Tag: United States

  • U.S. Authorities Seize $76 Million in Illegal Vapes

    U.S. Authorities Seize $76 Million in Illegal Vapes

    Image: FDA

    The U.S. Food and Drug Administration and U.S. Customs and Border Protection (CBP) announced they seized approximately 3 million units of unauthorized e-cigarette products, with an estimated retail value of $76 million. The seizures were part of a joint operation to examine incoming shipments and prevent illegal e-cigarettes from entering the United States.

    “The FDA is on high alert and, in coordination with our federal partners, remains committed to stopping unauthorized e-cigarettes at our nation’s borders,” said FDA Commissioner Robert M. Califf in a statement. “These products too often end up in kids’ hands, and the newly formed federal task force is well positioned to collectively combat this unscrupulous activity.”

    In June, the FDA and the Department of Justice announced a joint federal task force to curb the distribution and sale of illegal e-cigarettes.

    “CBP’s trade enforcement mission places a significant emphasis on intercepting illicit products that could harm American consumers,” said Troy A. Miller, a senior official performing the duties of the commissioner for CBP. “We will continue to work with our enforcement partners to identify and seize unsafe and unlawful goods.”

    In preparation for the operation, the joint team worked for several months to review shipping invoices, identify potentially violative incoming shipments and complete other investigative work that led to this successful operation. Upon examining shipments, all of which originated in China, the team found various brands of illegal e-cigarettes, including Geek Bar and others. In an attempt to evade duties and detection, most of these unauthorized e-cigarettes were intentionally mis-declared as items with no connection to vaping products and with incorrect values. Products that are seized and forfeited to the government will be disposed of in accordance with CBP authorities.

    “This isn’t the first joint seizure operation, and it won’t be the last—we will continue to relentlessly pursue those attempting to smuggle illegal e-cigarettes,” said Brian King, director of the FDA’s Center for Tobacco Products. “The $76 million these bad actors just put in the dumpster should be a sobering reminder that their time and money would be better spent complying with the law.”

  • Austin Smokers Invited to Join IQOS Wait List

    Austin Smokers Invited to Join IQOS Wait List

    Photo: momius

    Philip Morris International will hold several events in Austin, Texas, this weekend, to mark the upcoming introduction of its IQOS tobacco heating product in the United States.

    In anticipation of launch, current nicotine users who are over the age of 21 and live in designated areas of Austin will be given the opportunity to join a wait list to be among the first to try IQOS once the product becomes available.

    “We believe having a portfolio of satisfying alternatives can help traditional tobacco users switch completely and walk away from cigarettes for good,” said Stacey Kennedy, CEO of PMI in the U.S. operations “Austin is a hotbed for innovators, entrepreneurs and trailblazers. Cultural trends adopted here have a ripple effect, so it was a natural place to introduce IQOS in the U.S.”

    Austin is a hotbed for innovators, entrepreneurs and trailblazers. Cultural trends adopted here have a ripple effect, so it was a natural place to introduce IQOS in the U.S.

    Stacey Kennedy, CEO of PMI’s U.S. business

    The (re)introduction of tobacco-heating products into the U.S. has been eagerly awaited by investors and tobacco harm reduction advocates, who hope the product will help transition smokers from deadly combustible cigarettes to less-harmful heating products. Tests suggest that heating tobacco produces lower levels of harmful chemicals than burning it. IQOS has been authorized by the U.S. Food and Drug Administration as a modified-risk tobacco product.

    In Tobacco Reporter’s October issue, Cheryl Olson reflects on how the launch of tobacco heating products may impact the U.S. market.

    IQOS was briefly test-marketed by PMI’s former U.S. partner, Altria Group. In September 2021, the International Trade Commission determined that the product infringed patents owned by British American Tobacco and barred IQOS imports.

    PMI and BAT subsequently resolved their intellectual property dispute, clearing the way for IQOS sales in the U.S. In October 2022, PMI reclaimed the U.S. commercialization rights to IQOS, saying Altria had failed to meet certain milestones stipulated in their agreement.

