UK Regulations
UK Gov 2022 Vaping Review – The data defining future regulations
Oct
The UK government has recently published (29th Sept 2022) the 8th in it’s series of annual reports reviewing e-cigarettes and related vaping products, summarising evidence for and against them to inform policies and regulations. The same reports that famously declared vaping to officially be 95% less harmful than smoking tobacco in 2015. Previously commissioned by Public Health England (PHE), the reports will now be overseen by the Office for Health Improvement and Disparities (OHID) in the Department of Health and Social Care.
The reports themselves are expectedly thorough and highly detailed, however we will summarise the key findings from this most recent review below.
Issues Addressed in the Report
Over the years, the evidence reviews have examined many areas in which vaping products have potential influence – of which you can read here. Their findings are typically produced by leading tobacco experts, with this 2022 report being led by academics at King’s College London supported by international collaborators.
This is the most comprehensive report to-date. Its primary focus is a systematic review of evidence around potential health risks of nicotine vaping. Further to this, the report also examines public perceptions of vaping harm, and dives into data exploring the prevalence of vaping in younger demographics.
The experts carried out a systematic literature review of the health risks and health effects of vaping and divided the findings into chapters. These include:
- biomarkers of exposure to nicotine and potential toxicants
- biomarkers of potential harm to health cutting across several diseases, including cancer, respiratory and cardiovascular diseases
- biomarkers specifically associated with cancer, respiratory, cardiovascular or other health outcomes
- poisonings, fires and explosions
- nicotine
- flavours
Vaping’s effectiveness in helping people quit smoking has already been thoroughly examined in their February 2021 update, and so was not covered this time around. The conclusions given in the 2022 report include reflection on the changes in England since the landmark 2015 report – with an intent to understand trends, owing to the influence covid-19 has had on the availability of relevant data.
Summary of Findings To-Date
Summarising the main events and findings since their reporting began in 2015, the report states that:
Regulations and licensing
Vaping products containing nicotine are regulated under the Tobacco and Related Products Regulations 2016 (TRPR), and need to be notified to the MHRA and comply to certain standards (for example, nicotine content is limited to 20 milligrams per millilitre (mg/mL)) before they can be legally sold in the UK. An analysis of notifications in 2016 to 2017 found that notified products were unlikely to cause serious harm.
Vaping products that do not contain nicotine come under the General Product Safety Regulations 2005, enforced by local authority trading standards.
Medicinally licensed vaping products are exempt from the TRPR and currently there is no licensed product in the UK. Although, in October 2021, MHRA published updated guidance to provide clearer information on the process and help speed up review times.
Adverse Reactions
MHRA also collects information on adverse events believed to be associated with vaping products containing nicotine through its Yellow Card scheme. Between 20 May 2016 (implementation of TRPR) and 13 January 2022, MHRA received 257 reports of adverse reactions (26 of those since January 2021). Each report represents an individual for whom more than one adverse reaction could have been reported. A report is not proof that the reaction was caused by a vaping product, just that the reporter thought it might have been.
Since January 2021, the MHRA has considered only 14 of the reports as serious, and no fatalities were reported.
Adverse reactions to licensed smoking cessation medications are also reported to the MHRA. In 2021 there were 297 reports for nicotine replacement therapy (NRT) and 78 for varenicline.
Age of Sale
There is a loophole in the legislation allowing free samples of vaping products to be given to people of any age. Surveys by the Chartered Trading Standards Institute to capture tobacco control activities, including enforcement of age of sale vaping and tobacco product laws, have not been carried out since 2020.
A specific project in Scotland between October and December 2021 focused on single use disposable vaping products. It found that most products had not been notified as required with many above the 20mg/mL nicotine content limit. It also identified some violations of age of sale laws.
Smokefree 2030
The All-Party Parliamentary Group on Smoking and Health made recommendations to help achieve the smokefree 2030 ambition. These included reducing the appeal and availability of vaping products and other nicotine products to young people, and updating its guidance for medicinal licensing of vaping products.
