Nicotine Pouches

Nicotine pouches are one of the latest products the tobacco industry is using to attract new users and keep people, especially youth, addicted to tobacco products. Nicotine pouches have demonstrated an exponential growth in sales in recent years and are sold in over 20 markets globally. Available in dozens of flavors including candy-like “Mango Tango” and “Berry Frost”, nicotine pouches are the latest addition to Big Tobacco’s portfolio of products marketed to youth. 

Nicotine pouches are part of a broader range of oral nicotine products including nicotine gums, lozenges and snus. These products are marketed as more discrete alternatives to smoke- and aerosol-producing products like e-cigarettes. Many users consume nicotine pouches concurrently with smoked tobacco products, using them as substitutes for tobacco products in situations where they cannot smoke. Nicotine pouches are among the latest products used by the tobacco industry to continue their sale of addictive and life-threatening tobacco products, and the manufacturing, marketing and sale of these products must be closely monitored and regulated. 

What Are Nicotine Pouches?

Nicotine pouches are emerging nicotine products, containing nicotine, cellulose, water, flavoring and sodium carbonate, which are placed inside the mouth between the lip and gum. Nicotine absorption occurs through the lining of the mouth. Most nicotine pouches are available in a range of nicotine strengths, typically between 1.5 and 8 mg per pouch,¹ with some products containing nicotine doses of up to nearly 50 mg per pouch. Nicotine pouches are distinguished from the smokeless tobacco product snus (a spitless, moist tobacco pouch)² because they do not contain tobacco leaf. However, nicotine pouches contain either nicotine derived from tobacco or synthetic nicotine.  

Nicotine pouch brands including Zyn, Velo and On! are produced by multi-national tobacco companies and come in a variety of flavors that have similarly attracted youth and young adults to e-cigarettes.³ Nicotine pouch use has significantly increased since 2016, and its use is most common among young adults aged 18-24.⁴ Nicotine from any product is a highly addictive substance that is particularly harmful to pregnant women and adolescents. Nicotine exposure in children and adolescents⁵ can affect brain development, negatively impact learning and attention spans and potentially lead to anxiety disorders.^{6,7 and 8} The U.S. Surgeon General concluded that “The use of products containing nicotine in any form among youth, including in e-cigarettes, is unsafe.”⁹ In general, nicotine has also been found to impact the cardiovascular system.¹⁰ Aside from inhalation or absorption of nicotine, accidental or purposely ingestion of nicotine-containing products like e-liquids is toxic and can result in serious cardiovascular and respiratory complications.^{11 and 12}

Nicotine Pouch Global Market

Nicotine pouches are available in at least 22 markets globally.¹³ The global value of the nicotine pouch market was over USD $3 billion in 2021, with 6.8 billion pouches sold.¹⁴ In 2021, the United States was the largest nicotine pouch market, worth approximately $2.3 billion. Between 2020 and 2021, the nicotine pouch market in the U.S. more than doubled, from 2.2 billion units to 4.5 billion units sold, accounting for approximately 66% of the total number of units sold globally.¹⁵ Other markets in which retail volume doubled from 2020 to 2021 include Croatia, Czech Republic, Denmark, Slovakia and the United Kingdom. Sweden was the second-largest market for nicotine pouches in 2021, selling approximately 1.1 billion units of nicotine pouches (797 million units sold in 2020), worth USD $225 million.¹⁶ Nicotine pouches continue to be launched in key “test” markets in low- and middle-income countries like Pakistan, South Africa and Kenya.¹⁷ Analysts covering the tobacco industry “believe oral nicotine is taking most of its share from traditional smokeless tobacco, but is also benefiting from increased poly-usage across nicotine categories.”¹⁸

The most popular brands include Zyn, manufactured by Swedish Match (in 2022, Philip Morris International [PMI] acquired more than 93% of shares in Swedish Match¹⁹) British American Tobacco‘s (BAT) Velo and Lyft, Altria Group‘s On! and Japan Tobacco International‘s (JTI)  Nordic Spirit. In 2021, Swedish Match, or PMI, held approximately half (48.5%) of the global retail volume for nicotine pouches with BAT (22.2%), Altria Group (10.7%), and JTI (1.9%) following.²⁰ Other tobacco companies with nicotine pouches that have more limited availability include Imperial Brands, manufacturer of ZoneX and Skruf, GN Tobacco Sweden AB with White Fox, PMI with Shiro and Swisher International Group with Rogue.

