GINN Submission on Estonia’s Public Consultation on Proposed Amendments to the Tobacco Act and State Fees Act

Public Consultation Submission

Introduction

The Global Institute for Novel Nicotine (GINN) welcomes the opportunity to provide comments on Estonia’s public consultation regarding the proposed amendments to the Tobacco Act and the State Fees Act.

GINN is an independent international organisation dedicated to advancing evidence-based nicotine policy through science, regulatory best practice, and stakeholder engagement. We support regulatory frameworks that protect public health, prevent youth access to nicotine products, ensure high product standards, and preserve access to lower-risk alternatives for adults who would otherwise continue smoking.

Estonia has demonstrated a strong commitment to reducing tobacco-related harm and strengthening consumer protection. Measures that improve regulatory oversight, combat illicit trade, and prevent underage access are important components of an effective nicotine policy. At the same time, regulation should reflect the well-established continuum of risk across nicotine products and distinguish between combustible tobacco, which remains the primary cause of smoking-related disease, and smoke-free nicotine products that present substantially lower health risks for adults who switch completely from smoking.

A proportionate regulatory framework should therefore balance three complementary objectives: protecting young people, maintaining rigorous product and manufacturing standards, and ensuring that adults who smoke retain access to appropriately regulated lower-risk alternatives. These objectives are mutually reinforcing and are best achieved through policies that are grounded in scientific evidence, operationally practical, and capable of adapting as the evidence base continues to evolve.

GINN’s comments focus on whether the proposed amendments achieve these objectives while minimising unintended consequences for public health, regulatory compliance, and the functioning of the legal market.

Overview of the Draft Measures

The proposed amendments introduce several significant changes intended to strengthen the regulation and enforcement of tobacco and nicotine products.

Among the most notable proposals is the introduction of mandatory electronic age verification for distance sales. Rather than relying on self-declaration, retailers would be required to implement systems capable of verifying that purchasers meet the legal minimum age at the point of sale. GINN supports the objective of improving online age assurance and agrees that effective age verification represents an important safeguard against youth access when implemented in a technologically neutral, privacy-conscious, and proportionate manner.

The draft legislation also proposes expanded enforcement powers, including the authority for competent authorities to seize or detain products where there are reasonable grounds to believe they are non-compliant or subject to confiscation. These provisions are intended to strengthen market surveillance and improve the ability of regulators to intervene earlier within the supply chain. Effective enforcement is an essential component of any regulatory framework; however, broader enforcement powers should be accompanied by appropriate procedural safeguards, transparent evidentiary standards, and clear mechanisms for review and appeal to ensure regulatory certainty for compliant businesses.

The consultation further proposes restrictions relating to the importation, purchase, manufacture, processing, supply, and possession of certain nicotine products that do not comply with prescribed flavour or nicotine-content requirements. These measures would extend regulatory intervention beyond retail sales and marketing to earlier stages of the supply chain. While strengthening compliance is a legitimate regulatory objective, it is important that any restrictions remain proportionate, evidence-based, and supported by a clear assessment of their likely public health impact, including potential effects on consumer behaviour, cross-border purchasing, and illicit trade.

Taken together, the proposed amendments represent a substantial expansion of Estonia’s nicotine regulatory framework. Their effectiveness will ultimately depend not only on their enforceability but also on whether they preserve incentives for adults who smoke to transition away from combustible tobacco while maintaining robust protections against youth uptake and non-compliant products.

GINN’s General Position

GINN supports the development of comprehensive regulatory frameworks that prioritise public health while recognising the differing risk profiles of nicotine products. Regulation should be proportionate to risk, informed by the best available scientific evidence, and designed to achieve clearly defined public health objectives without creating unnecessary barriers for adult smokers seeking lower-risk alternatives.

The Institute supports measures that strengthen youth protection, including effective age verification for online sales, responsible retail practices, product quality standards, and robust enforcement against illicit trade. These interventions directly address the primary public health objective of preventing underage access while promoting greater confidence in the legal market.

GINN also recognises the importance of providing regulatory authorities with appropriate enforcement powers to address genuinely non-compliant products. Effective market surveillance contributes to consumer protection, supports regulatory compliance, and helps maintain confidence in the integrity of the marketplace. However, expanded enforcement powers should operate within a transparent legal framework that provides clear evidentiary thresholds, procedural safeguards, and opportunities for independent review. Such safeguards promote both regulatory effectiveness and legal certainty for compliant manufacturers, distributors, and retailers.

