Tag: news

PMTA Filed for Njoy ACE 2.0 With Age Verification

Credit: Kristina Blokhin
Njoy, a subsidiary of Altria, submitted a supplemental premarket tobacco product application (PMTA) to the U.S. Food and Drug Administration for the commercialization and marketing of its ACE 2.0 device.
The new device includes access restriction technology designed to prevent underage use. This is achieved through Bluetooth connectivity, which authenticates the user before unlocking the device. The company has also re-submitted PMTAs for blueberry- and watermelon-flavored pod products, which are exclusively compatible with the Njoy ACE 2.0 device.
“Altria’s Vision is to responsibly lead the transition of adult smokers to a smoke-free future. We’re excited to build on our existing FDA-authorized products,” said Shannon Leistra, president & CEO of Njoy. “Njoy ACE 2.0 includes critical technology features to prevent underage access to flavored Njoy products while also responsibly providing flavored options for adult smokers and vapers.”
The Njoy ACE is the only pod-based vaping product currently with marketing authorization from the FDA. In the first quarter of 2024, Njoy announced it had broadened distribution to over 80,000 stores and expects to expand to approximately 100,000 stores by year-end.
Njoy also continued the roll-out of the brand’s first retail trade program, which is designed to help achieve optimal retail visibility and product fixture space, according to a press release.
“Given the widespread illicit flavored e-vapor marketplace, this product offers the FDA a sound solution for balancing the known risk to youth with an opportunity to offer adults legal, regulated choices,” said Paige Magness, senior vice president of Regulatory Affairs of Altria Client Services. “We hope the FDA prioritizes the review and authorization of this application given its interest in device access restriction technologies to reduce youth access.”
Njoy had previously received marketing denial orders for its blueberry (2.4% and 5% nicotine strengths) and watermelon (2.4% and 5% nicotine strengths) pods, noting that “…Rather, for flavored Electronic Nicotine Delivery System (ENDS), only the most stringent mitigation measures – specifically device access restrictions – have such mitigation potential.”
Njoy stated that it believes these applications sufficiently address the FDA’s concerns regarding underage use by incorporating device age and identity-based access restriction and demonstrating that these restrictions are effective at preventing underage access in virtually all cases. Currently, the FDA has not authorized the marketing of any non-tobacco-flavored vaping product.
May 20, 2024
Executive Appointments Made at Ispire Technology