   

Nicotine Pouch Marketing

Tobacco companies have mounted aggressive marketing campaigns to introduce consumers to nicotine pouches. Many companies have advertised the products as nicotine products that can be used by smokers in places where smoking is not allowed, for example, on an airplane. This type of marketing implies that the products are meant to be used as dual (or poly)-use products that encourage smokers to continue smoking rather than switching completely to pouches. Lifestyle promotion of nicotine pouches through social media has been a critical element of industry marketing. Tobacco companies like BAT use Facebook and Instagram to heavily promote nicotine pouches. According to reports by The Guardian, BAT has invested £1bn on marketing campaigns that harness the appeal of influencers, music stars and sporting events to market Velo, the company’s nicotine pouch product.

Industry Business Strategy and Claims

Each of the major multinational tobacco companies has revamped its strategic business platform to investors, the public, and regulators by offering a range of products based on their alleged reduced risk to users.

PMI has embraced this concept most vigorously by claiming it seeks a "Smoke-Free Future" while BAT asserts its “purpose is to build ‘A Better Tomorrow’ by reducing the health impact of our business by offering a greater choice of enjoyable and less risky products for our consumers.” JTI classifies its reduced-risk product line as one of its key "Sustainability Priorities." Imperial Brands claims it wants smokers to switch to products with lower health risks with the tagline "Something Better."

However, despite tobacco industry claims about shifting how they do business, tobacco companies continue to derive the vast majority of their profits from the sales of conventional cigarettes while also vigorously opposting policy changes (e.g. taxes, marketing restrictions) that reduce cigarette smoking. Further, the pattern of progression and transition from nicotine pouch use to products with known serious health harms like conventional cigarettes is unclear. Evidence does indicate that young non-smokers who use e-cigarettes, also a nicotine product, are 3x more likely to progress to conventional cigarette use compared to non-smokers that do not use e-cigarettes.²¹

Health Risks Associated With Nicotine Pouches

Although the tobacco industry markets emerging nicotine products as “clean” and “reduced-harm” products, the long-term health effects of nicotine pouch use are unknown. Reported side effects include gum and mouth irritation, nausea, hiccups and nicotine addiction.²² Nicotine addiction increases the risk of relapse with other tobacco products, and there is no data demonstrating that recreational nicotine pouches are a safe or effective way to quit smoking.²³ In addition, “nicotine use during adolescence has been shown to impact learning, attention span, and proneness to addiction,”²⁴ and is harmful to adolescent brain development.²⁵

Further research on the long- and short-term effects of nicotine pouch use and the effects on cessation and initiation of tobacco products is required to better understand their effects at an individual and population public health level.

Nicotine Pouch Regulation

Regulatory Options for Nicotine Pouches

While there are currently several brands of nicotine pouches on the market globally, these products are still a relatively new category of emerging products and therefore, are largely unregulated. In many countries and regions, nicotine pouches fall outside of existing tobacco control laws because they do not contain tobacco. Further, synthetic nicotine may pose challenges in countries that regulate products with tobacco-derived nicotine. In the absence of effective government regulation, nicotine pouches have the potential to create a new generation of nicotine and/or tobacco users and undermine the progress made in combating the tobacco epidemic. 

