Author: Staff Writer

  • Dutch Vapers Hoarding Flavored Vapes Ahead of Ban

    Dutch Vapers Hoarding Flavored Vapes Ahead of Ban

    Credit: NK

    Vapers in the Netherlands have been stocking up on products ahead of a flavor ban set to take effect in 2024, reports the NL Times, citing Emil ‘t Hart of the Esigbond Trade Association.

    “You see that the consumers are hoarding as much as possible in the specialist stores,” ‘t Hart was quoted as saying. “Especially the real vapers who had switched over from cigarettes are hoarding.”

    From Jan. 1, 2024, stores will not be allowed to sell vapes or fluids with flavors like peach, mango or mint. Only products with the taste of tobacco will be permitted. The government hopes its measure will prevent youngsters from starting the nicotine habit and then migrating to combustible products.

    ‘t Hart believes the measure will be counterproductive, however. “People who have smoked regular cigarettes before turning to e-cigarettes would then be tempted to go back to traditional cigarettes,” he said.

    According to ‘t Hart many vapers have been buying their e-cigarettes online from sellers in France, Spain or China, or at physical stores in neighboring Belgium and Germany.

    A legal challenge against the flavor ban, filed by the Esigbond in April, is currently making its ways through the courts. ‘t Hart expects a ruling this summer.

  • Taming the Cowboys

    Taming the Cowboys

    Altria has declared war on the illicit disposable devices that are impacting its bottom line.

    By Timothy S. Donahue

    The illicit e-cigarette market is soaring. Illicit products are estimated to account for more than 60 percent of the $8.3 billion U.S. vaping industry. Statista expects the U.S. electronic nicotine-delivery system (ENDS) market to grow at a compound annual growth rate of 3.93 percent from 2023 to 2028. If the illicit market continues to go unchecked, however, companies that market legal vaping products fear many consumers will simply switch back to combustible products.

    “It is very much worth noting that this rapid apparent substitution is happening in an environment where half the vapor market is illicit; the FDA [U.S Food and Drug Administration] has hugely hampered vaping products making it onto the legal market, and consumers are hugely misled on relative risks,” said David Sweanor, an adjunct law professor at the University of Ottawa and a longtime tobacco harm reduction advocate. “As with other markets seeing similarly historic drops in cigarette use as alternative sales soar, it raises the question of just how rapidly cigarette sales could fall if policies were aimed at facilitating that rather than doing things to stymie it.”

    Altria, parent to Njoy, a leading brand of legal vaping products in the U.S., according to Nielsen, told investors during a recent conference call that the current state of the market is “intolerable” for both legitimate manufacturers and consumers. Altria CEO Billy Gifford said the regulated market is being overrun by illegal flavored disposable products manufactured and distributed by companies violating the rules and guidance laid out by the FDA. He said that regulation not enforced is indistinguishable from no regulation at all.

    “Illegal e-vapor products circumvent the actions of regulators, responsible manufacturers and retailers by evading scientific review, quality manufacturing controls, marketing oversight and legal aids or purchase restrictions. Despite recent actions by the FDA, enforcement has been inadequate and ineffective,” explained Gifford. “We believe the FDA has good tools necessary to bring order to the market. For our part, we are actively engaged with regulators, state and federal lawmakers, and trade partners and other stakeholders to build awareness of these serious issues and drive marketplace enforcement.”

    According to Gifford, the lack of enforcement has forced Altria to take a “targeted but necessary action.” The company filed a lawsuit in the District Court for the Central District of California against 34 organizations. Njoy alleges that the defendants are manufacturing, marketing, distributing, selling and/or marketing their flavored disposable ENDS unlawfully for three primary reasons:

    • They are not authorized pursuant to FDA marketing granted orders as part of the premarket tobacco product application process.
    • California bans the retail sale of flavored ENDS.
    • The defendants do not comply with the Prevent All Cigarette Trafficking Act’s delivery sale age verification, registration and filing, record keeping, tax payment and labeling requirements.

