Author: Staff Writer

PMI Applies to Sell IQOS Iluma in the U.S. Market

Photo: vfhnb12
Philip Morris International Oct. 20 submitted premarket tobacco product applications (PMTAs) and modified risk tobacco product applications (MRTPAs) for IQOS Iluma heated tobacco products with the U.S. Food and Drug Administration (FDA).
IQOS Iluma products are PMI’s most-innovative heated tobacco products. They deliver substantially similar reductions in the formation of harmful and potentially harmful constituents as earlier versions of IQOS products authorized by FDA
According to PMI, IQOS Iluma has demonstrated higher rates of full switching by adults who smoke and improved consumer satisfaction in many countries.
IQOS Iluma products rely on a fundamentally different heating technology from previous versions of IQOS products and contain numerous technological advancements including improved device and battery longevity.
IQOS Iluma products are currently available in 27 markets internationally
PMI’s applications are supported by a thorough scientific assessment, including aerosol chemistry, in vitro toxicology, a pharmacokinetic study, and consumer perception and behavior studies, as well as the comprehensive scientific dataset generated with previous versions of the IQOS system
The IQOS Iluma devices operate on the Smartcore Induction System that heats tobacco from within Terea Smartcore Sticks—heated tobacco sticks designed to be used only with IQOS Iluma devices
PMI has submitted applications for three Iluma devices and five variants of the tobacco sticks: Terea Blue, Terea Green, Terea Sienna, Terea Bronze, Terea Amber

Internationally, IQOS Iluma products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking. We believe that same success can be replicated in the U.S.
Stacey Kennedy, president Americas and CEO of PMI’s U.S. business
“Tens of millions of American adults today smoke cigarettes and will likely continue to do so. They should have a range of scientifically substantiated better alternative nicotine products to choose from, and PMI is committed to providing them with new choices,” said Stacey Kennedy, president Americas and CEO of PMI’s U.S. business, in a statement.
“Internationally, IQOS Iluma products have demonstrated how ground-breaking consumer-centric innovation can lead more adults to stop smoking. We believe that same success can be replicated in the U.S. and drive a rapid decrease in smoking rates among adults. These are strong applications, and we urge the FDA to prioritize them for review.
“Since 2008 PMI has invested more than $10.5 billion to scientifically research, develop, and commercialize smoke-free products, an investment that was further bolstered last year through our acquisition of Swedish Match. We are focused on providing adults who smoke with alternatives that can reduce their risks compared with smoking and help make America cigarette-free.”
PMI will have the full rights to commercialize all IQOS products in the U.S. as of April 30, 2024, per the terms of an agreement with Altria Group, Inc. ending the companies’ commercial relationship covering IQOS in the U.S.
October 21, 2023
Researchers Identify Vape Flavors Used to Quit Smoking

The most interesting data is that when a smoker decides to quit smoking using modified-risk electronic tools, they gravitate toward flavors different from tobacco.
Konstantinos Farsalinos, co-author
A recent survey revealed that the most utilized flavors to quit smoking in the U.S. are those of fruit, baked goods and chocolate.
A team of European researchers affiliated with the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), the University of West Attica and the University of Patras conducted an online survey on a sample of about 70,000 adult vapers in the U.S. The study focused on comparing flavor use between current-smoking vapers (dual use) and former-smoking vapers and on specifically examining patterns of flavor use among former-smoking vapers at the time of quitting smoking.

Graph: CoEHAR
“This is the largest survey ever conducted on the use of electronic cigarettes in terms of sample size,” said study author Konstantinos Farsalinos in a statement. “The most interesting data is that when a smoker decides to quit smoking using modified-risk electronic tools, they gravitate toward flavors different from tobacco, with a clear preference for fruit, dessert and chocolate flavors. We can deduce, therefore, that these specific flavors are more useful for those who want to quit or avoid relapses.”
When it comes to regulating vape flavors, Riccardo Polosa, founder of the CoEHAR, urged lawmakers to strike a balance between the need to protect young people and the desire to help adult smokers quit.
October 19, 2023
Cannabis And Nicotine Vape Markets Diverging

