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From: <fabio@boscacci.it>
To: "Justiits- ja Digiministeerium" <info@justdigi.ee>
Cc: "press - JUSTDIGI" <press@justdigi.ee>
References: <CAAH=UBPPOWAQFQHZDe_tVbXHAMXdTo-HPPNE6v=CiuENze8kFA@mail.gmail.com>
Subject: Comment on proposed new nicotine product restrictions - JDM/26-0826
Date: Tue, 28 Jul 2026 18:20:07 +0300
Keywords: liivia
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Tähelepanu! Tegemist on välisvõrgust saabunud kirjaga.
Tundmatu saatja korral palume linke ja faile mitte avada.


Response to the Estonian Consultation on the Draft Amendments to the Tobacco 
Act

Submitted on behalf of Fondazione Boscacci

  _____

Executive Summary

Fondazione Boscacci - an Italian foundation involved in research on social 
issues, with a particular focus on public health welcomes the opportunity to 
comment on the Estonian Government's consultation regarding proposed 
restrictions on nicotine pouches and other smoke-free nicotine products.

We support the legitimate objective of protecting youth and non-users from 
nicotine initiation. However, we are concerned that two elements of the 
proposal risk undermining public health objectives:

1.	The proposed nicotine limit of 4 mg/g for nicotine pouches and related 
products.
2.	The introduction of a restrictive positive list of permitted flavouring 
substances, apparently inspired by the Dutch RIVM approach.

These measures are not proportionate to the risks involved, are unsupported 
by a comprehensive assessment of unintended consequences, and may ultimately 
discourage smokers from switching away from combustible tobacco products to 
substantially lower-risk alternatives. The likely effect is not nicotine 
abstinence, but behavioural substitution, including continued smoking, 
product circumvention, illicit trade, cross-border purchasing and informal 
product modification.

A modern public health framework should focus on reducing disease caused by 
combustion rather than reducing access to significantly lower-risk 
alternatives.

  _____

1. The proposal risks confusing nicotine with smoking

The overwhelming burden of tobacco-related disease is caused by inhalation 
of toxic products of combustion, not by nicotine itself. The critical public 
health distinction is therefore between combustible and non-combustible 
products.

Nicotine is addictive and not risk-free. However, nicotine has never been 
classified as a carcinogen and is not established as a direct cause of 
cancer.

Several respected public health authorities have concluded that the 
principal harms from tobacco use arise from smoke exposure and that access 
to substantially lower-risk nicotine products can contribute positively to 
smoking reduction and smoking cessation.

The question facing policymakers should therefore not be whether nicotine 
products are entirely harmless, but whether they provide a significantly 
lower-risk alternative to smoking. The evidence suggests they do.

  _____

2. The proposed nicotine limit of 4 mg/g is unlikely to achieve its intended 
aim

The proposal would restrict nicotine pouches to a maximum nicotine 
concentration of 4 mg per gram of nicotine-containing mixture.

This threshold is dramatically below the current levels used by adult 
consumers across Europe and would effectively eliminate much of the existing 
category from the legal market. In practical terms, the proposal functions 
as a de facto product ban rather than a proportionate product standard.

For adult smokers seeking a satisfactory substitute for cigarettes, nicotine 
delivery is not incidental but fundamental. The ability of smoke-free 
products to compete with cigarettes depends in part on their capacity to 
provide sufficient nicotine delivery and user satisfaction.

Research cited in the supporting materials indicates that nicotine pouches 
can deliver nicotine levels comparable to some cigarettes and electronic 
cigarettes while maintaining substantially lower toxicant profiles than 
combustible products.

Other analyses have concluded that nicotine pouches should be placed close 
to nicotine replacement therapies on the toxicant exposure continuum and are 
likely to expose users to markedly lower levels of harmful compounds than 
combustible tobacco.

The public health question is therefore not whether nicotine pouches contain 
nicotine, but whether reducing nicotine concentration to a level that 
diminishes product utility will discourage switching from smoking.

There is a serious risk that this proposal will do exactly that.

