With two young kids at home and a yearning to live healthier, 38-year-old Ian P. decided in January 2025 to kick his long-time smoking and vaping habit. “I tried nicotine gum first but it wasn’t giving me enough nicotine. My cravings were very strong,” he says. “I’d seen Zyn around and thought it might be a better option.”
Gaining considerable traction on social media and particularly popular with young men in the U.S., Zyn is not a Food and Drug Administration (FDA)-approved smoking cessation aid. It is the leading brand of a booming new category of smokeless tobacco products called oral nicotine pouches (ONPs), which sell at gas stations, convenience stores and through online retailers worldwide.
Tucked between the lip and gum, these small, teabag-like sachets hold powdery white nicotine salt, which is gradually released into the bloodstream through the lining of the mouth. Because they don’t contain actual tobacco leaves and aren’t burned, ONPs lack many of the carcinogens found in traditional tobacco products.
ONPs are a cornerstone in what the tobacco industry is promoting as a “harm reduction” strategy that gives smokers apparently safer ways to consume nicotine. They have also been a financial boon for an industry that has seen cigarette sales steadily decline over the past several decades.
In 2024 alone, Zyn owner Philip Morris International sold 581.4 million cans of the product in the U.S. and generated $1.88 billion in net revenue. Zyn is now the fourth leading nicotine product in the U.S. behind Marlboro, Newport, and Camel, but ahead of all other cigarette brands.
The Long, Shady Road to FDA Authorization
ONPs first started selling in the U.S. about a decade ago. This was done without FDA marketing authorization, which is required to legally market any new tobacco product in the U.S.
With shockingly little pushback from authorities and regulators, ONPs built a considerable following and sold outside the regulatory framework for years. This includes the nearly five-year-long period during which the FDA was considering marketing authorization applications from major tobacco companies for Zyn and other ONPs like Velo and on!
To the dismay of anti-tobacco public health advocates, in January 2025, Zyn became the first ONP officially greenlighted by the FDA to sell in the United States.
In its long-awaited decision to authorize the sale of 20 flavors and strengths of Zyn, the FDA pointed to research (in good part industry-funded) suggesting that Philip Morris International’s nicotine-filled sachets offered “greater benefits than risks” to adults who “use cigarettes and/or smokeless tobacco products and completely switch to these products.”
A Mouthful of Zyn, a Heart Full of Regret
On these grounds, Ian P. should have been an ideal Zyn candidate. But he considers his crossover to oral nicotine pouches — as opposed to staying with an FDA-approved smoking cessation aid like nicotine gum or patches that could have helped him quit nicotine altogether —“one of the stupidest decisions” of his life.
“The pouches were so convenient, I ended up with one under my lip from the moment I got up until I went to bed. After a few months, I had to go to a higher strength pouch to satisfy my cravings,” says Ian.
“The pouches were so convenient, I ended up with one under my lip from the moment I got up until I went to bed. After a few months, I had to go to a higher strength pouch to satisfy my cravings.”
Like others in the thousands-strong “QuittingZyn” support group he’s part of on Reddit, Ian began to struggle with digestive issues and insomnia at the peak of his addiction. “I decided to quit. But it’s been a nightmare,” he says. During his months-long withdrawal, Ian experienced anxiety, heart palpitations, and panic attacks severe enough to land him in the emergency room.
Who’s Really Using Zyn
As much as he has struggled, Ian — who says he hasn’t resumed smoking and is determined to quit his nicotine habit entirely — may be a best-case scenario when it comes to oral nicotine pouches. That’s because a considerable portion of buyers aren’t using these products in the way the FDA described in its authorization decision.
A glimpse of high school athletic fields littered with spent pouches (despite a federal law banning sales of tobacco products to people under 21), young adults lining up for dollar-a-can Zyn at industry-sponsored festivals, and Tik-Tok “Zynfluencers” raving about the “buzz,” “hyperfocus,” and athletic performance boost that “Zynning” supposedly provides, gives a pretty good idea of how wide the appeal has spread. (Zyn’s hockey-puck-shaped container has even been pictured in the hands of Health and Human Services Secretary Robert F. Kennedy Jr.)