Where GINN encourages greater caution is in relation to measures that may unintentionally reduce lawful adult access to lower-risk nicotine products without demonstrably improving youth protection or public health outcomes. Policies affecting flavours, nicotine concentrations, cross-border purchases, or product availability should be supported by transparent scientific evidence and comprehensive impact assessments that consider both intended and unintended consequences.

Experience across multiple jurisdictions demonstrates that regulation is most effective when it simultaneously discourages youth uptake, supports adult smoking cessation and switching, encourages compliance within the legal market, and limits opportunities for illicit trade. Conversely, regulatory measures that substantially reduce the attractiveness or accessibility of regulated smoke-free alternatives may risk slowing smoking cessation, encouraging informal markets, or increasing cross-border purchasing without delivering proportional public health benefits.

GINN therefore encourages Estonia to continue developing a regulatory framework that combines rigorous consumer protection with evidence-based, risk-proportionate regulation. Such an approach is more likely to achieve sustainable public health gains while maintaining regulatory credibility, supporting lawful market participation, and preserving appropriate access to lower-risk nicotine products for adults who would otherwise continue smoking.

Risk-Proportionate Regulation

An effective nicotine regulatory framework should recognise that not all nicotine products present the same level of risk. A substantial body of scientific evidence supports the principle of a continuum of risk, with combustible tobacco products posing by far the greatest health risks due to combustion and toxic smoke exposure, while appropriately regulated smoke-free nicotine products present considerably lower risks for adults who switch completely from smoking.

This distinction is fundamental to effective public health policy. Regulations designed for combustible tobacco should not automatically be applied to smoke-free nicotine products without demonstrating that equivalent restrictions are necessary, proportionate, and likely to achieve meaningful public health benefits. A risk-proportionate approach enables regulators to maintain robust consumer protections while preserving incentives for adults who smoke to transition away from combustible cigarettes.

The consultation proposals include measures relating to nicotine concentration, flavours, product availability, and enforcement. While each of these measures seeks to address legitimate regulatory objectives, their cumulative impact should be assessed against broader public health outcomes rather than individual product characteristics alone. Policymaking should consider whether proposed restrictions are likely to reduce smoking prevalence, support adult switching, limit youth uptake, and strengthen regulatory compliance simultaneously.

GINN encourages Estonia to continue developing a framework that reflects the differing risk profiles of nicotine products and focuses regulatory intervention where it is likely to deliver the greatest public health benefit. Such an approach is consistent with internationally recognised principles of better regulation, including proportionality, transparency, evidence-based decision-making, and periodic policy review as scientific evidence evolves.

Flavours

GINN recognises that flavours remain one of the most debated aspects of nicotine regulation. They require careful consideration because they are relevant to two important public health objectives: preventing youth initiation while supporting adult smokers who transition away from combustible cigarettes.

Measures aimed at reducing youth appeal are both legitimate and necessary. Marketing, branding, packaging, and product presentation should not be designed to attract underage consumers, and regulators should continue to take decisive action against products or commercial practices that target young people.

At the same time, evidence indicates that flavours can play an important role for many adults who have switched completely from smoking. For some users, non-tobacco flavours contribute to the acceptability of smoke-free products and may reduce the likelihood of returning to combustible cigarettes. Regulatory decisions should therefore distinguish between flavour characteristics that may appeal to young people and the broader role that flavours can play within adult smoking cessation and harm reduction.

The proposed amendments would treat non-compliance with flavour requirements as a basis for wider restrictions on the importation, purchase, possession, manufacture, and supply of products. As the scope of regulatory consequences expands, it becomes increasingly important that flavour standards are supported by transparent scientific criteria, clearly defined legal terminology, and predictable regulatory processes.

While measures to reduce youth appeal are both appropriate and necessary, regulatory approaches should distinguish between restricting youth-oriented marketing and prohibiting flavours themselves. International regulatory experience increasingly demonstrates that these objectives need not be mutually exclusive.

One example is the United Kingdom’s proposed approach, which focuses on restricting flavour descriptors, branding, packaging, and product presentation that may appeal to young people, rather than prohibiting flavour categories outright. Such an approach seeks to reduce youth appeal while preserving consumer choice for adults who have successfully transitioned away from combustible tobacco.

This distinction is important because flavours appear to play a meaningful role in helping many adult smokers move away from cigarettes. If the objective of tobacco harm reduction is to encourage smokers to abandon combustible tobacco, limiting available alternatives primarily to tobacco-flavoured products may unintentionally reduce their attractiveness as substitutes. For many adults, the appeal of smoke-free products lies precisely in providing an experience that differs from smoking rather than replicating it.

