Philip Morris International’s (PMI’s) nicotine pouches, typically commercialized as ZYN, are smokeless products that provide nicotine orally. Because they do not burn tobacco, they provide nicotine with significantly fewer and lower levels of harmful chemicals and lower toxicity compared with combustible products like cigarettes. Epidemiological evidence from Sweden demonstrates that snus use is linked to reduced health risks compared with smoking. Since nicotine pouches, provided they adhere to strict manufacturing requirements, have an even lower toxicant profile than snus, it is reasonable to expect that they are significantly less harmful than cigarettes and, from a toxicological perspective, less harmful than snus. Learn more here about the science behind PMI’s nicotine pouches and how they differ from other oral smokeless products.
Nicotine pouches are permeable sachets that contain nicotine combined with components such as flavorings and fillers. PMI’s nicotine pouches come in various sizes, shapes, weights, moisture content, flavors, and nicotine strengths.
The nicotine pouch is placed between the upper lip and gums, and the duration of use is determined by individual user preferences. During this time, nicotine is extracted into the saliva and absorbed through the oral mucosa into the bloodstream.
The main ingredients in nicotine pouches are nicotine, binders and/or fillers, pH adjusters, water for moist products, and flavorings, all at varying concentrations, depending on the product considered and the market where it is commercialized.
The nicotine used in PMI’s nicotine pouches is pharmaceutical grade and is extracted from tobacco leaves. The German Institute for Risk Assessment (BfR) recommends an upper limit of 16.6 mg of nicotine per pouch, and our products fall in this range.
Nicotine pouches contain fillers and stabilizers to help modulate the rate of nicotine and flavor release, the sensory experience of the pouch inside the mouth, and the moisture content. They include:
Nicotine absorption via the oral mucosa is more efficient when nicotine is in its unprotonated (i.e., free base) form, which is the predominant form at pH higher than 8. If the pH is too neutral or acidic, nicotine won’t transfer through the oral mucosa and if the pH is too basic, it may increase oral irritation. Therefore, pH adjusters such as sodium carbonate (sometimes in combination with sodium bicarbonate or calcium chloride) are used to adjust the pH of the pouches to reach absorption levels within the desired range.
Food-grade flavors and/or sweeteners are used to differentiate the products and cater to diverse preferences and tastes of adult users. Salt is also added to moist products to enhance flavor and prevent the growth of bacteria.
Serving as a holder for the nicotine-containing substrate, the pouch is made of a nonwoven, permeable material to allow the release of nicotine.
The harm reduction profile of nicotine pouches is supported by the extensive research on Swedish snus, as well as harm reduction data specific to nicotine pouches. This provides clear empirical evidence that these products have a potential to positively impact public health when used as substitutes for more harmful forms of tobacco and nicotine use, such as cigarettes.
Our nicotine pouches contain significantly fewer and lower levels of harmful chemicals than cigarette smoke and fewer and lower levels than other oral tobacco products (e.g., dipping tobacco, chewing tobacco, and snus).
The scientific evidence supporting the role of nicotine pouches in tobacco harm reduction is substantial. For example, in one study, nicotine pouches were found to have substantially lower numbers and levels of harmful and potentially harmful constituents (HPHCs), compared with cigarette smoke, and had similar toxicant levels to oral nicotine replacement therapy (NRT) products such as gum and lozenges.
In a separate study, PMI researchers analyzed 36 HPHCs in two formulations of PMI’s nicotine pouches. For comparison, the same screening was conducted on other oral tobacco products (Swedish Match’s snus and moist snuff) as well as NRT products—lozenges and gums. In PMI’s nicotine pouches, most HPHCs were below the limit of quantification, with only a few detected, all at consistently significantly lower levels than the other oral tobacco products tested. These results were comparable to those observed for the tested NRT products. Importantly, tobacco-specific nitrosamines (TSNAs), classified as Group 1 carcinogens by the International Agency for Research on Cancer (IARC), and polycyclic aromatic hydrocarbons (PAHs), were below the level of quantification in both PMI’s nicotine pouches and NRT products. PMI’s nicotine pouches also released fewer and lower levels of HPHCs compared with Swedish Match’s snus.
PMI has also conducted in vitro studies assessing mutagenicity and genotoxic potential of our nicotine pouch as part of the premarket tobacco product application (PMTA) to receive marketing authorization from the U.S. Food and Drug Administration (FDA). These studies found that our nicotine pouches do not demonstrate mutagenic and genotoxic potential, in contrast with cigarette smoke.
More recently, PMI researchers measured toxicity levels in extracts from cigarette smoke, Swedish snus, nicotine pouches, and loose moist snuff. None of the extracts from the five nicotine pouches tested induced cytotoxicity or gene expression responses to cellular damage and stress.
In addition, participants in studies on nicotine pharmacokinetics have generally reported a comparable reduction in the urge to smoke between nicotine pouch use and smoking cigarettes, indicating that nicotine pouches may be an acceptable substitute to cigarettes for adult smokers.
Clinical evidence is provided by a study comparing the levels of biomarkers of exposure to specific HPHCs in cigarette smoke and biomarkers of potential harm linked to the onset of smoking-related diseases in exclusive users of nicotine pouches and cigarette smokers. Results show that exposure to HPHCs is substantially lower in nicotine pouch users than in smokers, and pouch users exhibit favorable changes in biological pathways negatively impacted by smoking.
On January 16, 2025, the FDA authorized the marketing of 20 different varieties of PMI’s nicotine pouch through the PMTA pathway. After an extensive scientific review, the FDA concluded these products meet the regulatory public health standard as appropriate for the protection of public health.
The FDA noted that “Among several key considerations, the agency’s evaluation showed that, due to substantially lower amounts of harmful constituents than cigarettes and most smokeless tobacco products, such as moist snuff and snus, the authorized products pose lower risk of cancer and other serious health conditions than such products.” The FDA also stated, “In addition, based on evidence suggesting the potential for reduction in lung cancer risk following significant reduction in cigarettes per day, the new products may also pose a benefit to adults who switch and significantly reduce their cigarette use.”
Based on the totality of evidence available, fully switching to nicotine pouches is deemed less harmful than smoking cigarettes. Nicotine pouches are not risk free and contain nicotine, which is addictive. The best choice any smoker can make is to quit all forms of tobacco and nicotine use altogether.