    IQOS is already available in about 80 countries, and since launching in Japan 10 years ago, it has helped more than 22 million people worldwide make the switch from cigarettes, according to PMI. A 2019 study by researchers at the American Cancer Society showed that cigarette sales decreased five times faster after IQOS was introduced in Japan.

    IQOS is now PMI’s top revenue earner, surpassing the company’s bestselling Marlboro cigarette brand.

    PMI’s latest integrated report shows that 38 percent of the company’s total net revenue now comes from its smoke-free business, which also includes the popular Zyn nicotine pouches .

    “For the first time in history, smoke-free products have surpassed cigarette combustibles,” PMI CEO Jacek Olczak said at the Technovation event on Oct. 9 in Neuchâtel, Switzerland, according to Malaya Business Insight.

  • US Youth Tobacco Use at 25-Year Low

    US Youth Tobacco Use at 25-Year Low

    Photo: ViDi Studio

    Current tobacco product use among U.S. middle school and high school students has dropped to the lowest recorded level in 25 years, according to newly released data from the 2024 National Youth Tobacco Survey (NYTS). Within the past year alone, at least half a million fewer students are using tobacco products, contributing to this important progress.

    In 2024, 2.25 million middle school and high school students reported current use (use on one or more days during the past 30 days) of any tobacco product compared to 2.80 million in 2023. This decline was largely attributable to the significant drop in the number of students who reported current e-cigarette use (2.13 million youth in 2023 compared to 1.63 million youth in 2024).

    Within the past year, a significant decline also occurred in current hookah use (290,000 in 2023 compared to 190,000 in 2024). Cigarette smoking reached the lowest level ever recorded by the survey, with only 1.4 percent of students reporting current use in 2024.

    “Reaching a 25-year low for youth tobacco product use is an extraordinary milestone for public health. However, with more than 2 million youth using tobacco products and certain groups not experiencing declines in use, our mission is far from complete,” said Deirdre Lawrence Kittner, director of the Centers for Disease Control and Prevention’s (CDC) Office on Smoking and Health, in a statement. “We must remain committed to public health efforts to ensure all youth can live healthy, tobacco-free lives.”

    We’re headed in the right direction when it comes to reducing tobacco product use among our nation’s youth. But we can’t take our foot off the gas.

    Brian King, director, CTP

    The CDC and the U.S. Food and Drug Administration analyzed NYTS data to assess the use of nine tobacco products among U.S. middle school (grades 6–8) and high school (grades 9–12) students. Detailed information on use of e-cigarettes and nicotine pouches from the 2024 NYTS was recently published. The most recent release provides further data from the survey, including findings on other types of tobacco product use and detailed breakdowns of tobacco product use by school level, sex, race and ethnicity.

    Youth e-cigarette use declined to the lowest level in a decade; however, for the 11th year in a row, e-cigarettes remained the most commonly used tobacco product (5.9 percent) among youth who reported current tobacco product use. In 2024, nicotine pouches became the second most commonly used tobacco product among youth (1.8 percent), followed by cigarettes (1.4 percent), cigars (1.2 percent), smokeless tobacco (1.2 percent), other oral nicotine products (1.2 percent), heated-tobacco products (0.8 percent), hookah (0.7 percent) and pipe tobacco (0.5 percent).

    The report also found varying progress across population groups. For example, during 2023–2024, current use of any tobacco product, e-cigarettes and multiple tobacco products all significantly declined among female students, and current use of any tobacco product, e-cigarettes, cigars, hookah and multiple tobacco products declined among Hispanic students. In contrast, during 2023–2024, current use of any tobacco product, e-cigarettes, oral nicotine products, any combustible tobacco product and multiple tobacco products all increased among American Indian or Alaska Native students, and current use of nicotine pouches increased among white students. No significant changes occurred in current use of cigarettes, smokeless tobacco, heated-tobacco products and pipe tobacco for all assessed races and ethnic groups.

