September 2023. ETHRA wrote to EU health attachés ahead of a meeting of the Working Party on Public Health to discuss information from the Commission and Presidency on COP10 preparation.

Dear Member of the Working Party on Public Health,

I write on behalf of the European Tobacco Harm Reduction Advocates (ETHRA). ETHRA is the voice of 27 million EU consumers of safer nicotine products (SNPs). The safer nicotine products we use include vapes, nicotine pouches, snus, and heated tobacco products. ETHRA is a consortium of 24 grassroots consumer associations in 17 European countries, supported by experts in tobacco control and nicotine research. We are a voluntary operation with no industry funding or conflicts of interest. Our transparency registration number is 354946837243-73.

We read with great interest and some concern the recently published main documents and the provisional agenda for the 10th session of the Conference of the Parties (COP10) to the World Health Organization’s Framework Convention on Tobacco Control (FCTC). The application of the key policy recommendations contained in these documents would deny continued use of safer nicotine products for millions of European consumers who have successfully stopped smoking with the help of these products and deprive tens of millions of smokers of the opportunity to reduce their health risks in the future.

As the Commission and the Presidency coordinate with national governments to prepare for COP10 in Panama in November, we believe the EU position at COP10 should reflect the views of the impacted populations (in this case current users of safer nicotine products but also people who smoke), as well as the EU’s core principles relating to the internal market, proportionality, and non-discrimination in policymaking.

The policy recommendations, namely to severely restrict flavours in safer nicotine products, ban open-tank vapes (e-cigarettes), ban disposable vapes, prevent all forms of marketing or ban nicotine pouches, and to ban or regulate heated tobacco products in the same way as combustible cigarettes are at odds with the EU’s ambition to reach the WHO’s Sustainable Development Goal (SDG) target 3.4, which aims to reduce premature deaths from four key NCDs by one third by 2030. A large proportion of these premature deaths are caused by diseases such as cancer, cardiovascular disease, and COPD, caused by smoking combustible cigarettes. Encouraging people who smoke to transition to non-combustible safer nicotine products has been a proven and effective way to reduce smoking prevalence.

Rigorous application of the EU’s core principles justifies risk-proportionate regulation. The critical distinction should be between combustible (harmful) and non-combustible (far less harmful) products.

Safer nicotine products function as substitutes for cigarettes. There is an abundance of government-funded and other independent research that bears this out. Measures such as increases in e-cigarette taxes, product flavour bans, advertising bans and access restrictions on safer nicotine products can increase smoking. The fact that safer nicotine products are substitutes for cigarettes should be the central consideration in regulatory policies for nicotine. Yet, the WHO and the FCTC continue to ignore the evidence and instead position these products solely as a threat, failing to consider that safer nicotine products offer opportunities for public health. Countries that ban safer nicotine products have not eliminated their use; instead, they expose consumers to the unsafe and unregulated products, which remain widely available on the black and grey markets.

We are alarmed that the documents released for COP10 do not provide any consideration of the benefits of safer nicotine products. The documents fail to measure the risks of safer nicotine products against the risks of smoking. The documents discount the evidence that safer nicotine products help smokers quit: it is astonishing that “gold standard” scientific evidence such as the Cochrane review, which concluded that there is a “high certainty evidence that nicotine e-cigarettes are more effective than traditional nicotine-replacement therapy (NRT) in helping people quit smoking”, is ignored. There is no consideration that flavours in safer nicotine products are useful for people trying to stop smoking. Theseconcerns have been raised before but, despite the evidence, have been ignored by the WHO and FCTC secretariat.

The potential individual and public health benefits of safer nicotine products have been recognised for decades, including by WHO bodies. Here are a few examples:

In 1997, leading experts convened by the United Nations concluded that “to attain a substantial reduction in tobacco-caused death and disease in existing smokers and in future generations, it is important to adopt a triadic approach of coordinated (i) tobacco-use prevention, (ii) smoking cessation, and (iii) reduction of exposure to tobacco toxins in people who are unable or unwilling to completely abstain from tobacco” (quoted inHatsukami et al.).

In 2000, theWHO monograph Advancing Knowledge on Regulating Tobacco Products observed that “trends in global mortality will only be marginally affected by strong preventive measures. However, death rates in current smokers would clearly be significantly reduced if two measures were successful: widespread use of effective means of treating tobacco dependence - especially if the cessation rate could be dramatically increased - and a substantial reduction in exposure to the harmful constituents of tobacco products,” adding that “innovative thinking is needed to ensure that the pace of progress in tobacco control dramatically accelerates.”

In 2003, the then recently established WHOScientific Advisory Committee on Tobacco Product Regulation stated that “The major acceptable public health rationale for development of new or modified tobacco products is the potential for a reduction in the harm caused by existing tobacco products. (…) Only the population which switches to a potentially less harmful product can experience a reduction in harm.”

Consequently, the 2003 WHO FCTC treaty defined tobacco control as “a range of supply, demand and harm reduction strategies that aim to improve the health of a population by eliminating or reducing their consumption of tobacco products and exposure to tobacco smoke.”

The future work of the WHO and the FCTC in relation to safer nicotine products should focus on toxicity reduction, which should be a core objective for product regulation.

In 2015, WHO TobReg, the successor of the Scientific Advisory Committee on Tobacco Product Regulation, recognised the benefits of reducing toxicity of new products by saying that the “development of new tobacco products that are less toxic or less addictive could be a component of a comprehensive approach to reducing tobacco-related deaths and disease, particularly among tobacco users who are unwilling to quit or are unable to break their dependence on tobacco.”

Even the most recent and comprehensiveWHO publication on tobacco product regulation states that “policy approaches could be considered to incentivise smokers to adopt less hazardous forms of tobacco or nicotine use, including restrictions on access and marketing and use, as well as differential taxation, such that taxes on cigarettes and combusted tobacco are much higher than those on cleaner nicotine-delivery products.”

Yet, to date, these recommendations from the WHO’s own bodies have been ignored, despite there being virtually no progress in reducing the number of smokers worldwide: A2021 Lancet paper estimated that the number of smokers in the world increased from 0.99 billion in 1990 to 1.14 billion in 2019. The MPOWER measures are just not doing the job.

If the WHO and the FCTC are serious about reducing smoking, they must transparently review all the evidence with an open mind. Safer nicotine products represent an opportunity to eradicate smoking for good. Millions of consumers around the world are living proof that safer nicotine products work. We hope that the position of the EU in this debate ensures that this opportunity is not missed.

ETHRA remains at your disposal and would be eager to supply any further information which you might require. We look forward to hearing from you.

Damian Sweeney

On behalf of ETHRA and partners.