Advertising and Social Media
A review of vaping product marketing in the UK between 2016 and 2019 found high compliance with the advertising code in advertisements, but not in social media posts. It found that young people who had never smoked or vaped noticed posts relating to vaping more than adults who smoked. However, compared with the US and Canada, UK regulations were found to have limited exposure to marketing among adults and young people.
New and Upcoming Regulations / Guidelines
In March 2022, OHID published the post-implementation review of the TRPR. The review assessed whether the regulations had met their objectives. This review concluded that the evidence indicated the TRPR’s main objectives were being met, and provided a strong argument for retaining the regulations. It also proposed some amendments which could help support the government’s smokefree 2030 ambition.
A new tobacco control plan for England will be published this year (2022) and will define the Gov’s strategy towards meeting the smokefree deadline. This follows the Khan Review, published in June 2022, which provided strong guidance to government including must-do’s to achieve the 2030 target.
The report reveals that despite being covered by the General Product Safety Regulations (GPSR 2005), non-nicotine vaping products are likely to be reviewed as it is felt current regulations require better definition and closer consideration. The emergence of nicotine pouches has further driven the desire to update regulations in this area.
Vaping among young people
(2022 ASH survey of 11–18-year-olds)
- smoking prevalence (including occasional and regular smoking) was 6% in 2022 (compared with 4.1% in 2021 and 6.7% in 2020)
- vaping prevalence (including occasional and regular vaping) was 8.6% in 2022 (compared with 4% in 2021 and 4.8% in 2020)
- 8% of 11-18-year-olds who currently vape were using disposable models – highlighting a clear need to bolster regulation and enforcement in this area to curtail underage use.
- Fruit flavours were preferred by the majority of young people surveyed.
(2021 ITC Youth survey of 16-19-year-olds)
- smoking prevalence (defined as smoking more than 100 cigarettes in their life and having smoked in the past 30 days) was 7.9% in February 2021 (compared with 8.5% in February 2020 and 6.2% in August 2019)
- vaping prevalence (defined as vaping on more than 10 days in their lifetime and having vaped in the past 30 days) was 9.1% in February 2021 (compared with 9.4% in February 2020, and 7.7% in August 2019)
Although it is illegal to sell vaping products to under 18 year olds, many young people under the age of 18 bought and owned their own vaping devices. In the 2021 ASH-Y survey, just under a quarter (24.8%) of young people aged 11 to 17 said that they were given products by friends. But others also reported buying them, for example:
- 1% said they bought them from newsagents
- 1% said they bought them online
- 3% said they bought them from a supermarket
Similarly, in the ITC Youth survey, young people aged 16 to 17 who had vaped in the past 30 days commonly reported being given products (37.5%).
The above denotes the established belief that official bodies are struggling to prevent youth access. This is a subject which has received much attention since the disposable vaping boom, and is likely to define regulations moving forward.
Vaping in Adults
(ASH Data)
Vaping prevalence among adults in England was lower than smoking prevalence across all groups and seemed to have increased by around 1 percentage point from 2020 to 2021, to between 6.9% and 7.1%. This equated to about 3.1 to 3.2 million vapers. In 2022, based on ASH-A data, adult vaping prevalence in England was 8.3%.
There was some variation in vaping prevalence by socio-demographic groups and smoking status. Using 2021 STS data, the highest vaping prevalence was among:
- men (7.8%)
- people from the north of England (8.3%)
- people from social grades C2, D and E (8.8%)
- current smokers (22% compared with 11.6% among former smokers and 0.6% among never smokers)
E-Liquid Flavours
Data was assessed examining the toxicity of certain flavouring ingredients and compounds, in relation to the popularity of specific flavours amongst consumers, with Fruit being the most popular overall.
A systematic review of the evidence on youth use of e-liquid flavours concluded that existing research does not yet provide a clear understanding of how flavours in vaping products are associated with young people taking up or stopping smoking.
Potential toxicants in flavours
In 3 studies, levels of tobacco specific nitrosamines and volatile organic compounds were significantly reduced in smokers and dual users who switched to vaping products with different flavours. Biomarker levels slightly differed between flavours, but this was not tested for statistical significance. Users of fruit-only flavoured vaping products had significantly higher concentrations of a biomarker for acrylonitrile (CNEMA) compared to users of a single other flavour in one study.
