Tag: Modern Oral

FDA Accepts L!X Pouches’ PMTA

Image: TJP Labs
The U.S. Food and Drug Administration has accepted for review TJP Labs’ premarket tobacco product application for L!X nicotine pouches.
“TJP Labs created L!X nicotine pouches for adult (21+) users of nicotine-containing products who cannot or choose not to discontinue nicotine use, especially those who wish to transition to noncombustible, oral-use products,” said TJP Labs CEO David Richmond-Peck in a statement.
“The acceptance of our application by the FDA showcases our team’s dedication to providing adult users with alternatives that can potentially reduce the harm associated with traditional combustible tobacco products.
“Our facility’s Health Canada Drug Establishment License (DEL), Natural Health Products Site-License, ISO 9001:2015, HACCP and cGMP certifications speak to the rigorous quality standards at TJP Labs and will further bolster our ability to service high-volume international markets.”
TJP Labs is a full-service contract manufacturer of premier next-generation products, focusing on modern oral nicotine pouches and oral delivery solutions for caffeine and other nutraceutical products. The company is headquartered in Pickering, Ontario, Canada.
L!X nicotine pouches are marketed by TJP Labs’ subsidiary L!X Innovations.
January 13, 2023
Study Shows Velo Offers Reduced Risk

Photo: BAT
Users of BAT’s Velo modern nicotine pouch showed significant reduced risk of smoking-related diseases compared to smokers, according to a new cross-sectional clinical study published in Biomarkers.
The study included participants who had been using Velo exclusively for over six months as well as current smokers, former smokers and never-smokers. For the Velo consumers and current cigarette smokers, usage patterns and overall consumption were not controlled under the study protocol as the aim was to assess the impact among people using the products in their “normal” way rather than in a controlled way. Four different groups were enrolled and studied.
The results showed that the levels for the biomarkers of exposure, based on priority toxicants as defined by the World Health Organization, were substantially lower in Velo consumers compared with smokers. The data also showed favorable differences between the Velo consumers and smokers in the majority of the biomarkers of potential harm, with four achieving statistical significance and the others having similar levels across the Velo consumers, former and never smoker groups.
A single set of samples of blood, urine and other clinical measurements was tested for certain toxicants and a range of biomarkers thought to be linked to the development of diseases such as cancer and cardiovascular disease.

“These results add further evidence that supports the important contribution Velo can make to tobacco harm reduction.”
David O’Reilly, director of scientific research, BAT
“These results are very important for Velo and the modern oral nicotine product category,” said David O’Reilly, director of scientific research at BAT, in a statement.
“They build on the extensive scientific evidence, including epidemiological data, that already exists for oral tobacco and add to the weight of evidence that supports our belief that Velo is a reduced-risk product for smokers who completely switch from cigarettes as compared to continued smoking. We have already generated data that shows Velo has a toxicant profile better than snus and comparable to nicotine-replacement therapy. These results add further evidence that supports the important contribution Velo can make to tobacco harm reduction.”
Based on the biomarkers measured, compared to smokers, Velo consumers who had been using the product exclusively showed significantly lower levels in biomarkers of exposure to priority tobacco toxicants; significant favorable differences in a biomarker of potential harm relevant to lung cancer risk; significant favorable differences in a number of biomarkers of potential harm relevant to cardiovascular disease; and significant favorable differences in a biomarker of potential harm relevant to general inflammation.
For the biomarkers that showed no significant difference between the Velo consumers and smokers, similar levels were observed between the Velo and former and never-smoker groups.
Participants were based in Denmark and Sweden, aged 19–55 years old and in good general health.
December 13, 2022
Cancer Society Concerned About Nicotine Pouches

Photo: Andrii
The American Cancer Society is concerned about the growing popularity of nicotine pouches.
Overall U.S. sales of nicotine pouches increased during 2019–2022, according to a new study published in the Journal of the American Medical Association (JAMA) Network Open. The data also showed sales of 8 mg nicotine concentration level (highest available) products rose more rapidly than those with different concentration levels.
“Our findings are important as nicotine is a highly addictive substance. The growing popularity of nicotine pouches may increase the risk of children finding these products to be attractive and risk-averse health outcomes and addiction to nicotine,” said Nigar Nargis, senior scientific director of tobacco control research at the American Cancer Society and senior author of the study, in a statement. “Health campaigns warning of potential adverse health outcomes of nicotine pouches are needed.”
Study authors analyzed data comprising weekly Nielsen IQ Retail Scanner point of purchase sales from August 2019 through March 2022 for 2,182 local trade areas in the contiguous 48 states and Washington, D.C. Sales trends of four nicotine pouch brands (Zyn, Rogue, On! and Velo) were analyzed.
The results showed overall sales increased from 126.06 million units from August to December 2019 to 808.14 million units from January to March 2022. Zyn (58.8 percent) led the overall unit share followed by On! (24.6 percent), Velo (12.1 percent) and Rogue (4.8 percent) during the study period. Zyn sales peaked in September 2021 and increased more than other brands from October 2021 to March 2022; however, Rogue sales increased more rapidly than all other brands.
December 8, 2022
U.K. Urged to Ban Pouch Sales to Minors

