Regulatory change across the European Union: flavoured heated tobacco (HnB) sticks withdrawn from sale as of 18 January 2025

As of 18 January 2025, a regulation prohibiting the sale of flavoured heated tobacco (HnB) sticks comes into force across the entire European Union. The new rules result from Commission Delegated Directive (EU) 2022/2100, adopted in 2022, which extends earlier regulations on flavoured tobacco products and covers all heated tobacco products other than traditional tobacco-flavoured variants, while excluding e-cigarettes. The aim of these changes is to reduce the attractiveness of flavoured nicotine products and, consequently, to limit the number of individuals initiating or continuing the use of such products.

The regulation applies to all European Union Member States and was adopted at EU level on 29 June 2022 in the form of Commission Delegated Directive (EU) 2022/2100. The Directive established a uniform implementation timetable, requiring Member States to transpose its provisions into national law by 23 October 2023, while allowing for transitional periods at national level. As a result, the ban on the sale of flavoured heated tobacco sticks applies as of 18 January 2025, including in Poland, where the sale of flavoured sticks ends on that date. In Spain, the ban was implemented through a national decree regulating tobacco products, and similar legislative measures have also been adopted in Germany, France, Italy and the Netherlands. This regulatory change forms part of a broader public health strategy implemented under the Europe’s Beating Cancer Plan, which aims to reduce the prevalence of tobacco product use to below 5% of the population by 2040.

The withdrawal of flavoured HnB sticks may significantly affect user preferences and behaviours. Individuals who previously used flavoured variants will be required to switch to traditional tobacco-flavoured sticks. This change may lead to a transformation of the market, fostering the development of flavoured products designed for heating that do not contain tobacco. For some users, it may also serve as an incentive to reduce consumption or discontinue the use of nicotine products altogether.

From a clinical research perspective, the regulatory change represents a significant shift in the scope of ongoing analyses. For many years, BRG has conducted research on nicotine products, examining their effects on the human body as well as user behaviours and risk perception. The new regulations open up additional analytical areas, enabling the assessment of the impact of the flavour ban on consumer decisions and the movement of users between different categories of nicotine products. Such data are particularly important in the context of public health and in evaluating the effectiveness of regulatory measures.

Education and communication remain key to the process of adapting to the new regulations. At BRG, great emphasis is placed on providing study participants with reliable information about legal changes and the reasons why flavoured additives in nicotine products have become a particular focus of regulatory attention. Research indicates that added flavours may increase product attractiveness, enhance social acceptability and facilitate initiation of use, including among younger users. At the same time, certain flavouring substances, such as menthol, are also being examined for their potential toxic properties and their impact on addiction mechanisms. During clinical studies, participants receive substantive support that helps them better understand both the regulatory context and the composition of the products they use.

Individuals interested in participating in studies or seeking further information on nicotine products can find up-to-date details at www.udzialwbadaniu.pl, where current recruitment opportunities and descriptions of ongoing projects are published.

BRG continues to expand its research activities to provide reliable knowledge that supports informed health-related decisions among adult users of nicotine products and responds to the dynamically evolving regulatory environment.