Key Points
● The European Commission launched a public consultation on the EU Cardiovascular Health Plan from August 11 to September 15, 2025, planned as a non-legislative Commission Communication.As of August 30, the consultation platform had received 59 submissions, with 8 directly referring to nicotine or harm reduction products.
● Harm reduction advocates (e.g. Alan Kleiman, World Vapers’ Alliance) called for proportionate, evidence-based, risk-proportionate regulation, stressing that the cardiovascular risks of non-combustible nicotine products are significantly lower than those of cigarettes.
● Restriction advocates (e.g. Dutch Heart Foundation, European Heart Network) urged stricter measures, including flavour bans, generational sales bans, and regulating all nicotine products in the same way as cigarettes.
● The core divide is whether to pursue “complete nicotine elimination” or to recognise harm reduction products within a risk-differentiated regulatory framework.
● TPD III has not yet been formally proposed, and media reports suggest it may be delayed until 2026. If the Cardiovascular Health Plan’s prevention section makes reference to nicotine, it could serve as a policy basis in future legislative battles, directly shaping debates on flavour bans, regulation of nicotine pouches, and e-liquid nicotine caps—hence the high level of attention from both industry and public health groups.
2Firsts, September 1, 2025, -During the European Commission’s public consultation on the EU Cardiovascular Health Plan, 2Firsts received an anonymous email. The sender warned that if the plan adopts a negative stance on reduced-risk products (RRPs) under its “prevention” pillar, it could later be used as political cover for stricter measures in the upcoming Tobacco Products Directive III (TPD III) and in national cardiovascular plans.
EU Cardiovascular Health Plan: Key Points
According to the Commission’s website, the consultation opened on August 11, 2025, and will run until September 15, 2025. It is led by the Directorate-General for Health and Food Safety (DG SANTE) and is planned for adoption in the fourth quarter of 2025 (indicative timing).
The initiative takes the form of a non-legislative Commission Communication. Its objectives include:
● improving population health through prevention, early detection, and treatment;
● fostering innovation in healthcare, including the use of artificial intelligence and the European Health Data Space;
● reducing inequalities across regions, genders, and socio-economic groups;
● supporting Member States in developing or strengthening their national cardiovascular plans.
The published summary and the full “Call for Evidence” text make no explicit reference to “tobacco,” “nicotine,” or “reduced-risk products.” However, the emphasis on addressing “unhealthy behaviours” as part of prevention leaves open the possibility that nicotine consumption could be included in future interpretations.
Public Feedback: 59 Submissions, 8 Mention Nicotine
As of August 30, the Commission’s website listed 59 submissions. Based on keyword searches and manual review, 2Firsts identified 8 submissions directly referring to nicotine or alternative products. Feedback on this point showed a clear divide.
Harm Reduction Advocates: Calling for Risk-Proportionate Regulation
● Alan Kleiman, a physician from Mexico, wrote that the primary drivers of cardiovascular harm are combustion products, not nicotine itself. Citing scientific evidence, he argued that non-combustible products such as e-cigarettes and nicotine pouches present significantly lower long-term risks than cigarettes. He called for “proportionate, evidence-based, risk-proportionate regulation.”
● The World Vapers’ Alliance (Austria) stressed that the plan must recognise and include vaping, nicotine pouches, and heated tobacco products as harm reduction tools. The group pointed to cases in Sweden, the Czech Republic, and Greece as evidence that pragmatic, risk-based policies can rapidly reduce smoking rates and alleviate cardiovascular disease burdens.
● Individual respondents from Lithuania and France described their personal experiences switching from cigarettes to pouches or e-cigarettes, reporting improvements in breathing capacity, physical fitness, and quality of life, and urging policymakers to acknowledge these benefits.
Restriction Advocates: Demanding Tighter Controls
● The Dutch Heart Foundation supported the plan but urged that the upcoming revision of the TPD include stricter measures such as a ban on e-cigarette flavours, the option for Member States to introduce generational sales bans, and discontinuation of the authorisation of new nicotine products.
● The European Heart Network (Belgium) recommended revising EU tobacco legislation to cover all nicotine products and e-cigarettes, ensuring smoke-free environments, and incorporating other cross-border health determinants such as diet, alcohol, and air pollution.
● The Czech consumer organisation Generace bez kouře expressed concern that the Commission might equate traditional cigarettes with lower-risk nicotine products, resulting in “undifferentiated policies” detrimental to public health.
Analysis: Ambiguity and Policy Contestation
Although the Commission’s draft documents do not mention nicotine or RRPs explicitly, stakeholder submissions reveal that the issue has already become a focal point of contention.
● Harm reduction advocates stress that combustion is the primary cause of cardiovascular harm and that non-combustible nicotine products should be recognised as lower-risk alternatives within the policy framework.
● Restriction advocates push for a comprehensive approach, urging that all nicotine products fall under equally strict regulation to achieve long-term public health goals.
The debate reflects a long-standing tension in EU health policy: whether to pursue a path of “nicotine elimination” or to recognise tobacco harm reduction under a continuum-of-risk approach.
2Firsts Comment
Nicotine, due to its addictive properties and acute cardiovascular effects, is widely regarded as a significant public health issue and therefore frequently appears in health and policy debates. A reliance on scientific evidence and rational inquiry is essential to guide policy development in a constructive direction.
Distinguishing between nicotine-related risks, combustion-related harms, tobacco harm reduction, and the role of nicotine in different contexts remains one of the core challenges in ongoing discussions—and one that warrants continued scrutiny in future policymaking.
The public consultation remains open, with a deadline of September 15, 2025.2Firsts will continue to follow this debate.
Background | Tobacco Products Directive III (TPD III)
The EU’s regulatory framework for tobacco products originated with Directive 2001/37/EC, adopted by the European Parliament and Council on June 5, 2001. This was the Union’s first directive to set comprehensive rules for the manufacture and presentation of tobacco products.
It was revised in 2014 as Directive 2014/40/EU (TPD II), which has applied since 2016. TPD II introduced major changes including:
● mandatory health warnings covering 65% of cigarette packaging;
● a ban on flavoured cigarettes;
● first-ever EU-wide standards for e-cigarettes, including a nicotine concentration cap of 20 mg/ml, a maximum tank size of 2 ml, and a refill bottle limit of 10 ml.
With the rise of e-cigarettes, heated tobacco products, and nicotine pouches, the Commission has deemed TPD II no longer sufficient. It has conducted evaluations and published a 2021 implementation report.
As of August 30, 2025, the Commission has not yet tabled a formal proposal for TPD III. Media and policy-watch sources have suggested that the process may be delayed until 2026, but no official timeline has been confirmed.
Among stakeholders and some Member States, closely watched issues include:
● whether to introduce an EU-wide ban on flavours in e-cigarettes or nicotine pouches;
● how to regulate nicotine pouches explicitly;
● whether to adjust the nicotine cap for e-liquids;
● further harmonisation of labelling and packaging requirements.
Although the EU Cardiovascular Health Plan is a non-legislative communication, any reference to nicotine in its prevention section could later be cited as supporting evidence in the legislative debate over TPD III. This is one reason why both industry and public health groups are closely watching the consultation.
Cover image generated by ChatGPT
