On the 12th June 2023 the Ministry of Health released a Public Consultation document to what appears to have been a very select group. The document was not openly available on their website, and those who managed to get their hands on it were only given 2 weeks to respond. To make that even more interesting we also found changes that were secretly made to their documentation just 2 days before the public submissions were due, meaning those who had already completed their submission had no further say, and those who were yet to put their submission in had less than 1 working day to update their document.
After many, many requests to meet with the Ministry of Health (all of which have been declined or excessively delayed), the vape industry are very frustrated. We are being forced to ‘deal with’ ongoing changes to the laws that affect our businesses, livelihoods, operations, and more importantly – our customers.
Our Submission “to clarify how nicotine levels for vaping products are expressed”
(sent to firstname.lastname@example.org at 4:10pm on 26th June 2023)
26 June 2023
To whom it may concern:
This document is the formal submission on the ‘Proposal to clarify how nicotine levels for vaping products are expressed in the Smokefree Environments and Regulated Products Regulations 2021’ consultation by NZVAPOR LIMITED
Consent for submission
We do consent to our full submission being published on the Ministry of Health website.
We do consent to our names being published with our submission
Privacy and other declarations
Our organisation represents vaping product retailers, distributors and manufacturers.
We have commercial interests as manufacturers, distributors, and retailers of vaping products.
We do not agree with the Ministry’s proposal to set the maximum allowable nicotine concentration at 28.5mg/mL for reusable vaping products that contain nicotine salts.
Having regard to the clinical studies and data, our position is that retaining the existing 50mg/mL nicotine strength limit for nicotine salt vaping products will best serve the statutory objective of minimising harm.
The statutory objective is to minimise harm by supporting smokers to quit.
The purpose of the Smokefree Environments and Regulated Products Act 1990 is to provide for the regulation of vaping products in a way that seeks to minimise harm, especially harm to young people and children.
Measures to address youth vaping have already been consulted upon; the Ministry’s current proposal to reduce the maximum nicotine strength in nicotine salt vaping products from 50mg/mL to 28.5mg/mL falls outside of that. A total ban of disposable vaping products – which are preferred by young people – irrespective of whether the battery is removeable, and enforcing the current prohibition on sales to under 18s is the best way to protect young people.
Reducing the nicotine levels in products may have the unintended consequence of increasing the harm of these products to young people because lower nicotine products are more palatable to people who have never smoked and users may take more puffs to get the same hit (exposing them to more of the other chemicals present in the vapour).
Supporting smokers to quit
Smoking is the leading cause of preventable death and disease in New Zealand, killing approximately 5,000 people each year – both smokers and those exposed to second-hand smoke. Māori and Pacific communities are disproportionately represented in these adverse health outcomes. For instance, lung cancer mortality among Māori women is over four times that of non-Māori women, and is among the highest mortality rates for lung cancer in the world.
Although people smoke cigarettes for the nicotine, which provides a dopamine/feel-good response, it is the carcinogenic toxicants and carbon monoxide that are generated in the tobacco combustion process that cause death and disease.
Nicotine itself, although addictive, is not harmful in the sense of causing or contributing to cancer or cardiovascular and respiratory diseases, or in the sense of having antisocial impacts like other addictive substances.
Given the profound harm caused by smoking, it is imperative to assist smokers to quit by offering alternative nicotine delivery systems that are significantly less harmful.
Vaping products need to be able to emulate the ‘nicotine hit’ of a cigarette
Smokers who wish to quit need access to vaping products with nicotine levels that provide a comparable ‘nicotine hit’ to smoking a cigarette.
This was the rationale for the Ministry’s Technical Expert Advisory Group’s recommendation of a maximum nicotine strength of 60mg/mL in nicotine salt vaping products. The Expert Group cited the Pax Laboratory Research which showed that nicotine salt vaping products with nicotine strengths of 59mg/mL were able to emulate the ‘nicotine hit’ of a cigarette.
The Ministry accepted the Expert Group’s advice but at a slightly reduced level of 50mg/mL.
