July 2026: Questions Raised Over ZYN Safety Review Following Former FDA Scientist’s Claims
Questions have been raised over the safety review of Philip Morris International’s ZYN nicotine pouches after a former U.S. Food and Drug Administration (FDA) toxicologist alleged that the agency authorized the products without fully determining the composition of the pouch material or adequately evaluating potential microplastics exposure.
According to an investigation published by STAT News and The Examination, a former FDA toxicologist claims the agency failed to determine what ZYN’s pouch material was made of before granting marketing authorization in January 2025. The toxicologist, who worked at the FDA’s Center for Tobacco Products, alleged that concerns over the possibility that the pouches could shed microplastic particles during use were dismissed during the review process. The former FDA scientist argued that the FDA should have required additional information from the manufacturer regarding the pouch material and its potential health and environmental impacts before completing its scientific review.
The FDA rejected suggestions that it had overlooked the issue, telling The Examination that its review “did not identify new or additional concerns about the ingredients/materials of these products specifically.” However, the agency did not disclose the composition of the pouch material when asked by the publication. Philip Morris International also declined to specify the material, although its website describes the pouches as being made from cellulose, or plant fiber.
The allegations come just weeks after the FDA granted modified-risk orders allowing 20 ZYN nicotine pouch products to be marketed with claims that completely switching from cigarettes to the products reduces the risk of developing several smoking-related diseases. The agency said its decision followed an extensive scientific review and concluded that the modified-risk claims were supported by the available evidence and would benefit the health of the population as a whole.
Researchers interviewed by The Examination said there is currently little published research on whether nicotine pouches release microplastics during use or whether any such exposure poses health risks. While some scientists noted that semi-synthetic cellulose materials could potentially shed microscopic particles under certain conditions, they also acknowledged that direct evidence relating to nicotine pouches remains limited. Former FDA officials cited in the investigation argued that the composition of every component of a tobacco product should be evaluated as part of the agency’s premarket review.
The allegations are likely to intensify scrutiny of the FDA’s review of nicotine pouches at a time when the category is experiencing rapid growth in the United States and internationally. They do not, however, establish that ZYN poses previously unidentified health risks, and neither the FDA nor independent researchers have concluded that users are exposed to harmful levels of microplastics from the products.
September 2025: Nicotine pouches are becoming popular in the U.S., especially among people trying to quit smoking
A new study1 suggests nicotine pouches — small, tobacco-free packets placed under the lip — may be catching on among smokers and other nicotine users looking for an alternative. Researchers analyzed data from more than 110,000 U.S. adults in the 2022–2023 Tobacco Use Supplement to the Current Population Survey and found that 2.65% had ever tried nicotine pouches, 0.42% were current users, and 0.18% used them daily.
Use isn’t evenly spread across the population. Men were far more likely to use pouches than women, and non-Hispanic White adults reported higher usage than other racial or ethnic groups. Pouch use was more common in the western U.S., and young adults aged 18–24 were the most likely to have ever tried one — though daily use was concentrated among slightly older adults.
The biggest predictor of pouch use was a history of nicotine use. People who use nicotine pouches tend to already be smokers, vapers, or smokeless tobacco users. Occasional smokers were 2.4 times more likely to use pouches, occasional vapers were 3.9 times more likely, former smokers were 3.9 times more likely, and smokeless tobacco users were more than 10 times as likely to use pouches compared with people who had never used those products. Daily pouch use was particularly common among people who had quit smoking since 2019, suggesting pouches may help some recent quitters stay off cigarettes.
Crucially, uptake among nicotine-naive adults was nearly zero, easing concerns that pouches are attracting large numbers of people who might otherwise have avoided nicotine altogether. Still, the researchers caution that the data are cross-sectional and self-reported, meaning it’s impossible to say whether pouches directly caused people to quit smoking. As nicotine pouch sales grow and the FDA begins authorizing some products for sale, the study highlights the need for continued monitoring to see whether they play a meaningful role in harm reduction – or simply add to nicotine dependence.
August 2025: Nicotine pouches can efficiently deliver nicotine in a dose/time-dependent manner
A British American Tobacco (BAT)-financed study investigates how efficiently oral nicotine pouches (NPs) deliver nicotine in different strengths and usage durations – an important consideration for their potential application in tobacco harm reduction2. Although not risk-free, such products might offer an alternative to combustible tobacco if they provide sufficient nicotine satisfaction.
Researchers conducted a seven-way randomized crossover pharmacokinetic (PK) study in healthy individuals who were already oral pouch users. The study assessed VELO Freeze nicotine pouchesin two nicotine strengths, 11 mg and 20 mg; each used for 10, 20, or 30 minutes, plus an additional condition where the 20 mg pouch was used for 30 minutes with saliva expulsion.
