FDA approval of 20 nicotine pouch products is another step forward for tobacco harm reduction
The FDA in the U.S. has granted marketing authorisation for Zyn nicotine pouch products (five variations on mint plus five other flavours in two different strengths).
In its letter to PMI (who own Zyn manufacturers Swedish Match), the FDA wrote:
Based on our review of your MRTPAs [Modified Risk Tobacco Applications] we determined that the proposed modified risk tobacco products, …as actually used by consumers would significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products. Therefore, we authorize marketing of the tobacco products as modified risk tobacco products with the following modified risk information – “Using ZYN instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema and chronic bronchitis”.
While generally welcoming the FDA decision as a big win tobacco harm reduction, there has been some debate among THR experts about the public messaging. The ‘lower risk’ wording is the same as applied to General snus products (Swedish Match’s line of snus products in the U.S.).
General snus had already been legally sold in the U.S. since 2015 through the PMTA pathway but could not make reduced-risk health claims. The key change came in 2019 when the FDA issued the first-ever MRTP (Modified Risk Tobacco Product) orders for tobacco products, applied to eight General snus products. This allowed the manufacturer to state that switching completely from cigarettes to these snus products reduced risk of certain diseases compared with smoking: the first time the FDA permitted a tobacco product to be marketed with a reduced-risk claim. For convenience, the company recommended the same wording for Zyn.
However some experts argue that this could still confuse current smokers that using pouches puts them at a lower risk of these diseases when there is no evidence to support any direct link between pouch use and these diseases. Nor is there any indication of how much lower the risk is. PMI are mandated to conduct consumer-focused post-market surveillance specifically, “assessing behaviour and consumer understanding of the claim at multiple time points”. So we’ll see.
Since 2020, nicotine pouches have made serious inroads into the US non-combustible market. One market research analysis indicates use has increased around fourfold; market value has risen from USD 1 billion to around USD 5 billion with sales volumes tripling even in the past few years. Vaping remains the larger nicotine category, with roughly 17–18 million adult users versus 5–8 million pouch users, but pouch sales are currently growing much faster than vape sales.
The most frequently cited advantage by consumers is that pouches can be used almost anywhere. They produce no visible aerosol or vapour, have virtually no odour, can be used indoors or in places where vaping is prohibited and attract little attention from others. This makes them particularly attractive in workplaces, public transport, restaurants, and during travel.
Many consumers say they prefer not inhaling anything, avoiding coughing or throat irritation, and avoiding concerns about long-term respiratory effects. Some former vapers switch because they dislike inhaling aerosol or have experienced respiratory discomfort.
Pouches require no charging, batteries, coils, e-liquid or maintenance. A can of pouches typically contains 15–20 pouches that are ready to use immediately. Consumers cite longer nicotine delivery: many pouches release nicotine over 20–60 minutes. Consumers often describe the nicotine effect as less repetitive than taking frequent puffs from a vape. This can make quitting smoking feel like a more complete behavioural change.
But despite the growth of pouches, vaping remains more popular overall because many users value faster nicotine delivery, a stronger "hit", the hand-to-mouth ritual like smoking, a wider variety of flavours and the sensory experience of inhaling vapour. For smokers trying to quit, that behavioural similarity can make vaping a more acceptable substitute.
Naturally, the key poster argument against any relaxation of non-combustible product regulations is the kids. However even the FDA admit that “current evidence shows the relatively low risk of youth initiation of nicotine pouch use”.
The 2025 annual U.S. National Youth Tobacco Survey indicated less than 2% of middle and high school students reported using nicotine pouches in the previous 30 days which would have included one-time use. The FDA concluded that youth nicotine pouch use remained low and stable between 2024 and 2025. Several studies have found that pouch use is increasing among certain groups rather than across all teenagers - use was highest among: boys, white adolescents and rural students. This would be in line with the traditional use of oral tobacco among America’s rural white population.
Oral tobacco use originated as a dominant form of tobacco use in agrarian and frontier economies reinforced by military service and manual labour culture. Use peaked in the late 19th and early 20th centuries and declined with cigarette dominance but persisted regionally and has partially transitioned into modern nicotine pouch use.
In a wider context, the anti-THR lobby has been hopping up and down about White House interference with the FDA which forced its hand on authorising fruit-flavours and sent FDA Commissioner Makary looking for a new job. Clearly, science should be free of political interference, but that only happens in a galaxy far, far away. It certainly doesn’t happen in the USA where those in the pockets of Big Philanthropy pile on the political pressure to push through state-level anti-THR legislation.
Organisations like the American Lung Association (ALA) have rightly attacked the tobacco industry for years for consistently lying about the dangers of their product. But hang on, the ALA is now “appalled’ that the FDA is allowing the industry to tell the truth about the relative safety of a non-combustible tobacco product. You just wonder if their outrage has anything to do with the undisclosed financial donations and sponsorships they receive from the likes of Pzifer and GKN who manufacturer guess what: smoking cessation products and medicines. But there is probably more at play here – such as some heightened moral agenda against recreational use of nicotine now that it can be delivered at much lower risk than smoking.
Meanwhile the FDA decision has consolidated Zyn’s position as brand leader and hopefully will encourage more current smokers to switch. Game, set – and match.