Notification Detail

Draft Law No XIIIP-3849(3) amending Article 9(2) of Law No I-1143 on the control of tobacco, tobacco products and related products of the Republic of Lithuania

Notification Number: 2021/434/LT (Lithuania )
Date received: 08/07/2021
End of Standstill: 11/10/2021

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Message 002

Communication from the Commission - TRIS/(2021) 02580
Directive (EU) 2015/1535
Translation of the message 001
Notification: 2021/0434/LT

No abre el plazo - Nezahajuje odklady - Fristerne indledes ikke - Kein Fristbeginn - Viivituste perioodi ei avata - Καμμία έναρξη προθεσμίας - Does not open the delays - N'ouvre pas de délais - Non fa decorrere la mora - Neietekmē atlikšanu - Atidėjimai nepradedami - Nem nyitja meg a késéseket - Ma’ jiftaħx il-perijodi ta’ dawmien - Geen termijnbegin - Nie otwiera opóźnień - Não inicia o prazo - Neotvorí oneskorenia - Ne uvaja zamud - Määräaika ei ala tästä - Inleder ingen frist - Не се предвижда период на прекъсване - Nu deschide perioadele de stagnare - Nu deschide perioadele de stagnare.

(MSG: 202102580.EN)

1. Structured Information Line
MSG 002 IND 2021 0434 LT EN 08-07-2021 LT NOTIF


2. Member State
LT


3. Department Responsible
Lietuvos standartizacijos departamentas
Algirdo g. 31, LT-03219 Vilnius
Tel. +370 (5) 270 9358
Elektroninis paštas: dir9834@lsd.lt


3. Originating Department
Lietuvos Respublikos sveikatos apsaugos ministerija
Vilniaus g. 33, LT-01506 Vilnius
Tel. +370 (5) 266 1400
Elektroninis paštas: ministerija@sam.lt


4. Notification Number
2021/0434/LT - X00M


5. Title
Draft Law No XIIIP-3849(3) amending Article 9(2) of Law No I-1143 on the control of tobacco, tobacco products and related products of the Republic of Lithuania


6. Products Concerned
electronic cigarettes and fillers with liquid suitable for filling electronic cigarettes


7. Notification Under Another Act
-


8. Main Content
The purpose of the draft law is to prohibit the placing on the market of the Republic of Lithuania of electronic cigarettes and fillers containing liquids suitable for filling electronic cigarettes (hereinafter referred to as “electronic cigarette fillers”), provided that this liquid contains flavours other than tobacco smell and/or taste.


9. Brief Statement of Grounds
The draft law aims to prohibit the placing on the market of the Republic of Lithuania of electronic cigarettes and electronic cigarette fillers containing liquid if this liquid (both nicotine and nicotine-free) contains flavours other than tobacco smell and/or taste, thus reducing the attractiveness and demand of electronic cigarettes and electronic cigarette fillers (especially for young people who are particularly attracted to flavoured smoking products), which becomes particularly relevant due to the worrying trend towards the increase of the use of electronic cigarettes (especially among young people) in Lithuania [1, 2, 3, 4].



In accordance with the provisions of recital (47) of the preamble to the Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (hereinafter referred to as the “Tobacco Products Directive”):

“(47) This Directive does not harmonise all aspects of electronic cigarettes or refill containers. For example, the responsibility for adopting rules on flavours remains with the Member States. It could be useful for Member States to consider allowing the placing on the market of flavoured products. In doing so, they should be mindful of the potential attractiveness of such products for young people and non-smokers. <...>“



At the request of the European Commission, the Scientific Committee on Health, Environment and Emerging Risks (SCHEER) delivered a scientific opinion on electronic cigarettes [5] in 2021:

“<...> SCHEER concludes that there is moderate evidence that electronic cigarettes are a gateway to smoking for young people. There is strong evidence that nicotine in e-liquids is implicated in the development of addiction and that flavours have a relevant contribution for attractiveness of use of electronic cigarette and initiation.”



