Context

On June 12th 2023 Manatū Hauora opened a 2 week consultation seeking feedback on the way that the nicotine strength for reusable vaping products containing nicotine salts is expressed in the Regulations. 

For more information on how the maximum nicotine strength for vaping products is expressed in the current regulations please click here.

In the consultation document, Manatū Hauora explain the intent behind this proposal is to align with the purposes of the act: 

"This approach is aligned with the purposes of the Act, to provide for the regulation of notifiable products in a way that seeks to minimise harm, especially harm to young people and children by making sure that products don’t have excessive levels of nicotine, which is the addictive substance in vaping products."

 

Purposes of the Smokefree Environments and Regulated Products (Vaping) Amendment Act 2020.

In section 3A of the act, the purposes of the Act are as follows: 

(a) to reduce the exposure of people who do not themselves smoke to any detrimental effect on their health caused by smoking by others; and
(b) to prevent the normalisation of vaping; and
(c) to regulate and control the marketing, advertising, and promotion of regulated products (whether directly, including through the appearance of regulated products and packages, or through the sponsoring of other products, services, or events) in order to improve public health by—
(i) discouraging people, especially children and young people, from taking up smoking; and
(ii) discouraging non-smokers, especially children and young people, from taking up vaping or using smokeless tobacco products; and
(iii) encouraging people to stop smoking, vaping, or otherwise using regulated products; and
(iv) discouraging people who have stopped smoking, vaping, or otherwise using regulated products from resuming smoking, vaping, or using regulated products; and
(d) to support smokers to switch to regulated products that are significantly less harmful than smoking; and
(e) to regulate the safety of vaping products and smokeless tobacco products; and
(f) to monitor and regulate the presence of harmful constituents found in regulated products and their emissions; and
(g) to give effect to certain obligations and commitments that New Zealand has as a party to the WHO Framework Convention on Tobacco Control, done at Geneva on 21 May 2003.

Current 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.

Proposed Regulations:

The proposed regulations seek to lower the maximum nicotine concentration for products containing nicotine salts from 50mg/mL to 28.5mg/mL

 Discussion:

While we appreciate the efforts from Manatū Hauora to take steps to remove confusion regarding the interpretation of clause 15 of Schedule 5 of the Regulations relating to vaping products, the proposal to reduce the maximum nicotine concentration within nicotine salt vaping substances from 50mg/mL to 28.5mg/mL goes against the purposes of the act, will not make vaping any less addictive and will increase usage frequency and consumption of vaping products across all age demographics. 

We urge Manatū Hauora to

• Review the original rationale for the current 50mg/mL limit
• Consider the current scientific evidence related to concerns raised related to addiction and frequency of youth vaping in the consultation paper
• Be aware of the unintended consequences and how this proposal will contradict the purposes of the Act.    

Original rationale for the current 50mg/mL concentration limit for nicotine salts

Rationale for maximum nicotine limits in context of New Zealand vaping regulations were first discussed in 2018 by the Technical Expert Advisory Group (TEAG) consisting of leading tobacco harm reduction experts, smoking cessation providers and key vaping industry representatives who were tasked with recommending fit for purpose vaping regulations (Electronic Cigarette Technical Expert Advisory Group).

Within the TEAG meeting minutes, it documents discussion on the maximum limit of 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 eliquids made using nicotine salts; with a recommendation of a 60mg/mL limit for nicotine in vaping liquids made using nicotine salts (based on the efficacy of JUUL) and a 36mg/mL limit for nicotine in vaping liquids made using freebase nicotine.

Although the TEAG recommendation was later reduced to 50mg/ml, Multiple presentations by Professor Hayden McRobbie highlight the importance of 50mg+ nicotine concentrations in context of maximising the efficacy of vaping products as a means to successfully transition smokers to less harmful alternatives.

Manatū Hauora Concerns 

In the consultation document Manatū Hauora raises 2 concerns with the current 50mg/mL limit.

1. Increases the risk of addiction
2. Linked to the frequency of youth vaping

These concerns are based on an incorrect assumption that the concentration of nicotine in a vaping substance is directly linked to the level of addictiveness, i.e. under this assumption, a 3mg/mL freebase eliquid would be 94% less addictive than a 50mg/mL nicotine salt. 

The reason the concentration of nicotine in a vaping substance is not directly linked to the level of addictiveness is because users manage their nicotine intake by way of flexing their vaping style aka "nicotine titration" (longer, more frequent puffs or the type of device used).

For example, vapers using low nicotine freebase e-liquid are generally more prone to using high powered devices and consume significantly more e-liquid per day than a higher mg "Mouth to lung" style vaper using a low powered device.

The proposal to reduce the maximum nicotine limit from 50mg/mL to 28.5mg/mL will not reduce the risk of addiction, but rather increase the frequency of nicotine consumption across all vaping demographics. 

In contradiction with the purposes of the Act.

Reducing nicotine maximum nicotine levels is in contradiction to the purposes of the Act. 

S3A (d) of the Act specifies purpose "being to support smokers to switch to regulated products that are significantly less harmful than smoking"

Reducing the maximum nicotine limit creates a barrier to switching for more dependent smokers; the proven devices of today that work for converting smokers will be unable to deliver lower concentrations of nicotine at sufficient dosages. In addition, many ex smokers currently relying on easy to use, low powered devices that are proven to work for smoking cessation in New Zealand; These consumers will be forced to find larger alternatives, higher powered devices in order to retain their desired nicotine output. 

Reduced nicotine levels make it harder for smokers to switch to significantly less harmful products.

 S3A (e), (f)(e) of the Act relate to purposes of "regulating the safety of vaping products and monitoring and regulating the presence of harmful constituents." 

The Vaping Regulatory Authorities own communications acknowledge that there is no evidence of increased users' harm attributable to nicotine vaping products containing up to 50mg/mL nicotine. 

"At this stage, there is no evidence that vaping products being sold in New Zealand have levels of nicotine high enough to significantly increase users’ risk of harm"

There is no expert advice, fact based evidence or rationale for the proposed 28.5mg/mL limit on nicotine salt vaping substances. The only reason for this limit is that some 28.5mg/ml nicotine salts are formulated by reacting with 21.5mg/ml of acid, and when adding these two numbers together it happens to sum to 50mg (a number currently specified in the regulations).