  _____

3. The proposed positive list is effectively a flavour ban

The proposal would restrict flavours to tobacco and establish a positive 
list of permitted flavouring substances. According to information available 
during the consultation, this approach appears closely aligned with the 
Dutch RIVM model.

Experience from the Netherlands suggests that such approaches function as de 
facto flavour bans rather than targeted ingredient controls.

In his 2022 submission regarding the Dutch proposal, Clive Bates concluded:

“The proposed whitelist approach to ingredients will amount to an almost 
complete ban on commercially viable vaping products.”

His concern was not merely theoretical. The central criticism was that 
policymakers evaluated the restrictions as if users would simply stop 
consuming nicotine products. Behavioural responses were largely ignored.

Consumers deprived of preferred flavours do not necessarily become 
abstinent. Instead they may:

*	continue smoking;
*	return to smoking;
*	purchase products abroad;
*	seek products through illicit channels;
*	mix ingredients themselves; or
*	switch to other unregulated products.

These outcomes are entirely foreseeable and should be incorporated into any 
regulatory impact assessment.

  _____

4. Flavours are not merely cosmetic: they play a role in smoking 
substitution

A central weakness of flavour-restriction policies is the assumption that 
flavours primarily attract youth while offering little value to adults.

The evidence does not support such a simplistic interpretation.

Recent analyses highlighted by Tobacco Harm Reduction Network note that 
flavours can assist adults who smoke in transitioning to lower-risk 
alternatives. The organisation specifically criticises attempts to evaluate 
flavour restrictions without considering the role of flavours in harm 
reduction and smoking substitution.

The review further notes evidence that adult smokers overwhelmingly prefer 
non-tobacco flavours when switching away from cigarettes.

Likewise, the Dutch expert submission coordinated by Clive Bates concluded 
that adult users rely extensively on non-tobacco flavours and that flavours 
form part of the competitive advantage allowing smoke-free products to 
displace cigarettes.



Removing this competitive advantage risks preserving cigarette consumption 
rather than reducing it.

  _____

5. Policymakers must consider substitution effects

A recurring concern across the evidence reviewed is the tendency to assess 
flavour bans in isolation rather than considering what users do next.

The THR Network review highlights evidence suggesting that reductions in 
vaping may be accompanied by increased cigarette smoking. It specifically 
argues that any assessment of flavour restrictions should evaluate 
cross-product substitution and net public health impact rather than vaping 
prevalence alone.

Similarly, the Dutch expert submission repeatedly warns that measures which 
make smoke-free products less attractive may ultimately strengthen the 
cigarette market and slow progress away from smoking.

Public health is not improved if fewer people vape but more people smoke.

That is the fundamental policy question that any flavour restriction must 
answer.

  _____

Conclusion

Fondazione Boscacci respectfully recommends that Estonia reconsider:

1.	The proposed 4 mg/g nicotine limit, which risks functioning as a de facto 
prohibition of effective nicotine pouch products.
2.	The proposed positive list approach, which appears likely to operate as a 
de facto flavour ban, replicating a model whose public health implications 
remain highly contested. A more proportionate and evidence-based approach 
would focus on:

*	preventing youth access,
*	enforcing age restrictions,
*	controlling marketing aimed at minors,
*	ensuring ingredient safety,
*	maintaining product quality standards, and
*	preserving access for adult smokers to lower-risk alternatives.

Estonia has the opportunity to adopt a genuinely risk-proportionate 
regulatory framework that protects young people while preserving 
opportunities for harm reduction among adults who smoke. The proposed 
measures, as currently drafted, risk doing the opposite.

References

Abrams DB, Glasser AM, Villanti AC, Pearson JL, Rose S, Niaura RS. (2018). 
Managing nicotine without smoke to save lives now: Evidence for harm 
minimization. Preventive Medicine, 117, 88-97.

Azzopardi D, Liu C, Murphy J, et al. (2021). Chemical characterization of 
tobacco-free nicotine pouches and their position on the toxicant delivery 
continuum compared with combustible cigarettes, smokeless tobacco products 
and nicotine replacement therapy. Scientific Reports, 11, 13867.