A study has been conducted in the United States on the introduction of flavours in vaping products and satisfaction among adults (“The role of flavours in vaping initiation and satisfaction among U.S. adults”). This study found that the majority of current consumers of e-cigarettes (62.9%) generally used flavours other than tobacco (including fruit, mint/menthol, sweets, coffee, etc.), 24,2% used tobacco flavours and 12.9% used odourless e-cigarettes. The taste was a common reason for switching to e-cigarettes, which was chosen by 29.5% of subjects. The taste, especially fruit, has led young adults aged 18-24 to start using electronic cigarettes, compared to adults aged 35-44. Those who used tastes, especially mint/menthol and others, other than tobacco, were more likely to confirm high satisfaction with the use of electronic cigarettes and the dependence of electronic cigarettes more likely than respondents who did not use flavoured e-cigarettes.



As stated in the Report from the European Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on the application of the Tobacco Products Directive [6], published on 20 May 2021:

“There is strong evidence that flavours in e-liquids are attractive to youths and adults. Significantly, young people use non-traditional flavours in particular, such as candy and fruit. These flavours strongly influence young people by decreasing harm perception and increasing the will to try. Member States are increasingly banning flavours for e-cigarettes.”



The World Health Organisation (WHO) Report on the Global Tobacco Consumption Epidemic 2019 (Chapter ‘Electronic Cigarettes, Key Information and Country Recommendations’) recommended that “Parties should apply bans on product advertising and odours in order to protect young people.”



It is important to note that Lithuania, basing the proposed legal regulation on the grounds mentioned in recital 47 of the preamble to the Tobacco Products Directive, the latest scientific evidence and WHO recommendations, would follow the successful example of other countries (both in the EU and the world) by introducing a ban on scented electronic cigarettes and their fillers, thus contributing to the objective of reducing the prevalence of e-cigarette use, which becomes particularly relevant in the context of the rapidly increasing use of e-cigarettes in Lithuania (especially among young people).







1 https://ntakd.lrv.lt/uploads/ntakd/documents/files/Eurobarometras%202020%20Lietuva.pdf

2 https://ntakd.lrv.lt/uploads/ntakd/documents/files/HBCS2018_LT.pdf (p. 42)

3 http://www.espad.org/sites/espad.org/files/2020.3878_EN_04.pdf

4 https://ntakd.lrv.lt/lt/naujienos/lietuvoje-kinta-rukymo-iprociai-jauni-zmones-vis-dazniau-renkasi-elektronines-cigaretes-bei-naujoviskus-bedumius-tabako-produktus-vietoje-iprastu-tabako-gaminiu

5 https://ec.europa.eu/health/sites/default/files/scientific_committees/scheer/docs/scheer_o_017.pdf

6 https://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1621500846386&uri=COM%3A2021%3A249%3AFIN

7 https://www.who.int/teams/health-promotion/tobacco-control/who-report-on-the-global-tobacco-epidemic-2019 (p. 59)


10. Reference Documents - Basic Texts
Reference(s) to the basic text(s): Draft:

https://e-seimas.lrs.lt/portal/legalAct/lt/TAP/fc4af810ce7111eb91e294a1358e77e9?jfwid=19qe94pe8n



Comparative Draft Version:

https://e-seimas.lrs.lt/portal/legalAct/lt/TAK/1cf7d650ce7211eb91e294a1358e77e9?jfwid=19qe94pe8n


11. Invocation of the Emergency Procedure
No


12. Grounds for the Emergency
-


13. Confidentiality
No


14. Fiscal measures
No


15. Impact assessment
Given the purpose of this draft legislation and its regulatory nature, no negative impact is expected.