Available market evidence also indicates that mint and menthol remain among the most commonly used flavour categories by adult nicotine pouch consumers. More broadly, there is currently limited evidence that prohibiting all non-tobacco flavours, in isolation, substantially reduces youth uptake. A more proportionate regulatory approach may therefore be to establish science-based standards governing flavouring substances, ingredient safety, and marketing practices, rather than implementing blanket flavour prohibitions.

Sweden’s experience provides an important example in this regard. Over several decades, widespread availability of regulated smoke-free nicotine products in a variety of strengths and flavours has coincided with the lowest smoking prevalence in Europe. While many factors have contributed to Sweden’s success, its experience illustrates how providing adult smokers with appealing lower-risk alternatives can support long-term reductions in cigarette smoking while maintaining regulatory oversight of the legal market.

Nicotine Concentration

Nicotine concentration limits should be based on a transparent assessment of scientific evidence, patterns of consumer use, abuse liability, and expected public health outcomes. Establishing maximum nicotine levels without a clearly articulated evidence base risks unintended consequences that may undermine broader tobacco control objectives.

The consultation refers to a proposed maximum nicotine concentration of 4 mg per gram. Before adopting such a limit, it is important to demonstrate why this threshold represents the most appropriate balance between youth protection, product safety, and the needs of adults who smoke. This assessment should include consideration of consumer behaviour, switching success, product satisfaction, and potential behavioural responses if legal products no longer provide an adequate substitute for combustible cigarettes.

Where nicotine limits are set below levels that adult consumers find effective, some individuals may continue smoking, increase product consumption to compensate, seek products through informal or cross-border markets, or return to combustible tobacco. These potential behavioural responses should form part of any comprehensive regulatory impact assessment.

Beyond the scientific rationale for establishing a maximum nicotine concentration, it is equally important to consider how nicotine delivery influences adult switching behaviour. Nicotine pouches deliver nicotine through the buccal mucosa, resulting in a slower rate of absorption than combustible cigarettes, where nicotine reaches the bloodstream rapidly through the lungs.

Clinical pharmacokinetic studies consistently demonstrate that cigarettes typically achieve peak plasma nicotine concentrations within approximately 5–8 minutes, whereas nicotine pouches generally reach peak concentrations over a substantially longer period, often between 20 and 65 minutes depending on product characteristics and user behaviour.

This slower nicotine delivery means that products with relatively low nicotine concentrations may provide insufficient nicotine satisfaction for some adult smokers, particularly during the critical early stages of switching from cigarettes. Although total nicotine exposure over time may be comparable, the lower and slower nicotine delivery profile may reduce the product’s ability to effectively replace combustible cigarettes for smokers with higher nicotine dependence.

Evidence also suggests that nicotine strength influences the acceptability of smoke-free alternatives among adult smokers. Studies have reported that higher-strength nicotine pouches may improve product satisfaction and support complete switching among smokers with greater nicotine dependence. Regulatory decisions concerning maximum nicotine concentrations should therefore consider not only toxicological safety but also behavioural outcomes, including switching success, smoking relapse, and continued cigarette consumption.

Experience from jurisdictions that have adopted highly restrictive nicotine limits also warrants careful consideration. Where legal products fail to meet adult consumer demand, unintended consequences may include increased cross-border purchasing, growth of illicit markets, or continued smoking. Such outcomes may weaken rather than strengthen public health objectives by reducing product oversight, limiting age verification, and increasing access to unregulated products.

For these reasons, GINN encourages Estonia to ensure that any maximum nicotine concentration is supported by a comprehensive scientific and behavioural evidence base that considers its likely impact on adult smoking cessation, product substitution, consumer behaviour, and overall public health outcomes.

The proposed amendments also extend the regulatory consequences of nicotine-content requirements beyond product sales, allowing non-compliance to trigger restrictions affecting importation, possession, manufacture, and processing. As regulatory obligations expand across the supply chain, the supporting scientific justification should be equally robust and transparent.

GINN therefore encourages Estonia to publish the evidence underpinning the proposed nicotine threshold, including its expected public health benefits, comparison with approaches adopted in other jurisdictions, and assessment of likely impacts on adult smokers seeking to switch from combustible tobacco. Transparent decision-making strengthens regulatory credibility, facilitates stakeholder confidence, and supports the development of policies that are both proportionate and effective over the long term.

A science-led approach to nicotine concentration should ultimately seek to minimise smoking-related harm, discourage youth uptake, maintain product quality and safety, and preserve access to regulated lower-risk alternatives for adults who would otherwise continue smoking.