Photo: Ink Drop
Ispire Technology has appointed Jim McCormick chief financial officer. The company also announced the appointments of John Patterson as senior vice president of international nicotine; Dennis Lider as senior vice president of cannabis product sales; and David Hessler as senior vice president of operations.
McCormick has more than three decades of diverse leadership experience to his new role. He started his career in public accounting with KPMG Peat Marwick in 1989, transitioning to consumer goods with Mid-America Pepsi-Cola and later joining BAT’s associate company Brown & Williamson Tobacco in 1992. At BAT, he held various international general management and CFO positions across Europe, South America, Southeast Asia, Sub-Saharan Africa and Northern Africa.
Patterson has more than 25 years of extensive experience in the tobacco and next-generation nicotine categories, spanning both U.S. domestic and international markets, notably in the U.K. and the EU. Beginning his career at Altria, Patterson has since held pivotal roles across Europe for Philip Morris International, NJOY and most recently Juul Labs, where he served as senior director and country manager for the United Kingdom.
With more than 20 years of CPG sales leadership experience, Lider boasts over a decade of executive leadership in revenue management. Since 2019, he has held senior-level positions with publicly traded cannabis companies, overseeing wholesale, retail and distribution sales functions. Lider brings a wealth of experience in international market expansions, corporate business development, global sales management and channel diversification.
Hessler, senior vice president of operations, began his career in California’s shipping industry after graduating from Georgetown University’s School of Foreign Service. He went to Moscow in 1992, where he spent two decades in the global cigarette industry with PMI and JTI. Hessler led At JTI’s global supply chain organization’s customer service department in Geneva, managing operations across 190 markets with over 5,000 SKUs.
“We’re thrilled to announce this significant talent upgrade at Ispire as we gear up for rapid expansion both domestically and internationally,” said Ispire Co-CEO Michael Wang in a statement.
May 20, 2024
Judge Allows Ohio Cities to Enact Local Flavor Laws
Credit: Promesa Art Studio
A judge in Ohio has ruled that the state law that prohibits cities from banning flavored tobacco is unconstitutional.
Franklin County Common Pleas Judge Mark Serrott’s Friday ruling allows bans in Columbus and other cities to stay in effect.
Columbus City Attorney Zach Klein said in a statement that he applauded the decision, according to media reports.
He said, “While we know this may not be the end of the fight, this decision is a significant win for both the city of Columbus and for the health and safety of children and families.”
Columbus, Cleveland, Cincinnati and 11 other cities sued the state back in April.
The state can appeal the ruling.
May 20, 2024
Colombia: President Signs Bill Regulating Vapes
Credit: Andrea
Colombian President Gustavo Petro approved new legislation on May 15 regulating the use of e-cigarette devices, according to the Colombian media outlet El Nuevo Siglo.
The law, labeled by lawmakers as Anti-Tobacco Law 2.0, prohibits the direct or indirect sale of e-cigarettes and e-cigarette devices to minors within the country.
The law went into effect on May 9. It amended the Anti-Tobacco Law No. 1335 of 2009 to address the emerging use of e-cigarette devices and electronic nicotine delivery system (ENDS) products.
Vaping products are now subject to the same regulations as traditional tobacco products.
The law prohibits the sale of these products to minors and mandates the Department of Health and Social Protection to run educational campaigns on the health risks of vaping.
There is a transition period to allow the industry to adjust to the new regulations.
May 17, 2024
Vietnam Taking Measures to Manage Illegal Vapes
Credit: Harvepino
The Prime Minister of Vietnam, Pham Minh Chinh, has requested that authorities take various measures to manage the country’s illegal e-cigarette market.
Chinh has requested that the Ministry of Health communicate more about the harmful impacts of e-cigarettes and propose solutions to restrict the market.
The Ministry of Finance would instruct customs to manage the transportation of e-cigarettes through the border and to tackle smuggling, according to media reports.
The Ministry of Industry and Trade needs to manage the domestic market and fine individuals and organizations that sell e-cigarettes.
This move is strange because last month, the Ministry of Industry and Trade was assigned the task of presiding over and coordinating with ministries and ministerial-level agencies to develop appropriate regulations to manage the products.
May 17, 2024
Study Links Social Media Usage With Youth Vaping
Credit: Feng Yu
In a recent study published in Thorax, researchers found associations between the use of social media platforms and the risk of combustible cigarette smoking and vaping among youth.
The study is based on a survey of almost 11,000 young British people ages 10 to 25 who were tracked from 2015 through 2021.
Overall, 8.5 percent said they currently smoked, 2.5 percent said they vaped and about 1 percent did both, according to media reports.
How much time they spent on TikTok, Instagram, and other social media platforms tracked well with their odds of smoking or vaping, the study found.
Just 2 percent of people who reported no social media use engaged in cigarette smoking, but that rose to 17 percent among those who said they were on social media seven-plus hours per day.
Similarly, less than 1 percent of those who avoided social media vaped, compared to 2.5 percent of those who used it seven or more hours daily.
Dr. Graham Wheeler, honorary senior lecturer at the Imperial Clinical Trials Unit, Imperial College London, and statistics director for Statistical Innovation in Specialty and Primary Care at GSK, said the results of this large study are similar to the findings of other research into the association of social media use and smoking habits.
“However, the researchers didn’t record the social media platforms used, or how the users interacted with friends on these platforms. For example, are stronger associations seen amongst users of TikTok or Instagram compared to Whatsapp?
“Social media use is self-reported, so may not be an accurate record of actual use.
“The researchers also assessed how the interaction of social media use and variables such as age, household income and sex were associated with cigarette and e-cigarette use. However, they did not report the interaction of social media use with parental use of cigarettes and e-cigarettes, which is one of the strongest variables associated with children’s smoking habits. We don’t know if this trend of higher odds of being a smoker increasing with social media usage changes when comparing children of parents who are smokers and children of parents who are not smokers.
“This survey reports responses given at a single point in time, rather than following non-smokers over time to see if the likelihood of them taking up cigarette smoking or e-cigarette use is associated with increasing levels of social media use.”
May 17, 2024
RLX Technology Sees Boost in Revenue and Income

Photo: RLX Technology
RLX Technology reported net revenues of RMB551.6 million ($76.4 million) in the first quarter of 2024, up from RMB188.9 million in the same period of 2023. Gross margin was 25.9 percent, compared with 24.2 percent in the 2023 period. U.S. GAAP net income reached RMB132.6 million, compared with U.S. GAAP net loss of RMB56.3 million in the same period of 2023.
“We started 2024 with a steady first quarter,” said Ying (Kate) Wang, co-founder, chairperson and CEO of RLX Technology in a statement. “Our international business is developing positively as we refine our regional strategies. Despite challenges posed by regulatory changes across various regions, we continue to identify opportunities and leverage our core strengths to prudently enter potential markets.
“Domestically, we are encouraged by the positive impact of China’s recent regulatory crackdown on illegal products, but much progress remains to be made. We remain committed to collaborating with regulators and advocating for a well-regulated and healthy e-vapor industry. As a trusted e-vapor brand for adult smokers, we are dedicated to optimizing our product portfolio with premium, compliant, and innovative products that meet our users’ needs and drive growth in this evolving industry.”
The first quarter marked RLX Technology’s fifth consecutive quarter of sequential revenue growth, according to Chief Financial Officer Chao Lu. “With our resilient business model, effective regional strategies, and consistent strong execution, we are confident of sustaining this growth trajectory and delivering sustainable value to our stakeholders,” he said.
ADS[2] were RMB0.166 (US$0.023) and RMB0.159 (US$0.022), respectively, in the first quarter of 2024, compared with non-GAAP basic and diluted net income per ADS of RMB0.139 and RMB0.136, respectively, in the same period of 2023.
May 17, 2024
Vaping Surges Nearly 600 Percent in Malaysia