Photo: Andrii
U.K. health campaigners are calling for the closure of a loophole that allows nicotine pouches to be sold to under-18s, reports the BBC.
Nicotine pouches, which are made without tobacco, are not regulated by rules that cover tobacco products, vaping products or medical products in the U.K. As a result, there are no age restrictions on sales.
Action on Smoking and Health (ASH) says the lack of rules is a “Wild West.”
Leading manufacturers, however, have introduced their own restrictions on age of sale and warnings on packaging.
In a recent ASH survey of 13,000 people, about one in 25 said they had tried nicotine pouches, and awareness was highest among 18-year-olds to 24-year-olds, with 45 percent having heard of them.
Leonie Brose, reader in nicotine research at King’s College London, agreed the current regulation should be reviewed.
“If you are a smoker, then moving to something else is a good idea, but if you’ve never smoked, it’s not a good idea to take up nicotine because it is addictive and may produce a dependence,” she said.
Japan Tobacco International, which sells Nordic Spirit nicotine pouches, welcomed the call for more regulation.
Spokeswoman Nicky Small told the BBC that the company has spearheaded a self-regulation framework that governs the marketing of the product and limits access to over-18s.
October 31, 2022
BAT Conducts New Study of Velo

Photo: BAT
BAT has conducted a cross-sectional clinical study of Velo, which is designed to provide new insights into the real-world health impact of its modern oral nicotine pouch product compared to smoking. Protocol details explaining the design have been published in the journal JMIR Research Protocols.
The study evaluates exposure to certain toxicants and early indicators associated with smoking-related disease in people who have been exclusively using Velo for over six months and compares them with groups of smokers, former smokers and never-smokers.
The results are currently being analyzed and will be published by the end of the year.
“Modern oral nicotine pouches are an exciting product category, which build upon the extensive scientific evidence available for snus but are designed to offer adult consumers an improved tobacco-free, reduced-risk alternative,” said Sharon Goodall, BAT’s group head of regulatory sciences, in a statement.
“We have already generated data that shows Velo has a toxicant profile better than snus and is comparable to nicotine-replacement therapy. However, we wanted to generate further evidence to demonstrate the important contribution it can make to tobacco harm reduction. I believe the results of this study will provide important new information, and we look forward to sharing them once available.”
October 17, 2022
Institute: Pouches Safer Than Smoking

Photo: Swedish Match
In the statement published on Oct. 7, 2022, the German Federal Institute for Risk Assessment (BfR) confirmed that tobacco-free nicotine pouches can reduce health risks compared to smoking. To protect consumers, the BfR recommends regulation of the manufacture, presentation and sale of nicotine pouches.
In a detailed study on the material composition of tobacco-free nicotine pouches performed in August 2022, BfR scientists found that aside from nicotine, the pouches contain no substances presenting health concerns. In some samples, however, they detected traces of tobacco-specific nitrosamines (TSNA) similar to those found in medical nicotine-replacement products.
The BfR scientists did express concern about inadequate labeling and missing warnings on some products.
“These critical comments can be resolved in principle,” said Jan Muecke, CEO of the German Association of the Tobacco Industry and Novel Products (BVTE), in a statement. “It would make a lot of sense to set appropriate limits for nicotine and TSNAs and to introduce binding regulations on warnings and labeling obligations. A high level of consumer protection must be guaranteed.”
Muecke said the BVTE would welcome regulation of nicotine pouches under tobacco laws. Contrary to their counterparts, other European countries, German regulators treat nicotine pouches as food products. As a result, they are illegal in Germany.
Muecke said he hoped the BfR assessment would prompt regulators to rethink. “We want tobacco-free nicotine pouches to provide consumers of tobacco and nicotine products with another potentially less harmful alternative,” he said.
October 13, 2022
Strom Nicotine Pouch Debuts in U.K.