Marketing data reflect the growing popularity of ONPs. Between July 2021 and May 2024, unit sales tripled. Market forecasters expect ONP sales in the U.S. to top $49 billion, a meteoric rise from the already significant $3.95 billion racked up in 2024. With the FDA’s recent announcement that it will fast-track the authorization process for other ONP brands, those numbers may well go higher.
A supposed harm-reducing product becoming an addictive phenomenon in and of itself isn’t without precedent.
“We saw the same thing with vaping, which was touted as a way to help adults stop smoking. But we ended up with an epidemic of vaping among high school kids and young adults who weren’t smokers in the first place,” says John Maa, M.D., who sits on the advisory committee of the University of California Office of the President’s Tobacco Related Disease Research Program. “Zyn is worse because of this myth about its performance enhancement.”
Among other research reaching similar conclusions, a 2023 study published in the International Journal of Environmental and Public Health “did not report any improvement in physical performance” in subjects who were orally administered high doses of nicotine.
Perceived performance benefits aside, Zyn’s appeal extends beyond big tobacco’s ‘harm reduction’ strategy. Based on findings from a nationally representative survey, a researcher from the University of Southern California Keck School of Medicine estimated that of all people who used Zyn and other ONPs in 2022, 25% were smokers who continued to smoke. A considerable 40% had never been regular smokers.
Even more concerning, another USC study showed that ONP and dual ONP/e-cigarette use among high school students nearly doubled between 2023 and 2024. New data from the CDC Foundation shows that use by individuals 27 and under has nearly quadrupled since 2022.
This amounts to a considerable number of people regularly lodging a relatively new, addictive nicotine product under their lip that has an astonishingly short track record when it comes to side effects and long-term safety. “In its decision, the FDA focused on lowering risk to current smokers but discounted the potential harm of addiction in a new generation of young users,” says Daniel G. Aaron, M.D., JD, associate professor of law at the University of Utah S.J. Quinney College of Law.
Here’s what to know and — equally important — what’s not known about this rising form of nicotine addiction.
What Exactly Are Oral Nicotine Pouches?
ONPs are similar to snus, another smokeless, spitless oral pouch that has come in and out of fashion in Scandinavia over the past two centuries. The dominant producer is Swedish Match, which Philip Morris International acquired in 2022. Snus are filled with powdered tobacco and are also meant to be tucked under the lip. They have gained considerable popularity in recent years, with 22% of Swedish males and 10% of females aged 16-84 reporting daily use. Proponents claim that consumer conversion to snus has contributed to Sweden’s declining smoking rate
s, which are among the lowest in Europe. Critics, however, link low smoking rates to Sweden’s strict smoking bans and see snus as a way for smokers (and tobacco companies) to work around government restrictions.
Swedish Match still makes traditional snus but introduced Zyn in 2014. Often referred to as “white snus,” Zyn was positioned as a healthier, tobacco-free product that might have a particular appeal to women. Numerous competitors soon entered the market, with leading brands coming from major tobacco companies.
In the U.S., oral nicotine pouch users are predominantly male. The pouches are promoted as “spitless” because you’re meant to swallow saliva that’s produced while using them and discard them after about 20-40 minutes, when the nicotine inside is “spent.”
ONPs come in varying strengths, ranging from about 3 milligrams of nicotine per pouch to 30 milligrams, and even more in brands that are sold online. The higher the milligrams, the greater the potency and the more potentially addictive ONPs can be.
In addition to nicotine, ONPs contain sweeteners and flavorings, which help mask the bitterness of nicotine and, assert concerned public health advocates who saw the same situation with vaping, enhance their appeal to underage users.
