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.

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 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.

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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