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

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