Following the position paper presented at Employment, Social Policy, Health and Consumer Affairs Council on the 21st of June, Denmark has now notified the commission that they intend to impose very strict limitations on nicotine pouches. The rules will not be a blanket ban as put in place/proposed in the Benelux countries but will ban most flavours and any product with a nicotine content above 9 mg per pouch.
A nicotine cap at 9 mg per pouch is less than half the amount of nicotine allowed in most countries that have a cap put in place and would remove approximately half of the products sold on the European market. Products with 6-12 mg of nicotine per pouch are the most popular strength with 40% of the sales and products with higher than 12 mg of nicotine per pouch represented 28% in 2023.
The NNPA supports the idea of a nicotine cap since there are extreme products on the market that should be restricted due to a very high nicotine content, but we strongly believe it is a mistake and counterproductive to set a too low nicotine cap. Since the main benefit of reduced risk products are to constitute an alternative to cigarette smoking, the products must be a valid option for a smoker. The nicotine pouch provides a slower, more sustained release of nicotine, peaking around 20–30 minutes and maintaining a more stable level while a cigarette results in a rapid spike followed by a quick decline. A nicotine pouch will therefore provide a significantly different experience than smoking a cigarette. 9 mg per pouch is likely to be insufficient for at least half of the pouch users and most cigarette users. Some of these users would thereby be discouraged to switch to nicotine poches as a low-risk alternatives or resort to dual use of products instead of adhering to a single source, low-risk use that does not involve combustion or inhalation.
It might be considered counterintuitive that there is no correlation between a lower nicotine cap and a lower health risk, but we strongly believe that the effect is the opposite, at least until a level where nicotine becomes a risk factor in itself. Leading research institutions and national authorities on chemicals have assessed this level to be somewhere between 16,6 mg and 20 mg per pouch. (example the German Federal Institute for Risk Assessment, BfR and the Finish Safety and Chemicals Agency, TUKES)
Since nicotine is addictive, it is a significant factor to consider in the context of tobacco-related harm reduction approaches, but it is not the nicotine that drives the risk from smoking. Nicotine-pouches are not risk-free, and, in our view, it would not only be acceptable, but rather advisable and strongly encouraged to set a limit for the nicotine content; the limit should though be set at a level that would not constitute a major risk factor in itself and at the same time would allow more smokers to switch.
Other Member States including neighbouring Nordic countries allow higher levels, with nicotine caps or standards ranging from 16.6 mg to 20 mg per pouch. A major deviation from the current practice risks fragmenting the internal market and creating incentives for cross-border illicit trade, as consumers may seek products from neighbouring countries. A 9 mg cap would mean that an expected cross border demand will include even products with very moderate levels of nicotine including medium strength products.
NNPA have a similar opinion on flavour bans and would like to see a different approach, i.e., limits on descriptors rather than specific flavours. It is difficult to see the value of a ban on flavours such as bergamot or other citrus compared to menthol flavours or why a smoky flavour should be banned when tobacco flavour is allowed. All these examples are traditional flavours of oral nicotine products and can hardly be considered to be unduly attractive to underage consumers. . To limit former smokers to tobacco or menthol flavours (as they both are quite commonly associated to smoking) also seems like a hurdle rather than encouragement in the context of breaking habits.
Other aspects of the Danish proposal include imposing a fixed number of pouches per can (20), plain packaging and standardized sizes and weight for the pouches themselves. We take note that the proposal on can size sits within the 20-24 bracket that already is the general practice as it represents 90% of sales according to our market research. It is however difficult to see the added value or safety of standardizing size and weight if there is a cap on nicotine content per pouch. What would the harm be if a pouch is 28 mm long instead of 30mm if this is what consumers prefer? One could also argue that this is an arbitrary trade barrier on the internal market and would have no other effect than distorting competition for producers, making the same product in a slightly different shape.
The NNPA does advocate that products should not have a design that in an undue way appeals to children (such as playful descriptors or cartoons on the box that could lead underaged consumers to believe this is a product for them). We do however consider responsible retailing and age verification in combination with supervision and sanctions is a significantly more important step to limit underage access rather than changing the colour of the box.
Unspecific or unproportional efforts to reduce the appeal of all nicotine products for the underage risk making reduced risk products less relevant and less attractive for adult smokers, which are the key target group that would benefit from switching from cigarettes. Imposing the same plain package on all product categories risks providing the wrong messages that all product categories are equally harmful and does not create any added incentive for smokers to make a less harmful choice. This would be a lost opportunity.
We do question the rationale behind the Danish proposal. Denmark has been moderately successful in its effort to limit smoking and has 14% smokers according to the latest Eurobarometer. It should however be noticed that this is still almost three times the prevalence of daily smokers in Sweden. By restricting nicotine pouches, in particular via what we consider a far too low limit on nicotine per pouch, Denmark risk losing a significant part of the benefits a consumer-friendly low risk product such as nicotine pouches can provide.
The experience of Sweden, with the lowest smoking rates in the EU (5.6% daily smokers), shows that aligning nicotine levels with responsible user preferences can significantly contribute to public health goals without driving users back to smoking or to the illegal market. If a majority of adult users prefer higher nicotine levels, a strict 9 mg per pouch limit could push them toward illegal, unregulated, and untaxed sources, which often provide nicotine pouches with extreme levels.
We hope Denmark will revise the legislation and take harm reduction measures in account before adapting a legislation that likely would have a negative net effect on public health.