    “We’re headed in the right direction when it comes to reducing tobacco product use among our nation’s youth,” said Brian King, director of the FDA’s Center for Tobacco Products. “But we can’t take our foot off the gas. Continued vigilance is needed to continue to reduce all forms of tobacco product use among youth. Addressing disparities remains an essential part of these efforts to ensure that we don’t leave anyone behind.”

  • Warm Reception?

    Warm Reception?

    Photo: Ina

    How heated tobacco might change the US

    By Cheryl K. Olson

    A new kind of nicotine alternative is sidling back onto the U.S. market. Modern heated-tobacco products (HTPs) were gone before most Americans knew they even existed. After a limited test, a patent dispute took them off U.S. shelves in 2021.

    The gradual return of HTPs has just begun, with a single brand. Within a few years, Americans will likely have access to multiple options now sold in other nations. 

    Conversations with a close family friend, a former pack-a-day smoker, piqued my interest in the potential of heated tobacco. While working for the European Union from Spain, he had sought out and rejected cigarette alternatives, from vapes to nicotine gum. For him, heated tobacco was a “radically different” revelation.

    “It soothed my needs. It felt right and reassuring,” he told me. “From the moment I bought my IQOS, in 2017, I never smoked a cigarette again.”

    Here’s a quick introduction to heated tobacco and its potential to attract and benefit Americans who smoke.

    What HTPs Are and Aren’t

    I asked Corey Henry, director of U.S. communications at Philip Morris International, to help me understand this product category. Basically, an HTP involves electronically heating a stick or capsule of tobacco to beneath the point of combustion, so it releases an aerosol but doesn’t burn. The design of the heating element varies.

    The primary difference between an HTP and an e-cigarette? “A heated-tobacco product has to have some tobacco presence, whether it’s a leaf or paste,” says Henry.

    HTP ancestors included Premier and Eclipse from R.J. Reynolds. These products were not electronic. The heat came from lighting a carbon tip (which glowed like a piece of charcoal on a barbecue); it was distributed through a rod. This approach did reduce some toxicants. PMI introduced the first electronic HTPs, including Accord in the U.S. and Heatbar in Germany.

    According to the Financial Times, HTPs have enjoyed steady worldwide growth, exceeding that of vaping. The global HTP retail market value is estimated to reach $38.9 billion this year. The largest markets thus far include Japan, Italy and South Korea. In addition to IQOS, major brands include BAT’s Glo and Japan Tobacco’s Ploom. 

    American Evolution

    The U.S. Food and Drug Administration first authorized the marketing of an IQOS “heat-not-burn” system in 2019. This included a holder and charger device plus several types of heated-tobacco units, called Heatsticks. That year, IQOS was gradually introduced in several Southeastern U.S. test markets by Philip Morris USA/Altria. Due to a dispute with R.J. Reynolds over technology patent infringement, IQOS left the U.S. market after just two years.

    In early 2024, PMI took over from Altria the exclusive U.S. commercialization rights to the IQOS tobacco-heating system. After some delay, the IQOS3 model (authorized by the FDA in 2021) will test-launch in Austin, Texas, this fall. Henry noted that internationally, IQOS launches usually start in one or two cities. “You can make assumptions going in, but then you’ve got to test those assumptions and adjust, adapt.”

    The national rollout of IQOS awaits the FDA’s OK of the latest evolution of IQOS, called Iluma. Applications were submitted to the FDA in October 2023; marketing authorization is anticipated in the second half of 2025. Iluma features various upgrades, including a slightly different heating technology and distinctive tobacco sticks. IQOS Iluma is available internationally in over two dozen markets.

    “There’s a great level of interest to see how IQOS does in the U.S., so they want to see it launch and expand rapidly,” says Henry. “What we say is patience. There’s 28 million smokers, there’s 50 states—it’s basically like the European Union.”

    U.S. HTP competitors are on the horizon. For example, a BAT submission for Glo has been under FDA review since 2021, along with a modified-risk tobacco product application submitted in 2023. Altria has partnered with JT Group to submit a PMTA to the FDA with the goal of bringing Ploom to the U.S. 