Beaglehole R, Bates C, Youdan B, Bonita R. (2019). Nicotine without smoke: 
fighting the tobacco epidemic with harm reduction. The Lancet, 394(10200), 
718-720.

Benowitz NL, Burbank AD. (2016). Cardiovascular toxicity of nicotine: 
Implications for electronic cigarette use. Trends in Cardiovascular 
Medicine, 26(6), 515-523.

Federal Institute for Risk Assessment (BfR). (2021). Health Risk Assessment 
of Nicotine Pouches. Berlin: German Federal Institute for Risk Assessment.

Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos S, Spyrou A, Voudris V. 
(2013). Impact of flavour variability on electronic cigarette use 
experience: An internet survey. International Journal of Environmental 
Research and Public Health, 10(12), 7272-7282.

Farsalinos K, Russell C, Polosa R, et al. (2023). Patterns of flavored 
e-cigarette use among adult vapers in the United States. Harm Reduction 
Journal, 20, 95.

Friedman AS, Pesko MF, Whitacre TR. (2024). Flavored e-cigarette sales 
restrictions and young adult tobacco use. JAMA Health Forum, 5(12).

Hajek P, Phillips-Waller A, Przulj D, et al. (2019). A randomized trial of 
e-cigarettes versus nicotine-replacement therapy. New England Journal of 
Medicine, 380(7), 629-637.

Hartmann-Boyce J, Lindson N, Butler AR, et al. (latest update). Electronic 
cigarettes for smoking cessation. Cochrane Database of Systematic Reviews.

International Agency for Research on Cancer (IARC). (2021). European Code 
Against Cancer: Does Nicotine Cause Cancer? Lyon: World Health Organization, 
International Agency for Research on Cancer.

Patwardhan S, Fagerström K. (2022). The new nicotine pouch category: A 
tobacco harm reduction tool? Nicotine & Tobacco Research, 24(4), 623-625.

Plurphanswat N, Hughes JR, Fagerström K, et al. (2020). Initial information 
about the potential public health impact of modern oral nicotine products. 
American Journal on Addictions, 29(4), 367-373.

Royal College of Physicians. (2016). Nicotine Without Smoke: Tobacco Harm 
Reduction. London: Royal College of Physicians.

World Health Organization Regional Office for Europe. (2021). Electronic 
Nicotine and Non-Nicotine Delivery Systems: A Brief. Copenhagen: WHO 
Regional Office for Europe.

Bates C. (2022). Regulation of e-cigarette flavours: Submission to the 
Netherlands consultation on flavour restrictions and positive ingredient 
lists. Counterfactual Consulting, London.

Letter from 100 Specialists in Nicotine Science, Policy and Practice. 
(2021). The Urgent Need to Reduce Deaths from Smoked Tobacco: Parties Should 
Challenge WHO to Modernise its Approach to Tobacco Policy.