Regulating or banning nicotine pouches is consistent with the general obligations of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC), which requires Parties to the Convention to implement measures for preventing and reducing nicotine addiction.²⁶

Global Regulatory Trends*

There are no clear global trends on how countries are approaching the regulation of nicotine pouches. Few countries have adopted laws or regulations to specifically address nicotine pouches. However, the regulatory landscape is quickly evolving, and more countries are beginning to take measures to regulate or amend their existing tobacco regulations to cover  these products.²⁷

Countries such as Kyrgyzstan²⁸, Mauritius²⁹ and Russia³⁰ have introduced bans which include prohibitions on the production, import and sale of nicotine pouches. Also, Belgium recently banned the sale of nicotine pouches effective July 1, 2023 (October 1, 2023 for retailers).³¹ BAT is challenging the decree banning nicotine pouches in the Council of State (Belgium‘s highest administrative court³²). At least two countries (Germany³ and the Netherlands³⁴) have banned or regulated nicotine pouches as harmful food products.

In other countries, nicotine pouches may be partially regulated as medicinal or pharmaceutical products. The brand Zonnic is approved for sale by the appropriate medical agencies in Canada,³⁵ Finland,³⁶ Norway,³⁷ and Sweden.³⁸ Consent or provisional consent is required from the Minister of Health to legally sell nicotine pouches in New Zealand.³⁹ To our knowledge, no nicotine pouches have been authorized for sale in New Zealand.

At least three countries (Denmark,⁴⁰ Iceland⁴¹ and Kenya⁴²) are regulating the use of nicotine pouches under their existing tobacco control and/or e-cigarette laws. In the Czech Republic, a decree⁴³ was adopted to specifically regulate nicotine pouches,⁴⁴ including the contents, packaging and health warnings. In the United States, the Food and Drug Administration regulates nicotine pouches. Other countries are considering legislative proposals to regulate nicotine pouches in this manner (for instance, Estonia,⁴⁵ and Lithuania has established a working group to draft a law).⁴⁶

*The country examples on this page are current as of August 30, 2023. While every attempt has been made to review applicable measures globally, this should not be considered an exhaustive reviews of every country’s laws on nicotine pouches. 

¹ Mallock N, Schulz T, Malke S, et al. Levels of nicotine and tobacco-specific nitrosamines in oral nicotine pouches. Tobacco Control. Available at:https://tobaccocontrol.bmj.com/content/early/2022/08/05/tc-2022-057280 (last visited October 17, 2022)
² Cancer Action Network. New and Emerging Smokeless Tobacco Products – Not a Safe Alternative to Cigarettes. Available at:https://www.tobaccofreekids.org/assets/content/ctfk/ht_tools2013/ACS%20CAN%20New%20an
³ World Health Organization (WHO). WHO Report on the Global Tobacco Epidemic, 2021: Addressing new and emerging products. Available at: https://apps.who.int/iris/rest/bitstreams/1359088/retrieve
⁴ Felicione NJ, Schneller LM, Goniewicz ML. Oral nicotine product awareness and use among people who smoke and vape in the U.S. American Journal of Preventive Medicine. 2022; 63, 611-618. https://doi.org/10.1016/j.amepre.2022.04.019
⁵ WHO Report on the Global Tobacco Epidemic: Addressing New and Emerging Products. Geneva; 2021.
⁶ University of Nebraska Medicine. 2021. Are nicotine pouches safer than chewing, smoking or vaping? Available from: https://www.nebraskamed.com/ca....
⁷ Yuan M, Cross SJ, Loughlin SE, Leslie FM. nicotine and the adolescent brain. The Journal of Physiology. 2015;593(16):3397–412.
⁸ Hall FS, Der-Avakian A, Gould TJ, Markou A, Shoaib M, Young JW. Negative affective states and cognitive impairments in nicotine dependence. Neuroscience & Biobehavioral Reviews. 2015Nov;58:168–85.
⁹ HHS, E-Cigarette Use Among Youth and Young Adults. A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health, 2016.
¹⁰ HHS, How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General, Centers for Disease Control and Prevention, Office on Smoking and Health, 2010 http://www.ncbi.nlm.nih.gov/books/NBK53017/.
¹¹ Seo AD, Kim DC, Yu HJ, Kang MJ. Accidental ingestion of e-cigarette liquid nicotine in a 15-month-old child: An infant mortality case of nicotine intoxication. Korean Journal of Pediatrics. https://doi.org/10.3345%2Fkjp.2016.59.12.490. Published December31, 2016. Accessed April 4, 2023.
¹² Henstra C, Dekkers BGJ, Olgers TJ, ter Maaten JC, Touw DJ. Managing intoxications with nicotine-containing e- liquids. Expert Opinion on Drug Metabolism and Toxicology. https://doi.org/10.1080/17425255.2022.2058930. Published March 29, 2022. Accessed April 4, 2023.
¹³ Euromonitor International. Passport database. London, UK. 2022.
¹⁴ Euromonitor International. Passport database. London, UK. 2022.
¹⁵ Euromonitor International. Passport database. London, UK. 2022.
¹⁶ Euromonitor International. Passport database. London, UK. 2022.
¹⁷ British American Tobacco p.l.c, New Category Acceleration Drives Profitability Forward to 2024, Press Release and Preliminary Results [Internet]. British American Tobacco; 2023 [cited 2023Mar20]. Available from: https://www.bat.com/group/sites/UK__9D9KCY.nsf/vwPagesWebLive/DOCNUNN9/$file/FY_2022_Announcement.pdf
¹⁸ Goldman Sachs, Americas Tobacco: Nielsen Data thru 2/20/21: Total nicotine volumes decelerate, March 2, 2021
¹⁹ PMI progresses toward sole ownership of Swedish Match, further supporting our ambition to deliver a smoke-free future [Internet]. PMI. Philip Morris International; 2022 [cited 2023Mar20]. Available from: https://www.pmi.com/media-center/news/PMI-progresses-toward-sole-ownership-of-swedish-match

