Children exposed to vaping indoors absorb less than one-seventh the amount of nicotine as children who are exposed to indoor smoking but more than those exposed to neither, according to a new study led by UCL researchers.
The study, published in JAMA Network Open and funded by Cancer Research U.K., looked at blood tests and survey data for 1,777 children aged three to 11 in the United States.
The researchers said that secondhand exposure to harmful substances in e-cigarettes would likely be much lower still, as e-cigarettes deliver similar levels of nicotine to tobacco but contain only a fraction of the toxicants and carcinogens.
The researchers looked at nicotine absorption in children, but they said the findings were likely to be similar for adults.
“Our study shows, using data from the real world rather than an artificial lab setting, that nicotine absorption is much lower from secondhand vapor than from secondhand smoking,” said lead author Harry Tattan-Birch of the UCL Institute of Epidemiology and Health Care in a statement.
“Nicotine itself is of limited risk, but it shows what the highest possible exposure might be from secondhand vaping. Exposure to harmful non-nicotine substances present in vapor will likely be substantially lower still.”
“This paper suggests that concerns about secondhand vaping may be somewhat overstated, with secondhand exposure to toxic substances likely to be very low,” said senior author Lion Shahab of the UCL Institute of Epidemiology and Health Care.
“The findings confirm the risks of smoking indoors around children, which should be avoided at all costs. However, as secondhand vaping still exposes children to more harmful substances than no vaping or smoking exposure at all, it is best to avoid indoor vaping around children too.”
The study used data from a nationally representative sample of children in the U.S. collected between 2017 and 2020 as part of the annual U.S. National Health and Nutrition Examination Survey.
Blood tests that detected the concentration of cotinine were used to assess how much nicotine the children had absorbed. Cotinine is a chemical the body produces after exposure to nicotine. Survey responses indicated if the children had been exposed to smoking or vaping indoors in the past week.
The researchers focused on data from children as, unlike adults, children were unlikely to have vaped or smoked themselves, meaning higher nicotine absorption was a result of secondhand vapor or smoke only. However, two children were excluded from the analysis for having a cotinine concentration that suggested they had vaped or smoked directly. Children exposed to both indoor smoking and vaping were also excluded from the analysis.
The team found that children exposed to indoor vaping absorbed 84 percent less nicotine than children exposed to indoor smoking while children exposed to neither absorbed 97 percent less.
The lower levels of nicotine among those exposed to secondhand vaping were consistent with previous laboratory studies finding that people retained 99 percent of the nicotine they produced during vaping. With tobacco cigarettes, smoke is generated both by smokers breathing out as well as by the lighted end of the cigarette. E-cigarettes, however, do not generate aerosol aside from when vapers exhale.
The researchers said their findings had implications for whether vaping should be allowed indoors, providing further evidence that the impact of vaping on bystanders’ health will be much less than smoking.
However, the researchers said there were other factors to consider when assessing whether indoor spaces should be made vape-free. In particular, if vaping commonly occurs indoors, this may normalize the behavior, encouraging people to start vaping and making it harder for them to stop.
Previous research from the same team showed that adults in England were much more likely to vape than smoke indoors, with nine in 10 vapers found to vape inside while only half of smokers smoked inside.
Inter Scientific, an independent global analytical testing and regulatory compliance firm, announced its membership in the UK Vaping Industry Association (UKVIA), the largest trade body representing the UK vaping industry.
The commitment underscores Inter Scientific’s focus on promoting high safety, quality, and compliance standards within the vaping industry, according to a press release.
Inter Scientific and UKVIA are committed to fostering a robust and responsible vaping industry. By collaborating, Inter Scientific aims to support UKVIA’s initiatives, leveraging its extensive expertise in regulatory affairs to help shape a sustainable future for vaping in the UK, according to the release.
David Lawson, CEO of Inter Scientific, stated, “We are thrilled to join UKVIA as a full board member and contribute to the advancement of the vaping industry in the UK. At Inter Scientific, we believe in the potential benefits to [the] public that the vape industry holds.
“Our collaboration with UKVIA will enable us to work closely with industry leaders to ensure the highest standards of safety, quality, and compliance are met, to benefit consumers and public health.”
Inter Scientific plans to actively participate in UKVIA’s working groups and committees, contributing knowledge and experience to address key industry challenges. The collaboration will focus on areas such as regulatory compliance, product safety standards, and public education.