With this in mind, the FDA limited the variety of flavors of Zyn that can legally be sold in the U.S., and strengths are limited to 3 and 6 milligram products. Still, shops and online stores peddle a wide variety of unauthorized ONP options, including 9 milligram “European” Zyns in youth-luring flavors like chili guava, icy blackcurrant, and sour ruby.
What Is Nicotine and Why Is It So Addictive?
Nicotine is a chemical compound that occurs naturally in tobacco plants. It is not considered a direct carcinogen and isn’t the prime cancer-causing culprit in cigarettes and leaf tobacco products. It is, however, the habit-forming stimulant that makes people want to continue using tobacco products and struggle to quit them.
Initially, nicotine can deliver a pleasant buzz, a feeling of alertness and a sense of well-being. It does this by activating receptors in the brain that release feel-good chemicals like dopamine. Nicotine also triggers the release of adrenaline, which can provide a short-term energy boost. Because nicotine is a stimulant, it can cause sleep issues, especially in high doses and when used near bedtime.
Over time, nicotine — like other addictive substances — rewires the reward system in the brain. Users develop a tolerance and generally must increase their intake just to feel “normal” and avoid unpleasant symptoms of withdrawal.
Nicotine is extraordinarily addictive, and people can spend years or even decades quitting their habit and relapsing.
“Nicotine binds with dopamine receptors in the brain and it hijacks them. That means you are no longer in control physiologically and chemically,” says biochemist Jeffrey Wigand, Ph.D. “I deal with addiction patients and have more trouble getting people off nicotine than I do cocaine and heroin.”
“Nicotine binds with dopamine receptors in the brain and it hijacks them. That means you are no longer in control physiologically and chemically.”
Dr. Wigand was the key researcher and whistleblower who revealed how the tobacco industry manipulated research and engineered its products to increase addiction. His disclosures played a pivotal role in the cases brought by states’ attorneys general against tobacco companies in the 1990s. These lawsuits resulted in a historic $368 billion settlement and landmark tobacco law reforms.
What Does FDA Authorization Mean?
“FDA authorization” might sound like Zyn has been approved as a safe product to use. But that’s not the case. Philip Morris International/Swedish Match, in fact, clearly state on their website that “nicotine pouches are not risk-free.”
FDA marketing authorization means that Philip Morris International applied for and was granted the right to sell Zyn legally in the United States. To receive marketing authorization, the FDA must believe it has sufficient evidence that a new product offers greater benefits to population health than risks.
That said, “if you look at the data in the [FDA’s] Zyn decision, the focus was on the potential benefits to adult smokers and they discounted the risk to youth because, at the time, the numbers had appeared to be low,” Dr. Aaron says. “They didn’t consider how splashily these products would be marketed and how easily they would become appealing to young people.”
Even in the case of adult smokers, there’s scant real-world evidence to show that a critical mass who start using Zyn actually quit smoking and switch over to ONPs entirely. And that was the necessary condition upon which the FDA based its authorization decision.
“We’re seeing a lot of dual use,” says Dr. Maa. “Instead of quitting, people are using ONPs in situations where they can’t smoke or vape, which ends up increasing their nicotine exposure.”
Short-Term Risks of ONPs
ONP side effects and their severity can depend upon whether you’ve used other nicotine products before, the strength of the pouches you’re using, and how many pouches you go through in a given time period.
When major brands are used by adults as intended, side effects typically aren’t severe or life-threatening. But off-brand brands that contain extremely high levels of nicotine, as well as the potential for abuse by dosing numerous pouches at once, increase the risk of adverse reactions.
Known side effects include:
- High risk of addiction
- Mouth and gum irritation
- Insomnia and poor-quality sleep
- Gastrointestinal issues, including nausea, acid reflux and bloating
- Elevated heart rate and blood pressure
- Oral, facial, and body-wide swelling from an allergic response to ONPs, which requires urgent medical attention
- Altered mental status, tremors, restlessness, headache and more severe symptoms of nicotine toxicity due to overdose
- Withdrawal symptoms that include cravings, irritability, restlessness, nausea, dizziness, difficulty concentrating, sleep disruption and anxiety.