16. TBT and SPS aspects
Technical barriers to trade

Yes

SPS aspect

No – the draft is neither a sanitary nor a phytosanitary measure

**********
European Commission

Contact point Directive (EU) 2015/1535
Fax: +32 229 98043
email: grow-dir2015-1535-central@ec.europa.eu

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At the end of the standstill period, you will find on the webpage https://ec.europa.eu/growth/tools-databases/tris/en/ , under the notification file, the information about the form of the reaction of the Commission and/or the Member States, if any, to the notification.


el
  Zacharias Papadakis on 08-09-2021
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en
  Luc Van Daele on 07-09-2021
Click to expand

Hasn't the EU not produced enough burocratic limitations on its citizens? Who do you think you are you can tell adults what flavours they are allowed to use or not use. Put an age limit on them and do your job to make that this age limit is respected. But if you can't do that, I'm will not be the victim of your incompetence.


en
  European Tobacco Harm Reduction Advocates (ETHRA) on 06-09-2021
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Introduction

European Tobacco Harm Reduction Advocates contribution to TRIS notification 2021/0434/LT - X00M outlines why prohibiting all e-liquid flavours, apart from tobacco, will have a detrimental effect on public health in Lithuania.

 

European Tobacco Harm Reduction Advocates (ETHRA) is a group of 22 grassroots consumer associations in 16 European countries which support the public health approach of tobacco harm reduction, where people switch from high-risk products like cigarettes to low-risk products like e-cigarettes. We are mostly ex-smokers who have used safer nicotine products (vapes, snus, nicotine pouches, heated tobacco products) to quit smoking and remain smoke free.  ETHRA represents approximately 27 million[i] consumers across Europe and is supported by experts in the field of tobacco control and nicotine research.  ETHRA is a voluntary organisation with no industry conflicts of interest – see our Transparency Register entry: 354946837243-73.

 

The draft law aims to “reduce the attractiveness and demand of electronic cigarettes and electronic cigarette fillers.”  If enacted, it will drastically restrict adult access to the products people use to quit smoking and remain smoke free, and cause harm by prolonging smoking.

 

Switching from smoking to vaping provides substantial health gains

The harms from smoking are due to the inhalation of toxic products of combustion, not from nicotine use. So, the critical distinction from a public health perspective must be between combustible smoked products and non-combustible smokeless products.  Significant public health gains can be made if smokers transition away from deadly combustible tobacco products to low-risk e-cigarettes.

 

The draft law disproportionately focuses on youth use of e-cigarettes, without due regard for the consequences for adult smokers.  Special Eurobarometer 506 shows that smoking prevalence in Lithuania is 5% higher than the EU average, at 28%[ii].  This makes it clear that smokers in Lithuania need more help and options to quit smoking rather than fewer.

 

Some countries recognise the potential vaping products have to reduce death and disease from smoking.  In the UK the Royal College of Physicians said in its 2016 report, Nicotine Without Smoke[iii]: “the available data suggest that they [e-cigarettes] are unlikely to exceed 5% of those [risks] associated with smoked tobacco products and may well be substantially lower than this figure”.

 

Public Health England[iv] also concluded that vaping was at least 95% less harmful than smoking,  and that  smokers should be assured that switching to vaping is much less harmful than smoking. A study by Stephens WE[v], suggested e-cigarette vapour has cancer potencies of just 0.4% of cigarette smoke.  Public health endorsement of vaping has contributed to the UK experiencing the sharpest decline in smoking prevalence in the EU, falling 21pp since 20062.  It should also be noted that vaping among never smoking youths in the UK is extremely low, Public Health England’s latest evidence update reports that “between 0.8% and 1.3% of young people who had never smoked were current vapers[vi]

 

The French Cancer Institute[vii] also recognises the huge harm reduction potential of vaping in their latest campaign, stating:  “Without tobacco, without smoke and without combustion, the electronic cigarette represents an opportunity to reduce cancer mortality related to tobacco. It should be used with a view to quitting smoking for good.

 

The latest call for a balanced approach towards the regulation of e-cigarettes comes from 15 past presidents of the Society for Research on Nicotine and Tobacco, the preeminent scientific professional society focused on nicotine and tobacco. This landmark paper[viii] states that the potential benefits of vaping for adult smokers are substantial. However, the past presidents regret that those  benefits are not being fully realised in today’s environment of misinformation and a singular focus on the welfare of kids, to the detriment of the health of adults who smoke.

