Revolutionary new nicotine pouch technology Seratek® plans to begin the regulatory process to enter the US market
Contains nicotine. Nicotine is an addictive substance. For adult nicotine users only.
Advertisement
UPPSALA, Sweden, Oct. 21, 2025 (GLOBE NEWSWIRE) — Nicotine pouch use is soaring in the US, with online discussion up 745% in two years, as Swedish company Emplicure announces it is intending to apply for regulatory approval and launch Seratek®, a patented technology designed to deliver nicotine more quickly at lower strength, in the USA.
Cigarettes remain an unresolved public health problem. The Centers for Disease Control and Prevention (CDC) estimates more than 480,000 Americans die from smoking-related illnesses every year — about one in five US deaths.
Despite tighter regulation and the growth of e-cigarettes and heated tobacco, smokeless alternatives have yet to make a decisive dent in smoking prevalence. But nicotine pouches are emerging as the fastest-growing product in the category, with demand in the US fuelling shortages of leading brands and sparking lively debate online about price, flavours and availability.
Independent studies suggest Seratek® could raise the bar. A pharmacokinetic study published in 2025 found Seratek® released 80% of nicotine within the first five minutes under controlled conditions, even at lower strengths. In a consumer taste test in Sweden (2025) with 123 adult pouch users, Seratek® was preferred over international market leaders on flavour, comfort and discreteness.
The company behind the nicotine pouch technology has now confirmed it is preparing to file a Premarket Tobacco (PMT) application for Seratek®, to satisfy the regulatory authorisation required to sell nicotine pouches in the USA.
Nicotine pouches were first introduced in Sweden in 2014, building on the country’s long tradition of oral nicotine use. Sweden has now reached smokefree status with adult smoking prevalence under five per cent, one of the few countries in the world to achieve this. No health claims are made for Seratek®.
The global nicotine pouch market was worth around USD 8 billion in 2024 and is forecast to exceed USD 100 billion by 2035 (Barclays Equity Research, 2025). The US and Nordic countries are expected to account for more than two-thirds of this growth. Shortages of leading brands are already a common topic in online communities, where consumers regularly discuss price, availability and flavour choice.
Public conversation around nicotine pouches in the US increasingly focuses on regulation and taxation. At the same time, consumers continue to highlight the appeal of pouches as discreet, tobacco-free and convenient.
Emplicure CEO, Mattias Josander, a FMCG & nicotine-industry veteran who previously worked at Swedish Match, Red Bull & L’Oréal before joining Emplicure as CEO in May 2024, said:
“Our ambition is to accelerate the transition to a smokeless world. If vaccines were the life-saving breakthrough of the 20th century, nicotine pouches may well represent the public-health breakthrough of the 21st, given that cigarettes remain one of the largest causes of preventable death and suffering.
“Today all nicotine pouch products on the markets have limited product differentiation and use all the same technology. It is our belief that Emplicure has a role to play to accelerate this smokeless journey.
“For smokers to truly leave cigarettes behind, alternatives must actually work: they need to deliver nicotine quickly enough to satisfy, while avoiding unnecessary high exposure. This is the balance Seratek® strikes, faster onset at lower strength. By filling this gap, Seratek® is more than a commercial innovation. It is technology with the potential to make a real difference for humanity, providing technology designed for faster delivery with lower nicotine content, in line with what consumers say they want.”
Josander continues: “Our intent is to start the regulatory approval process in the USA. The US is and will remain more than 60% of the global nicotine pouch market (Barclays Equity Research 2025).”
Emplicure is a Sweden-based company founded in 2014 in Uppsala by Professor Håkan Engqvist to develop drug delivery systems using bioceramic and polymer technology.
For more information, visit www.emplicure.com
Contains nicotine. Nicotine is an addictive substance. For adult nicotine users only.
For more information please contact PR Agency One
Emplicure@pragencyone.co.uk | +44(0)161 871 9140
NOTES TO EDITORS
About Emplicure
Emplicure was founded in 2014 in Uppsala by Professor Håkan Engqvist to develop drug delivery systems using bioceramic and polymer technology. It is backed by prominent Swedish investors including Thomas von Koch, co-founder of EQT Partners, one of Europe’s largest private equity firms.
According to Barclays Equity Research (2025), the global nicotine pouch market was worth USD 8 billion in 2024 and is projected to exceed USD 100 billion by 2035, with the US and Nordics accounting for more than two-thirds of this growth.