Nicotine salt vaping products with nicotine strength of 50mg/mL have been available for purchase in New Zealand since at least 2017. The Ministry’s proposal would reduce the maximum nicotine strength to 28.5mg/mL – less than half of what was proposed by their Expert Group.
Adverse consequences of reducing nicotine strength from 50mg/mL to 28.5mg/mL
A reduction in the maximum nicotine strength from 50mg/mL to 28.5mg/mL will make them pharmacologically less effective and, accordingly, will have adverse public health consequences:
- There will be some relapse to smoking, perpetuating the harm to vulnerable communities (including Māori and Pacific communities, and people with severe mental health issues) and burdening the public health system;
- People will engage in ‘compensatory behaviour’: they will self-titrate to get the amount of desired nicotine, which means inhaling a lower nicotine vaping product more deeply and/or more frequently, exposing the user (unnecessarily) to the chemicals in the vapour; and/or
- People may import from overseas unregulated/low-quality vaping products with higher nicotine levels for private use.
No public health benefit in reducing nicotine strength from 50mg/mL to 28.5mg/mL
The only reason given by the Ministry for the proposed reduction in nicotine strength from 50mg/mL to 28.5mg/mL is the suggestion that “higher levels of nicotine mean an increase in the risk of addiction, including for young people who have not previously smoked”.
The Ministry has not cited any studies or clinical/empirical evidence to support its proposition that higher nicotine strength is a proxy for nicotine addictiveness.
We refer to the Ministry to a study by Professor Jonathan Foulds which found that nicotine dependence of users of vaping products with nicotine levels of 59mg/mL was indexed as being “low to medium” and, pertinently, similar to the nicotine dependence of users of lower-nicotine vaping products.
Additionally, the Ministry has not cited any evidence that young people are using higher nicotine vaping products. We support the Ministry’s efforts to reduce the availability of vaping products to young people as discussed in its submission dated 15 March 2023. However, our observation is that young people tend to use what is made available to them and what is cheap. Reducing the availability of vaping products through stronger enforcement and banning single-use vapes will be much more effective in protecting our young people.
We wish to record the following concerns about the process that the Ministry has adopted in consulting on this issue:
- The Ministry’s misrepresentation to stakeholders that the consultation concerns only how the nicotine levelsshould be expressed in the Regulations, rather than it was proposing to reduce materially the nicotine strength in nicotine salt vaping products from 50mg/mL to 28.5mg/mL;
- The Ministry’s misrepresentation to stakeholders in the 12 June 2023 email and news article that the “proposal is in line with the existing regulations’ intent”;
- The Ministry’s misrepresentation in the 12 June 2023 consultation document that, if clause 15 is not amended, it would mean that there would be products in market with nicotine strength of 50mg/mL “rather than the 28.5mg/mL that was intended” – we note that this phrase was removed by the Ministry (without any acknowledgement that it had done so, or any explanation as to why it had done so) from the version that was available on the Ministry’s website as at 26 June 2023;
- The absence of expert input into what is a highly technical and consequential matter;
- The lack of explanation to industry, experts and stakeholders as to the scientific basis for the proposed reduction in nicotine strength from 50mg/mL to 28.5mg/mL, so as to enable meaningful engagement with those issues;
- The inadequacy of a two-week period for consultation on a technical and fundamental issue, particularly in circumstances where the process had not previously been signalled to industry, experts and other stakeholders – this is compounded by the fact that only those who received the email from the Ministry on 12 June 2023 would be aware of the consultation process and would have access to the online “survey”. The consultation process was not, at any stage, listed on the Ministry’s consultation homepage and was not able to be located using the Ministry’s consultation search engine; and
- The procedural flaws were not cured by the Ministry uploading an explanatory document on 22 June 2023 – this was two working days before the process came to an end and was not brought to the attention of any stakeholders, including by email to the original email distribution list. It was not capable of assisting anyone who had already made a submission by 22 June 2023, or anyone whose submission was already underway by 22 June 2023.