“By working collaboratively, Inter Scientific and UKVIA aim to enhance the credibility and trustworthiness of the vaping industry, ensuring that consumers have access to safe and reliable products,” the release states.
The vaping industry has significantly changed in the 10 years since Vapor Voice started publishing.
By Timothy S. Donahue
The vaping industry has changed dramatically during the past decade. When Vapor Voice published its first issue in 2014, the e-cigarette industry was about six years old and still in its infancy. Cig-a-likes and tobacco flavors were still popular, but flavors and mods started taking off. In an online article on Dec. 14, 2019, Vapor Voice reported that Clearette was named “Best E-Cigarette and Vapor Line of 2014” in a competition organized by ECig Review Central.
ECig Review Central gathered 25 leading vapor enthusiasts from around the United States. The judges were blindfolded and sampled 20 prominent e-cigarette brands over six hours. “I liked the bold e-cigs the best,” said one judge. “The throat hit was perfect, and the draw was extremely smooth.”
Each tester was given a 15-minute to 20-minute break between individual e-cigarettes. Judges rated taste, quality and delivery on a scale of one to 10. In 2014, 21 out of 25 judges rated Clearette’s line as the best tasting. “The entire line was incredible,” stated another judge. “I was thinking it might be a tobacco company’s, but it wasn’t. The vapor tasted just like smoke.” Sadly, like many early vapor companies, Clearette and ECig Review Central are no longer in business.
These early devices provided little vapor, and battery life was short compared to today’s products. One early industry leader, Njoy, is still producing products, albeit now under the Altria umbrella. The difference between Njoy’s original Daily disposable and its current Daily disposable exemplifies the vapor industry’s technological growth. In addition, Njoy’s Ace pod system is the most technologically advanced vaping product to have received marketing authorization from the U.S. Food and Drug Administration.
Vapor Voice’s first print edition followed Altria’s announcement to launch its MarkTen e-cigarette nationwide. Altria also purchased Green Smoke for $110 million in cash and up to $20 million in incentive payments. Both the MarkTen and Green Smoke products are no longer on the market. Later that year, Greg Conley started the American Vaping Association, a nonprofit vapor industry advocacy organization that has now become part of the American Vapor Manufacturers Association, and the Oxford English Dictionary voted “vape” as the word of the year. Philip Morris International also launched its heated-tobacco product, IQOS, in Milan, Italy, and Nagoya, Japan.
In 2014, the U.S. Food and Drug Administration also released its proposed rule for extending its authority to all tobacco products, including e-cigarettes, cigars, hookah and pipe tobacco (“the deeming rule”). The new regulations for electronic nicotine-delivery system (ENDS) products were finalized in 2016. The final deeming regulations were officially published on May 10, 2016, and became effective 90 days later on Aug. 8, 2016.
The deeming rule changed the vaping industry. Many would say it nearly decimated it. The FDA’s channels for manufacturers and retailers to gain permission to sell their products threatened to put them out of business. According to the Brooklyn Law Review in a 2017 paper, “Through the far-reaching ‘Deeming Rule,’ e-cigarette manufacturers are forced to comply with financially burdensome and time-consuming requirements before taking most of their products to market.”
The Juul Experience
Credit: Insurance Journal
In 2015, we had our first introduction to Juul Labs. During a tobacco industry event in New York, Brian Haynes, with Troutman Pepper, and myself were shown a Juul device by Gal Cohen, Juul Labs’ head of Scientific and Regulatory Affairs. We snuck off into the back corner of a bar together, and he let us both take a few puffs. He wouldn’t let us have one. It blew our minds. We knew then that it was potentially an industry-altering product.
Juul altered the industry too. Its impact could be summed up as “the good, the bad and the ugly.” The good was that Juul was a technological marvel at the time. The Juul device helped smokers switch to vaping faster than any product before it. Sales began to soar. Juul was the catalyst for the rapid growth of the vaping industry from 2016 to 2019.
In 2017, Kevin Burns joined Juul Labs as CEO about two years after the company launched Juul. Juul was estimated to make up about 40 percent of the e-cigarette industry at that time. Then, in December 2018, Altria Group invested $12.8 billion in Juul Labs, acquiring a 35 percent interest and valuing the company at $38 billion. Altria claimed Juul Labs would remain a fully independent company.
