Products Act 1990 (the Act), with specific vaping regulation introduced in November 2020. These regulations are aimed at minimising the harm caused by these vaping products, while recognising that there are a significant number already being legally being sold in New Zealand that could provide a valuable tool in helping some people quit smoking.

Under these regulations, vaping retailers, manufacturers, and importers that notify a vaping product with the Authority are responsible for ensuring their notifications are accurate, and that their products comply with the product safety requirements set out in the Smokefree Environments and Regulated Products Regulations 2021 (the Regulations). Products that are not notified, or notified incorrectly, cannot be legally sold in New Zealand.

One of these requirements when notifying is that vaping substances for sale in New Zealand cannot exceed concentrations of 20mg/mL for freebase nicotine or 50mg/mL for nicotine salts. These two separate limits reflect that some vaping substances use nicotine derived by tobacco by itself, as a freebase, while others mix the nicotine with an acid, such as benzoic acid, creating a salt.

Recently, the authority has had reports that some vaping substances for sale in New Zealand may not be complying with some of these regulations, specifically the limit on nicotine salts, and some vaping retailers, manufacturers or importers may have misinterpreted the regulations limiting nicotine salt levels and provided misleading information when notifying their products with the Authority.

The main risk with levels of nicotine beyond the permitted level in New Zealand is a vaping product will be more likely to continue a person’s addiction long-term.

The Ministry has received a representation from Action on Smoking and Health (ASH) also asking for the Ministry to review the current limits on nicotine salts to ensure that smokers are not discouraged to switch to vaping if the nicotine levels are not comparable with smoking tobacco.

The Ministry has responded saying that the Ministry will promptly consider the issue raised by ASH though the current regulations should guide retailers and others in the industry at this stage.

BACKGROUND

To support compliance with the regulation the Authority has recently:

• Requested all notifiers to review their notifications for nicotine vaping substances. If any notifiers that find that their products exceed the nicotine salt limit, we have instructed them to withdraw their product notification and cease selling those products immediately, including communicating these actions to any distributors and retailers that may be stocking their products.
• Requested all retailers contact their suppliers to establish whether any nicotine salt vaping substance products they are selling need to be withdrawn, because they do not comply with the nicotine limit. The Authority has asked that when products have been withdrawn, retailers cease selling them immediately.
• Asked retailers to regularly review the ‘Notified Products Register’ to confirm that the vaping products they are selling have been notified with the Authority.
• Reminded vaping retailers, manufacturers, and importers that breaching vaping regulations will result in enforcement action, and potentially prosecution. If they are convicted, the courts can issue a fine of up to $400,000.

In addition, the vaping authority will be taking several additional steps to support vaping retailers, manufacturers, and importers to comply with regulations.

These include:

• Reviewing the nicotine levels and ingredients for each product that has been notified to the Ministry. If the authority finds products that have been notified with an excess of nicotine, nicotine salts, or prohibited ingredients it will work with notifiers to verify the accuracy of their notification.
• Proactively purchasing samples of vaping products from vape retailers, both online and at retail stores, and testing those samples to determine their ingredients and flavour profiles (ensuring products purchased from general retailers do not include flavours other than mint, menthol and tobacco)
• Testing vaping substances labelled as containing 5% nicotine salts to ensure their nicotine salt content is no more than 50mg/mL.
• Purchasing vaping devices from vape retailers, both online and at retail stores, and assessing their compliance with product safety requirements.
• Working with Te Whatu Ora Health New Zealand to ensure health promotion and compliance activities are carried out regularly and consistently throughout the country.

The Authority will continue to monitor, educate and, where necessary, take enforcement actions, to support compliance with vaping regulations designed to minimise the harm to New Zealanders from these products.

Email 2: November 4^th 2022

Tēnā koe notifier,

 Following the email we sent to you on 27 October 2022 (included below) clarifying nicotine limits for vaping substance, there has been commentary on whether the Smokefree Environments and Regulated Products Regulations 2021 were intended to place a 50mg/mL limit on the maximum strength of nicotine salt permitted in a vaping substance, or whether that limit was intended to apply to the strength of freebase nicotine in a nicotine salt vaping substance.

 The product safety requirements state that the strength of nicotine salt in a vaping substance must not exceed 50mg/mL, and all vaping substances notified or sold in New Zealand must comply with this requirement. There are no plans to review this requirement.

