As previously reported by Pouchforum Following the Spanish TRIS notification (2025/0044/ES) on its proposed Royal Decree regulating novel nicotine products, the Spanish proposal on regulation of novel nicotine products met a wall of critique in the form of no less than six Member States tabling so called “Detailed Opinions” i.e. the strongest form of critique available in the TRIS system.
Madrid has now responded to the detailed opinions submitted by Romania, Hungary, Czechia, Greece, Italy, and Sweden, as well as comments from Croatia and the European Commission. The replies present a consistent line of reasoning, framed around public health objectives, but they also reveal the central weakness of the proposal: the nicotine content limit which is set far too low and introduced without scientific basis, without regard to consumer behavior, and with no consideration of how this will affect patterns of nicotine use. In practice, it risks keeping smokers with combustible tobacco as their only workable option.
Spain argues that its draft decree is designed to protect young people, prevent early nicotine initiation, and close regulatory gaps left by Directive 2014/40/EU, which does not explicitly cover newer categories such as nicotine pouches, nicotine-free e-cigarettes, or herbal sticks designed for heating. In Madrid’s view, the rapid growth of these unharmonized products requires urgent national action which to some extent can be considered a valid point of view, but in this case, bad regulation also has consequences. By halting the positive trend of consumers using reduced risk products instead of regular cigarettes the assumed good intention from Madrid is likely to have a negative impact on public health.
The government’s responses rest on three pillars. First, they cite Article 36 of the Treaty on the Functioning of the EU (TFEU), which allows Member States to restrict the free movement of goods when necessary to protect public health. It should however be evident that a low risk product replacing widely available cigarettes would not fulfill this criterion. Second, they rely on the precautionary principle, claiming that strict limits are justified even without long-term evidence. It is true that there is a lack of ling term studies on nicotine pouches but there is no lack of data on nicotine, smoking and studies on very similar products such as snus. There are also available assessments from multiple renowned institutions and public authorities, including for example the FDA stating clearly that nicotine pouches are far less harmful than cigarettes. Third, they present epidemiological data showing a rise in the use of new nicotine products among minors, particularly e-cigarettes, with the average age of initiation now as low as 12 years. This is a legitimate concern, and tighter rules on retail, marketing, and enforcement are clearly needed. But youth protection can and should be achieved without undermining harm reduction for adults. If existing systems are deemed strong enough to control cigarette sales in order to prevent underage access, then significantly lower-risk products should be regulated under those same systems.
Spain also proposes measures including mandatory health warnings, plain packaging, bans on ingredients such as caffeine or taurine, restrictions on flavors and marketing, and extending smoke-free rules to cover these categories. All of these are presented as proportionate and necessary. Some measures such as proper labelling should be considered an uncontroversial and normal product regulation while treating low risk alternatives the same as cigarettes could be discussed from different perspectives, such as if this really would entail an optimization of public health efforts. But the real sticking point is the nicotine cap: a maximum of 0.99 mg per pouch. This single provision is what transforms regulation into something equal to prohibition.
Why Proportionality Matters
There is no serious objection to regulating nicotine products. Clear warnings, age limits, and ingredient standards are all legitimate public health tools. But proportionality demands that regulation not destroy the very function of the product. Setting the nicotine content so low makes pouches ineffective for the purpose smokers use them: as a satisfying, lower-risk alternative to cigarettes.
Most pouches on the market contain between 4 and 12 mg of nicotine. This range allows them to replicate the nicotine delivery that keeps people smoking, while eliminating combustion, carcinogens, lung exposure and the majority of cardiovascular effects. Spain’s chosen limit of 0.99 mg corresponds to the very lowest dose in medicinal nicotine products, a level that does not match real consumer needs. Imposing it on pouches strips them of their function. In practice, it amounts to a ban without calling it one.
Protecting youth is a valid priority. But proportionality means weighing that against the opportunity to accelerate smoking cessation. Sweden’s experience proves that pragmatic harm reduction works by regulating, not neutering, snus and pouches, the country has reduced daily smoking rates to around 5%—the lowest in Europe. That achievement was not built on prohibition but on giving smokers workable alternatives.
It is also misleading to suggest pouches are “unregulated” simply because EU harmonization has not yet caught up. Member States already have tools: age-of-sale restrictions, rules on packaging and marketing, bans on flavor descriptors with candy names etc., and targeted enforcement. These can and should be applied without undercutting the essence of the product.
If Spain’s proposal stands, smokers will lose access to an option that has demonstrably reduced harm elsewhere. Instead of supporting quitting, the measure risks entrenching combustible tobacco use, the true driver of smoking-related disease and death. That is not precaution. It is disproportion and a very displaced intention to protect that will likely cause more harm than good.
Spain’s intentions may be legitimate, but the nicotine cap undermines their effectiveness. A stronger public health strategy would recognize that real harm reduction comes not from removing alternatives, but from regulating them responsibly. ´
The NNPA has also submitted its own Stakeholder Contribution (available under “contributions”) on the Spanish TRIS notification but only submissions from Member states are mandatory to reply and are the only feedback that will stop the process.