- Stillbirth, premature birth, low infant birth weight and birth abnormalities are linked to nicotine exposure during pregnancy and can cause harm to infants who are exposed to nicotine via breastmilk.
Long-Term Risks Are Less Understood
“More research is needed,” is a common refrain from tobacco and addiction experts when it comes to knowing the long-term risks of using ONPs. The reason is that ONPs are relatively new and independent research on them is limited.
“The [FDA] system puts industry in the role of submitting studies to support their products. As a result, we have many instances of companies providing biased science to support their own profit motive,” says Dr. Aaron, who worked as an assistant chief counsel at the FDA from 2020 to 2022.. Although this isn’t proven as yet to be the case with Zyn and other ONPs, tobacco has in the past presented misleading evidence about the safety of its products.
It took decades for the link between cigarettes and lung cancer to become publicly known. One in four high school students was vaping by the time health experts were aware of what vapers were inhaling and the toll it was taking on their lungs and bodies.
When it comes to ONPs:
- Can having a pouch of nicotine lodged under your lip all day, every day cause gum recession, tooth decay, and oral lesions that could become precancerous or cancer?
- Can the accelerated heart rate and high blood pressure that comes with chronic nicotine pouch use increase the risk of developing cardiovascular disease?
- Can swallowing nicotine and chemical-laden saliva impact potentially accelerate the growth of cancerous cells as it passes through the digestive tract, day after day?
- Can ongoing exposure to nicotine elevate blood sugar levels, reduce insulin sensitivity, and increase the risk of type II diabetes, as has been seen with other tobacco products?
Experts in the field think all the above and more are tangible risks, but it will take years to prove that this is the case.
In the meantime, “we are experimenting on [and addicting] a generation of young people…so that the tobacco industry can maintain profits in a market where people aren’t smoking as much,” says Thomas Carr, director of nationwide policy for the American Lung Association.
Adolescents and Young Adults Are Especially Vulnerable
When it comes to nicotine, 90 percent of adult daily smokers started using before they were 18, according to the U.S. Department of Health and Human Services.
It’s not just peer pressure. Teens and young adults are, in general, biologically more vulnerable to addiction than adults.
This is, in part, because the region of the brain involved in decision making and impulse control doesn’t fully develop until the mid-20s. It may be why young people crave stimulation and rewards and tend toward risk-taking behavior.
The reward-seeking adolescent and young adult brain also appears to be exquisitely sensitive to the effects of nicotine. As a result, young people may get hooked faster and have a harder time stopping than mature adults.
Early use of nicotine doesn’t just increase a young person’s risk of developing a lifelong addiction to a range of tobacco products, according to a 2019 study on nicotine gateway effects on adolescent substance abuse.. Human and rodent studies suggest that short-term and chronic nicotine exposure can change the developing adolescent brain and is linked to long-term issues that include:
- Increased vulnerability to other addictive substances
- Higher risk of psychiatric disorders during adulthood, including anxiety and depression
- Impaired cognitive function, which includes memory and learning
- Increased impulsivity and inattention lasting into adulthood
Nicotine Isn’t the Only Threat
The relatively short list of main ingredients found in ONPs includes nicotine salt, fillers, stabilizers, pH adjusters, flavors and artificial sweeteners. Lab testing also shows that even major brands contain potentially harmful chemicals, including ammonia, chromium, formaldehyde, and nickel. These are at low levels, however, and are comparable to what’s found in FDA-approved nicotine replacement therapies.
FDA regulation, to some extent, ensures that Zyn pouches contain what their manufacturer says they do. The same is likely true for other major brands whose parent companies have applied for FDA authorization.
More at issue is what may be inside unauthorized ONPs that are flooding the market. A 2024 analysis of ONP contents found that 26 of 44 pouches — mostly minor online brands — had trace levels of known carcinogens referred to as tobacco-specific nitrosamines. TSNAs form when tobacco is cured and processed and can end up in ONPs as a result of poor quality control.
