EU nicotine policy shift: cracks in pragmatism

Core insight: On the eve of the 11th Conference of the Parties to the World Health Organization Framework Convention on Tobacco Control (COP11), the European Union has shown a critical softening of its policy stance on new nicotine products. This marks a shift in the EU’s tobacco control strategy from an ideologically driven “one size fits all” tough ban to a more pragmatic regulatory framework that acknowledges scientific evidence and allows for policy differences among member states, opening a strategic gap for the legalization of global tobacco harm reduction (THR) strategies.

Driving factors:

• Internal political and public opinion pressure: Strong internal forces have driven policy revisions. On the one hand, the pan-European public consultation on the nicotine tax proposal received over 13,000 opinions, demonstrating strong public opposition to a “one size fits all” tax increase. On the other hand, the successful case of Sweden (reducing smoking rates to 5% through nicotine pouches) and the failed lesson of Denmark (flavor bans leading to black markets) have forced the EU to face the differences in national conditions.
• External scientific evidence and successful cases: Evidence supporting harm reduction strategies is increasing globally. Countries such as Japan and New Zealand have successfully reduced smoking rates by promoting new products, while the US Food and Drug Administration (FDA) has re-authorized Juul for marketing. These international cases collectively weaken the theoretical basis of extreme bans, forcing the EU to reassess its tough stance.
• Adjustment of global negotiation strategy: In the face of growing differences among member states, if the EU continues to adhere to a tough unified ban, it may lead to the breakdown of its internal alliance. Therefore, abandoning the absolute ban and allowing countries to have a certain degree of discretion is a negotiation strategy that maintains internal unity, is more realistic and flexible, and aims to enter COP11 in a more unified but non-rigid manner.

Key evidence:

• Fundamental shift in wording: The latest internal draft of the EU has removed the strong language describing non-combustible products as “extremely harmful.”
• The scientific shift of regulatory basis: The new text clearly requires that regulation should refer to “proportionality, scientific evidence, emission data, and real-world impact analysis,” marking a shift in policy from ideology to evidence-based decision-making.
• Significant relaxation of key policies: Regarding the widely concerned flavor restrictions, policies have shifted from mandatory regulations to “delegated to national discretion.”
• Supported by real-world data: The document acknowledges that Sweden has successfully reduced smoking rates to nearly 5% through the use of products such as snus and nicotine pouches, providing strong evidence for differentiated regulation.

Strategic insights:

The EU’s position adjustment is not the ultimate victory of tobacco harm reduction strategy, but a fundamental battlefield shift. The focus of global tobacco control policies is shifting from “whether new products should be completely banned” to “how to scientifically differentiate and regulate these products.” This pragmatic shift driven by real data and strong public opinion indicates that “harm reduction” has risen from a peripheral initiative to a core debate topic in global public health policies. The negotiation process and final outcome of COP11 will become a key indicator of whether this pragmatism can overcome injunctions and become a future global trend.