As the European Commission prepares to revise the Tobacco Products Directive, next-generation products such as vapes, heated tobacco, and oral nicotine pouches face renewed regulatory scrutiny. Kostas Papikinos, Senior Product Stewardship Toxicologist at Imperial Brands, examines the role of flavours in these products, which has become a frequent focus of regulatory debate.
Some regulators worry that flavours may encourage youth uptake and have proposed or implemented flavour bans. However, the cited research argues that flavour diversity and availability can help adult smokers try next-generation products and, over time, switch away from cigarettes. This is discussed by Fearon, I. M., Stevenson, M., and Nahde, T. (2025) in Flavoured Vaping Products in Tobacco Harm Reduction: A Regulatory Perspective, published in Cureus, 17(8), e89196.
Imperial Brands’ next-generation products are not licensed smoking-cessation devices and are not marketed as such.
Provided youth protections remain robust, the potential shift from cigarettes to these products among adult smokers is significantly greater than any potential pathway towards regular smoking or nicotine use among never-smokers, including young people. This is discussed by Beaglehole, R., Bonita, R., and Pang, T. (2026) in Smoke-Free Nicotine Products Can Accelerate the End of the Smoking Epidemic, published in Nature Health.
Managing flavours responsibly
One aspect of the debate that has received less attention is how flavours are managed once they are approved for use. They must be manufactured, marketed, and used responsibly and transparently, within frameworks that prioritise consumer safety and broader public health.
Incidents such as EVALI in the US demonstrate how quickly harm can arise from adulterated products, unregulated ingredients, and inadequate quality control. They also underline the need for clear ingredient standards, robust manufacturing controls, and appropriate oversight as current and future regulations develop.
The challenge for manufacturers is to manage flavours proportionately, recognising their potential role in harm reduction while guarding against unintended consequences. Standardised testing procedures and a comprehensive understanding of these products are therefore essential to achieving this, rather than optional extras.
Best practice in this area is holistic and involves several key elements
- Regulatory compliance: Manufacturers should maintain up-to-date knowledge of changing ingredient rules in each market. Prohibited substances, such as diacetyl, historically associated with “popcorn lung”, and vitamin E acetate should never be included. Diacetyl was banned as an e-liquid ingredient under the EU Tobacco Products Directive in 2016.
- Stringent ingredient selection: Only high-quality ingredients with well-characterised safety profiles should be used, while substances associated with known respiratory, carcinogenic, mutagenic, or reproductive hazards should be excluded as a precaution.
- Exposure limits: Limits should be established by combining ingredient-specific toxicological data with real-world patterns of consumer use, ensuring typical exposure remains well below levels of potential concern. These limits should be continually reviewed and updated as new evidence emerges.
- Aerosol chemistry analysis: Identifying new compounds that may form when ingredients are heated, including thermal degradants and reaction products, and comparing their concentrations with toxicological reference values to keep them below levels of concern.
- Systematic in vitro toxicological screening in ISO-accredited laboratories: Key endpoints, including genotoxicity, mutagenicity, and cytotoxicity, should be assessed before ingredients or flavours are approved. In responsibly manufactured products, these tests may show substantially lower toxicological activity than cigarette smoke.
- Stability testing: Monitoring chemical integrity and potential degradation over time to ensure that significant breakdown products do not emerge during the product’s shelf life and that the product consumers use remains consistent with its intended safety and performance profile.
- Transparency: Publishing relevant data, including full ingredient lists, and sharing information with regulators to support evidence-based policymaking.
A pragmatic path forward
As the European Commission considers the future regulatory framework, the evidence suggests that policy should move away from prohibition driven solely by the precautionary principle. Evidence-led ingredient controls, rigorous risk assessment, and targeted youth protections instead offer a more credible and proportionate approach to supporting public health.