dott. Fabio Boscacci

 <mailto:fabio@boscacci.it> fabio@boscacci.it

ita: + 39 3271477734 <tel:+393271477734>

_________________________________________



Sedi Operative
Milano • Roma

tel. +39 02 82396390 <tel:+390282396390>

 <mailto:fabio@boscacci.it> info@boscacci.it

 <http://www.boscacci.it/> boscacci.it



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<div dir=3D"ltr"><br>
<b style=3D"font-family: Aptos, sans-serif; font-size: 12pt;"><span =
lang=3D"EN-US">Response to the Estonian Consultation on the Draft =
Amendments to the Tobacco Act</span></b></div>
<div dir=3D"ltr">
<div dir=3D"ltr">
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">Submitted on behalf of Fondazione =
Boscacci</span></b></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">Executive Summary</span></b><span =
lang=3D"EN-US"></span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Fondazione Boscacci - an Italian foundation =
involved in research on social issues, with a particular focus on public =
health welcomes the opportunity to comment on the Estonian Government's =
consultation regarding proposed restrictions on nicotine
 pouches and other smoke-free nicotine products.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">We support the legitimate objective of protecting =
youth and non-users from nicotine initiation. However, we are concerned =
that two elements of the proposal risk undermining public health =
objectives:</span></p>
<ol style=3D"margin-top:0cm;margin-bottom:0cm" start=3D"1" type=3D"1">
<li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The proposed nicotine limit of <b>4 mg/g</b> for =
nicotine pouches and related products.</span></li><li =
class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The introduction of a restrictive <b>positive list =
of permitted flavouring substances</b>, apparently inspired by the Dutch =
RIVM approach.
</span></li></ol>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">These measures are not proportionate to the risks =
involved, are unsupported by a comprehensive assessment of unintended =
consequences, and may ultimately discourage smokers from switching away =
from combustible tobacco products to substantially
 lower-risk alternatives. The likely effect is not nicotine abstinence, =
but behavioural substitution, including continued smoking, product =
circumvention, illicit trade, cross-border purchasing and informal =
product modification.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">A modern public health framework should focus on =
reducing disease caused by combustion rather than reducing access to =
significantly lower-risk alternatives.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">1. The proposal risks confusing nicotine with =
smoking</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The overwhelming burden of tobacco-related disease =
is caused by inhalation of toxic products of combustion, not by nicotine =
itself. The critical public health distinction is therefore between =
combustible and non-combustible products.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Nicotine is addictive and not risk-free. However, =
nicotine has never been classified as a carcinogen and is not =
established as a direct cause of cancer.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Several respected public health authorities have =
concluded that the principal harms from tobacco use arise from smoke =
exposure and that access to substantially lower-risk nicotine products =
can contribute positively to smoking reduction and
 smoking cessation. </span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The question facing policymakers should therefore =
not be whether nicotine products are entirely harmless, but whether they =
provide a significantly lower-risk alternative to smoking. The evidence =
suggests they do.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">2. The proposed nicotine limit of 4 mg/g is =
unlikely to achieve its intended aim</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The proposal would restrict nicotine pouches to a =
maximum nicotine concentration of
<b>4 mg per gram of nicotine-containing mixture</b>. </span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">This threshold is dramatically below the current =
levels used by adult consumers across Europe and would effectively =
eliminate much of the existing category from the legal market. In =
practical terms, the proposal functions as a
<b>de facto product ban</b> rather than a proportionate product =
standard.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">For adult smokers seeking a satisfactory substitute =
for cigarettes, nicotine delivery is not incidental but fundamental. The =
ability of smoke-free products to compete with cigarettes depends in =
part on their capacity to provide sufficient
 nicotine delivery and user satisfaction.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Research cited in the supporting materials =
indicates that nicotine pouches can deliver nicotine levels comparable =
to some cigarettes and electronic cigarettes while maintaining =
substantially lower toxicant profiles than combustible products.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Other analyses have concluded that nicotine pouches =
