Subject: Comment on proposed new nicotine product restrictions - JDM/26-0826
From: <[email-masked]>
To: "Justiits- ja Digiministeerium" <[email-masked]>
Cc: "press - JUSTDIGI" <[email-masked]>
Date: Tue, 28 Jul 2026 18:20:07 +0300

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:[email-masked]> [email-masked]

ita: + 39 3271477734 <tel:+393271477734>

_________________________________________

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