 

Vaping is an effective means of smoking cessation

Quitting smoking can be a long and arduous journey that can involve multiple relapses to smoking.  Therefore, it is crucial that smokers have as many options available to them as possible.  As a consumer product vaping can reach more smokers and is an effective and popular means of smoking cessation. Data from Belgium, France, Ireland and the UK[ix] attest to this efficacy. 

 

Scientific reviews and studies provide solid evidence that vaping is an effective means of smoking cessation.  An ongoing living review by the Cochrane Tobacco Addiction Group consistently finds that vaping is more effective than Nicotine Replacement Therapies (NRTs)[x]. Randomised Control Trials (RCT), considered the gold standard, also confirm that vaping is more effective than traditional smoking cessation methods like NRTs alone.  Hajek et al[xi] found vaping to be almost twice as effective as NRTs and Walker et al[xii] found e-cigarettes combined with NRT’s to be 2.5 times more effective than patches alone.

 

A further RCT[xiii] which aimed to assess the efficacy of e-cigarettes compared to NRTs for smokers who had previously been unable to quit, found that after six months 19% of the e-cigarette group had maintained smoking abstinence compared with only 3% of the NRT group.

 

Flavours are critical to the success of vaping       

Attractive flavours are critical factors in the effectiveness of e-cigarettes for smoking cessation, this is also why NRTs come in a range of fruity and mint/menthol flavours.  The TRIS notification detail even acknowledges that flavours in e-liquids are attractive to adults.  A common misconception is that tobacco flavour is sufficient for adult smokers to transition away from smoking, when in reality it is common for vapers to migrate from tobacco flavour to fruits and sweet flavours[xiv].

 

It shouldn’t come as any surprise that adults enjoy things that taste good, this is certainly the case when it comes to smoking cessation aids. This was demonstrated by researchers in the Netherlands[xv] who concluded: “Adults who have completely switched from smoking to e-cigarettes have often initiated e-cigarette use with fruity flavours rather than tobacco flavours, or switched from tobacco to non-tobacco e-liquid flavours over time.”  The ability to disassociate from the flavour of tobacco, and enjoyment of the product being used, are important factors to avoid relapse to smoking.

 

A large-scale survey by Farsalinos et al[xvi] examined the flavour preferences of adults who had completely switched from smoking to vaping and concluded that fruit and dessert/pastry/bakery flavours, were the most prevalent choices. 

 

A study published in the Journal of the American Medical Association[xvii] examined the association of flavoured e-cigarettes with subsequent smoking cessation and found that adults who vaped non-tobacco flavours were more likely to quit smoking than those who vaped tobacco flavours. 

 

Given the important role flavours play in smoking cessation it is imperative that the unintended consequences of a flavour ban are considered.  Such a ban would be disastrous for smoking cessation and public health as it would remove the products responsible for huge reductions in smoking prevalence from the market.

 

Vape flavour bans encourage black markets

The added danger with limiting or banning flavours is that consumers are then forced to use the black market to obtain the product they need (or go back to smoking). This was the experience in Estonia where a flavour ban and high taxation led to an explosion of black-market products, reported to account for 62-80%[xviii] of all sales. In response, Estonia recently amended its legislation to permit more flavours.

 

States in the USA that have banned flavours have also seen thriving black markets develop as ex-smokers seek out the only products that have successfully kept them smoke free. Black market sales of flavoured vaping products are reported to be a regular occurrence in car parks around Long Island New York[xix]. Prohibition hasn’t eliminated the product; it has simply driven it underground and criminalised those whose only crime is wanting to remain, or become, free from cigarette smoking.

 

ETHRA recently conducted a survey[xx] of nicotine consumers in Europe, which attracted over 35,000 EU responses. We found that 94.6% of current vapers used a flavour other than tobacco.  When asked about reactions towards the possibility of a flavour ban, 28% said they would be likely to restart smoking, and 71% would consider using the black market or other alternative sources.   