 As noted previously, we are concerned that non-compliant products have been notified, and that those products are being sold in New Zealand despite not meeting the product safety requirements. Last week we asked all notifiers to review each of their vaping product notifications to ensure they comply with notification requirements and the product safety requirements, and to immediately withdraw notifications for any non-compliant products. To date, no product notifications have been withdrawn.

 We will be working closely with National Public Health Service Smokefree Enforcement Officers to identify notified products that do not comply with the product safety requirements based on their product notifications, labelling or chemical make-up. We are also comparing ingredients on product notifications with product ingredient labels to identify any false, misleading or incomplete notifications. Confirmed breaches for product notifications that have not been withdrawn will result in those notifications being suspended or cancelled, and enforcement action will be taken if required.

 If you have any questions, please email vaping@health.govt.nz.

 Ngā mihi,

 Vaping Regulatory Authority

Press Release 2:

 Email 3: November 17^th 2022

 Thank you for your recent emails.

 We are currently reviewing all product notifications to identify any that may not comply with the statutory requirements. We will be working with manufacturers, importers and retailers to ensure that all products sold in New Zealand are compliant with the product safety requirements.

 The maximum concentration of nicotine salt permitted in a vaping substance sold in New Zealand is 50mg/mL. This means that the concentration of pure nicotine in a nicotine salt vaping substance must be lower, typically between 26 and 37mg/mL, depending on the type of nicotine salt present.

 Nicotine limits in New Zealand are intended to balance the desire for higher nicotine content from some existing smokers with the need to restrict nicotine levels to reduce the likelihood of long-term addiction. The regulations set a higher permitted nicotine concentration for nicotine salts than in other countries to better support smokers to quit, whilst ensuring nicotine content is not excessively high such that it significantly increases people's addiction.

 Whilst regulators in other jurisdictions have used different methods for setting maximum nicotine levels, the limit under New Zealand law applies to the concentration of nicotine salt contained in a vaping substance. Depending on the nicotine salt used, the maximum nicotine content in a nicotine salt vaping substance is between 26 and 37mg/mL, which is somewhat higher than in those other jurisdictions, but it is more closely aligned than the 50mg/mL limit would be if it applied to nicotine rather than to nicotine salts.

 The regulations also require the labels of all vaping substances to include nicotine concentration in mg/mL, providing consumers with a clear and simple way to compare different products. As with the nicotine salt levels, some manufacturers/importers (notifiers) have chosen not to comply with this requirement, and that is more likely to be the source of any confusion amongst consumers. The Vaping Regulatory Authority (VRA) will also be engaging with notifiers to ensure that they comply with the packaging and labelling requirements. 

 Our distribution list was based on the email addresses recorded in the HARP system for each manufacturer and importer. Our email may have been flagged as spam or junk so please check those folders in your email system.

 All queries should be emailed to vaping@health.govt.nz, and we will respond as soon as we can.

 Kind regards,

Vaping Regulatory Authority 

Press Release 3:

New Zealand Ministry of Health . (2021, August 11). Vaping regulations released today. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/news-media/news-items/vaping-regulations-released-today

New Zealand Ministry of Health. (2018, May 9). Ministry to consider risk-proportionate regulation for vaping and heated tobacco products. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/news-media/news-items/ministry-consider-risk-proportionate-regulation-vaping-and-heated-tobacco-products

New Zealand Ministry of Health. (2021, August 10). Smokefree Environments and Regulated Product Act 1990 Proposals for regulations: Summary of submissions 2021. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/publication/smokefree-environments-and-regulated-product-act-1990-proposals-regulations-summary-submissions-2021

New Zealand Ministry of Health. (2021, January 26). Vaping regulations consultation opens today. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/news-media/media-releases/vaping-regulations-consultation-opens-today

New Zealand Ministry of Health. (n.d.). About the Vaping Regulatory Authority. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/our-work/regulation-health-and-disability-system/regulation-vaping-and-smokeless-tobacco-products/about-vaping-regulatory-authority

New Zealand Ministry of Health. (n.d.). Electronic Cigarette Technical Expert Advisory Group. Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/our-work/preventative-health-wellness/tobacco-control/vaping-smokefree-environments-and-regulated-products/electronic-cigarette-technical-expert-advisory-group

Responses to Official Information Act requests. (2022, June 8). Retrieved from New Zealand Ministry of Health: https://www.health.govt.nz/system/files/documents/information-release/h202204837_response.pdf