    Altria is asking for the court to provide appropriate restitution for harm suffered by Njoy due to the defendants’ unfair competition.

    “We want to protect harm reduction and the opportunity for the 30 million smokers in the U.S.,” said Gifford. “We really need to have enforcement where the smokers can make informed choices as they are moving across categories. I think that there’s an underlying positive is that we see adult smokers moving over, so they’re ready to have potentially reduced harm products. We just need them to be regulated and based on science to be in the marketplace.”

    Sal Mancuso, Altria’s chief financial officer, said that traditional cigarette volumes continued to decline in the third quarter of 2023. He said that the decline is impacted by the number of illegal products on the market; however, because illicit products are largely distributed through nontraditional untracked channels, the company has had to refine its ability to estimate the illicit product impacts on the legal vaping industry.

    “With the information we have today, we believe that there is more cross-category movement than previously assumed. And we now estimate that growth of illegal flavor[ed] disposable e-vapor products contributed to industry, cigarette industry declines in the range of 1.5 percent to 2.5 percent and over the last 12 months,” said Mancuso. “We will continue to monitor this dynamic trend and are actively pursuing better data sources to enhance our estimates in this space.”

    “We believe the FDA has good tools necessary to bring order to the market.”

    Amplifying Actions

    Altria Group completed its acquisition of Njoy Holdings in May. In 2022, Njoy Holdings received marketing orders for its Njoy Ace device along with several tobacco-flavored pods. At the time of writing, Njoy Holdings had received six of the 23 marketing orders granted by the FDA for the entire vaping product category, including pods, disposables and open systems. The regulatory agency is still reviewing Njoy’s premarket tobacco product applications for several Njoy menthol-flavored e-vapor products.

    Gifford said that the company executed Njoy’s business plans with “speed and focus,” adding that the goal is to grow the Njoy brand responsibly and sustainably. To set the foundation for success, Altria first strengthened Njoy’s supply chain. He said the company successfully solidified the entire Njoy supply chain from sourcing direct materials through the shipment to retail.

    “As a result, we do not anticipate capacity constraints as we execute our initial expansion plan. Next, during the third quarter, our teams prioritized closing inventory gaps at retail and expanding distribution of ACE,” said Gifford. “Prior to the acquisition, Njoy had a small-scale sales force, which resulted in inventory volatility and significant distribution gaps at retail …. Upon completion of the Njoy transaction, we immediately unleashed our sales force to focus on closing the inventory gaps in stores that already had distribution. We improved inventory conditions in stores and are actively working to close remaining gaps at retail.”

    Pamala Kaufman, a financial analyst with Morgan Stanley, asked Gifford if he believed Njoy could be successful and grow in a marketplace dominated by illegal products. Gifford said that the FDA still needs to get through its authorization process, and the agency’s actions will translate to the marketplace.

    Since its acquisition by Altria, distribution grew to approximately 42,000 stores during the third quarter of 2023 for the Njoy Ace, the company’s flagship device. The product is now distributed in all the top 25 U.S. convenience store chains by vaping product volume, according to Gifford. The company has also started to amplify visibility with new point-of-sale and fixture signage at retail.

    “During the fourth quarter, we continue to expect ACE expansion to reach a total of 70,000 stores by year end, representing approximately 70 percent of e-vapor volume and 55 percent of cigarette volume sold in the U.S. multi-outlet and convenience scanner,” said Gifford. “As we continue to expand distribution and close inventory gaps, we expect to further enhance visibility and product fixture space at retail.”

    Last month, Njoy unveiled its first retail trade program. The program allows retail partners to sign up for the program at various levels with merchandising options designed to position Njoy “strategically and responsibly” to current combustible tobacco consumers while boosting the awareness of the Njoy brand. Gifford said the company is beginning to test various promotional plans and anticipates more disruptive execution at retail in the fourth quarter. Moving into 2024.