should be placed close to nicotine replacement therapies on the toxicant =
exposure continuum and are likely to expose users to markedly lower =
levels of harmful compounds than combustible
 tobacco. </span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The public health question is therefore not whether =
nicotine pouches contain nicotine, but whether reducing nicotine =
concentration to a level that diminishes product utility will discourage =
switching from smoking.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">There is a serious risk that this proposal will do =
exactly that.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">3. The proposed positive list is effectively a =
flavour ban</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The proposal would restrict flavours to tobacco and =
establish a positive list of permitted flavouring substances. According =
to information available during the consultation, this approach appears =
closely aligned with the Dutch RIVM model.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Experience from the Netherlands suggests that such =
approaches function as
<b>de facto flavour bans</b> rather than targeted ingredient =
controls.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">In his 2022 submission regarding the Dutch =
proposal, Clive Bates concluded:</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">=E2=80=9CThe proposed whitelist approach to =
ingredients will amount to an almost complete ban on commercially viable =
vaping products.=E2=80=9D
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">His concern was not merely theoretical. The central =
criticism was that policymakers evaluated the restrictions as if users =
would simply stop consuming nicotine products. Behavioural responses =
were largely ignored.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Consumers deprived of preferred flavours do not =
necessarily become abstinent. Instead they may:</span></p>
<ul style=3D"margin-top:0cm;margin-bottom:0cm" type=3D"disc">
<li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
continue smoking;</li><li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
return to smoking;</li><li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
purchase products abroad;</li><li class=3D"MsoNormal" =
style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">seek products through illicit =
channels;</span></li><li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
mix ingredients themselves; or</li><li class=3D"MsoNormal" =
style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">switch to other unregulated products. =
</span></li></ul>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">These outcomes are entirely foreseeable and should =
be incorporated into any regulatory impact assessment.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">4. Flavours are not merely cosmetic: they play a =
role in smoking substitution</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">A central weakness of flavour-restriction policies =
is the assumption that flavours primarily attract youth while offering =
little value to adults.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The evidence does not support such a simplistic =
interpretation.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Recent analyses highlighted by Tobacco Harm =
Reduction Network note that flavours can assist adults who smoke in =
transitioning to lower-risk alternatives. The organisation specifically =
criticises attempts to evaluate flavour restrictions without
 considering the role of flavours in harm reduction and smoking =
substitution. </span>
</p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The review further notes evidence that adult =
smokers overwhelmingly prefer non-tobacco flavours when switching away =
from cigarettes.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Likewise, the Dutch expert submission coordinated =
by Clive Bates concluded that adult users rely extensively on =
non-tobacco flavours and that flavours form part of the competitive =
advantage allowing smoke-free products to displace cigarettes.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">&nbsp;</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Removing this competitive advantage risks =
preserving cigarette consumption rather than reducing it.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">5. Policymakers must consider substitution =
effects</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">A recurring concern across the evidence reviewed is =
the tendency to assess flavour bans in isolation rather than considering =
what users do next.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">The THR Network review highlights evidence =
suggesting that reductions in vaping may be accompanied by increased =
cigarette smoking. It specifically argues that any assessment of flavour =
restrictions should evaluate cross-product substitution
 and net public health impact rather than vaping prevalence alone. =
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Similarly, the Dutch expert submission repeatedly =