Soon after Altria’s investment, Juul Labs began to decline. The company and its advertising practices came under fire. The FDA accused Juul of creating a vaping “epidemic” by hooking youth on vapes, and Burns even went as far as to say he would apologize to parents whose “children were addicted to the company’s products” as concern grew around the teen vaping epidemic.
There was also the great EVALI scare. The outbreak of “e-cigarette or vaping product use-associated lung injury,” to use the outbreak’s official but misleading name, started in 2019 and was caused by illegal, unregulated cannabis vaping products laced with vitamin E acetate. The U.S. Centers for Disease Control and Prevention, however, wrongly blamed nicotine vaping products. This episode, too, almost ended the e-cigarette industry.
EVALI and the youth “epidemic” became too much of a burden for Juul Labs. Burns resigned as CEO of the company in September 2019. K.C. Crosthwaite, who was serving as the chief growth officer for Altria, was named his successor. In October 2019, Juul Labs announced it would be laying off about 500 employees by the end of the year. Several Juul Labs executives also moved on from the troubled company that year.
Stung by Juul’s disappointing performance, Altria announced in October 2019 that it was reducing the value of its investment in Juul by $4.5 billion. In January 2020, the FDA issued a policy prioritizing enforcement against unauthorized flavored e-cigarette products that appeal to kids, including fruit and mint flavors. However, the flavor restriction didn’t apply to disposable e-cigarettes. “Under this policy, companies that do not cease manufacture, distribution and sale of unauthorized flavored cartridge-based e-cigarettes (other than tobacco or menthol) within 30 days risk FDA enforcement actions,” the agency stated.
Juul subsequently pulled all its flavored pods from the U.S. market except for tobacco and menthol. The impact of the FDA’s rule was devastating for the pod-based Juul and all other pod-based vaping systems. By October 2020, Altria further reduced Juul’s valuation to approximately $10 billion. By March 2021, the valuation was cut to $4.3 billion; by March 2022, it was reduced to $1.6 billion. In July 2022, the valuation of Juul Labs was further cut down to $450 million, which was only 3.5 percent of its original value.
The fall of Juul may go on to be one of the most significant corporate collapses of this century. Coupled with the FDA’s nonenforcement policy of flavored disposable vaping products, Juul Labs’ downfall caused substantial changes in the vaping industry. No longer were pod systems a dominant force. Instead, sales of disposable vaping products exploded.
Disposables are King
Njoy ACE
The vapor industry has grown dramatically since Vapor Voice started publishing. In 2014, the vaping industry was worth an estimated $7.2 billion, according to Statista. In 2023, its value had grown to more than $23 billion. The global vaping industry is expected to reach more than $26 billion by 2028. The disposable e-cigarette market size was valued at $5.7 billion in 2021 and is poised to grow from $6.8 billion in 2022 to $14.8 billion by 2030, according to SkyQuest Technology.
While favored by consumers, disposable products present their own issues for the industry. It started with the rise of Puff Bar, which entered the U.S. market in 2019. At the time, it was owned by Cool Clouds Distribution of California. Cool Clouds sold Puff Bar to the brand’s Chinese manufacturer, DS Technology Licensing, in early 2020.
During the summer of 2020, the FDA instructed Puff Bar to stop selling its products. This decision was made because Puff Bar became a popular alternative to Juul after the latter discontinued some of its flavored products. Critics accused Puff Bar of targeting young people. In February 2021, Puff Bar resumed sales with a new design and synthetic nicotine, which, at the time, was not regulated by the FDA. Most disposable makers followed the same playbook. In 2020, U.S. lawmakers asked the FDA to force Puff Bar off the market.
Puff Bar sales began to decline; however, it wasn’t long before another disposable brand, Elf Bar, took over the market. Founded in 2007, iMiracle Shenzhen Technology was originally an e-commerce firm. In 2018, the company switched to disposable e-cigarettes and launched the Elf Bar brand with synthetic nicotine. In 2022, the FDA said it needed Congress to act to bring synthetic nicotine under its purview.
Congress closed the loophole last year. Under the new rules, companies were supposed to remove their flavored synthetic vapes from the market and file premarket tobacco product applications with the FDA. New products continued to be launched anyway. Puff Bar and Elf Bar began introducing products under different brand names, and thousands of other manufacturers followed suit.