 

Consumers turning to an unregulated black market, with no manufacturing standards, could pose significant health risks.  Oil based flavourings, which are unsuitable for vaping, could easily be added to liquids by those unaware of the inherent danger of inhaling oil-based flavours.

 

Smoking increases where flavour bans are enacted

A recent study by Friedman A[xxi] examined the effects of a flavour ban in San Francisco relative to other districts without a flavour ban.  The study concluded that “San Francisco’s flavor ban was associated with more than doubled odds of recent smoking among underage high school students relative to concurrent changes in other districts.”  

 

 

Youth vaping has not led to an increase in smoking


Although youth vaping in Lithuania is relatively high, this hasn’t translated into an increase in smoking.  The TRIS notification detail cites youth vaping figures from the European School Survey Project on Alcohol and Other Drugs (ESPAD), as part of the rationale for the proposal to prohibit e-liquid flavours.  However, the same ESPAD[xxii] survey shows that youth smoking rates are low.  Past 30-day smoking, 1-5 cigarettes per day, is only 4.2%, this falls further to 2.2% for those smoking 6-10 cigarettes.  It could be argued that youth use of vapour products has diverted them away from the most harmful method of nicotine consumption, which is smoking.

 

 

Conclusions


We are dismayed that the Government of the Republic of Lithuania wishes to limit the appeal of e-cigarettes when adult smoking prevalence remains stubbornly high at 28%.  This 28% represents approximately 784,000 Lithuanian smokers who could greatly benefit from switching to a less harmful alternative to smoking.  Vaping is proven to help smokers quit, and flavours are an essential part of this. 

 

Removing flavours will keep more people smoking by making vaping less attractive.  The Royal College of Physicians (London) explained this in 2016[xxiii]: “if [a risk-averse and precautionary] approach also makes e-cigarettes less easily accessible, less palatable, or acceptable, more expensive, less consumer-friendly or pharmacologically less effective, or inhibits innovation and development of new and improved products, then it causes harm by perpetuating smoking. Getting this balance right is difficult.” 

 

We suggest that robust age of sale legislation is a much better way of tackling the issue of youth use.  The current proposal to restrict flavoured e-liquid will have an extremely negative effect on adult smokers by removing the products that have helped millions of EU citizens quit smoking for good.



[i] Estimate of 27 million consumers provided by ECigIntelligence/TobaccoIntelligence. The actual figure is likely to be far higher because the data for smokeless tobacco is taken from research (Leon et al 2016) using data gathered in 2010 in only 17 countries

[ii] Comissão Europeia (2021) Special Eurobarometer 506: Attitudes of Europeans towards tobacco and electronic cigarettes.

[iii] Royal College of Physicians (London), Nicotine without smoke: tobacco harm reduction, April 2016

[iv] McNeill A, Brose LS, Calder R, Bauld L & Robson D (2018). Evidence review of ecigarettes and heated tobacco products 2018. A report commissioned by Public Health England. London: Public Health England

[v] Stephens, W. E. (2018) ‘Comparing the cancer potencies of emissions from vapourised nicotine products including e-cigarettes with those of tobacco smoke’, Tobacco Control, 27(1), pp. 10–17. doi: 10.1136/tobaccocontrol-2017-053808.

[vi] McNeill, A., Brose, L.S., Calder, R., Simonavicius, E. and Robson, D. (2021). Vaping in England: An evidence update including vaping for smoking cessation, February 2021: a report commissioned by Public Health England. London: Public Health England.

[vii] Institut National Du Cancer. (2021). Tabac et prévention des cancers. Available at: https://www.e-cancer.fr/Acces-thematique/Tabac-et-prevention-des-cancers

[viii] Balfour, D. J. K. et al. (2019) ‘Balancing Consideration of the Risks and Benefits of E-Cigarettes’.