Age Verification and Youth Access

GINN strongly supports robust measures to prevent youth access to nicotine products. Protecting young people should remain a central objective of nicotine regulation and is best achieved through effective age verification, responsible retail practices, enforcement against unlawful sales, and proportionate penalties for non-compliance.

The proposed requirement for electronic age verification during distance sales represents a positive step towards strengthening online safeguards. Replacing simple self-declaration mechanisms with systems capable of verifying legal age at the point of purchase reflects evolving best practice and has the potential to improve confidence in online retail channels.

As these requirements are implemented, GINN encourages Estonia to adopt an outcome-based regulatory approach that specifies the level of assurance required rather than prescribing a single technological solution. This allows retailers to adopt secure, effective, and innovative verification systems while ensuring compliance with privacy legislation and principles of data minimisation.

Youth protection policies are most effective when regulatory interventions focus on points of access rather than unnecessarily restricting product choice for adults. Strong retailer accountability, routine compliance monitoring, effective enforcement, and meaningful sanctions against unlawful sales provide direct mechanisms for reducing youth access without diminishing the availability of appropriately regulated lower-risk alternatives for adults who smoke.

A comprehensive youth protection strategy should therefore combine effective age verification with retailer education, enforcement against illicit trade, responsible marketing standards, and ongoing evaluation to ensure regulatory measures continue to achieve their intended public health objectives.

Enforcement and Regulatory Oversight

Effective regulation depends not only on well-designed legislation but also on credible, transparent, and proportionate enforcement. GINN recognises the importance of equipping competent authorities with appropriate powers to address genuinely non-compliant products, combat illicit trade, and maintain confidence in the regulated market.

The proposed amendments expand the powers available to enforcement authorities, including the ability to seize or detain products where there are reasonable grounds to believe they are non-compliant or subject to confiscation. Enhanced market surveillance can contribute significantly to consumer protection when exercised within a clear legal framework supported by appropriate procedural safeguards.

To maintain confidence in the regulatory system, enforcement powers should be accompanied by transparent evidentiary standards, clearly defined procedures, reasonable timelines for review, and accessible mechanisms through which affected businesses may challenge regulatory decisions. These safeguards help ensure consistency, fairness, and legal certainty while supporting voluntary compliance across the supply chain.

Regulatory oversight should also remain focused on demonstrable public health risks. Enforcement measures are most effective when directed towards counterfeit products, illicit operators, sales to minors, and products that fail to meet established safety or quality standards. A predictable and rules-based enforcement framework encourages responsible market participation while reducing uncertainty for compliant manufacturers, distributors, and retailers.

Cross-Border Sales and Adult Access

Cross-border trade presents complex regulatory challenges, particularly within the European Single Market. While governments have legitimate interests in ensuring compliance with domestic legislation, restrictions affecting cross-border purchasing should be carefully assessed for their proportionality, enforceability, and likely impact on consumer behaviour.

The proposed amendments extend regulatory controls beyond domestic retail sales by applying restrictions to the importation, purchase, possession, and movement of certain nicotine products that do not comply with national requirements. This represents a significant expansion of regulatory oversight across the wider supply chain and reflects an intention to intervene before products reach the domestic market.

GINN encourages Estonia to assess whether such measures are likely to achieve their intended public health objectives or whether they may inadvertently encourage informal purchasing channels, cross-border sourcing, or continued cigarette consumption among adults who are unable to access products that meet their needs within the regulated market.

Experience from other jurisdictions demonstrates that durable regulatory frameworks are those that encourage compliance within the legal market while limiting opportunities for illicit trade. Policies that become difficult to enforce or that substantially reduce consumer confidence in the regulated market may ultimately weaken rather than strengthen public health outcomes.

Any restrictions affecting cross-border sales should therefore be supported by a transparent legal rationale, evidence-based impact assessment, and periodic review to ensure they remain effective, proportionate, and responsive to changing market conditions.

Administrative and Regulatory Implementation

Successful regulation depends not only on legislative design but also on practical implementation. Regulatory requirements should be sufficiently clear, predictable, and proportionate to enable businesses to comply while allowing authorities to administer the framework efficiently and consistently.

The consultation recognises that enhanced age verification systems and expanded compliance obligations will require operational adjustments by retailers and online sellers. GINN welcomes the decision not to mandate a single technological solution, allowing businesses flexibility to implement verification systems that achieve the required level of assurance while reflecting differences in business models and operational capacity.

