Update on electronic cigarettes and heated tobacco products| Tabaccologia

Using electronic cigarettes in a clinical setting or as a consumer product?

When used in a clinical setting with behavioural support, such as in a smoking cessation service, electronic cigarettes (e-cigs) are effective for quitting smoking [1,2]. If we look at nicotine abstinence, instead of smoking cessation, e-cigs record half successes in comparison with nicotine replacement therapy (NRT), because the risk of keeping on e-cigs after quitting is about 9 times compared to NRT [3]. Finally, e-cig use after quitting increases relapse in traditional smoking [4].

As a consumer product, instead, e-cig is not associated with smoking cessation, even among people with some motivation to quit [1,5,6].

Cardiovascular risk of e-cigs

The cardiovascular (CV) risk in dual use of e-cigs and traditional cigarettes is similar to that in exclusive tobacco smokers [7-10]. Nicotine & Particulate Matter (PM) from e-cigs determine increases of heart rate, systolic & diastolic blood pressure; reactive oxygen species; decrease of antioxidant activity; increase of endothelial dysfunction and platelet activation. Moreover, PM from ambient air pollution and tobacco smoking studies determine higher risk of CV mortality (acute myocardial infarction) [7-10]. Thus, e-cigs should not be regarded as a CV safe product. Given the non-linear dose-response relationship between smoking and CV mortality, increasing e-cig use & decreasing smoking may not result in proportional reduction of CV mortality.

Youths and e-cigs

Youth and young adult e-cigarette users had a 3-time risk of subsequent cigarette initiation and a 4-time risk of past 30-day cigarette smoking [11]. The question is: have e-cigs renormalized youth smoking (i.e., e-cigs determine an increase of tobacco users), or e-cigs may be displacing smoking, diverting adolescents from tobacco cigarettes? Three studies from New Zealand, USA, and UK did not support the renormalization hypothesis [12-14]. There are no studies for EU countries on renormalization vs displacement of smoking. Anyway, current smokers in Italy did not increase in last years. In fact, among students aged 13-15 years from Global Youth Tobacco Survey (GYTS) [15], smoking prevalence decreased from 23% in 2014 to 20% in 2018; among students aged 15-19 from ESPAD® Italia [16], smoking prevalence decreased from 34% in 2018 to 27% in 2021, even though current e-cig or heated tobacco products (HTP) users increased in both surveys in last years.

Consumption of HTPs and e-cigs in Italy

In Italy HTP consumption has increased by 6 times since 2018, reaching 9.2 tons in 2021, against 61 of traditional cigarettes, which decreased by 30% since 2010. Despite the fact that from PASSI surveillance system [17] in 2020 the prevalence of HTPs is 1.6% and of e-cig 2.0%, the majority of traditional cigarette smokers (91%) exclusively keep on smoking traditional cigarettes. Thus, Italians seems to be still loyal to traditional cigarettes, despite the introduction of novel tobacco products.

Australia vs UK on e-cig regulation

Even if Australia and UK, both with an excellent level of implementation of tobacco control policies, have chosen a very restrictive regulation and promotion of e-cig to quit, respectively, in 2021 they are both moving towards a medical prescription of e-cigs [18].

Australia developed a very successful anti-tobacco mass media campaign since 1996, was the first Country to implement the Plain Package since 2012, and increased tobacco taxation, so much that in 2021 a 20-cigarette package costed around 23 euro.

In Australia from October 2021, e-cigs with nicotine cannot be sold, unless the user has a prescription from a medical doctor. Even though in Australia nicotine vaping products are not recognised as an effective and safe support to quit, some doctors may recommend use of e-cigs for long-term smokers who have tried to quit using approved medications but failed, and who still want to quit, and have discussed e-cig use with their physicians [19].

In April 2022, the Australian Report: E-cigs and Health outcomes was released, highlighting that for many health outcomes there are still too few studies to conclude that e-cigs are not dangerous [20]. For smoking & nicotine cessation: this report concludes that:

1. there is limited evidence that, in the clinical context, freebase nicotine e-cigs may be more efficacious than existing NRT, and that nicotine e-cigs may be more efficacious than no intervention or usual care;
2. trials demonstrating efficacy were limited to products with freebase nicotine concentrations ≤ 20mg/mL;
3. there is no evidence that nicotine salt products are efficacious for smoking cessation;
4. there is insufficient evidence that freebase nicotine e-cigs are efficacious outside the clinical setting;

Even UK developed a very powerful tobacco control strategy: the reimbursement of smoking cessation treatments entered into force in 1999; a 20-cigarette package in 2021 costed around 13 euro; each year since 2012 the anti-tobacco mass media campaign «Stoptober» tries to convince smokers to make a quit attempt; plain package was introduced in 2018. The only important difference in comparison to Australia is that since 2015 Public Health England endorsed e-cigs for smoking cessation. In October 2021, UK announced that e-cigs could be prescribed on the National Health System in England to help people stop smoking. An updated guidance to go through the regulatory approvals process for medicinally licensed e-cig products was released for manufacturers [21].

It’s not a new story in England: even though in 2016 one e-cig device (e-Voke) was licensed for medical use by the UK medicines regulator, it was never marketed since this product was already out of date. A license for medical use is very difficult to achieve for e-cigarettes, and manufacturers are more interested in extending consumer choice and delivering ever better next-generation e-cigs.

Why prescription in England? Approved e-cigs can be promoted as smoking cessation aids; the approval may determine further reassurance to health professionals, and may improve confidence among smokers.

A Delphi survey on e-cigs

A Delphi survey among some international experts on e-cigs & HTPs was conducted [22]. Main conclusions for implementing restrictive regulations worldwide are reported here:

e-cigs

1. components of e-liquids should be provided on the product;
2. an upper limit of nicotine concentration should be defined;
3. a warning on the lack of evidence in long term safety and the e-cig addiction potential should be stated;
4. e-cigs should not be regulated as consumer products but as a new category of products;
5. e-cigs should be sold in specialised shops (shops selling tobacco or in pharmacies), with sale restriction for minors.

HTPs

1. they have the same addictive potential than conventional cigarettes;
2. they should be regulated as a tobacco product with similar warning messages than cigarettes; advertisement should not be allowed.

Both e-cigs

1. their use should not be allowed in indoor public places;
2. a specific tax should be implemented for e-cigs, and taxes on HTPs should not be lower than those for conventional cigarettes.

References

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