    The FDA’s list of authorized e-cigarettes includes a Logic Vapeleaf product that vaporizes capsules that contain tobacco. This is technically a heated-tobacco product. The product appears to be no longer marketed.

    Attractions and Risks

    One reason for a slow U.S. rollout is the low level of familiarity with heated tobacco. People need to get clear on the basics: It generates an aerosol; it doesn’t burn tobacco.

    “There’s always an initial period of awareness and education that you have to do with adults who smoke, to help them understand what it is and what it isn’t,” says Henry. “When people hear the concept, the reaction is, ‘So … it’s like vaping?’”

    We don’t even know how much awareness or confusion may exist. A large government survey fielded in May 2019 asked whether adults had heard of or tried heated-tobacco products (or heat-not-burn). Overall, 8.6 percent said they had heard of heated tobacco, and one-half of 1 percent had tried it. Here’s the catch: The brands mentioned in the survey questions were IQOS, Glo and Eclipse. Respondents who claimed knowledge of heated tobacco were likely thinking of the outdated Eclipse.

    Responses to the 2023 National Youth Tobacco Survey are another example. One percent of respondents (representing 370,000 teens) claimed to have used an HTP. Given that the category was not sold anywhere in the U.S. at the time, this is impossible; it can only be a misunderstanding. The next few youth surveys in the U.S. will require cautious interpretation of this topic.

    What makes us think people who smoke will switch to HTPs? Randomized controlled studies have shown that vaping works to help people stop smoking, even those without plans to quit. For HTPs, we’re not there yet. That kind of evidence would raise the comfort level of health professionals and public health advocates. An Italian trial found good results for HTPs, comparable to e-cigarettes, for smoking cessation.

    Japan makes a good test of HTPs’ potential; sales of e-cigarettes are restricted, and oral products are culturally unappealing. Reduced-risk products are reportedly close to 40 percent of total tobacco industry volume in Japan, with cigarette sales nearly halved since 2015. The latest estimates suggest nearly 12 percent of adults use HTPs. It’s less clear yet how many switch completely from cigarettes to HTPs.

    According to Henry, PMI’s research finds that internationally, about 72 percent of smokers who switch to IQOS do so fully. He anticipates similar results in the U.S.

    Do people have lower exposure to some toxicants and carcinogens when they use HTPs instead of cigarettes? A Cochrane review of randomized controlled trials found moderate-certainty evidence for that. Also, the FDA authorized IQOS 2.4 and 3.0 versions to be marketed with reduced-exposure messaging. Specifically, “Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.”

    ‘Easier to Navigate’

    HTPs are designed to mimic the physical sensations of smoking. “We think that bridge is a little easier to navigate with heated tobacco because there’s a level of familiarity,” says Henry. For example, “Your experience with an IQOS heat stick is six minutes or 14 puffs, about the same time that a smoker will smoke a cigarette.”

    Due to this familiarity, my friend in Spain found switching to heated tobacco a quick and smooth adjustment. “With a coffee, when talking with someone, the routine in which I use IQOS is identical to my routine when I smoked,” he said. He learned to keep an extra charger at his office and in his car.

    “The charger you hold in your hand has a very nice feel,” he said. “It’s light, it fits anywhere. So I didn’t miss having a cigarette in my hand,” he said. He also praised the absence of stale smoke smell in his home, car and clothing.

    What else might attract Americans to heated tobacco? One U.K. survey of nicotine users found that common reasons for trying HTPs included curiosity; lack of smell, smoke and ashes; greater social acceptability; wanting to cut down or quit cigarette use; and enjoying the flavors or taste.

    A Harm Reduction Journal study of the U.S. IQOS experience found that people who switched to the initial version were somewhat more educated and higher-income than the average smoking adult. That’s not unusual for early adopters of a new technology. It will be interesting to see how use patterns evolve as people get familiar with the device and see others switch to it. 

