The European Union is reassessing whether its tobacco and nicotine framework remains fit for a market that has changed significantly since the Tobacco Products Directive (TPD) was adopted. Nicotine pouches, e-cigarettes, heated tobacco products and other novel products have expanded rapidly, creating regulatory questions that the existing framework does not address consistently.
One possibility receiving attention is a move from the EU’s largely notification-based approach toward stronger pre-market assessment requirements. Such a change could fundamentally alter how novel nicotine products reach consumers. However, an EU-wide pre-market authorisation regime has not yet been formally proposed or agreed. At this stage, it should be viewed as a potential regulatory direction within the wider review of EU tobacco legislation rather than settled policy.
Where the EU Review Stands
In April 2026, the European Commission published its evaluation of the Tobacco Products Directive and Tobacco Advertising Directive. The evaluation concluded that the existing framework has contributed to public-health and internal-market objectives but is increasingly challenged by the emergence and growing use of novel tobacco and nicotine products, including among young people.
The evaluation is an important step in the policy process, but it is not a legislative proposal. The Commission has also undertaken consultation and evidence-gathering work as it considers revisions to the wider tobacco-control framework. Any eventual proposal would still need to move through the EU legislative process before new requirements could take effect.
For now, different product categories remain subject to different rules. Novel tobacco products are subject to notification before national market placement, while Member States may introduce authorisation requirements. E-cigarettes and refill containers are also subject to pre-market notification through the EU Common Entry Gate, but notification does not amount to EU marketing approval. Tobacco-free nicotine pouches remain outside comprehensive harmonisation under the current TPD, leaving Member States to apply substantially different national approaches.
The distinction between notification and authorisation is important. Under notification, manufacturers provide specified information before placing products on the market and remain responsible for compliance. A genuine authorisation system would potentially require a regulator to assess the evidence and issue an affirmative decision before sales could begin.
Why Pre-Market Assessment Is Being Discussed
The speed of innovation within the nicotine market presents regulators with a difficult problem. Products can change quickly in formulation, nicotine strength, flavour, design and delivery characteristics, while regulatory systems may take considerably longer to respond.
A stronger pre-market framework could allow authorities to examine product composition, toxicology, nicotine delivery, manufacturing standards and other relevant characteristics before commercialisation. Depending on its design, regulators could also consider consumer behaviour, youth appeal and the likelihood that products would be used by adults who smoke, existing nicotine users or people who previously did not use nicotine.
For nicotine pouches in particular, a common framework could also address some of the regulatory fragmentation currently seen across Europe. National approaches vary significantly, including differences in nicotine limits, product standards and market-access rules.
Greater consistency could therefore provide benefits for regulators and responsible manufacturers alike. The more difficult question is what evidence should be required and whether the burden should differ according to product characteristics and relative risk.
Lessons From the United States
Any European discussion of pre-market authorisation will inevitably invite comparisons with the United States.
Under the US system, new tobacco products generally require FDA marketing authorisation before they can legally enter the market. The regulator assesses whether permitting a product would be appropriate for the protection of public health, considering potential effects on both users and non-users.
The US experience also demonstrates an important distinction between permission to sell a product and permission to make reduced-risk claims. These are separate regulatory decisions requiring different evidence.
However, the US model has also demonstrated the practical challenges associated with evidence-intensive pre-market review. Applications can require substantial scientific and regulatory resources, raising questions about cost, processing capacity, innovation and the ability of smaller manufacturers to participate.
Europe does not necessarily need to replicate this model. If pre-market assessment becomes part of the future EU framework, policymakers have an opportunity to design a system around European market conditions and regulatory objectives.
The Case for Proportionate Requirements
The central issue for GINN is proportionality.
A credible pre-market system should be capable of establishing that products meet appropriate safety and quality standards without assuming that every nicotine category requires an identical evidential burden.
Combustible cigarettes, heated tobacco products, e-cigarettes and nicotine pouches differ considerably in their composition, mode of use and exposure profiles. A future framework should be capable of recognising these differences while maintaining strong protections against youth access and inappropriate marketing.
This could mean establishing clear category-specific evidence requirements covering areas such as ingredients, contaminants, nicotine delivery, manufacturing controls, packaging and consumer information. Additional evidence could be required where manufacturers seek to make specific health or reduced-risk claims.
Clear standards would also matter for innovation. If every minor change in flavour, packaging or formulation triggered an entirely new authorisation process, regulatory costs could become substantial without necessarily producing equivalent public-health benefits. A proportionate framework could distinguish between material product changes and modifications that can be addressed through simpler procedures.
Avoiding New Regulatory Barriers
A poorly calibrated authorisation system could have unintended consequences.
Extensive evidence requirements may create high fixed compliance costs that are easier for large multinational businesses to absorb than smaller manufacturers. Lengthy review periods could also slow responsible product development and create uncertainty around investment and market entry.
There is also a broader harm-reduction consideration. For adults who smoke, access to acceptable non-combustible alternatives may influence whether they move away from cigarettes. A system designed to strengthen product oversight should therefore avoid creating unnecessary barriers to appropriately regulated alternatives.
This does not mean lowering standards. It means ensuring that regulatory requirements correspond to the questions policymakers actually need answered.
What Companies Should Consider Now
Manufacturers should not assume that an EU pre-market authorisation regime is inevitable. The legislative process remains open, and the eventual framework may look very different from the US model.
Nevertheless, the direction of EU policy suggests that manufacturers should be prepared for stronger evidence requirements around novel nicotine products. Building robust information on ingredients, toxicology, nicotine delivery, manufacturing quality, product stability and consumer use will become increasingly valuable regardless of the precise regulatory model ultimately chosen.
Companies should also be able to demonstrate responsible approaches to youth protection, marketing and post-market monitoring while avoiding unsupported cessation or reduced-risk claims.
Early engagement with the EU policy process will be important. Decisions about product categories, evidence standards, substantial modifications and regulatory pathways will determine whether a future framework provides predictable market access or creates unnecessary complexity.
Getting the Balance Right
The EU has an opportunity to modernise a regulatory framework designed for a very different nicotine market.
A stronger pre-market assessment system could improve product oversight, provide greater consistency between Member States and give regulators better evidence before new products become widely available. But its effectiveness would depend heavily on how it is designed.
For GINN, the objective should be a framework that is rigorous enough to protect consumers and young people, while proportionate enough to recognise differences between products and support responsible innovation.
The debate is therefore not simply about whether Europe should require more evidence before products reach the market. The more important question is what evidence is necessary, how it should differ between product categories, and how regulators can create a predictable pathway that protects public health without unnecessarily restricting adult access to non-combustible alternatives.
As the EU prepares the next phase of tobacco and nicotine regulation, getting that balance right will be critical.