warns that measures which make smoke-free products less attractive may =
ultimately strengthen the cigarette market and slow progress away from =
smoking.
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Public health is not improved if fewer people vape =
but more people smoke.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">That is the fundamental policy question that any =
flavour restriction must answer.</span></p>
<div class=3D"MsoNormal" align=3D"center" =
style=3D"text-align:center;margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<hr size=3D"2" width=3D"100%" align=3D"center">
</div>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">Conclusion</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">Fondazione Boscacci </span></b><span =
lang=3D"EN-US">respectfully recommends that Estonia =
reconsider:<b></b></span></p>
<ol style=3D"margin-top:0cm;margin-bottom:0cm" start=3D"1" type=3D"1">
<li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">The proposed 4 mg/g nicotine =
limit</span></b><span lang=3D"EN-US">, which risks functioning as a de =
facto prohibition of effective nicotine pouch products.
</span></li><li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">The proposed positive list =
approach</span></b><span lang=3D"EN-US">, which appears likely to =
operate as a de facto flavour ban, replicating a model whose public =
health implications remain highly contested. A more proportionate and =
evidence-based
 approach would focus on:</span></li></ol>
<ul style=3D"margin-top:0cm;margin-bottom:0cm" type=3D"disc">
<li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
preventing youth access,</li><li class=3D"MsoNormal" style=3D"margin:0cm =
0cm 8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
enforcing age restrictions,</li><li class=3D"MsoNormal" =
style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">controlling marketing aimed at =
minors,</span></li><li class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
ensuring ingredient safety,</li><li class=3D"MsoNormal" =
style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
maintaining product quality standards, and</li><li class=3D"MsoNormal" =
style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">preserving access for adult smokers to lower-risk =
alternatives.
</span></li></ul>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm 8pt =
18pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Estonia has the opportunity to adopt a genuinely =
risk-proportionate regulatory framework that protects young people while =
preserving opportunities for harm reduction among adults who smoke. The =
proposed measures, as currently drafted, risk
 doing the opposite.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<b><span lang=3D"EN-US">References</span></b></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Abrams DB, Glasser AM, Villanti AC, Pearson JL, =
Rose S, Niaura RS. (2018).
<i>Managing nicotine without smoke to save lives now: Evidence for harm =
minimization</i>. Preventive Medicine, 117, 88-97.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Azzopardi D, Liu C, Murphy J, et al. (2021). =
<i>Chemical characterization of tobacco-free nicotine pouches and their =
position on the toxicant delivery continuum compared with combustible =
cigarettes, smokeless tobacco products and nicotine
 replacement therapy</i>. Scientific Reports, 11, 13867.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Beaglehole R, Bates C, Youdan B, Bonita R. (2019). =
<i>Nicotine without smoke: fighting the tobacco epidemic with harm =
reduction</i>. The Lancet, 394(10200), 718-720.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Benowitz NL, Burbank AD. (2016). <i>Cardiovascular =
toxicity of nicotine: Implications for electronic cigarette use</i>. =
Trends in Cardiovascular Medicine, 26(6), 515-523.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Federal Institute for Risk Assessment (BfR). =
(2021). <i>Health Risk Assessment of Nicotine Pouches</i>. Berlin: =
German Federal Institute for Risk Assessment.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Farsalinos KE, Romagna G, Tsiapras D, Kyrzopoulos =
S, Spyrou A, Voudris V. (2013).
<i>Impact of flavour variability on electronic cigarette use experience: =
An internet survey</i>. International Journal of Environmental Research =
and Public Health, 10(12), 7272-7282.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Farsalinos K, Russell C, Polosa R, et al. (2023). =
<i>Patterns of flavored e-cigarette use among adult vapers in the United =
States</i>. Harm Reduction Journal, 20, 95.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Friedman AS, Pesko MF, Whitacre TR. (2024). =
<i>Flavored e-cigarette sales restrictions and young adult tobacco =
use</i>. JAMA Health Forum, 5(12).</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Hajek P, Phillips-Waller A, Przulj D, et al. =
(2019). <i>A randomized trial of e-cigarettes versus =
nicotine-replacement therapy</i>. New England Journal of Medicine, =
380(7), 629-637.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Hartmann-Boyce J, Lindson N, Butler AR, et al. =
(latest update).
<i>Electronic cigarettes for smoking cessation</i>. Cochrane Database of =