    A Role to Play

    Some health advocacy groups have criticized PMI’s claims, suggesting that benefits of IQOS had been overstated. I’ve often wondered how my public health colleagues would view vaping if it had been framed differently at the start. Vaping burst into wide awareness as the subject of a youth-use moral panic. That first impression is hard to overcome. I applaud a careful, gradual, unflashy U.S. reintroduction for HTPs.

    As one industry observer pointed out to me, the few e-cigarettes now authorized for sale by the FDA represent older technologies. New HTP technologies entering the market may benefit from that contrast. Another unknown affecting the fate of HTPs is whether sticks will be taxed like cigarettes or at a lower rate that encourages switching.  

    Now that nondeadly alternatives to smoking exist, it’s critical to speed up switching for those who can’t or don’t want to quit. More options are most welcome. 

    “There really isn’t a silver-bullet solution for smoke-free product alternatives,” says Henry. “It’s important that we distinguish heated tobacco from e-vapor, but in a way that isn’t disparaging. They each have a role to play.”

    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
  • Trump Vows to Save Flavor

    Trump Vows to Save Flavor

    Photo: Alexander

    Former U.S. President Donald Trump said he will save flavored e-cigarettes if reelected, according to Newsmax.

    “I saved flavored vaping in 2019, and it greatly helped people get off smoking,” Trump wrote in a Sept. 20 post on his Truth Social account. “I raised the age to 21, keeping it away from the ‘kids.’ Kamala and Joe want everything banned, killing small businesses all over the country. I’ll save vaping again.”

    In his first term, Trump promised to crack down on sales of flavored products but then backtracked, saying vaping could help people stop smoking. Trump’s watered-down proposal banned the sale of all sweet-flavored and fruity-flavored vape pods and cartridges but allowed gas stations and convenience stores to continue selling menthol cartridges and vapes. It also allowed vape shops to sell a broad range of e-cigarette liquids in open-tank vaping systems.

    Free market advocates and small business vape shop owners and vape makers supported the new proposals while anti-tobacco advocates accused Trump of caving to pressure from the nicotine business.

    VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products.

    Tony Abboud, executive director, VTA

    The Vapor Technology Association (VTA) welcomed Trump’s latest comments.

    “Today, VTA had the opportunity to meet with President Donald J. Trump,” wrote VTA Executive Director Tony Abboud on Sept. 20. “We had a wide-ranging conversation, and we thanked President Trump for taking two bold and decisive actions in 2019: saving flavored vapes for adults and protecting youth by raising the age to 21.

    “Since then, youth vaping has dropped to an all-time low, and many adults have used flavored vaping to quit smoking. VTA’s meeting with President Trump represents a great day for small businesses across America who fear the Biden-Harris administration’s efforts to shut down small businesses and deprive adults who smoke of their flavored vaping products. We are pleased that former President Trump is continuing to fight for vapers.”

  • Testing the Waters

    Testing the Waters

    Philip Morris International is getting ready to reintroduce IQOS in the US.

    By Stefanie Rossel

    During its 2024 second-quarter financial results presentation on July 23, Philip Morris International at last confirmed the long-awaited reintroduction of its IQOS heated-tobacco product (HTP) in the U.S. In the fourth quarter of this year, the company will start test marketing its IQOS3 device in Austin, Texas, according to PMI Chief Financial Officer Emmanuel Babeau.

    A large-scale launch of IQOS, he stressed, will take place only after the Food and Drug Administration has authorized PMI’s most recent model, IQOS Iluma, which the company expects to happen in the second half of 2025.

    The company submitted premarket tobacco product applications (PMTAs) and modified-risk tobacco product (MRTP) applications for Iluma in October 2023. Until Iluma’s FDA marketing authorization, Babeau said, the company will sell its IQOS3 model in only a few U.S. cities, primarily to fine-tune its approach in anticipation of the nationwide introduction of IQOS Iluma.

    Once it has secured FDA approval for Iluma, the company will apply the IQOS marketing strategy that has been successful internationally, with some tweaks for the U.S. market. Among other things, this will involve engaging with consumers to explain the product, creating a dedicated sales force and setting up its own points of sale.