Study Data
The pharmacokinetic study cited (April 2025, peer-reviewed, randomised crossover design; n=12) evaluated nicotine absorption under controlled clinical conditions. The primary endpoint was AUC 0–5 minutes. SERATEK® delivered nicotine more quickly in the first five minutes despite using a lower formulation strength relative to the comparator. PK studies describe nicotine absorption; they do not assess product safety or long-term health outcomes.
The Still Devastating Impact of Cigarettes
Cigarettes continue to kill at scale: According to the World Health Organization, 7 million people die every year from tobacco-related illnesses including lung cancer, heart disease and chronic obstructive pulmonary disease (COPD). In the United States alone, the Centers for Disease Control and Prevention (CDC) reports that more than 480,000 people die annually from cigarette smoking (around one in five US deaths).
Reducing but still significant smoking prevalence: If adult smoking prevalence has considerably reduced in the UK and in the US thanks to stricter regulations and the launch of smokeless alternatives (mostly e-cigarettes, heated tobacco products), it is still over the 10% bar (from 25% in 2007 to 12% in 2023 in UK, from 27% in 2002 to 12% in 2019) and smoking remains a large public health concern.
A clear intent from all stakeholders to accelerate smokeless alternatives: All stakeholders acknowledge the problem, starting with tobacco companies that are all pursuing ambitious smokeless targets with a vision for their smokeless alternative products (e-cigarettes like Juul, Vuse, Blu; heated tobacco product like IQOS, Glo, Ploom) to reach between 25% and 50% of their revenue by 2030.
Yet results to-date remain modest: Despite all efforts, e-cigarettes and heated tobacco products represent still a small (yet faster growing) part of the total tobacco market (less than $50bn overall vs. >$1tr for the global nicotine market).
Nicotine Pouches: A Tobacco-Free Alternative to Cigarettes
Nicotine pouches are designed for oral use: The user places the pouch between their upper lip and gum, allowing the nicotine to be absorbed through the mouth tissues.
Small, discreet & convenient: Nicotine pouches are small, discreet and portable.
Swedish origins: Nicotine pouches were introduced first in 2014 in Sweden, a country with a long tradition of oral (smokeless) nicotine, from loose through portioned snus to now nicotine pouches.
Sweden as a public health example: With a smoking prevalence under 5%, Sweden is the first country in the world to have officially achieved smokefree status, coinciding with its long tradition of oral nicotine. No health claims are made for Seratek®.
The NP phenomenon: exponential growth, mass potential with smokers & already authorised by the FDA
NP represented in 2024 only 2% volume share of the global nicotine market with $8bn retail sales value (RSV) but it has been growing exponentially.
In the US alone, it is on track in 2025 to capture more than 10% volume share (>1bn cans worth >$5bn RSV, projected to reach $20bn RSV by 2030) with growth over 50%, led by ZYN, a brand part of PMI’s Swedish Match acquisition in 2023. More than the numbers, NP have become in the USA part of culture (see below press articles – non-exhaustive list):
- Wall Street Journal: Zyn Nicotine Pouches Take Off—and Land in the Culture Wars
- The New York Times: What’s That In Your Mouth, Bro?
- GQ: How Zyn Conquered the American Mouth
Latest equity research note on NP by Barclays predicts that NP will reach $100bn RSV globally by 2035 with USA and Nordics accounting for over two-thirds of the global NP market.
A number of large countries have already supported the introduction of nicotine pouches, starting with USA, UK, Nordics & UAE. In January 2025, the FDA authorised ZYN in the USA and is now fast-tracking the regulatory process of nicotine pouches.
“To receive marketing authorisations, the FDA must have sufficient evidence that the new products offer greater benefits to population health than risks,” said Matthew Farrelly, Ph.D., director of the Office of Science in the FDA’s Center for Tobacco Products. “In this case, the data show that these nicotine pouch products meet that bar by benefiting adults who use cigarettes and/or smokeless tobacco products and completely switch to these products.”
All nicotine pouch players have been extremely prudent to market nicotine pouches strictly to adult nicotine users, ensuring to avoid some of the mistakes made by some smokeless brands like JUUL in the past.
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d73d833a-35ff-4a38-9286-aecaea6e2a0f
Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. USA Newshour takes no editorial responsibility for the same.