In a promising turn of events, several European Union member states are now opting for a balanced regulatory approach rather than the disproportionate blanket bans on nicotine pouches we saw being proposed, for example, in Belgium earlier this year. Finland and Hungary have recently announced draft proposals to regulate the sale and usage of nicotine pouches, highlighting a growing recognition of the potential benefits of harm reduction strategies. This trend is not only welcome but could also contribute to setting the direction of the upcoming revision of relevant EU directives.


Hungary’s Decree on Nicotine Pouches
Hungary has taken decisive steps to regulate nicotine pouches through a draft decree that proposes amendments to its existing regulations, and the European Commission has already been notified. The draft outlines several crucial changes in regulation that align with approaches observed in several other member states, including a ban on stimulants and on additives suggesting health benefits such as vitamins. Furthermore, the decree mandates that nicotine pouches must display health warnings and include an information sheet with detailed usage instructions, risk warnings, and contact details. These rules lay a solid foundation to prevent misleading marketing and to offer relevant consumer information.
The decree also establishes a maximum nicotine content of 17mg per consumption unit. In addition, it includes amendments for other tobacco and nicotine-related products.


Anticipating Market Trends
Looking at niche market trends, Pouchforum and NNPA have anticipated regulations on maximum nicotine content to promote consumer safety by preventing a potential spiraling development of extreme nicotine content, especially those trends that may be occur among products not fulfilling the regulatory requirements. In the long term, a scientific approach may also lead to avoiding excessive and non-evidence-based regulatory reactions to the entire product category. In the case of Hungary, the chosen level 17 mg per unit falls within the range we have expected, which also allows manufacturers to market products that maintain an appeal to existing users or smokers. The proposal of a ceiling is indeed welcome when adopted with a clear regulatory intention and based on scientific evidence. However, it is becoming increasingly evident that a common European limit based is needed to avoid a patchwork of national rules. Many of these rules may only differ within what should be considered a margin of error.


The standstill period, during which the European Commission and Member States may raise objections to the regulations, ends on 8 November 2023. Hungary may not enact the regulations until the notification process has concluded. If approved, the new regulations would come into effect on 29 March 2024.


Finland’s Move Towards Regulation
In Finland, in the program of the recently elected government, nicotine pouches are proposed to be included under the scope of tobacco legislation. Their sale is proposed to be allowed with adherence to specified regulations aiming to prevent use among young individuals, curb gray imports and illegal trade, and counter organized crime. Retail sales are subject to permits and similar nicotine limits as neighboring countries apply. Furthermore, only flavors targeted towards adults are permitted. Nicotine pouches and other nicotine products covered by tobacco laws, but not subject to excise tax, are to be included in excise tax regulations in a manner similar to nicotine liquids for electronic cigarettes. The tax level is set to prevent excessive diversion of consumption from taxable sales while contributing to reducing the harm caused by smoking. Finland’s approach underscores the importance of regulation in ensuring responsible usage and safeguarding public health in the context of nicotine pouches.

A Promising Outlook
The initiatives taken by Finland before the summer, and now Hungary indicate that these countries are opting for a comprehensive approach that considers several relevant factors such as public health, consumer choice, and the protection of risk groups like minors. By implementing reasonable restrictions, they aim to mitigate potential risks, where relevant, while acknowledging potential harm reduction benefits. The detailed aspects of the proposals can and will be discussed; however, the main direction towards regulating rather than imposing a disproportionate and not evidence-based ban is clear, and recently more and more countries are embracing this approach.


While regulatory measures are vital, these developments also underscore the importance of evidence-based decision-making. As more research emerges regarding nicotine pouches and harm reduction, it is becoming evident that well-informed policies can contribute to better public health outcomes, and possible negative aspects can be minimized with selective rules tailored for specific purposes.
As member states continue to refine their regulatory approaches, they contribute to a broader conversation about the role of harm reduction in addressing public health issues. This positive shift reflects a nuanced understanding of the potential risk reduction associated with nicotine pouches, fostering an environment where evidence, public health, and consumer well-being is prioritized.

Visited 154 times, 1 visit(s) today

Leave a comment