Photo: Seth Michael
The cannabis vaping and tobacco vaping industries in the U.S. are on contrasting paths, largely shaped by regulatory dynamics, according to an article published by Bloomberg. While tobacco vaping faces increased restrictions on nicotine levels, flavored products and youth usage, the cannabis vape sector benefits from limited regulation, making it a significant player in the marijuana market.
The U.S. Food and Drug Administration’s ban on flavored vape products in particular has been detrimental to the nicotine vape sector, impacting prominent brands like Vuse Alto, which was recently the subject of an FDA marketing denial order.
In comparison, cannabis vapes are growing rapidly, with an estimated $6.8 billion in sales for the year. These numbers might underestimate the market due to the influence of illicit cannabis sales, which are hard to track. However, as cannabis legalization progresses state by state, questions arise about when this sector might face more regulations.
Some suppliers to the nicotine vape business see substantial potential in the cannabis sector, as the U.S. vape parts market alone is estimated to be a $700 million opportunity. Meanwhile, the rise of disposable vapes also poses a challenge, as concerns about waste and youth appeal lead to potential regulatory hurdles.
October 18, 2023
Netherlands: No Vaping Taxes Before Elections

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The Netherlands will not impose an excise tax on vapor products before the November 2023 elections, reports DutchNews.nl, citing De Telegraaf.
The news source added that even if the Netherlands received EU approval to impose a vapor product excise tax, the process would take several years to complete.
Although this current government did not work toward creating a vapor product excise tax, Junior Health Minister Maarten van Ooijen said that he would encourage the next cabinet to move ahead on a “national tax on e-cigarettes.” Van Ooijen added that such a tax would be “in the interests of public health.”
High cigarette prices have assisted smokers to move toward vapor products in recent years. However, the current cabinet focused on prohibiting flavored e-liquids and online vapor product sales to combat rising youth rates of vapor product usage.
“We need to take action against vapes as soon as possible to protect our children, as other EU countries have done,” Van Ooijen said.
The EU is expected to revise its Tobacco Products Directive in 2025.
October 17, 2023
BAT Uses Rooibos Tea in Heat Sticks for IQOS

BAT has begun selling heat sticks made from nicotine-infused substances such as rooibos tea to counter an incoming EU ban on flavored heated-tobacco products, according to Reuters.
Health experts have warned that the safety of the new products is unclear.
BAT has launched heat sticks containing nicotine-infused rooibos tea rather than tobacco in nine European markets, including Germany and Greece. The company plans to roll the product out globally.
BAT stated that the move will provide “adult nicotine users and smokers with the widest possible range of reduced-risk products.”
“Anything that burns or is vaporized … and inhaled into the lungs, probably will cause some effects,” said Erikas Simonavicius, a research associate at King’s College London, of the unknown risk factors of the tea-infused heat sticks. Tobacco companies have not yet published any research showing the health implications of rooibos or other zero-tobacco heat sticks, said Simonavicius.
BAT is the first big tobacco company to publicly state what its zero-tobacco sticks are made from. The company declined to comment on whether it had conducted research on the health implications of the product.
Philip Morris International plans to roll out a zero-tobacco stick later this year, according to statements made during the company’s investor day in September. PMI declined to comment on what the product is made from or its health implications.
According to Jacek Olczak, PMI CEO, the company’s product could avoid the regulatory scrutiny of tobacco products.
According to BAT, its new zero-tobacco heat sticks are not subject to EU tobacco rules, meaning the company can sell its sticks in flavors even after a ban on flavored heated-tobacco products is implemented later this month.
“The obvious advantage these new products should provide is a way to keep menthol and flavor varieties on the EU market,” said Owen Bennett, a Jefferies analyst.
Experts do not think the regulatory advantages will last long, however, according to Bennett and Phil Gorham, senior equity analyst at Morningstar.
“The next generation of regulation is going to target nicotine,” Gorham said.
October 16, 2023
Clifford Douglas to lead Smoke-Free Foundation