Photo: Andrii
Scandinavian Tobacco Group has launched its Strom nicotine pouch in the U.K., reports Convenience Store.
Strom will be available in three flavors—fresh mint, minty orange and juicy berry—to retailers across Manchester for a six-month trial period between October and March before being rolled out to other cities across the U.K. throughout 2023 and beyond.
“Nicotine pouch sales are really gathering pace, and that’s why we’re really excited to pilot our Strom brand in Manchester before rolling out the product to the rest of the U.K.,” said Alastair Williams, STG’s U.K. country director. “Retailers would be forgiven for thinking that the nicotine pouch category is already quite crowded, but we’re coming to the market with something more authentic, premium and sophisticated than what is already out there.
“Strom offers a prolonged taste delivery, which enables an extended flavor sensation for your mouth and throat as well as providing an equal nicotine release for a consistent and smooth experience. We’re also excited to be putting a huge marketing spend behind our regional ad campaign to raise consumer awareness and drive sales.”
October 11, 2022
Smart Sachets

Photos: Amplicon
Amplicon presents the first pouch with controlled nicotine release.
By Stefanie Rossel
All nicotine pouch brands presently on the market use a form of cellulose as a carrier material. Powdered cellulose is drenched in a mixture of pharmaceutical grade nicotine, flavors and a pH alignment to bring the product’s pH to the optimum level for nicotine uptake. Although the blend is moistened with polyglycol or glycerol, the pouches are slightly dry. This leads to the user feeling the nicotine effect and perceiving the taste within a few seconds after placing a pouch behind the lip. For some users, the sudden intense nicotine hit is too much—they react physically; sometimes they even get sick. Cellulose has another downside: During consumption, it may dissolve into a slimy lump in the consumer’s mouth, thereby quickly losing its flavor.
Release of pouch nicotine is controlled mainly by the solubility of the nicotine, which means the size of the pouches also determines the release profile. In nontraditional snus markets, users prefer small pouches. These, however, release nicotine and flavor in a very short time.

Hakan Engqvist
A Swedish consumer products company set out to solve these issues. In June, Amplicon presented its Freee nicotine pouches, which it describes as the next generation of oral nicotine. While from the outside the pouches look like those already on the market, they are filled with a powder made of bioceramics. Under the microscope, bioceramic granules look like Swiss cheese, having a porous inner structure. The bioceramics used for the pouches belong to a family of chemically bonded ceramics. The substances can be found in nature. For example, hydroxyapatite, a bioceramic generated in the body by biomineralization, forms the basis of the hard matter of all mammals. For the past 40 years, bioceramics have been used clinically for hard tissue replacement.
Amplicon’s Freee bioceramic platform also contains water, bulk and the active ingredients nicotine and flavor, which bind to that platform. Substance release takes place through diffusion and dissolution. This allows for a more constant, controlled release of nicotine and flavor and better absorption by the human body. The company uses nicotine salt in its pouches. Water-soluble flavors integrate best with the material, but oil-based flavors can be used as well.
The technology allows manufacturers to produce pouches that are small but pack the punch of much larger products, says Amplicon founder Hakan Engqvist, who is also a professor in materials science at Uppsala University. “Our technology enables customized nicotine-delivery and a much-improved nicotine and flavor experience, and it allows for pH stability over time. It also maintains the consistency of the pouch better. Feedback from consumer tests has been positive.”
Current pouch products, he explains, also have an issue with shelf life because their pH levels are less stable than they are in bioceramics.

Tomas Hammargren
Intelligence Inside
The new pouch technology stems from pharmaceutical research. “We have been and are still working on an opioid-based pain relief formulation,” says Engqvist. “Through different routes, we started to work with solid vape to load nicotine into the ceramics and thereby reduce the use of e-liquid and instead just have a tablet. Controlled release of nicotine from pouches then became the next development, quite natural in a snus country such as Sweden.”
Engqvist has lots of experience with bioceramics. Amplicon’s parent company, Emplicure, which he also co-founded, combines biomaterials with existing pharmaceutical substances to deliver drugs precisely and safely. Its controlled-release technology targets unmet medical needs, especially in opioid-based pain relief where its formulations offer not only improved therapy with less discomfort but also reduce the risk of opioid abuse, according to the company.
Its patented bioceramic platforms are based on tunable nanostructures that enable the distribution of active substances in bioceramic materials. The active substance is then released to achieve the desired effect by controlled diffusion. The release and dosage of the active substances can be tuned by adjusting the size of the pores, the choice of biomaterial and the excipients.
Amplicon was established to leverage Emplicure’s technology in the nicotine market. In June, the company filed for a trademark registration for Freee nicotine pouches at the European Intellectual Property Office. The company presently manufactures the pouches in-house at pilot scale but says it is able to scale up production from laboratory volumes to commercial volumes. Control over the making of the ceramic powder will stay with Amplicon, which has received a lot of interest in its technology from both established distributors and pouch manufacturers, says Tomas Hammargren, chairman of Amplicon.
The product is scheduled to hit the market by mid-2023. Initial target markets will include both new, “non-pouch” geographies, such as Europe, Japan and Korea, and existing pouch markets, according to Hammargren. “To reach all important markets, such as Southern Europe or Asia, a pouch product needs to be as small as possible but has to provide a good nicotine and flavor hit, which is difficult to achieve with cellulose,” he says. “It’s hard to imagine an Italian woman putting a big pouch under her lip. The same is true for Asia. Our product is more urban, metropolitan and attractive to female and new users, hence we are confident that it will also be successful in existing oral nicotine markets. It will be the perfect complement for vapers and users of heated-tobacco products in places where smoking and vaping is banned.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

