Smoke Free Sweden urges risk-based nicotine rules in EU TPD consultation

Smoke Free Sweden has asked the European Commission to aim its tightest nicotine rules at cigarettes and other combustible tobacco, and to regulate vapes, nicotine pouches and heated tobacco in line with their lower risk, in a submission to the Commission’s public consultation on tobacco control.

The group says the revision of the Tobacco Products Directive (TPD) should tie the strength of regulation to relative risk. Its submission argues that tighter flavour bans and very low nicotine limits would make quitting harder and push smokers back to cigarettes or to unregulated sellers.

Harm reduction advocates want combustible and smoke-free products regulated apart

The submission asks the Commission to stop treating cigarettes and smoke-free nicotine products as the same category during the TPD revision. It argues that the strictest measures belong on the products the group links to most tobacco-related illness and death.

Smoke Free Sweden also asks for stronger enforcement of age-of-sale rules, responsible marketing rules and retail licensing. It says these should protect young people while keeping adult smokers’ access to alternatives.

On product design, the group states that flavours matter to many adults trying to quit and that nicotine levels must be strong enough to satisfy dependent users. Its position is that products adults find unappealing or too weak are unlikely to deliver public health benefits.

Dr Delon Human, who leads Smoke Free Sweden, said Sweden reached the lowest smoking rate in Europe by giving adult smokers access to what he described as accessible, affordable and adequately dosed alternatives. He said that strategy has given Swedes the lowest tobacco-related disease rates in the EU, and he put the number of adult smokers across the continent at 94 million.

The consultation questionnaire faces a charge of structural bias

Critics quoted by Planet of the Vapes say the questionnaire groups combustible tobacco with smoke-free nicotine products, which they argue tilts the process against tobacco harm reduction.

Dr Human, a former secretary-general of the World Medical Association, called the questionnaire risk-blind. He said it frames tighter restrictions across all product categories as the logical response, and that a consultation should test policy options openly rather than steer respondents towards more restrictions and bans.

The submission grounds its harm reduction argument in Article 1(d) of the WHO Framework Convention on Tobacco Control, which it says includes harm reduction in the definition of tobacco control. It concludes that conventional tobacco control and harm reduction should work together.

Dr Human framed the revised TPD as a choice between extending Sweden’s approach across Europe and imposing what he called indiscriminate restrictions that leave cigarettes the most accessible and satisfying nicotine option.

Retailers and nicotine suppliers face the same TPD revision whichever product they sell

A revised TPD would set rules for the EU market, so vape retailers, nicotine pouch suppliers and heated tobacco sellers would all work under one framework. The submission targets flavour limits and nicotine ceilings as the restrictions most likely to change what consumers buy.

The submission’s call for retail licensing would add a compliance step for shops if the Commission takes it up. The article does not say how many member states the revision would bind, nor does it give the current TPD limits on flavours and nicotine.

The article does not state when the consultation closes or when the Commission will publish its proposal. The Commission has not responded to the bias criticism in this report, and Smoke Free Sweden’s submission is one input among those the Commission is collecting.

Questions readers ask

What is Smoke Free Sweden asking the EU to do?

It wants the European Commission to apply the strictest nicotine rules to cigarettes and other combustible tobacco, and lighter rules to vapes, nicotine pouches and heated tobacco in proportion to risk. It also asks for stronger age-of-sale enforcement, marketing rules and retail licensing, and warns that tighter flavour bans and very low nicotine limits could push smokers back to cigarettes or unregulated sellers.

Why do critics call the EU consultation questionnaire biased?

Critics quoted by Planet of the Vapes say the questionnaire groups combustible tobacco with smoke-free nicotine products despite different risk profiles. Dr Delon Human called it risk-blind, arguing it frames tighter restrictions across all categories as the logical response. He said a consultation should test policy options openly rather than steer respondents towards more restrictions and bans.

Who is affected by the TPD revision?

A revised TPD would set rules for the EU market, affecting vape retailers, nicotine pouch suppliers and heated tobacco sellers. The submission focuses on flavour limits and nicotine ceilings, which would change product ranges and strengths. Its call for retail licensing would add a compliance step for shops if the Commission adopts it.