    “We will continue to refine our promotional plans, implement Njoy’s retail trade program, further expand distribution and evolve our consumer engagement strategy. Our strategies will focus on informing adult vapors and smokers of the attributes of ACE, such as battery capacity and pod size, relative to other leading brands, generating trial and growing brand loyalty,” said Gifford. “In addition, plans for a new brand equity campaign are well underway. We expect the equity campaign to further amplify the brand’s presence at retail and drive consumer engagement.”

    Jacob de Klerk, an analyst for Redburn Atlantic, asked Gifford what the impact would be on Njoy’s projected market growth if the FDA doesn’t approve any flavors other than tobacco. Would only allowing tobacco flavors create enough demand for Njoy to remain profitable? Gifford said he believes there is room, and he wouldn’t rule out the potential for an authorized menthol product.

    “I wouldn’t rule out menthol. We feel good about the application—the current application in front of the FDA from a menthol standpoint. I think if you look at some of the recent marketing denial orders, it was related to ‘new following,’” he replied. “When we made the Njoy transaction, there was virtually no new following. As far as additional flavors are concerned, we’re excited and currently looking forward to being able to file [marketing applications] in the near future. We believe that [flavor] allows for adult consumers to have it as an offramp but not an on-ramp for underage users. So, we still see the potential for flavors.”

  • PMI Prevails in Investors’ Lawsuit Over IQOS Studies

    PMI Prevails in Investors’ Lawsuit Over IQOS Studies

    Photo: fotofabrika

    A U.S. appeals court on Dec. 26 dismissed a securities fraud class action brought by shareholders against Philip Morris International, reports Bloomberg Law.

    Investors accused the tobacco manufacturer of misleading them about the methods and results of IQOS clinical studies presented to the U.S. Food and Drug Administration. PMI sought the approval so that its former parent company, Altria Group, could sell the device within the U.S.

    Investors also targeted company statements about projected IQOS sales in Japan, the only country at that time where PMI sold the line of products nationwide.

    The U.S. Court of Appeals for the Second Circuit ruled that statements by PMI and its executives that the IQOS studies were “rigorous,” “the best science,” and “very advanced” were inactionable puffery. The court rejected the investors’ argument that such statements could be proven true or false.

    Optimistic remarks about sales performance in Japan, meanwhile, were allowable forward-looking statements, the court ruled.

  • PMI to Introduce Heated, Tobacco-Free LEVIA Sticks

    PMI to Introduce Heated, Tobacco-Free LEVIA Sticks

    Photo: PMI

    Philip Morris International is set to introduce LEVIA, a tobacco-free product boasting a cellulose-based composition with nicotine, aiming to reduce harm significantly compared to conventional cigarettes.

    In an interview with Daily News Egypt, Gizelle Baker, PMI’s vice president of global scientific engagement, emphasized the company’s commitment to offering satisfying alternatives to smokers, understanding the complexity of breaking the smoking habit. PMI’s strategy, she noted, involves varied device types, price points, flavors, and addressing rituals associated with smoking.

    Designed as a nicotine-delivery system resembling e-cigarettes but without tobacco, LEVIA emits 99 percent fewer harmful chemicals than cigarettes, according to PMI. Paired with the ILUMA device, LEVIA aims to provide a sensory smoking experience while minimizing health risks. PMI’s approach to reducing secondhand smoke involves eliminating smoke production by not burning tobacco.

    Bakes said PMI envisions a smoke-free future by eliminating combustion, not necessarily tobacco or nicotine. The company aims to diversify its portfolio beyond smoking-related products into wellness and healthcare sectors, leveraging expertise gained from tobacco research. This transition includes exploring new smoke-free products beyond oral, tobacco-heating systems and vape options, according to Baker.

    The company’s acquisitions in drug manufacturing indicate a shift towards diverse offerings beyond tobacco. PMI foresees future innovative products based on scientific advancements and customer satisfaction across both device and consumable categories.