This is where the industry stands today. Disposables dominate the market while pod systems continue to trail far behind. However, the FDA has tried to clamp down on the growth of illegal disposables. The agency has issued over 550 warning letters and more than 100 civil money penalty actions to retailers for selling unauthorized e-cigarettes.
Primarily, the regulatory agency’s actions have proved ineffective. Few retailers responded to the FDA’s actions. This has forced many states to step in. Due to the federal agency’s inability to control illegal flavored products, many state legislatures have introduced premarket tobacco product application (PMTA) registry bills. These bills require retailers only to sell products on a state list filled with products authorized by the FDA (of which there are only 23) and products with a PMTA under review by the regulatory agency. The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) has issued calls to action for several registry bills. Vaping companies are also being sued for selling flavored disposables without authorization.
Credit: Postmodern Studio
Altria and BAT subsidiary R.J. Reynolds (the maker of Vuse vaping products) have taken legal action to kill their vape competition. Last October, Altria subsidiary Njoy filed a lawsuit in a federal district court against dozens of manufacturers, distributors and retailers of disposable vapes, including the Breeze, Elf Bar, Esco Bar, Flum, Juice Box, Lava Plus, Loon, Lost Mary, Mr. Fog and Puff Bar brands. Njoy asked the court to bar imports by the companies and said it would “consider further litigation activity.”
In January, a U.S. District Court in California dismissed the lawsuit against many of the disposable vape manufacturers, distributors and retailers. The court found that the defendants did not participate in “the same transaction, occurrence or series of transactions or occurrences,” and therefore were improperly joined in the lawsuit. However, the case against iMiracle, the manufacturer of Elf Bar, has not been dismissed. The case is still pending.
The environmental impact of disposables is also a growing issue. Many companies are moving away from these products as more countries and U.S. states seek to ban them. Martin Miller, Chief Commercial Officer for Plxsur, a company that recently reached $1 billion in consolidated revenues, (see “Keeping Pace,” pg. 18) said safeguarding the environment and delivering safe and innovative products are core to the company’s sustainability agenda.
“We have worked closely with our partner companies to put in place commercial strategies to migrate consumers away from disposables. Our Italian business, Puff [no relation to Puff Bar], has already successfully migrated many of its consumers using disposables to pod and open devices,” he said. “These alternative products have already outperformed legacy single-use vapes by volume. Adding to this, migration away from disposables is present across our entire group, with Ireland-based Hale having already launched a new pod system and others with an ever-growing portfolio of owned and third-party pod systems.”
The e-cigarette industry is still growing rapidly. The Federal Trade Commission issued its third report on e-cigarette sales and advertising nationwide in April. The report found that combined sales of cartridge-based and disposable e-cigarette products to U.S. consumers by nine leading manufacturers increased by approximately $370 million between 2020 and 2021. The total topped $2.67 billion. E-cigarette companies spent $90.6 million more advertising and promoting their products in 2021 than in 2020.
Reported sales of cartridge products increased from $2.133 billion in 2020 to $2.496 billion in 2021; sales of disposable, non-refillable e-cigarette products increased from $261.9 million in 2020 to $267.1 million in 2021. As technology improves and new products come to market, vaping products will continue to save the lives of many combustible tobacco smokers. That’s one thing that isn’t going to change any time soon.
Tracy Smith and Benjamin Toll have co-authored a commentary suggesting that health care providers providers talk with adult patients who smoke about the relative risks of different tobacco products, including e-cigarettes. (Photo: MUSC Hollings Cancer Center)
Healthcare providers who are working with adult patients struggling to stop smoking should consider discussing e-cigarettes as a potential tool if they’ve already tried FDA-approved medications, say tobacco researchers with MUSC Hollings Cancer Center.
Benjamin Toll, director of the MUSC Health Tobacco Treatment Program, and Tracy Smith, associate professor in the Addiction Sciences Division of the Department of Psychiatry and Behavioral Sciences, partnered with Brian King, director of the Center for Tobacco Products at the U.S. Food and Drug Administration, to write a commentary in Nature Medicine that lays out the relative risk of e-cigarettes compared with traditional combustible cigarettes. Existing scientific evidence indicates that both products have health risks, but that e-cigarettes generally have lower risks than cigarettes.