As Estonia develops its final framework, consideration should also be given to the administrative burden placed on compliant businesses, particularly small and medium-sized enterprises. Clear implementation guidance, reasonable transition periods, proportionate reporting obligations, and accessible regulatory support can significantly improve compliance while reducing unnecessary costs.

An effective regulatory system should encourage participation within the legal market rather than creating incentives for non-compliance. Administrative processes that are transparent, efficient, and proportionate strengthen regulatory certainty, support responsible businesses, and allow enforcement resources to focus on operators who deliberately fail to meet regulatory requirements.

Ultimately, the effectiveness of any nicotine regulatory framework will depend not only on the measures adopted but also on how consistently, transparently, and proportionately those measures are implemented in practice.

Recommendations

GINN respectfully recommends that Estonia consider the following principles when finalising the proposed amendments to the Tobacco Act and the State Fees Act:

1. Adopt a risk-proportionate regulatory framework. Regulatory measures should distinguish clearly between combustible tobacco products and lower-risk smoke-free nicotine alternatives, ensuring that regulatory requirements reflect the relative risks presented by different product categories.
2. Maintain youth protection as the primary regulatory objective. Continue strengthening measures that directly prevent youth access, including robust age verification for distance sales, retailer accountability, enforcement against unlawful sales, and responsible marketing standards.
3. Ensure regulatory decisions are evidence-based and transparent. Measures relating to nicotine concentrations, flavour restrictions, product standards, and market access should be supported by clearly published scientific evidence, comprehensive impact assessments, and transparent policy rationales.
4. Adopt product standards rather than blanket product restrictions where appropriate. Comprehensive manufacturing standards, ingredient requirements, quality controls, and responsible marketing provisions can often achieve public health objectives more effectively than broad prohibitions while preserving regulated access for adults who smoke.
5. Maintain technology-neutral implementation. Regulatory requirements for age verification and compliance systems should define desired outcomes rather than prescribe specific technological solutions, allowing innovation while ensuring effectiveness, privacy protection, and proportionality.
6. Ensure appropriate safeguards accompany enforcement powers. Expanded seizure, detention, and investigatory powers should operate within a transparent legal framework that includes clear evidentiary thresholds, procedural safeguards, timely review mechanisms, and accessible rights of appeal.
7. Assess the broader public health impact of market restrictions. Measures affecting flavours, nicotine concentrations, cross-border purchases, and product availability should consider their potential impact on adult smoking cessation, switching behaviour, illicit trade, consumer compliance, and overall smoking prevalence.
8. Support a stable and predictable regulatory environment. Clear implementation guidance, reasonable transition periods, and proportionate administrative requirements will encourage compliance, strengthen regulatory certainty, and support the effective functioning of the legal market.
9. Ensure nicotine concentration limits reflect both toxicological and behavioural evidence. Maximum nicotine levels should support adult smokers in transitioning away from combustible cigarettes while maintaining appropriate product safety standards. Regulatory decisions should consider nicotine pharmacokinetics, user satisfaction, and switching outcomes alongside toxicological assessments.
10. Adopt a balanced approach to flavour regulation. Rather than prohibiting flavour categories outright, Estonia should consider regulating flavour descriptors, marketing practices, and ingredient standards to reduce youth appeal while preserving consumer choice for adults using smoke-free alternatives.

By adopting these principles, Estonia can strengthen consumer protection while maintaining a regulatory framework that is evidence-based, proportionate, enforceable, and responsive to future scientific developments.

Closing

GINN appreciates the opportunity to contribute to this public consultation and commends Estonia’s continued efforts to strengthen the regulation of tobacco and nicotine products in pursuit of improved public health outcomes.

The proposed amendments provide an important opportunity to develop a modern regulatory framework that simultaneously protects young people, supports effective market oversight, promotes high product standards, and recognises the differing risk profiles of nicotine products. Achieving these objectives requires regulation that is proportionate, evidence-based, and capable of adapting as scientific knowledge and consumer behaviour continue to evolve.

Effective nicotine regulation should seek to reduce smoking-related harm by focusing regulatory attention where it delivers the greatest public health benefit. This includes preventing youth uptake, combating illicit trade, ensuring product quality and safety, supporting informed consumer choice, and preserving access to appropriately regulated lower-risk alternatives for adults who would otherwise continue smoking.

GINN believes that a balanced, science-led regulatory framework offers the strongest foundation for achieving sustainable public health improvements while maintaining regulatory credibility, encouraging compliance within the legal market, and fostering continued confidence among consumers, businesses, and public authorities.

GINN thanks the Ministry for considering these observations and looks forward to continued engagement as Estonia advances the development of a modern, evidence-based nicotine regulatory framework.