  • ECLAT Celebrates THR Study’s 10th Anniversary

    ECLAT Celebrates THR Study’s 10th Anniversary

    Photo: Wlodzimierz

    The Center of Excellence for the acceleration of Harm Reduction (CoEHAR) is celebrating the 10th anniversary of the ECLAT study, which according to the organization marked a significant shift in the science of harm reduction.

    Riccardo Polosa

    The project began in 2011 when a research group led by Riccardo Polosa of the University of Catania in Italy decided to evaluate the use of e-cigarettes on a sample of smokers who wanted to quit.

    After two years of recruitment and follow-ups, the first randomized controlled trial on electronic cigarettes came to light. The ECLAT study provided evidence for the first time that the e-cigarette could help people—even those who had no desire to give up smoking—quit combustible cigarettes.

    The ECLAT study subsequently became a source of inspiration for researchers worldwide. Even then, despite the technical limitations of vaping products at that time, the study showed that at the 52nd week, 8.7 percent of smokers using e-cigarettes quit smoking, while 10.3 percent reduced the consumption of traditional cigarettes by at least 50 percent. Moreover, 73.1 percent of those who had quit did not use the e-cigarette at the end of the study.

    Although these data may appear modest today, the ECLAT study paved the way for a line of research that now engages thousands of researchers worldwide. The most recent Cochrane literature review—which also incorporates the ECLAT study—confirms what was revealed in Catania 10 years ago: e-cigarettes are effective tools in the fight against smoking.

    Reflecting on the ELCAT research, Polosa called for continued innovation and evaluation. “If we want to definitively erase the history of smoking, we must continue with research, encouraging continuous innovation and evaluation studies,” he said in a statement. “Harm reduction can and is already saving millions of lives. The path is the right one and must be followed to the end.‘”

  • Flavored Vapes Still Available After California Ban

    Flavored Vapes Still Available After California Ban

    Image: Olga

    Californians, including minors, are still able to buy flavored vapes online a year after the state enacted a ban on such products, reports The Conversation, citing a study published in Jama Network Open.

    In effect since Dec. 21, 2022, California Senate Bill 793 prohibits the sale of most flavored tobacco products, including e-cigarettes, to people of all ages. Hookahs, premium cigars and loose-leaf tobacco are exempted from the legislation.

    Posing online as minors under the age of 21, researchers tried to buy flavored e-cigarette products from 26 websites that sold them in California. Before SB 793, they succeeded in 52 percent of attempts. After SB 793, the team’s success rate rose to almost 61 percent.

    The study did not explain why flavored e-cigarettes are still available from online retailers in California. “It may be that vendors are flouting the new law, are ignorant of it, or do not believe the new law applies to online sales,” speculated corresponding author John-Patrick Allem, associate professor of social and behavioral sciences at Rutgers University.

    Allem urged authorities to conduct a comprehensive evaluation of SB 793 compliance among brands and vendors that sell their products online in California to help determine the extent to which flavored e-cigarettes are still available.

    Another research team collected weekly Google search rates related to online shopping for cigarettes and vaping products in California from January 2018 to May 2023. They found that shopping queries were 194 percent higher than expected for cigarettes and 162 percent higher than expected for e-cigarettes—which according to the authors suggests consumers are searching on Google for vendors promoting banned products.

  • Singapore Cracking Down on Travelers With Vapes

    Singapore Cracking Down on Travelers With Vapes

    Image: monticellllo

    Singapore authorities will step up checks at air, land and sea checkpoints to prevent e-cigarettes from entering the city state, reports the South China Morning Post.

    “Incoming passengers may be screened for e-vaporizers and their components at the arrival halls, and those found with e-vaporizers or their components will be fined,” said the Ministry of Health and the Health Sciences Authority in a media release.

