The regulatory landscape for tobacco harm reduction is evolving: in June 2026, the US Food and Drug Administration issued a landmark authorisation, permitting, for the first time, a nicotine pouch to be marketed to adult smokers as a lower-risk alternative to cigarettes.
Nicotine pouches —tobacco-free, flavoured, and delivering pure nicotine— sit at the centre of the harm reduction debate: can they offer smokers a lower-risk pathway to nicotine without drawing in new users, particularly young people? The European Union has yet to answer that question with comparable clarity. Where the FDA has moved toward case-by-case, time-limited, and revocable authorisations with mandatory post-market surveillance, the EU relies on a fragmented, largely precaution-driven varied national rules.
In his keynote speech, Austrian Health Economist and Lawyer Bernhard Rupp asks what Europe can learn from the American experience and whether a more coherent regulatory framework on tobacco products is within reach. Professor Wolfgang Popp chaired this session.
Professor Rupp commented on FDA’s decision to grant authorization to nicotine pouches, which is grounded in years of scientific review covering toxicology, consumer behaviour, youth risk assessment, and population modelling, reflects a product-specific, evidence-led regulatory approach. However, it comes with strict strings attached: a five-year limit, a revocable status, and mandatory post-market surveillance.
Dr. Rupp clarified that nicotine pouches are tobacco-free products and presented the central policy question of whether they can reduce smoking-related harm without increasing youth or non-smoker use. He then outlined the FDA’s PMTA and MRTP pathways, explaining the permitted comparative claims, the required evidence package, and the necessity of weighing population-level benefits against potential harms.
The speaker detailed the safeguards attached to FDA authorization, including time limitations, revocability, post-market surveillance, and marketing restrictions designed to target adult smokers exclusively. He reiterated that while complete cessation remains the preferred outcome, providing accurate information about lower-risk alternatives can significantly benefit adult smokers.
Comparing the FDA framework with the EU’s regulatory gap, Dr. Rupp noted that the Tobacco Products Directive covers tobacco-containing products but excludes tobacco-free nicotine pouches. He then reviewed divergent national approaches within Europe, which include outright bans, marketing restrictions, regulation under food law, and Austria’s decision to integrate these products into existing tobacco legislation. Commenting on the European Commission’s more cautious position, he emphasized the lack of long-term data to support this position; also, he compared the U.S. system that involves a single-agency, two-pathway structure with the EU’s lack of a central authorization body and a dedicated process for reviewing product-specific evidence.
With reference to the examples of Germany’s classification of nicotine pouches under food law and France’s reported ban on these products, Dr. Rupp explained that European manufacturers lack a practical route to obtain an officially reviewed lower-risk claim, while existing advertising and labelling rules generally prohibit such comparisons.
The speaker contrasting U.S. and EU regulatory philosophies argued then, that Europe should selectively “cherry-pick” best practices rather than simply copying the U.S. system. Among lessons to be learned he included harmonized product assessments, net population health testing, time-limited authorizations, post-market surveillance, and transparent scientific advice. He pointed out that there are however structural differences that limit direct adoption of the U.S. approach, among others, the EU’s treaty-level precautionary principle, Article 13 advertising restrictions, the 27 distinct national competences, and lower public trust in industry-funded research.
Referring to the European Commission’s planned regulatory overhaul and expected conclusions in the fourth quarter, Dr. Rupp predicted a likely emphasis on flavours, packaging, labelling, digital advertising, and minimum excise taxation, before proposing concrete alternatives centred on harmonized categories, comparative risk assessments, and integrated monitoring.
At the conclusion of his presentation, Professor Rupp reiterated that Europe should focus on pragmatic lessons from the FDA, support adults seeking less harmful alternatives by providing accurate information and avoid prohibitions that could promote illicit trade.