Modern Oral - Tobacco Reporter

BAT Conducts New Study of Velo

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

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.

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

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.

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.

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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

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

Prague to Regulate Pouches Like Tobacco

The Czech Ministry of Health is preparing rules that would treat nicotine pouches as tobacco products, according to a Radio Prague international report.

Nicotine pouches are currently unregulated in the Czech Republic. “We are aware of the problems this causes,” said Ministry of Health spokesman Ondřej Jakob. “We are working on a decree that would determine the properties, the labelling and the regulation of the product. We are also working on an amendment to the current legislation.”

According to Jakob, the new decree could come into force within a few months.

Health activists have expressed concern about the growing popularity of nicotine pouches, especially among young people, in the Czech Republic. According to Marek Lžičař, an addictologist at St. Anne’s University Hospital in Brno, children can develop an addiction in just a few weeks.

“The risk of addiction is huge for anyone, both for children and adults, and it shouldn’t be downplayed,” he said. “It is definitely risky behavior that could be a gateway to the use of other tobacco products. It could also lead to the use of softer or harder drugs.”

Experts attribute the growing use of addictive substances among children to the long social isolation caused by the Covid-19 pandemic.

June 22, 2022

Streamline Launches ‘Fruit-Forward’ Pouches

The Streamline Group has launched Juice Head pouches, the latest addition to its line of premium, fruit-flavored nicotine products.

Featured in 6 mg and 12 mg tobacco-free nicotine strengths, Juice Head pouches are available in five premium, fruit first, mint second flavors: blueberry lemon mint, watermelon strawberry mint, mango strawberry mint, peach pineapple mint and raspberry lemonade mint.

Juice Head pouches are thin, white pouches that are made with Zero Tobacco Nicotine—a trademarked synthetic nicotine brand—and are available in 20-pouch cans and 5-can sleeves.

Compared to other nicotine pouches currently on the market, which are mainly offered in a variety of mint or mint with light fruit flavors, Juice Head pouches offer adult users a unique “fruit first, mint second,” rich flavor experience that’s on par with the brand’s world-renowned e-liquid flavors, according to the company.

“As the needs of our customers continue to evolve, we are proud to introduce a new product that’s unlike any other currently on the market and offers discreet, convenient, smoke-free, and tobacco-free nicotine satisfaction for adults around the world,” said Patrick Mulcahy, CEO and co-founder of the Streamline Group, in a statement.

“With the launch of Juice Head pouches, we plan to not only expand our product offering for our existing global customer base but to also introduce the Juice Head brand to an entirely new demographic of consumers, retailers and distributors that we had previously been unable to reach.

Juice Head is manufactured and distributed by Streamline Group, which is based out of Huntington Beach, California, USA.

April 19, 2022

Cerulean Debuts Snus Test Station

Cerulean has launched Orion, the world’s first automated test station for snus.

The Orion can handle oral pouches of all commercially available size formats, including mini, large, maxi and slim.

The instrument measures pouch weight, length, width, end seam width, longitudinal seam overlap width and pouch tensile strength. According to Cerulean, the Orion requires only a few minutes to configure and perform the test. The instrument is equipped with an intuitive user interface that provides key information, graphical representation of process capability and stores the data in a network accessible SQL database. A powerful vision system takes images of both sides of every pouch that are used to measure the pouch dimensions, seams width and longitudinal seam position.

The Orion test station reduces the number of operators per line and provides fast, consistent and repeatable users’ independent testing process with real time visualization of the test results, configurable report generators and readily available connectivity to LIMS and MES systems.

According to Cerulean, the Orion saves operator time and improves quality through independent, fast, consistent and repeatable testing of pouches. With a real time visualization of test results and configurable report generation, the Cerulean test station guarantees that the production process is always in control.

January 29, 2022

Maneson to Lead Sales at Lucy Modern Oral

Lucy has named Rob Maneson head of sales. Maneson will help the modern oral nicotine startup expand its distribution and retail presence.

Prior to joining Luci, Maneson held leadership positions at Imperial Brands, including that of senior vice president of sales for Fontem and CEO of JR Cigar. Earlier in the career, Maneson held sales positions at Altria and served as a category manager for tobacco products at RaceTrac Petroleum. He is a graduate of the University of Arizona where he earned a Bachelor of Science degree.

Additionally, Joe Johnson has been named national accounts director. He will work with major retailers around the country to grow Lucy’s retail presence.

Johnson comes to Lucy from Sweet Water Brewing Co. where he was vice president of national accounts. Prior to his six-year stint at Sweet Water, he served as category manager, alcohol beverages at RaceTrac Petroleum. Johnson earned his Bachelor of Business Administration at the University of Georgia, majoring in marketing.

Lucy was founded by former smokers who were dissatisfied with the traditional nicotine options available and set out to develop better alternatives. Its products include Kapsel and Slim nicotine pouches, along with a variety of flavors and nicotine strengths under the Chew + Park brand.

January 11, 2022

Tag: Modern Oral

Amplicon presents the first pouch with controlled nicotine release.

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