    The launch will be PMI’s second attempt to establish IQOS in the U.S. In April 2019, the company assigned the exclusive commercialization rights of the brand to Altria, which then launched IQOS in Atlanta and Richmond in the fourth quarter of 2019. One-and-a-half years later, IQOS was available in Georgia, Virginia, North Carolina and South Carolina. But plans for further commercialization were interrupted when the International Trade Commission (ITC) upheld a claim by BAT that IQOS products infringed two patents owned by British Tobacco America Group.

    In September 2021, the ITC ordered Philip Morris and Altria to stop importing and selling IQOS models 2.4, 3 and 3 Duo and their respective heat sticks. PMI then agreed to pay Altria $2.7 billion to take back the U.S. commercialization rights of IQOS as of April 30, 2024. In February 2024, PMI and BAT resolved all ongoing intellectual property disputes related to the former company’s HTP and vapor products.

    In 2020 and 2022, the FDA issued modified-risk granted orders for IQOS model 2.4 and model 3, respectively, as well as for three heat stick variants. These orders are valid for a fixed period. To continue marketing the MRTPs after the authorized term, the company in May 2024 applied to renew its IQOS3 exposure modification order.

    IQOS is the only HTP in the U.S. that has been granted not only a PMTA but also MRTP authorization.

    Pieter Vorster, managing director, Idwala Research

    Market With Potential

    PMI’s selection of Austin for its 2024 pilot may be a smart move, according to Pieter Vorster, managing director of Idwala Research. “Austin is known for having a vibrant tech industry, attracting young, tech-savvy people open to new technologies and innovation,” he says. “I suspect that the regulatory environment might also be somewhat less restrictive. Furthermore, PMI likely wanted to have a clean slate concerning product awareness.”

    Furthermore, Texas has a low cigarette tax rate, and IQOS will be taxed there as cigarettes, which will give PMI a clue how the product would perform when taxed similarly to cigarettes, according to TobaccoIntelligence. A progressive university town in an otherwise conservative state, the city also provides a unique variety of demographics. “This likely means that PMI will be able to assess IQOS’ attractiveness to an array of adult testers in a small area,” says Vorster.

    Expectations are high for IQOS’ nationwide rollout. Euromonitor expects the market for smokeless tobacco and smokeless alternatives to increase from $23.49 billion in 2022 to $32.05 billion in 2027, eating into the share of traditional cigarettes. The company predicts that the value of cigarettes, which currently account for most tobacco product sales, will drop by 30 percent from $97.80 billion to $68.37 billion during that period. Investors are waiting to see whether PMI can create a heated-tobacco market in a country where vapes dominate the sales of electronic nicotine-delivery systems.

    Vorster is optimistic, noting that the U.S. with its nearly 30 million smokers is significant for PMI’s transition strategy toward a smoke-free future. “The U.S. is one of the largest and most profitable markets for nicotine products globally,” he says. “Since PMI has no presence in cigarettes, it won’t be cannibalizing its own cigarette business. IQOS is the only HTP in the U.S. that has been granted not only a PMTA but also MRTP authorization by the FDA. Furthermore, very few vaping products have been given PMTAs, although this benefit is clouded by the rampant sales of illicit disposable vapes.”

    PMI aims to capture 10 percent of U.S. tobacco and HTP unit volume by 2030. While he does not consider the 10 percent target overly ambitious, Vorster lists a few caveats. “Vapers are unlikely to switch to an HTP as they would view it as a regressive step, closer to going back to smoking,” he says. “However, this could be influenced by the regulatory environment. If the current pace of PMTAs for vaping products is maintained and the sale of illicit, disposable vapes can be reduced significantly—which is unlikely in my view—then some vapers might be motivated to switch to IQOS. In the absence of what I described, new IQOS consumers will likely come from the smoking population, where the relatively high average nicotine content of cigarettes sold in the U.S. represents a significant hurdle for HTPs and, in particular, for the IQOS products that are currently authorized in the U.S.”