Photo: FSFW
The Foundation for a Smoke-Free World has named Clifford E. Douglas as president and CEO. Douglas most recently served as director of the University of Michigan Tobacco Research Network and as adjunct professor in the department of health management and policy at the University of Michigan School of Public Health. Prior to that he was the American Cancer Society vice president for tobacco control. Early in his career Douglas worked to eliminate smoking on airline flights and was an attorney and advisor in landmark lawsuits against tobacco manufacturers.
Douglas has also managed a $6 million campaign to eliminate smoking on college campuses, and worked to help Americans understand the relationship between smoking and Covid-19. Douglas has served as the assistant director of the Coalition on Smoking and Health; he was also the associate director of the American Lung Association national public affairs office and has been the tobacco control advisor to the U.S. Assistant Secretary for Health and the U.S. Surgeon General.
“For decades Cliff Douglas has been a strong and influential voice in the work to eliminate smoking in America and globally,” said Pam Parizek, chair of the Foundation board of directors, in a statement. “He understands both the science and societal elements of tobacco issues. His credentials are exceptional, and we are pleased he will lead our foundation effort to fund meaningful research and engage in evidence-based education efforts that help those at greatest risk stop smoking.”
The Foundation is a nonprofit, independent grantmaking organization, dedicated to ending the illness and death caused by smoking.
Douglas believes the Foundation is uniquely positioned to reduce smoking globally, “Our mission is to help end smoking in this generation,” he said. “I have committed myself to this mission for 35 years and look forward to leading this organization in innovative and impactful efforts to accelerate reductions in smoking prevalence and improve public understanding regarding the nature and health impact of nicotine, and as the U.S. Food and Drug Administration has highlighted, the continuum of risk among different tobacco and nicotine products. We will continue to be a strong and independent voice in helping people around the world find healthier lifestyles.”
“Our mission is to help end smoking in this generation. I have committed myself to this mission for 35 years and look forward to leading this organization in innovative and impactful efforts to accelerate reductions in smoking prevalence.
Clifford Douglas, CEO, FSFW
“The Foundation is about to enter a new era under the leadership of Cliff Douglas,” said Parizek. “We certainly are appreciative of those who have previously supported our work, and going forward the Foundation remains fully committed to our smoking cessation and tobacco harm reduction efforts around the world.”
Philip Morris International recently made a final grant to the Foundation and the pledge agreement between Philip Morris and the Foundation has been concluded. “Moving forward the Foundation will seek to collaborate with associations and institutions to accelerate our investments in life saving research projects based on the most up to date science,” said Parizek.
October 13, 2023
FDA Denies Marketing Order for Flavored Vuse Alto Pods

Image: Rangizz
The U.S. Food and Drug Administration on Oct. 12 issued marketing denial orders (MDOs) to R.J. Reynolds Vapor Co. for six flavored e-cigarette products under its Vuse Alto brand. This includes three menthol-flavored and three mixed berry-flavored products, with each flavor being offered in three nicotine strengths.
After reviewing the company’s PMTAs, the FDA determined that the applications lacked sufficient evidence to demonstrate that permitting marketing of the products would be appropriate for the protection of the public health, which is the standard legally required by the 2009 Family Smoking Prevention and Tobacco Control Act.
Specifically, evidence submitted by the applicant did not demonstrate that the menthol- and mixed berry-flavored products provided an added benefit for adults who smoke cigarettes—in terms of complete switching or significant smoking reduction—relative to that of tobacco-flavored products that is sufficient to outweigh the known risks to youth, according to the agency.
“We review each application on its own merits, and it’s the responsibility of the applicant to provide sufficient science to support the product they’re seeking to market,” said Matthew Farrelly, director of the FDA’s Center for Tobacco Product’s Office of Science. “If an application contained sufficient scientific evidence to meet the necessary public health standard, including a non-tobacco-flavored product, we’d authorize the product. But such evidence was lacking in this case.”
Vuse is the most commonly sold e-cigarette brand in the U.S., with Vuse Alto being its most popular sub-brand. Further, findings from the National Youth Tobacco Survey (NYTS) show that Vuse e-cigarettes, which are cartridge-based products, have been the second most commonly reported e-cigarette brand used by youth in the U.S. since 2021.
These actions are among many the FDA has taken to ensure any tobacco products that are marketed in the U.S. undergo science-based review and receive marketing authorizations by the agency. The FDA has received applications for more than 26 million deemed products and has made determinations on 99% of these applications.
To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. These authorizations include other products under the Vuse brand, including tobacco-flavored Vuse Vibe and Vuse Ciro devices and accompanying cartridges. Applications for six tobacco-flavored Vuse Alto products remain under FDA review.
October 12, 2023
American Vaping Association to End Operations

