New era: a milestone in the fight against smoking

The FDA’s Tobacco Products Scientific Advisory Committee (TPSAC) is now examining the scientific evidence to recognize nicotine patches as a modified-risk tobacco product (MRTP). The FDA is reviewing the classification, and the American organization negotiated with the manufacturer in the last week of January. The possible classification could also have an impact on European markets, although the composition and distribution of nicotine patches in Hungary are already strictly regulated.

It is noteworthy that the director of the FDA’s Office of Science has assessed that the claim that switching from traditional cigarettes to nicotine patches has more benefits than risks in the case of a complete switch from cigarettes is well-founded. An important detail of the agency’s observations is that the use of nicotine patches among young people is currently low, and the reduced risk claim examined did not increase the intention to use among young adults.

Tobacco and smoke-free, more favorable risk profile

A nicotine patch is a smokeless, nicotine-containing product containing nicotine salts but no tobacco, which the user places between the upper lip and gum. In this way, nicotine is absorbed through the mucous membrane of the mouth and enters the bloodstream, without – due to its smokelessness – the harmful substances resulting from combustion typical of traditional cigarettes, such as tar or carbon monoxide, being produced. This difference sharply separates nicotine patches from traditional combustible tobacco products from a health perspective.

According to data provided to the FDA, nicotine patches provide lower exposure to harmful substances for adult smokers than cigarettes and may facilitate a complete transition from cigarettes. After marketing authorization, MRTP designation could formally recognize a more favorable risk profile compared to cigarettes and allow this to be communicated to adult consumers.

According to industry experience, the majority of smokers who switch to nicotine patches have significantly reduced their daily cigarette consumption, and a significant number have quit smoking altogether. It is important to emphasize, however, that future results may be affected by regulatory, tax, market, legal and geopolitical risks. In any case, the FDA already expressed the public health benefits of nicotine patches with its decision in January 2025.

Swedish example: it doesn’t matter if it’s firecrackers or dynamite

The nicotine patch is a smokeless evolution that can be considered an improved version of Swedish snus. The traditional Scandinavian solution – pasteurized, orally administered, without burning – was the first oral tobacco product to receive MRTP approval from the FDA in 2019, and has been linked to Sweden’s low smoking rates and a decline in smoking-related diseases.

Karl Erik Lund, a researcher at the Norwegian Institute with decades of experience, stated in the columns of Aftenposten that the majority of the health risks of smoking are not related to nicotine itself, but to combustion, which is why snus and cigarettes can be compared like firecrackers and dynamite. The nicotine patch takes this logic further: it delivers nicotine to the body through the mouth, without burning or smoke, which significantly reduces the formation of harmful and potentially harmful compounds compared to cigarettes.

Strict Hungarian regulation

In Hungary, the composition and distribution of nicotine patches are already strictly regulated in order to enforce public health protection goals: one patch can contain a maximum of 17 milligrams of nicotine, and a box can contain a maximum of 20 patches. The product packaging is child-resistant, thus reducing the risk of accidental access by children. It can be stated that the domestic framework is stricter than the regulations currently planned or applied in many other European countries, and aims to minimize the risks of nicotine addiction, while providing the opportunity for the use of smoke-free alternatives among smokers.