Systematic Reviews.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">International Agency for Research on Cancer (IARC). =
(2021). <i>
European Code Against Cancer: Does Nicotine Cause Cancer?</i> Lyon: =
World Health Organization, International Agency for Research on =
Cancer.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Patwardhan S, Fagerstr=C3=B6m K. (2022). <i>The new =
nicotine pouch category: A tobacco harm reduction tool?</i> Nicotine =
&amp; Tobacco Research, 24(4), 623-625.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Plurphanswat N, Hughes JR, Fagerstr=C3=B6m K, et =
al. (2020). <i>Initial information about the potential public health =
impact of modern oral nicotine products</i>. American Journal on =
Addictions, 29(4), 367-373.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Royal College of Physicians. (2016). <i>Nicotine =
Without Smoke: Tobacco Harm Reduction</i>. London: Royal College of =
Physicians.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">World Health Organization Regional Office for =
Europe. (2021). <i>
Electronic Nicotine and Non-Nicotine Delivery Systems: A Brief</i>. =
Copenhagen: WHO Regional Office for Europe.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Bates C. (2022). <i>Regulation of e-cigarette =
flavours: Submission to the Netherlands consultation on flavour =
restrictions and positive ingredient lists</i>. Counterfactual =
Consulting, London.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US">Letter from 100 Specialists in Nicotine Science, =
Policy and Practice. (2021).
<i>The Urgent Need to Reduce Deaths from Smoked Tobacco: Parties Should =
Challenge WHO to Modernise its Approach to Tobacco =
Policy</i>.</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US"><br>
</span></p>
<p class=3D"MsoNormal" style=3D"margin:0cm 0cm =
8pt;line-height:115%;font-size:12pt;font-family:Aptos,sans-serif">
<span lang=3D"EN-US"></span></p>
<div class=3D"WordSection1">
<blockquote>
<div>
<p class=3D"MsoNormal"><span style=3D"font-family: Helvetica, =
sans-serif;">&nbsp;&nbsp;</span></p>
</div>
<div>
<div>
<p class=3D"MsoNormal"><img =
id=3D"x_7c48999a-8391-483b-9d0c-4cb058234218" =
src=3D"cid:AD7FCFEB-A236-49B3-A658-B719B6D95AEE" width=3D"239" =
height=3D"48" border=3D"0" alt=3D"image002.png" style=3D"width: =
2.4861in; height: 0.5in;"></p>
</div>
<div>
<p class=3D"MsoNormal">&nbsp;</p>
</div>
<div>
<p class=3D"MsoNormal">&nbsp;</p>
</div>
<p class=3D"MsoNormal"><span style=3D"font-family: &quot;Times New =
Roman&quot;, serif; color: rgb(0, 51, 102);">dott. Fabio =
Boscacci</span></p>
<p class=3D"MsoNormal"><em><span style=3D"color: rgb(0, 51, 102);"><a =
href=3D"mailto:fabio@boscacci.it"><span style=3D"color: rgb(0, 51, =
102);">fabio@boscacci.it</span></a>&nbsp;</span></em></p>
<p class=3D"MsoNormal"><span style=3D"font-family: &quot;Times New =
Roman&quot;, serif; color: rgb(0, 51, 102);">ita:&nbsp;<a =
href=3D"tel:+393271477734">+ 39 3271477734</a>&nbsp;</span></p>
<p class=3D"MsoNormal"><span style=3D"font-size: 7.5pt; font-family: =
&quot;Times New Roman&quot;, serif; color: rgb(0, 51, =
102);">_________________________________________</span></p>
<p class=3D"MsoNormal">&nbsp;</p>
<p class=3D"MsoNormal"><span style=3D"font-family: &quot;Times New =
Roman&quot;, serif; color: rgb(0, 51, 102);">Sedi Operative<br>
Milano =E2=80=A2 Roma</span></p>
<p class=3D"MsoNormal"><span style=3D"font-family: &quot;Times New =
Roman&quot;, serif; color: rgb(0, 51, 102);">tel.&nbsp;<a =
href=3D"tel:+390282396390">+39 02 82396390</a></span></p>
<p class=3D"MsoNormal"><span style=3D"font-family: &quot;Times New =
Roman&quot;, serif; color: rgb(0, 51, 102);"><a =
href=3D"mailto:fabio@boscacci.it"><span style=3D"color: rgb(0, 51, =
102);">info@boscacci.it</span></a></span></p>
<p class=3D"MsoNormal" style=3D"margin-bottom: 12pt;"><span =
style=3D"font-size: 8pt; font-family: &quot;Times New Roman&quot;, =
serif; color: rgb(0, 51, 102);"><a =
href=3D"http://www.boscacci.it/"><span style=3D"color: rgb(0, 51, =
102);">boscacci.it</span></a></span></p>
<p class=3D"MsoNormal">&nbsp;</p>
<p class=3D"MsoNormal"><em><span style=3D"color: rgb(0, 51, 102);">Sede =
Legale</span></em></p>
<p class=3D"MsoNormal"><em><span style=3D"color: rgb(0, 51, 102);">via =
Carlo No=C3=A8, 45</span></em></p>
<p class=3D"MsoNormal"><em><span style=3D"color: rgb(0, 51, 102);">21013 =
- Gallarate</span></em></p>
<p class=3D"MsoNormal"><span style=3D"font-size: 8pt; font-family: =
&quot;Times New Roman&quot;, serif; color: rgb(0, 51, 102);"><br>
<em>Questo messaggio pu=C3=B2 contenere informazioni di carattere =
riservato e confidenziale. Qualora non fosse il destinatario, =
la&nbsp;preghiamo di informarci immediatamente inviando una mail =
all'indirizzo di posta elettronica&nbsp;<a =
href=3D"mailto:info@boscacci.it"><span style=3D"color: rgb(0, 51, =
102);">info@boscacci.it</span></a>&nbsp;ed
 eliminare il messaggio, con gli eventuali allegati, senza trattenerne =
copia. Qualsiasi utilizzo non autorizzato del contenuto di questo =
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 pi=C3=B9 grave illecito, ed espone il responsabile alle relative =
conseguenze civili e penali.</em></span></p>
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