Greg Conley
The American Vaping Association (AVA) plans to shut down operations, reports Vaping360, citing a letter to supporters from AVA President Gregory Conley. The group was an advocacy organization representing both consumers and the independent industry, and it was in operation for almost 10 years.
“While this may be the end of AVA, our common goal remains,” wrote Conley in the letter, “ensuring that smokers have access to safer alternatives. Despite rough times to come, I am hopeful for the future.”
“As many of you may know, back in July 2022, I took on a new role as the director of legislative and external affairs for the trade association the American Vapor Manufacturers (AVM),” Conley wrote. “Since that time, AVA has gone dormant, although I have remained in my position as a volunteer to assist with administrative functions.”
Following the dissolution of the AVA, Conley will continue in his role with the AVM, representing AVM members rather than his more universal spokesperson role with the AVA.
The AVA’s remaining funds will be split into donations to the Consumer Advocates for Smoke-Free Alternatives Association and the Influence Foundation, which funds Filter’s online publication.
“Looking ahead,” Conley wrote, “the vaping industry—and the tobacco and nicotine industry as a whole—face immense challenges, from byzantine regulatory hurdles to billionaire-funded misinformation campaigns. My work with the AVM will continue and is geared toward addressing some of these challenges head-on.”
October 12, 2023
Disposables Claim Nearly 40% of Global Vape Market

Photo: Alexander Gavrilichev
Disposable e-cigarettes account for almost 40 percent of the vape sector, according to new analysis from ECigIntelligence.
After an initial boom in the United States, the disposables market is now growing at a faster pace in other countries.
Consumers are attracted to disposables mainly by convenience and low price, but there are variations in products internationally.
For example, due to the EU Tobacco Product Directive’s (TPD) restrictions on the amount of e-liquid in vape products, the size of disposables has increased much more in non-TPD countries.
On the other hand, in some TPD markets there has been an increase in zero-nicotine products, as these are allowed to have a larger tank capacity.
Another notable recent development is the emergence of products that address the environmental concerns associated with disposables, for example products made mostly of paper, or with biodegradable components.
To provide further insight into the global disposables market, ECigIntelligence has now launched a disposable e-cigarettes tracker.
The data shows how disposable vape pricing, technical features, flavors and nicotine strengths have developed since 2020 across brands carried by leading online retailers. Users can even select specific models and see their closest competitors in the market in terms of features such as number of puffs, e-liquid capacity, battery capacity, and physical shape.
“The disposables market has ballooned at such a rate that there is an urgent need for reliable, in-depth data,” said Tim Phillips, managing director of Tamarind Intelligence, which produces ECigIntelligence. “This new tracker will provide the intelligence that players at every level in the industry have been crying out for as they formulate their strategy on disposable products.”
October 11, 2023
Ireland Announces Vape Tax, Raises Cigarette Costs

Ireland increased the price of a pack of 20 cigarettes by €0.75 ($0.80) and announced a new tax on vaping products for next year, reports The Irish Times. Other tobacco products will be subject to a pro-rate increase.
The move “supports public health policy to reduce smoking levels in Irish society,” according to Finance Minister Michael McGrath.
“In light of public health interests, continuing delays to the revision of the Tobacco Products Tax Directive and the Program for government commitment to tax e-cigarettes and vaping products, I am proposing to introduce a domestic tax on these products [e-cigarettes and vaping products] in next year’s budget,” said McGrath.
“Considerable preparatory work” by the Department of Finance and Revenue will be necessary to draft the underpinning legislation, he said.
“Nicotine is one of the most addictive substances on the planet, and there has been an explosion in youth use of e-cigarettes that has been further fueled by the advent of disposable vapes,” said Chris Macey, director of advocacy with the Irish Heart Foundation. “We can’t afford to wait a moment longer than necessary to impose this tax.”
The Irish Heart Foundation called on the finance minister last week to introduce a €0.10 per milliliter tax on e-liquid.
Smokers’ rights group warned against unintended consequences. “Annual tax hikes on tobacco are punishing consumers for enjoying a perfectly legitimate habit,” said John Mallon, spokesperson for Forest Ireland. “Not only does it discriminate against consumers on lower incomes, [but] it will drive even more smokers to the black market.” Mallon said smokers “don’t deserve” the excise increase.
“Legitimate retailers will lose business to criminal gangs, and smokers who stay within the law will be further punished compared to those who, understandably, buy their tobacco from illicit traders,” he said.
October 11, 2023