To be clear—neither option is good for your health, Toll and Smith said. And they certainly don’t want any youth, or adults who don’t smoke, to take up e-cigarette use. But among adults who have already tried FDA-approved cessation medicines, if the choice is between continuing to smoke traditional cigarettes or switching completely to e-cigarettes, then a complete switch should be encouraged, they said. They were motivated to work with King to write this commentary because they saw confusion among the general public and doctors about the relative harms of each product.
“It really bothered me that there are well-intentioned, smart healthcare providers who think that e-cigarettes are worse than smoking cigarettes,” Toll said in a statement. “It’s simply not true.”
Toll, who is currently serving as president of the Society for Research on Nicotine and Tobacco, wanted to expand the conversation that health care providers can have with patients about ways to stop smoking.
There are seven FDA-approved smoking cessation aids, including medication and nicotine replacement options like the patch. These smoking cessation products, especially when combined with behavioral counseling, improve a person’s chances of quitting smoking. But because nicotine is so addictive, many people still struggle. That’s where Smith and Toll see a place for e-cigarettes.
“Doctors and other health care professionals don’t know what to say or how to talk about it,” Smith said. “I always say, ‘If you have somebody who smokes cigarettes, they are standing in a convenience store every single day, buying the most harmful tobacco product they could possibly be buying.’ And it’s a real injustice not to say to them, ‘Hey, there are nicotine products you could buy every day that would be a whole lot less likely to kill you.’”
However, Toll and Smith are very specific about which types of e-cigarettes they’re referring to. When they say that e-cigarettes have fewer toxicants and cause less harm than cigarettes, they’re referring specifically to the 23 products that have received FDA authorization for marketing. It’s worth noting that all 23 of these products are tobacco-flavored, not fruity, chocolatey or candy-flavored.
Smith explained that the FDA created two paths for e-cigarette manufacturers to gain authorization. The first path would allow manufacturers to market their e-cigarettes as smoking cessation devices.
“Thus far, no company has done that—as far as we know, they have not even applied,” Smith said.
The second path allows companies to market their products as tobacco products, but makes no claims about smoking cessation. Companies have to show that their products are appropriate for the protection of public health – specifically, that the benefits of the product for helping adults who smoke to transition completely outweighs the known risk of these products to youth and nonusers.
Besides the likelihood that the product will entice young people, the FDA looks at everything from environmental impact to whether users completely switch to the e-cigarette product from cigarettes. Complete switching, rather than going back and forth between e-cigarettes and cigarettes, is an important factor. If people use both products – something that researchers call “dual use” – then they’re still exposing themselves to the carcinogens and toxicants in cigarettes.
“So far, the FDA has issued more than a million denials and 23 authorizations,” Smith said.
Due to the rigorous nature of the reviews, Smith and Toll believe that doctors can reasonably share that list of 23 authorized e-cigarettes with people who are struggling to stop smoking.
In addition, there’s increasing evidence suggesting that e-cigarettes can help adults who smoke to completely transition away from cigarettes, they said. Recent large-scale studies published in JAMA Internal Medicine and the New England Journal of Medicine showed that e-cigarettes helped people to stop smoking. Further, Smith said, a Cochrane Review conducted earlier this year concluded that there is evidence from enough high-quality studies to say that e-cigarettes are more likely to help people to quit than nicotine replacement therapy, which includes nicotine gum, nicotine lozenges and the patch.
E-cigarettes remain controversial though.
“Some believe that we shouldn’t be allowing new tobacco products on the market that could potentially be appealing to youth, no matter what the benefit is to adults who smoke. And I’m just not in that camp because cigarettes are the primary way that tobacco kills people,” Smith said. “For me, because cigarettes are responsible for the vast majority of the deaths and illnesses from tobacco, I think that having less harmful alternatives out there for adults, especially if we can reduce the appeal to youth, is really important.”
The U.S. Food and Drug Administration on April 15 issued marketing denial orders (MDOs) to Shenzhen Yibo Technology Co. for 65 disposable e-cigarettes marketed as “MNGO Disposable Stick.”
The products involved include flavors such as tobacco, menthol, pink lemonade, strawberry mango, watermelon freeze, iced banana, and others, with each flavor offered in a range of nicotine concentrations from 2 percent to 6 percent.