August 1, 2022
Pouch Segment Growing Rapidly in Spots

Photo: Swedish Match
While not yet widely available, sales of nicotine pouches are developing rapidly in select geographies, according to a blog post by the Foundation for a Smoke-Free World (FSFW) of reduced-risk products. The largest markets are currently in high-income and middle-income countries, with Sweden and the United States topping the list, partly as a result of their strong oral tobacco cultures.
Of the 15 companies ranked by the FSFW’s Tobacco Transformation Index, which measures the extent to which nicotine companies are making progress toward reducing the consumption of high-risk products, seven currently offer nicotine pouches. In 2021, nicotine pouches represented 0.3 percent of the world tobacco market in value terms.
Twenty-four of the 36 countries covered by the Tobacco Transformation Index allow nicotine pouches. Of those 24 markets in 2021, the market size exceeded 10 million units in seven: the United States, Sweden, the United Kingdom, Germany, Ukraine, Switzerland and Poland.
Legislation differs among the studied geographies, with some countries treating nicotine pouches as consumer products and others viewing them as tobacco products. Germany’s Federal Office of Consumer Protection and Food Safety determined that nicotine pouches are a foodstuff containing an unauthorized novel food ingredient—nicotine—and thus illegal for sale.
July 11, 2022
Swedish Billionaire Invests in Sting Free
Erik Selin (Photo courtesy of Sting Free)
Swedish billionaire Erik Selin has invested SEK4.4 million ($434,247) in the Swedish nicotine pouch innovation company Sting Free. He has thus become the second largest shareholder in the company, which is now valued at just under SEK31 million. Sting Free’s other shareholders include Curt Enzell, inventor of the original snus pouch and Meg Tivéus, a former board member of Swedish Match.
Sting Free has developed and patented a pouch for modern oral nicotine products and snus, where one side has an integrated protective shield for the gums ((also see “Patching the Pouch,” Tobacco Reporter, July 2017). The shield effectively reduces the burning sensation and gum irritation that is normally caused by these products.
This is the third time Selin has invested in companies in the snus industry. He is already the largest Swedish shareholder in the snus giant Swedish Match and is also a major shareholder in Haypp Group, which is the largest e-trader of snus and modern oral nicotine pouches in Europe.
“We welcome Erik with open arms and could not have found a better partner,” said Sting Free founder and Chairman Bengt Wiberg.
“We are a tobacco harm reduction company whose technology has already received much media attention and an international award for removing the stinging sensation. The stinging sensation is often considered as being a deterrent for smokers and other nicotine users who have never tried smokefree oral nicotine products,” said Wiberg.
Sting Free AB recently conducted a survey with more than 1,000 snus and nicotine pouch using men and women in Sweden. The results show that the patented technology is in demand, especially among women and those who have, or are concerned about, oral health problems linked to their use of these types of products. The survey results shows that 59 percent of users dislike the familiar burning sensation and 56 percent have worried about their oral health in connection with their use of the products presently on the market.
The market for snus and tobacco-free nicotine pouches is presently worth approximately SEK9 billion per year in Scandinavia alone.
Before the end of 2022, Sting Free AB will launch its first tobacco-free nicotine pouch with the unique integrated Stingfree shield. “In the future our goal is to license the technology and thereby create a new standard in the industry that is as familiar to consumers as light products are for soft drinks or Gore-Tex is for clothes and shoes,” says Sting Free CEO Daniel Wiberg.
June 24, 2022