Key findings of the study include:
– Nicotine delivery increased with both nicotine strength and usage duration: maximum plasma concentration (Cₘₐₓ) ranged from 18.9 to 21.6 ng/mL for the 11 mg pouches and 26.7 to 33.6 ng/mL for the 20 mg, while the area under the concentration-time curve (AUC₀–₄ h) rose from 24.6 to 43.0 (11 mg) and from 36.4 to 65.6 h·ng/mL (20 mg)
– Extraction of nicotine from the pouch increased with time, but the proportion was higher for the lower strength: at 10 minutes, 28.0% of nicotine was extracted from the 11 mg pouch versus 22.4% from the 20 mg; at 30 minutes, these figures were 43.7% and 36.9%, respectively
– Minimal amounts of nicotine, flavorings, and sweeteners were swallowed. Only about 1.8% of nicotine ended up in saliva during 30-minute use. For the 20 mg pouch over 30 minutes, 30.1% of flavor components and 17.3% of sweeteners were extracted, but extremely little appeared in saliva – just 0.16% and 3.4%, respectively.
Study concludes that oral nicotine pouches can efficiently deliver nicotine in a dose-dependent and time-dependent manner during typical use, with very limited ingestion of nicotine, flavors, or sweeteners. This delivery profile suggests that smokers switching completely to pouches may be able to maintain their usual nicotine intake under normal usage patterns.
July 2025: ZYN nicotine pouches deliver nicotine more effectively than moist snuff
In a study, supported by the Food and Drug Administration’s Center for Tobacco Products among others, researchers assessed whether the proportion of freebase nicotine (FBN) in oral nicotine pouches influences nicotine delivery and craving relief compared to conventional moist snuff (dips)3. Conducted with 62 exclusive moist snuff users, researchers compared three conditions: a low freebase nicotine pouch (Rogue Peppermint 6mg; 27% FBN, 5.1 mg nicotine), a high-FBN pouch (ZYN Peppermint 6 mg; 70% FBN, 5.0 mg nicotine), and participants’ usual moist snuff, each administered across three 90-minute sessions with ≥48-hour washout.
In a controlled clinical setting, participants adhered to a minimum 12-hour nicotine abstinence before each 30-minute product use. Plasma nicotine and self-reported craving were measured at baseline and four subsequent time points (5, 15, 30, 60, and 90 minutes), with primary endpoints at 30 minutes: (a) plasma nicotine concentration, and (b) craving relief scores.
At the 30-minute mark, the high-FBN ONP delivered the highest mean plasma nicotine level at 14.8 ng/mL (SD 6.4), significantly outperforming low-FBN ONP (7.1 ng/mL) and moist snuff (12.3 ng/mL). This outcome underscores the direct correlation between FBN proportion and nicotine bioavailability, aligning with mechanistic evidence that increased unprotonated nicotine enhances mucosal absorption. Craving was lower for moist snuff (mean = 0.8) than either nicotine pouches (means = 1.4), with the low FBN nicotine pouch providing statistically significantly less craving relief than moist snuff. The findings suggest that user-perceived craving relief may depend on factors beyond plasma nicotine levels, such as oral sensory effects and delivery kinetics.
The proportion of freebase nicotine in oral nicotine pouches appears to statistically significantly influence their nicotine delivery, with higher freebase nicotine oral nicotine pouches delivering more nicotine than usual brand moist snuff. However, craving appears to be higher when using oral nicotine pouches than usual brand moist snuff. The study highlights that manipulating freebase nicotine levels in niotine pouches can optimize nicotine delivery, potentially enhancing their utility as a reduced-harm alternative to smokeless tobacco. However, the diminished craving relief – despite higher nicotine concentrations – signals that product design must holistically address both pharmacokinetic and sensory dimensions. For developers and regulators, balancing freebase nicotine content with user experience is critical to maximizing nicotine pouch’s competitive positioning and public health impact. Future R&D efforts may focus on optimizing product pH, release profiles, and formulation to reconcile both delivery efficiency and consumer satisfaction.
July 2025: Scrutiny on collateral risks associated with nicotine pouches intensifies
In parallel to the rising popularity of nicotine pouches like ZYN, there’s been a growing body of scientific research and extensive media coverage highlighting unintended and harmful consequences (“collateral risks”) – especially for vulnerable populations, such as children and pets. A study published in Pediatrics, based on Poison Control Center data, recorded 134,663 exposures of children under 6 to nicotine products from 2010 – 2023, with nicotine pouches showing the steepest increase: a 763 % rise from 2020 to 2023 (- pretty much in line with the sales volume increase). However, two deaths reported in toddlers is due to liquid nicotine ingestion and most cases caused mild symptoms like nausea or vomiting. Nevertheless, 1.2 % led to severe outcomes, such as seizures, and of these exposures, nicotine pouch ingestion was 1.5 times more likely to cause serious health effects than other nicotine forms.