According to the 2023 National Youth Tobacco Survey (NYTS), disposable e-cigarettes were the most commonly used device among current e-cigarette users, and almost 9 out of 10 current e-cigarette users reported using flavored e-cigarettes with fruit flavors being the most popular.
The MDOs also include several “Clear” flavor products that were described by the applicant as flavorless or unflavored. However, data submitted in the company’s applications showed these products contained ingredients that are flavor enhancers or are known to impart a menthol or mint flavor, according to the FDA. Based on the entirety of evidence, the agency determined that the products have a characterizing flavor.
“The onus is on tobacco companies to provide the evidence demonstrating that the necessary public health standard has been met, and when they fail to do so, FDA will appropriately deny the marketing authorization of new tobacco products,” said Brian King, director of FDA’s Center for Tobacco Products, in a statement. “In this case, the applicant did not meet the necessary bar.”
Broughton will open a dedicated facility for heated-tobacco products (HTPs) at its Oak Tree House site in Lancashire, U.K. The space will allow the scientific consultancy and testing specialist to assist manufacturers with a fully integrated HTP service, from the testing and characterization of products through to toxicology and regulatory submission support.
Broughton’s HTP facility will house new testing equipment, such as conditioning cabinets, smoke engines and analytical equipment.
Broughton can test an HTP for a specific suite of harmful and potentially harmful constituents based on the PMI-58 and regulatory required analytes to ensure there are no major toxicological concerns. Its team will also conduct paper-based toxicology assessments to confirm the absence of any other ingredients or materials of high concern.
“Heated tobacco is an area of growing interest in the next-generation nicotine market, as it’s widely accepted that most of the toxicants associated with combustible cigarettes are caused by the burning of tobacco,” said Chris Allen, CEO of Broughton.
“Developing and commercializing heated-tobacco products can offer smokers a reduced-risk alternative—the device heats sufficiently to release nicotine but not high enough for combustion.”
“Understanding the potentially harmful chemicals and the toxicological impact of a nicotine product is essential for marketing authorization,” said Malcolm Saxton, senior consultant at Broughton. “Our new facility will aid our provision of accredited, accurate and flexible testing for all stages of HTP product development.”
Qnovia has appointed four new members to its scientific advisory board (SAB). The new members are Neal Benowitz, professor at the University of California at San Francisco, Ian M. Fearon, independent consultant, Darla E. Kendzor, professor at University of Oklahoma Health Sciences Center, and Nicole Nollen, professor at University of Kansas.
“Our newly appointed advisors bring world-class scientific and multi-disciplinary expertise and reaffirm our commitment to advance novel therapies for the millions of people who seek to quit smoking,” said Qnovia CEO Brian Quigley in a statement.
“We are grateful for the leadership of the chair and founding member of our SAB, Dr. Jasjit S. Ahluwalia, a professor at Brown University, who has been instrumental in shaping the direction of our SAB over the past year. The expansion of our SAB complements the regulatory expertise of our policy and regulatory strategy advisor, Mitch Zeller, who served a prior appointment as director of FDA’s Center for Tobacco Products.”
Qnovia is a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx.
“Looking ahead, our SAB will serve a critical role as we advance the clinical development of our lead asset, QN-01, towards FDA and MHRA approval,” Quigley said. “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.
“Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial. We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year. Overall, we are highly encouraged by the data we have generated to date and believe that 2024 is going to be a pivotal year for Qnovia,” he added.
U.S. states must recognize the unintended consequences of passing laws requiring premarket tobacco product application (PMTA) registries for alternative nicotine products such as vaping devices, heaters, and nicotine pouches, according to the Consumer Choice Center, an organization claiming to represent consumers in more than 100 countries.
In the first months of 2024, more than a dozen bills have been introduced in U.S. states calling for a state-based registry for alternative nicotine products. Such legislation has already been passed in Oklahoma, Louisiana and Alabama.
“While the intention behind these bills is to manage consumer access to unregulated nicotine products on the illicit market, the reality is that the FDA is not approving enough new devices and products to create a competitive, regulated marketplace that meets consumer demand,” said Elizabeth Hicks, U.S. affairs analyst at the Consumer Choice Center.
While 26 million nicotine alternative products submitted PMTAs to the Food and Drug Administration, only 23 have been approved. Of those 23 approved products, 12 are tobacco-flavored e-liquid refills.