²⁰ Euromonitor International. Passport database. London, UK. 2022.
²¹ Summary Brief: Review of Global Evidence on the Health Effects of Electronic Cigarettes. Australian National University: National Centre for Epidemiology and Population Health. https://nceph.anu.edu.au/files/E-cigarettes%20health%20outcomes%20review%20summary%20brief%202022.pdf. Published April 2022. Accessed April 12, 2023.
²² University of Nebraska Medicine. 2021. Are nicotine pouches safer than chewing, smoking or vaping? Available from: https://www.nebraskamed.com/ca....
²³ University of Nebraska Medicine. 2021. Are nicotine pouches safer than chewing, smoking or vaping? Available from: https://www.nebraskamed.com/ca....
²⁴ University of Nebraska Medicine. 2021. Are nicotine pouches safer than chewing, smoking or vaping? Available from: https://www.nebraskamed.com/ca....
²⁵ World Health Organization (WHO). WHO Report on the Global Tobacco Epidemic, 2021: Addressing new and emerging products. Available at: https://apps.who.int/iris/rest/bitstreams/1359088/retrieve
²⁶ WHO Framework Convention on Tobacco Control, Article 5.2(b).
²⁷ For instance, Finland initially regulated nicotine pouches for import as a medicinal product but is now preparing amendments to their Tobacco Act to regulate these products.  https://www.fimea.fi/web/en/-/fimea-supports-legislative-reform-concerning-nicotine-pouches.
²⁸ Law No. 121 on the Protection of Health of the Citizens of the Kyrgyz Republic from the Effects of Tobacco and Nicotine Consumption and from Exposure to Ambient Tobacco Smoke and Aerosol.  Available at:https://www.tobaccocontrollaws.org/files/live/Kyrgyzstan/Kyrgyzstan%20-%20Law%20No.%20121_2021.pdf (Article 15(1)) (last visited October 17, 2022).
²⁹ Public Health (Restrictions on Tobacco Products) Regulations 2022, Sec.4(4)(e). Available at: https://d3vqfzrrx1ccvd.cloudfr...
³⁰ Federal Law No. 303-FZ of July 31, 2020 “On Amendments to Certain Legislative Acts of the Russian Federation on the Protection of Citizens’ Health from the Consequences of Consuming Nicotine-Containing Products.” Available at:https://www.tobaccocontrollaws.org/files/live/Russia/Russia%20-%20No.%20303-FZ%20on%20Nicotine%20Products.pdf (Article 19, Part 8) (last visited October 21, 2022). 
³¹ Royal decree prohibiting the marketing of certain similar products (Unofficial translation).  Accessed April 12, 2023.  https://www.ejustice.just.fgov.be/eli/arrete/2023/03/14/2023041247/justel
³² Le Soir. BAT challenges the ban on the sale of nicotine sachets before the Council of State. Accessed May 30, 2023.  https://www.lesoir.be/514982/article/2023-05-23/bat-conteste-linterdiction-de-vente-des-sachets-de-nicotine-devant-le-conseil