[ix] Interview on Tobacco Products Directive: notes by ETHRA, pps 8-9 Impact of e-cigarettes on smoking cessation. Available at: https://ethra.co/images/ETHRAs_notes_on_TPD_interview.pdf

[x] Hartmann-Boyce J, McRobbie H, Butler AR, Lindson N, Bullen C, Begh R, Theodoulou A, Notley C, Rigotti NA, Turner T, Fanshawe TR, Hajek P. Electronic cigarettes for smoking cessation. Cochrane Database of Systematic Reviews 2021, Issue 4. Art. No.: CD010216. DOI: 10.1002/14651858.CD010216.pub5.

[xi] Hajek, P. et al. (2019) ‘A randomized trial of E-cigarettes versus nicotine-replacement therapy’, New England Journal of Medicine, 380(7), pp. 629–637. doi: 10.1056/NEJMoa1808779.

[xii] Walker N, Parag V, Verbiest M, Laking G, Laugesen M, Bullen C. Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial. Lancet Respir Med. 2020 Jan;8(1):54-64. doi: 10.1016/S2213- 2600(19)30269-3

[xiii] Myers Smith, K., Phillips-Waller, A., Pesola, F., McRobbie, H., Przulj, D., Orzol, M., and Hajek, P. (2021) E-cigarettes versus nicotine replacement treatment as harm reduction interventions for smokers who find quitting difficult: randomized controlled trial. Addiction, https://doi.org/10.1111/add.15628.

[xiv] Russell C, McKeganey N, Dickson T, Nides M. Changing patterns of first e-cigarette flavor used and current flavors used by 20,836 adult frequent e-cigarette users in the USA. Harm Reduct J. 2018 Jun 28;15(1):33

[xv] Havermans, A. et al. (2019) ‘Nearly 20 000 e-liquids and 250 unique flavour descriptions: an overview of the Dutch market based on information from manufacturers’, Tobacco Control, p. tobaccocontrol-2019-055303. doi: 10.1136/tobaccocontrol-2019-055303.

[xvi] Konstantinos Farsalinos, A. et al. (2018) ‘Patterns of flavored e-cigarette use among adults' vapers in the United States: an internet survey. -N-6565 for "Regulation of Flavors in Tobacco’

[xvii] Friedman, A. S. and Xu, S. Q. (2020) ‘Associations of Flavored e-Cigarette Uptake with Subsequent Smoking Initiation and Cessation’, JAMA network open, 3(6), p. e203826. doi:10.1001/jamanetworkopen.2020.3826.

[xviii] Baltic Times, Estonian FinMin looking into prospect of lowering excise duty for e-cigarettes 25 Nov 2019

[xix] Filter, Vape Bans Are Creating a Thriving Illicit Market 8 July 2020

[xx] European Tobacco Harm Reduction Advocates. EU Nicotine Users Survey report. June 2021. Available at: https://ethra.co/news/80-ethra-eu-nicotine-users-survey-report

[xxi] Friedman AS. A Difference-in-Differences Analysis of Youth Smoking and a Ban on Sales of Flavored Tobacco Products in San Francisco, California. JAMA Pediatr. 2021;175(8):863–865. doi:10.1001/jamapediatrics.2021.0922

[xxii] Molinaro, S. et al. (2019) ESPAD Report. Additional Tables. Table 3a. Available at: http://www.espad.org/sites/espad.org/files/20203880_TD0320532ENN_PDF.pdf

[xxiii] Royal College of Physicians (London), Nicotine without smoke: tobacco harm reduction, April 2016. Section 12.10 page 187

 

 


en
  New Nicotine Alliance on 22-08-2021
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 Dear colleagues in Lithuania

Please do not implement a flavour ban. This will do nothing to change youth use, which has incidentally been significantly overstated, and will deter adults from stopping smoking by switching to a far less harmful product. Banning flavours actually protects the cigarette industry and keeps people smoking. In the UK we have a permissive approach to vaping, and smoking rates are falling faster than ever. Young people are protected by sound age of sale legislation. Please consider this instead of banning flavours. Thank you