“The FDA is hiding the ball here on product approvals and how few new products are actually coming to market. If the goal is to improve public health across the country, then consumers deserve to choose from a variety of different nicotine alternatives,” said Hicks.
The Consumer Choice Centers urges state legislatures to refrain from adding to counterproductive federal policies and instead advance tobacco harm reduction through a competitive marketplace.
The American Consumer Institute (ACI) unveiled a study that provides a pivotal analysis of the potential for tobacco harm reduction alternative products, such as vaping and modern oral, to significantly reduce smoking-related deaths across the United States.
Key findings from the study entitled “Transition from Tobacco to Vaping: The Health Impacts by State” by ACI Senior Policy Analyst Justin Leventhal, include:
A potential reduction of nearly 300,000 smoking-related deaths annually if e-cigarettes replace traditional smoking nationwide.
An estimated four million lives could have been saved from 2010 to 2024, surpassing deaths from the Coronavirus by a factor of four.
State restrictions and regulatory barriers on vaping products have been identified as significant obstacles for smokers seeking to quit, thereby increasing the annual death toll from smoking-related diseases.
Removing regulatory barriers on vaping products would enable a smoother transition for smokers toward safer products or kicking the habit entirely, potentially saving hundreds of thousands of lives each year.
“Evidence suggests that e-cigarettes are nearly twice as effective as traditional nicotine replacement therapies like gums and patches in aiding smoking cessation,” a press release states. “Despite this, recent years have seen an increase in regulations, taxes, and outright bans on vaping products, hindering the progress toward a smoke-free future.”
ACI calls for policymakers to reconsider these restrictive measures and focus on harm-reduction strategies that offer a pragmatic approach to reducing smoking-related mortality rates. By embracing tobacco harm reduction products as viable alternatives to smoking, states can significantly lower healthcare costs and mortality rates associated with tobacco use.
ECigIntelligence predicts that the global vaping market grew by almost $2 billion last year.
By Freddie Dawson
Further regulatory restrictions on e-cigarettes are expected, but these will not prevent the global vaping market from continuing to grow in 2024, ECigIntelligence predicts. The trend is distinctly toward tightening controls on vaping products. Just eight of the nearly 60 countries and regions tracked by ECigIntelligence’s Policy Radar have a positive outlook on the political climate when it comes to alternatives to conventional cigarettes.
Yet despite this, ECigIntelligence sees the overall vaping market still growing by almost $2 billion between 2023 and 2024.
So notwithstanding increased regulation in many markets, there is still enough demand for alternatives to traditional cigarettes to fuel growth. Perhaps it is important to put that growth into context. An increase of just under $2 billion (from $26.4 billion to a predicted $28.3 billion) is the smallest rise not impacted by Covid-19 in the overall global market since the increase from 2016 to 2017.
The much newer, less established heated-tobacco market is now expected to overtake vaping with our sibling site TobaccoIntelligence predicting the heated-tobacco market will reach an estimated $28.6 billion in 2024.
So while there is still growth in vaping, it is by a lesser amount than it has been (particularly when viewed as percentage growth of the existing market). And other alternatives fueled by the seemingly limitless resources of Big Tobacco companies are quickly overtaking.
This makes 2024 something of a pivotal year for vaping, with important elections coming up in existing markets—such as those for members of European Parliament (MEPs) as well as contests in Belgium, India, Indonesia, Mexico, South Africa, South Korea and Taiwan—two of which could potentially be crucial for the future of the global vaping market.
Europe: Elections, Directive Revisions and Developments
Clearly, EU elections, covering the majority of European markets as they do, could have a massive impact on the future of vaping. However, their very multi-country nature makes them difficult to predict and influence—particularly on issues such as tobacco control, which would be a relatively minor campaigning point for the vast majority of politicians running.
Nevertheless, there is a chance a milder outlook on alternatives to conventional cigarettes will emerge, with right-wing/centrist parties such as the European People’s Party, European Conservatives and Reformists Party, and Identity and Democracy Party polling well.
These groups are less likely to support strict regulation, which would—at the least—maintain the status quo at a significant time for nonsmoking nicotine products as both the EU Tobacco Products Directive (TPD) and Tobacco Excise Directive (TED) will be revised.
For example, ECigIntelligence believes it unlikely a centrist/right-leaning EU would support a policy like banning all nontobacco flavors in vaping products. But given the MEP elections, ECigIntelligence does not believe much progress will be made on advancing policies in the TPD and TED.