    If the U.S. bans menthol cigarettes, notes Vorster, the smokers of those products could represent a significant potential source of new IQOS consumers, provided IQOS’ menthol variants are allowed to stay on the market.

    Stepping Up Production

    In its second-quarter results, PMI estimated that more than 36 million people globally use the company’s smoke-free products. In the first half of 2024, PMI’s volume growth was driven by smoke-free products. The company shipped 68.7 billion HTP consumables units, an increase of 16.8 percent versus the previous year. This compares to 300.8 billion cigarettes, which grew by a mere 0.1 percent year-on-year. Shipments of oral smoke-free products increased 27.4 percent compared to 2023, up to 8.4 billion units. Zyn, PMI’s modern oral nicotine product, which became part of its portfolio through the company’s 2022 acquisition of Swedish Match, has grown exponentially and now dominates the U.S. nicotine pouch category. The product is so popular that PMI has been struggling to keep up with demand.

    However, Zyn has also attracted regulatory scrutiny. In response to a subpoena from the District of Columbia attorney, PMI in June suspended online sales of flavored Zyn variants on its U.S. website. In March, a law group in California filed a lawsuit against the company, claiming that PMI is targeting children and young adults with its flavored nicotine pouches.

    “Given the current trajectory and historical parallels with Juul, Zyn’s future will involve navigating through heightened regulatory scrutiny and social challenges,” says Vorster. “PMI’s ability to adapt its strategies, ensure regulatory compliance and address public concerns will be pivotal. If PMI can successfully manage these issues, Zyn could stabilize and continue to grow, albeit at a potentially slower pace. However, if the regulatory and legal pressures intensify, PMI might face significant hurdles that could hinder Zyn’s market expansion and profitability.”

    Swedish Match filed for a PMTA for Zyn in March 2020, but as of August 2024, the FDA had not decided on this application. “The delay in the FDA’s response to Zyn’s PMTA is likely due to a combination of high application volumes, resource constraints and the complexity of the review process,” says Vorster. “Current issues such as social backlash, regulatory scrutiny and legal challenges will significantly impact the FDA’s decision, potentially leading to more stringent regulations and conditions for approval. The FDA’s continued reliance on a scientific study that concluded that nicotine is harmful to developing brains means that products that are perceived to have youth appeal will find it hard to get approved as ‘for the protection of public health.’”

    While the regulatory approval process is outside its control, PMI has started tackling the product shortages by investing in production. On July 16, the company announced that it would invest $600 million to open a manufacturing facility in Aurora, Colorado, to produce Zyn pouches. The plant is expected to start preliminary operations in late 2025 and regular production in 2026. It will create 500 jobs. PMI is also increasing production of Zyn at its Owensboro, Kentucky site. Apart from meeting U.S. demand, the investments will help create capacity for export, the company said.

    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.
  • Smoking at Record Low

    Smoking at Record Low

    U.S. cigarette smoking has dropped to an all-time low of 11 percent, according to a new Gallup poll. Smoking is even less common in young Americans, with 6 percent of people under 30 saying they smoke.

    “The U.S. is on the verge of having a smoke-free Gen Z generation, yet instead of celebrating, vaping is under attack,” said Michael Landl, director of the World Vapers’ Alliance in a statement. “This doesn’t make any sense. The latest smoking rates clearly show that the myth of vaping being a gateway to smoking needs to be put to rest. Vaping is not a gateway to smoking; it’s a gateway away from smoking. Harm reduction works, even though politicians are making it harder for smokers to switch. It’s time to wake up!”

    Low smoking rates may be a result of decades of scientific data and warnings that the products are dangerous to use, according to a New York Post article. About 80 percent of American adults who were surveyed said that cigarettes are “very harmful” compared to 57 percent of respondents who said that e-cigarettes are “very harmful.”

    Most respondents also said chewing tobacco is “very harmful,” but few said the same for cigars, pipes or nicotine pouches, though seven out of 10 Americans believe the products are “somewhat harmful.”

