- Italy’s competition authority has fined Philip Morris Italia €7 million over its marketing of non-combustion products.
- The ruling targets claims including “smoke-free”, “smoke-free products” and “building/planning/accelerating a smoke-free future”.
- The authority said current scientific and clinical knowledge does not support claims that the products are harmless or less harmful.
- That finding cuts across the FDA’s public position that non-combusted products generally sit lower on the risk spectrum than cigarettes.
Italy’s competition authority has fined Philip Morris Italia €7 million after ruling that its “smoke-free” marketing misled consumers about the health risks of non-combustion tobacco and nicotine products.
The decision is significant because it goes further than warning that the products are not risk-free. The Autorità Garante della Concorrenza e del Mercato said the evidence did not support the idea that these products are harmless or less harmful than other tobacco products, including cigarettes.
In its ruling, the authority said the claims could “lead consumers – even minors – to mistakenly believe that they are products that have no harmful effects on health and/or less harmful than other tobacco products, in particular traditional cigarettes.”
That conclusion puts the Italian ruling at odds with the direction of travel at the US Food and Drug Administration, which continues to describe tobacco risk as a spectrum. The FDA says combustible products such as cigarettes are the most harmful, while non-combusted products, including vapes, smokeless tobacco and heated tobacco, generally carry lower health risks than cigarettes.
What the Italian regulator found
The case centred on Philip Morris Italia’s use of claims such as “smoke-free”, “smoke-free products” and “building/planning/accelerating a smoke-free future” across a wider marketing strategy for combustion-free tobacco products.
According to the authority, those claims misled consumers, including minors, into believing the products were harmless to health or less harmful than other tobacco products, particularly traditional cigarettes.
The products covered by the decision included heated tobacco devices, vapes used with liquid refills and oral nicotine products. The authority said they may still produce vapours, emissions or aerosols, contain tobacco and/or nicotine, and may create dependence.
The finding followed an investigation prompted by Italy’s Ministry of Health.
The authority said: “The evidence acquired during the inspection and during the investigation rather indicate that a lower harmfulness or non-harmfulness of these products is not at all demonstrated in the light of current scientific/clinical knowledge, also for the presence of nicotine.”
Philip Morris Italia has been ordered to report “within sixty days of notification of the measure” on the steps it has taken to stop the practice.
Why this matters to harm reduction
The ruling lands in the middle of a bigger regulatory dispute over how governments should talk about safer nicotine products.
The FDA’s own public health material is clear that nicotine is addictive, and that no tobacco product is safe. But it also separates addiction from the main causes of smoking-related death, saying the greatest harms come from the thousands of chemicals in tobacco and tobacco smoke.
The FDA has also renewed modified risk orders allowing specific IQOS products to be marketed in the US with reduced-exposure claims, after concluding that switching completely from cigarettes to IQOS can significantly reduce exposure to harmful or potentially harmful chemicals.
In January 2025, the FDA also authorised 20 ZYN nicotine pouch products after a scientific review, saying the authorised products posed lower risks of cancer and other serious health conditions than cigarettes and most smokeless tobacco products because they contained substantially lower amounts of harmful constituents.
The Italian decision takes a much more restrictive view. It treats “smoke-free” style language as capable of misleading consumers because it may be understood as a health claim, even when linked to products without combustion.
A clash over consumer understanding
The authority also rejected the idea that “smokeless” or “smoke-free” wording can be defended simply because similar terminology appears in regulation.
In its decision, it drew a distinction between technical classification and consumer-facing advertising. A regulatory category used by experts, it said, cannot simply be turned into a marketing slogan for the general public.
That is the core tension. Regulators such as the FDA increasingly acknowledge that nicotine products carry different levels of risk. Italy’s competition authority has now ruled that, at least in commercial marketing, claims built around the absence of smoke may still mislead consumers unless the health implications are proved and clearly explained.
For an industry built around moving smokers away from combustion, the ruling is more than a fine. It’s a direct challenge to one of the central phrases used to describe the shift from cigarettes to lower-risk nicotine products.
Note: quotes are translated from Italian.