One longitudinal observational study of people who vaped found that:
- flavour preferences changed over time
- 9% self-reported an adverse reaction that they associated with the flavour they used
- a third had never used a cinnamon or cinnamaldehyde containing vaping product
Findings from 13 cell and 9 animal studies suggest there is limited evidence that some flavourings in vaping products, particularly cinnamaldehyde, or buttery or creamy flavours have the potential to alter cellular responses but less than exposure to tobacco smoke.
It was however decided that a more standardised approach is needed to evaluate the risks associated with flavourings in e-liquids and aerosols in human and cell studies, independent of nicotine and PG/VG.
Harm Perception Amongst the Public
It is generally felt that more needs to be done to enforce accurate communication of facts and risks associated with vaping, in order for it to reach its potential as a quitting aid.
Among 11 to 18 year olds, using 2021 ASH-Y data:
- 7% accurately perceived that vaping was less harmful than smoking
- 4% inaccurately thought that the harms from vaping and smoking were about the same
- 6% inaccurately thought that vaping was more harmful than smoking
- 3% said they did not know
Among 16 to 19 year olds (using ITC Youth data), we see slightly different patterns in 2021, with most (62.9%) accurately perceiving vaping is less harmful than smoking. Yet, we also saw:
- 8% inaccurately perceived vaping to be equally harmful to smoking
- 10% inaccurately perceived vaping to be more harmful than smoking
- 10% reported that they did not know
Among adult smokers in 2021 STS data, just over a third (34.1%) accurately perceived that vaping was less harmful than smoking. But around a third (32.1%) inaccurately thought that the harms from vaping and smoking were about the same, 11.9% inaccurately thought that vaping was more harmful than smoking, and 22% said they did not know.
In the ASH-A survey, overall, few (13.9%) current adult smokers and vapers accurately believed that none or a small amount of the risks of smoking were due to nicotine, with:
- 9% reporting ‘under half the risk’
- 3% reporting ‘around half the risk’
- 9% reporting ‘much more than half’ or ‘nearly all’ the risk
- 1% reporting that they did not know
EVALI increased people’s harm perceptions of vaping, including inaccurate perceptions relative to smoking. In addition, warning labels highlighting that vaping is harmful and addictive generally increased people’s perceptions that vaping is harmful to health and is addictive.
A major outcome of this area of the report is that deeper research must be carried out into the implications of warnings on vaping products, and how they may need t change to more accurately reflect relative risks – this could lead to big changes for vaping manufacturers and retailers, as well as the bodies that police them including the MHRA and ASA. This may also spark a review of the TRPR.
Conclusions
The main conclusions drawn by the report’s end, vaping is an effective means to quit, and that the relative health risk is a small fraction comparative to tobacco – the 2015 statement holds true.
It was decided that there is a greater need to discourage non-smokers and non-vapers from starting vaping, as there is evidence finding higher absolute toxicants in the bodies of those who use vaping products. However smokers absolutely should be encouraged to use them, as the risk is far lower.
The recent increase in young people using disposable vaping products makes this an even greater concern, because if it continues, it could undermine the approach and regulatory framework for vaping products adopted in England.
Public perceptions of absolute and relative vaping harm are not in line with the evidence, and the report’s findings indicate that these perceptions influence subsequent vaping and smoking behaviours. It also found that interventions can influence perceptions. So, understanding and changing misperceptions is very important.
Don’t get caught out!
The contents of the report summarised above could very well dictate the future of vaping regulation and influence the way in which the industry operates and is enforced. Ensuring total compliance with current legislation, and ensuring necessary agility to navigate the changes that could follow this report into 2023 and beyond, is more vital than ever before.
Contact us today to ensure you and your business are safeguarded so you can enjoy a profitable and successful enterprise, without worrying about understanding everything you have read here today – our regulatory expertise specialises in vaping and we are more than prepared to secure your business.
Our Sources:
https://www.gov.uk/government/publications/vaping-in-england-evidence-update-february-2021
https://www.gov.uk/government/publications/nicotine-vaping-in-england-2022-evidence-update