    Smokers are also less inclined than nonsmokers to say that cigarettes are harmful; 80 percent of nonsmokers said cigarettes are harmful while 58 percent of cigarette smokers said the products are harmful. In comparison, 63 percent of vapers said e-cigarettes are harmful while 79 percent of nonvapers said e-cigarettes are harmful.

     

  • ITC Judge Urges Njoy Ban

    ITC Judge Urges Njoy Ban

    Photo: JHVEPhoto

    An administrative law judge (AJL) of the International Trade Commission (ITC) has recommended a ban on importing Njoy Ace products into the United States following a patent-infringement claim filed by Juul Labs.

    Ace is the first pod-based vapor product and the only pod-based menthol vapor product authorized by the U.S. Food and Drug Administration as appropriate for the protection of public health. According to Njoy parent company Altria Group, an exclusion order banning the importation of Ace would severely limit FDA-authorized choices for adults and undermine public health.

    “Altria and NJOY respectfully disagree with the ALJ’s initial determination, and Njoy looks forward to presenting its position to the full ITC, which is expected to issue a final decision by December 23, 2024,” Altria Group wrote in a statement.

    In August 2023, Njoy filed a similar, independent patent infringement complaint against Juul with the ITC seeking a ban on the importation and sale of Juul products in the U.S. A hearing before the ALJ was held in June 2024, and an initial determination is expected in late September. A positive outcome in this case would not preclude an exclusion order against Njoy Ace from taking effect.

    “We continue to work to bring this issue to resolution,” Altria wrote in its statement. “The parties have engaged with a mediator to attempt to negotiate a resolution of these disputes. In addition, Njoy recently filed substantial equivalence (SE) exemption requests with the FDA to allow Njoy to market an already-developed Ace product with minor modifications that we believe avoid three of the four Juul patent claims at issue in the case.”

  • ID Fraud Widespread: Survey

    ID Fraud Widespread: Survey

    Photo: Nok

    Nearly half (45 percent) of participants in a survey among adults aged 18-25 in the U.S. reported knowing someone who successfully used a fake ID to gain access to age-restricted products, such as tobacco, according to a new report by Scandit.

    The survey, which encompassed over 2,000 respondents across all 50 states, also found that 71 percent of respondents said it was either “very easy” or “somewhat easy” to acquire a fake ID and over 30 percent admitted to considering or buying a fake ID themselves. This issue is exacerbated in places with stricter regulations and a higher population of college students, with New England landing as the region with the highest percentage of under-21s considering fake IDs (45 percent) and the highest rate of successful fake ID use at 59 percent across the age range surveyed.

    “The widespread use of fake IDs presents a significant financial, compliance and reputational challenge for many businesses across the U.S., underscoring the need for greater vigilance and ensuring employees are better trained on and equipped for ID verification,” said Scandit CEO Samuel Mueller.

     

  • Altria Worried About Illicit Pouches

    Altria Worried About Illicit Pouches

    Photo: Tobacco Reporter archive

    Altria Group is worried about growing illicit sales of modern oral products in the United States, reports Reuters. The company has shared data on illegal nicotine pouches with the U.S. Food and Drug Administration.

    “This illicit market echoes the beginning of the illicit e-vapor market several years ago,” Altria CEO William Gifford told analysts during a financial update. “We believe it is critical that the FDA acts decisively to regain control of the oral nicotine pouch category to prevent another widespread illicit market from taking hold,” he added.

    Altria said it had identified more than 350 unique illegal nicotine pouches on sale, with new brands launching every month.

    Gifford said Altria had also observed an increase in illicit cigarettes, one survey of discarded packs in California finding that some 25 percent were non-U.S. brands, mostly originating from duty-free channels or China.

    Last month, Philip Morris International said it had observed sales of its nicotine pouches intended for the Scandinavian market on sale in the United States.

    Recently, British American Tobacco’s CEO expressed concern about the continued lack of enforcement against unauthorized single-use vapes in the U.S., which makes it difficult for authorized brands to compete in that market.