    Vaping is illegal in Singapore, and offenders can be fined up to SGD2,000 ($1,490). Those who import, distribute or sell such products face stiffer penalties, including a possible jail term.

    Despite the ban, the number of people caught using and possessing vapes has been rising, including among underage consumers.

    Apart from the border checkpoints, checks will be stepped up at places such as the central business district, shopping centers, parks and smoking areas as well as public entertainment outlets such as bars and clubs.

    Since Dec. 1, enforcement officers from the National Environment Agency have been empowered to take action against people who use or own vapes.

    Singapore authorities said that their multi-agency approach is aimed at protecting its population.

    The World Health Organization said last week that urgent action is needed to control e-cigarettes to protect children and nonsmokers.

  • Warning Letters for Vapes Resembling Alcohol Products

    Warning Letters for Vapes Resembling Alcohol Products

    Image: FDA

    On Dec. 20, 2023, the U.S. Food and Drug Administration issued warning letters to three online retailers for selling and/or distributing unauthorized e-cigarettes that imitate packaging for bottles of alcohol. These retailers sold Luckee Vape Daniels brands, which are flavored disposable e-cigarette products that come in a variety of common alcoholic drink flavors that may be appealing to young people, including icy pina colada, frozen strawberry daiquiri, frozen mangorita and watermelon martini.

    Data from the 2023 National Youth Tobacco Survey indicate that disposable products are the most commonly used type of e-cigarettes among U.S. middle and high school students. Among current youth e-cigarette users, approximately nine in 10 reported using flavors, with fruit flavors being the most popular (63.4 percent) and about one in 14 (7.2 percent) reporting use of products with alcoholic drink flavors.

    “FDA is committed to taking action across the supply chain, including among retailers, to remove unauthorized tobacco products from the marketplace,” said Brian King, director of the FDA’s Center for Tobacco Products, in a statement. “This includes continued monitoring of the online marketplace to identify and combat against emerging products of concern.”

  • FDA: New 5-Year Strategic Plan Announced for CTP

    FDA: New 5-Year Strategic Plan Announced for CTP

    Image: Tada Images

    On Dec. 18, Brian King, director of the U.S. Food and Drug Administration Center for Tobacco Products, published a statement about the release of the center’s comprehensive strategic plan. The new strategic plan outlines CTP’s programmatic and workforce initiatives for the next five years.

    The CTP’s strategic plan defines five goals, 10 outcomes and several corresponding objectives. As outlined in the goals and outcomes in the plan, the center is collectively committed to issuing impactful regulations, using robust science to inform application reviews, pursuing timely and impactful compliance and enforcement strategies, and educating the public about the risks of tobacco products.

    King said the CTP will also continue to invest in its staff by advancing operational enhancements and supporting the further development of its workforce.

    In conjunction with the strategic plan, the CTP also published the center’s policy agenda of rules and guidance documents that are in development or planned for development. According to the agency, this policy agenda will create a more efficient approach to meeting the CTP’s strategic plan. The agenda will be updated annually.

  • Indonesia Adds Vape Products to Inflation Basket

    Indonesia Adds Vape Products to Inflation Basket

    Image: alexlmx

    Indonesia is adding e-cigarettes and vape liquids to its inflation basket, a collection of goods and services used to calculate the Consumer Price Index rate, reports Bloomberg.

    The change will update the composition of Indonesia’s consumer basket to reflect changes in technology, income and people’s consumption patterns, especially after the pandemic, according to the country’s statistics office.

    Other new inclusions include face masks, hand sanitizers, TV receivers and fares for Jakarta’s recently-launched Mass Rapid Transit line. Online shopping for men’s and women’s shoes, Muslim clothing, mobile phones and perfume will also be tracked in five major cities, including Jakarta, Bogor and Surabaya.

    Items like TV antennas, DVDs and print magazines have been dropped from the basket.

    Indonesia is one of the world’s largest tobacco markets. Vapes have gained popularity in recent years, especially in urban areas.