³³ German Federal Institute for Risk Assessment (BfR). Health Risk Assessment of Nicotine Pouches.  Available at:https://www.bfr.bund.de/cm/349/health-risk-assessment-of-nicotine-pouches.pdf (last visited October 17, 2022).
³⁴ Netherlands Food and Consumer Product Safety Authority (NVWA).  Ban on nicotine pouches (snus) without tobacco.  Available at:https://www.nvwa.nl/onderwerpen/roken-en-tabak/verbod-op-nicotinezakjes-snus-zonder-tabak (last visited October 17, 2022).
³⁵ https://health-products.canada...
³⁶ https://www.fimea.fi/web/en/se...
³⁷ https://www.felleskatalogen.no...
³⁸ https://www.lakemedelsverket.s...
³⁹ Smokefree Environments and Regulated Products Act 1990 (as amended), Sec. 54 (3). Available at https://d3vqfzrrx1ccvd.cloudfront.net/uploads/legislation/New%20Zealand/New-Zealand-SF-Act-1990-national.pdf. 
⁴⁰ Act No. 2071 amending the act on the prohibition of tobacco advertising, etc., the act on tobacco products, etc., the act on electronic cigarettes, etc. and various acts.  Available at:https://www.tobaccocontrollaws.org/files/live/Denmark/Denmark%20-%20Act%20No.%202071%20of%202020.pdf.
⁴¹ Law on amendment of the Act on Electronic Cigarettes and Refill Containers for Electronic Cigarettes, No. 87/2018.  Available at: https://www.stjornartidindi.is/Advert.aspx?RecordID=a2bcb322-dab8-4d86-aee0-b76e425ffcb5 (last visited October 17, 2022).
⁴² New Report Outlines Continued Illegalities in Sale of Nicotine Pouches, September 8, 2022.  Available at: https://www.capitalfm.co.ke/news/2022/09/new-report-outlines-continued-illegalities-in-sale-of-nicotine-pouches/.
⁴³ Decree on Nicotine Pouches without Tobacco.  Available at: https://assets.tobaccocontrollaws.org/uploads/legislation/Czech-Republic_20230516_Decree-on-Tobacco-Free-Nicotine-Pouches_ONP_CS.pdf (last visited July 10, 2023).
⁴⁴ Consolidated Appropriations Act, 2022.  H.R.2471.  Available at: https://www.congress.gov/bill/117th-congress/house-bill/2471.  See also https://www.fda.gov/tobacco-products/products-ingredients-components/regulation-and-enforcement-non-tobacco-nicotine-ntn-products
⁴⁵ Draft Tobacco Act Amendment. Available at: https://www.riigikogu.ee/tegevus/eelnoud/eelnou/33ad6ad4-0e9a-4aa2-80cb-a62408fd9cf4/Tubakaseaduse%20muutmise%20seadus (last visited October 17, 2022).
⁴⁶ Minister of Economy and Innovation of the Republic of Lithuania.  Order Concerning the Establishment of a Working Group on the Regulation of Non-Tobacco Nicotine Pouches for Oral Use. Available at: https://e-seimas.lrs.lt/portal/legalAct/lt/TAD/ec9c4f2143f811eca8a1caec3ec4b244/asr (last visited October 17, 2022).