Pouches from many smaller brands also have a high nicotine content, in some cases as much as 50 mg per pouch — more than eight times the strongest authorized by the FDA for Zyn, which was 6 mg.
“Such nicotine contents are concerning as they are expected to induce and maintain addictive behaviour in users. Further, nicotine is toxic upon ingestion and has negative effects on the cardiovascular system,” the researchers in the 2024 analysis of ONP contents warned.
Risks such as these are why some health experts have argued in favor of FDA authorization for ONPs, since regulation can, to some extent, ensure what is going into them.
But even with certain products being authorized, “some companies may have no intention of going the authorization pathway. They want to make as much money as they can until they [are caught],” says Tory Spindle, Ph.D., a tobacco researcher and associate professor at the Johns Hopkins School of Medicine.
What’s more, counterfeits of mainstream ONP brands are common. It’s enough of a problem that Philip Morris International told MedShadow that it has “a dedicated team combating illicit trade and the criminals who profit from it in the U.S. and around the world.”
Such efforts may help somewhat, but cracking down on illicit and counterfeit ONPs is roughly equivalent to a global game of Whac-a-Mole. With so many of these products coming from outside the country and very often from “white label” manufacturers that allow any party to choose flavors and put a brand label on containers of ‘pre-formulated’ pouches, “there’s essentially no way to know what is going into many of those pouches,” says Dr. Maa.
From ‘Health Hack’ to ‘I Can’t Stop’
Jake Trease, a 33-year-old barber in the Dallas area, turned to nicotine after reading online about how the stimulant might help with ADHD symptoms. “Zyn seemed harmless, more pure than leaf tobacco or cigarettes. It was just nicotine salt, and it was very convenient,” he says.
At first, it seemed to Trease that Zyn was helping to even out his moods. He also appreciated the energy boost because he was a new dad and wasn’t getting much sleep. After a few months, however, any benefits Trease might have felt were gone. What he was left with was chronic headaches, agitation, cravings, and a 20-pouch-a-day addiction.
“There were mornings I woke up with a Zyn still in from the night before. My wife was disgusted. I decided to quit for her sake. But that was an empty promise. I kept going back to it. I knew the amount I was using couldn’t be good for me. But I was like, hold on, I can’t stop. I’m not in control,” says Trease.
“There were mornings I woke up with a Zyn still in from the night before. My wife was disgusted. I decided to quit for her sake. But that was an empty promise. I kept going back to it. I knew the amount I was using couldn’t be good for me. But I was like, hold on, I can’t stop. I’m not in control.”
Currently in the process of quitting, Trease is down to two pouches a day. While he says his withdrawal hasn’t been too difficult, other ONP users have experienced life-disrupting symptoms that include intense cravings, irritability, restlessness, nausea, dizziness, difficulty concentrating, sleep difficulties and anxiety.
Says Trease, “the tobacco companies are notorious for underplaying the risks of their products. Pouches are being marketed as a safer alternative to cigarettes. But was it worth the risk for me? No. Of course not.”
A Tsunami of New Nicotine Products Is Coming Your Way
ONPs are just one of many “smoke free” nicotine products that tobacco companies are rolling out in the name of “harm reduction.”
Major players in the industry now have their own e-cigarette brands. And serious money is behind “heat not burn” technology, as seen in products like Philip Morris International’s IQOS, and SWIC from Altria Group, the parent company of Philip Morris USA, which sells Marlboro cigarettes.
These sleek devices may look like vapes but hold cartridges of compressed tobacco. Tobacco companies promote the idea that heating tobacco is less harmful than burning it because it produces fewer toxins.
Skeptics abound.
“I’ll repeat what I said many years ago,” says Dr. Wigand. “Tobacco companies aren’t in the cigarette business. They are in the business of selling addictive nicotine. And they will use whatever nicotine delivery system it takes to capture their market. The reality is that these new products will take an industry that was dying and potentially make it more profitable than ever. “