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Vaping prevalence in Malaysia has surged 600 percent in 12 years, reports the New Straits Times, citing a recent study.
The 2023 Global Adult Tobacco Survey (GATS) found that some 5.8 percent of Malaysian adults are e-cigarette users compared with only 0.8 percent in 2011.
GATS is a nationally representative household survey conducted in more than 30 countries globally.
The report also revealed an increase in the percentage of people who used both tobacco and e-cigarettes, from 0.8 percent in 2011 to 3.9 percent last year.
The 15–24 age group had the highest prevalence (8.6 percent) compared with 7.1 percent for those between 25 and 44.
The top 3 reasons cited for using e-cigarettes were flavors, the perception of lower risk compared to smoking, and more enjoyment.
The GATS also found that 41 percent of adult smokers in Malaysia have no plans to quit the habit.
Another 13 percent said they were thinking about quitting smoking within the next 12 months, and another 37 percent said they planned to stop someday.
The survey found that around 4.8 million or 19 percent of adults in Malaysia smoke, with 3.7 million or 14.6 percent of adults smoking daily.
GATS Malaysia 2023 queried 5,780 households across all states, with respondents aged 15 years and above, over two months.
May 16, 2024
Costa Rica to Ban Synthetic Nicotine Products

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Costa Rican authorities have announced their intent to prohibit vaping, e-cigarette and other tobacco products containing synthetic nicotine in the country.
A proposed resolution will prohibit the “sale, use, commercialization, advertising, promotion, and sponsorship of vaping liquids containing synthetic nicotine and cannabinoids,” the Ministry of Health wrote in a statement.
It will also affect products that “have incorporated cannabinoid-type liquids” because they “represent a health risk,” according to the statement.
The provision will be in effect while the government prepares to reform the law regulating next-generation tobacco products and electronic nicotine delivery systems.
The National Anti-Tobacco Network (Renata) reacted positively to the decision in a statement, highlighting that it “applauds” the government for the new regulation.
“Costa Rica could be on the verge of experiencing a next epidemic of vaping patients,” they argued.
Retailers call the proposal an “injustice,” said Michael Araya, owner of the La Pegona chain of smokers’ stores, according to a media report.
“I’m totally frustrated,” he said. “A lot of people are going to be out of work; continuing in a smoke shop without selling smoking products doesn’t make sense, a very hard blow to all the investment,” Araya added.
May 16, 2024
Korea Seeks to Regulate Synthetic Nicotine as Tobacco

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The government of South Korea aims to regulate synthetic nicotine as tobacco, reports the Yonhap News Agency.
The Ministry of Health and Welfare and the Ministry of Economy and Finance want to revise the Tobacco Business Act to include synthetic nicotine in the definition of tobacco.
Tobacco in South Korea is governed by the National Health Promotion Act, under the jurisdiction of the health ministry, and the Tobacco Business Act governed by the finance ministry.
The current rules define tobacco as a product “manufactured in a state suitable for smoking, sucking, inhaling steam, chewing or smelling, by using tobacco leaves as all or any part of the raw materials.”
That language fails to capture e-cigarette liquids made with synthetic nicotine, which is created in a laboratory rather than from tobacco leaves. As a result, vapes are not subject to product requirements, such as health warning labels, age restrictions and tobacco taxes, in South Korea.
The push for new legislation follows an announcement by British American Tobacco that it is mulling the launch of a new synthetic nicotine product in the country. South Korea is reportedly the only nation where the tobacco giant is considering a synthetic nicotine product.
“We have decided to push for the revision of the Tobacco Business Act when the 22nd National Assembly opens,” an official at the health ministry was quoted as saying. “We will provide necessary materials to the finance ministry and there is already an abundance of evidence proving that synthetic nicotine is tobacco.”
The consumption of e-cigarettes has been rising steadily in South Korea, reaching 16.9 percent of tobacco sales in 2023.
May 16, 2024