EU urged to adopt risk-based nicotine regulation despite ‘biased’ review

International health experts are urging Europe to regulate tobacco and nicotine products according to their relative risk, as the bloc prepares to overhaul its rules to combat smoking.

In a submission to the European Commission’s public consultation on tobacco control, Smoke Free Sweden advocates argue that the strictest regulations should be focused on cigarettes and other combustible tobacco, which account for the vast majority of tobacco-related illness and death.

Smoke-free alternatives – such as nicotine pouches, vapes and heated tobacco products – should instead be regulated in proportion to their substantially lower risk so they can be used to help smokers kick their deadly habit.

Excessive restrictions such as tighter flavour bans and rock-bottom nicotine limits could make quitting harder, driving smokers either back to cigarettes or the unregulated black market, the submission warns.

Dr Delon Human, leader of Smoke Free Sweden, said: “Sweden has achieved the lowest smoking rate in Europe by allowing adult smokers access to accessible, affordable and adequately-dosed alternatives. This proven public health strategy has given Swedes the lowest tobacco-related disease rates in the EU.

“The 94 million adult smokers across the continent deserve the same opportunity and policymakers have a responsibility to examine what Sweden has achieved and to regulate based on the evidence.”

The submission stresses that flavours matter to many adults trying to quit smoking and that nicotine levels need to be strong enough to satisfy dependent users. Products that are unappealing or too weak are unlikely to deliver real public health benefits.

It also calls for tougher age-of-sale enforcement, responsible marketing rules and retail licensing to protect young people while preserving adult smokers’ access to safer alternatives.

Accusations of structural bias

The Commission has been accused of ‘structural bias’ in the consultation process ahead of its revision of the Tobacco Products Directive (TPD).

Critics say the consultation questionnaire is unfairly tilted against tobacco harm reduction, by lumping combustible tobacco together with smoke-free nicotine products despite their very different risk profiles.

“The questionnaire is risk-blind,” said Dr Human, a former secretary-general of the World Medical Association. “By treating cigarettes and smoke-free alternatives as though they present the same danger, it frames tighter restrictions across all product categories as the logical response.

“A consultation should test different policy options openly. It should not be structured in a way that points respondents towards a predetermined conclusion of more restrictions and more bans.”

Smoke Free Sweden’s submission concludes that conventional tobacco control and harm reduction should work hand in hand, noting that harm reduction is explicitly included in the definition of tobacco control under Article 1(d) of the WHO Framework Convention on Tobacco Control.

“The revised TPD presents Europe with a choice,” Dr Human said. “It can follow the evidence and extend Sweden’s success across the continent, or it can impose indiscriminate restrictions that leave cigarettes – the deadliest product – as the most accessible and satisfying nicotine option. The health of millions of Europeans depends on getting that choice right.”