In absolute terms, a single tin of ZYN (15 pouches at 3mg or 6 mg each) contains 45-90 mg of nicotine while higher-concentration pouches can exceed 15 mg per pouch and 300 mg per can. The National Library of Medicine suggest that ingestion of just 1-2 mg nicotine (less than one pouch) can trigger vomiting, tremors, high heart rate, and seizures for kids. Estimated lethal dose can be as low as 10 mg as kids are far more sensitive to nicotine than adults. Altough the lethal dose of nicotine is widely quoted as 50–60 mg for adults, but modern research suggests that adults can sustain up to 500–1,000 mg nicotine ingestion, depending on individual sensitivity and route of exposure. However, symptoms of nicotine poisoning can occur as low as 2–5 mg nicotine absorbed. For dogs, lethal dose of nicotine is estimated as 9–12 mg/kg while signs of toxicity can occur at 1 mg/kg and severe poisoning is observed at doses above 4 mg/kg. Cats are known to be slightly more sensitive to nicotine than dogs and toxic effects can be observed at lower doses.
Following widespread media coverage on the issue, ZYN-owner, Philip Morris International (PMI) issued a statement noting that each ZYN can features a warning about keeping the product out of the reach of children and ZYN packaging is designed be child-resistant.
Significant amounts of artifical sweeteners detected in nicotine pouches sold in the U.S.
Duke University researchers detected significant amounts of artifical sweeteners in popular nicotine pouches sold in the U.S. Acesulfame-K is identified in ZYN, on! and some VELO pouches. Acesulfame-K, also know as Acesulfame potassium or Ace-K, is a synthetic calorie-free sugar substitute (artificial sweetener) often marketed under the Sunett and Sweet One trademarks. In the European Union, it is known under the additive code E950. Another artificial sweetener, Sucralose (E955), is identified in other VELO pouches. Sucralose is about 600 times sweeter than sucrose (table sugar) and 3 times as sweet as both Ace-K.
Popular nicotine pouch brands already note sweeteners in the list of ingredients. This is no secret! However, based on the fact that some artificially sweetened nicotine pouches – such as ZYN Chill and ZYN Smooth – are marketed as “Unflavored” of “Flavor ban-approved”, researchers underline the Industry’s rejection of sweet taste as a determinant for the presence of a characterizing flavor. Moreover, researchers call on U.S. FDA to treat sweetness imparted by artificial sweeteners as a component of a characterizing flavor, with the aim to reduce product appeal and initiation by never users, and especially youth attracted to sweet flavors.
Nicotine Pouch Awareness Among US Adults
According to a recent study commissioned by the Center for Tobacco Research at the Ohio State University, only 25% of adults could identify a nicotine pouch if they saw them although 70% believe nicotine pouches are harmful to health and lead to addiction4. Moreover, the survey also found that those between the ages of 18–29 are more likely to know someone who uses nicotine pouches, as opposed to the older adults. They survey was conducted from July 19-22, 2024, among a sample of 1,008 adults. Respondents were asked about their ability to recognize nicotine products with and without the visual aid of packaging, as well as their perceptions about the health effects of these products.
Researchers are concerned that nicotine pouches could be a gateway to nicotine addiction for Gen Z as the easy of use and availability in low- and high-nicotine concentrations make these products appealing to both new users and existing nicotine users. Researchers note that flavor restrictions, prohibiting online sales and increasing the price could discourage youth experimentation and, therefore, reduce their risk of becoming addicted to nicotine.
Prevalence of Nicotine Pouch Use Among US Adults
According to the findings of a study based on a nationally-representative sample5 (September 2022 data) and funded by the National Institutes of Health (NIH), only 2.9% of adults in the USA had ever used nicotine pouches with 0.4% reporting current use.
Both the “ever use” and “current use” occurrences are higher among the current smokers (10.8%-1.0%) and former smokers (6.7%-0.7%) compared to the never smokers (1.1%-0.2%). Nicotine pouch use, both past and present, is markedly higher among non-Hispanic white men. Moreover, among current smokers who tried to quit in the past year, more reported trying to switch to e-cigarettes (21.6%) than nicotine pouches (5.2%) to help them quit.
Despite a 641% increase in sales between 2019 and 2022, the prevalence of nicotine pouch use remains low among the US adults. Researchers question whether the nicotine pouches are
– mostly sold to the adolescents who are not represented in the sample
– used to “top off” nicotine in situations where other tobacco products cannot be consumed.
Researchers estimate that current nicotine pouch users are composed of current smokers (25%), former smokers (35%) and never regular smokers (40%).
The study is part of the USC Tobacco Center of Regulatory Science, one of seven national centers supported by the NIH and the US FDA to collect evidence that can inform tobacco product regulation.
References:
- https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2838608 ↩︎
- https://accp1.onlinelibrary.wiley.com/doi/epdf/10.1002/jcph.70090 ↩︎
- https://onlinelibrary.wiley.com/doi/10.1111/add.70114 ↩︎
- https://medicalxpress.com/news/2024-09-survey-nicotine-pouches-skyrocketing-popularity.html ↩︎
- https://jamanetwork.com/journals/jama/article-abstract/2820917 ↩︎