Outside of elections, there are also a variety of other proposals expected to see significant developments through 2024, particularly in the areas of flavor bans and plain packaging as—in a continuation from 2023—fears over youth uptake of e-cigarettes continue to rise in more jurisdictions.
Focus on Australia Under Labor Government
In Australia, an overall new tobacco plan is also being drafted with the recently elected Labor government now taking control. Labor is thought to have a more skeptical view on the benefits of nonprescription nicotine products in smoking cessation, which could change how the country’s already delayed tobacco plan tackles these products.
This means that new regulations, such as a proposal to bring in plain packaging and a flavor ban for vaping products (regardless of nicotine content) as well as heated-tobacco products, could be adopted. Health warning requirements for vaping products are envisaged as well, and a ban on disposable vaping products is also expected to be in the bill.
Further measures could also be taken, such as a prohibition on the import of nicotine-free e-cigarettes (and limiting their sale to pharmacies only). However, there may be a chance conditions for prescribing e-cigarettes are eased—though that would be poor solace in comparison to the stringency of the other proposals.
Flavor Bans and Other Global Regulations
We could also see other countries enacting their own flavor bans. For example, Slovenia is expected to make such a move in 2024 while a proposal is under discussion in Canada that would limit e-liquid flavors to tobacco, mint and menthol.
ECigIntelligence thinks it is very likely that the Canadian ban will be approved, given it is government-backed and the measures proposed would not be considered controversial among the wider voting population. However, as it is still early stages in the formulation of the proposal, a date for when it would come in is not yet predictable.
Dutch authorities could move to introduce plain packaging—though it is unlikely the measure would enter into force in 2024 as it currently is only an adopted motion to take action.
The Netherlands is also looking at implementing retail regulations such as a registration obligation for all points-of-sale, which would be introduced in 2024. And, eventually, a generational ban on vapor products could be brought in.
A proposal to ban the sale of tobacco and related products, including e-cigarettes, in supermarkets as of July 2024 is expected. Sales will still be allowed after that at fuel stations, in convenience stores and in specialist shops. An effective date for the measure is not yet final. Entry into force is subject to its passing through the upper and lower houses of Parliament, which has not happened yet but is thought to be likely.
Ireland is also looking to limit the sales of vaping products. There, government officials will consider a ban on disposable vaping products in 2024. Results of a consultation showed almost 85 percent of participants supporting a ban. Such a move also appears to enjoy some government backing, with ministers expressing lukewarm support. However, such a move would have to be agreed on by government coalition members, and it may run into hurdles from EU single-market rules.
It will be interesting to see how these measures impact 2024 market estimates, such as those in Australia (expected to increase around $72 million to $478 million), Canada (expected to rise $50 million to $757 million), Ireland (only growing $4 million to $128 million) or the Netherlands (expected to fall $17 million to $160 million)—if they do indeed go forward in 2024.
Disposables are Still Big, China Losing Ground
It should be noted that disposables are the primary—and sometimes sole—category driving growth, so how regulation goes in 2024 is crucial to how growth in the overall vaping market develops. Intense media coverage of youth uptake and environmental issues is expected to continue and probably increase in most cases—also doing the market few favors.
Already, two major markets have announced bans on disposable products with both France and the U.K. moving forward with the intention to enact regulations to prohibit their sale.
Details on how the bans will be implemented as well as exact timescales remain light. In the U.K., the intention is for a ban to come into effect in 2025. But with an unpopular government, looming elections and other priorities, whether such a deadline will be made—or any deadline at all for that matter—is open to speculation.
In France, more details are clear as a bill has been approved by the country’s senate. Vaping products that cannot be refilled or are powered by a nonrechargeable battery would be prohibited under the new law, although no date for when the ban will come into effect has yet been announced. And the law must still face EU scrutiny on issues such as freedom of movement of goods.
A 2021 attempt by Belgium to ban disposables was met with a negative opinion from the European Commission. This was because the EU TPD—still in force, although currently under revision—prevents member states from prohibiting or restricting “the placing on the market of tobacco or related products, which comply with this directive.”
It seems unlikely that the European Commission could come up with a different opinion on a disposable vape ban in France, putting the plan still in the realms of uncertainty.
Nonetheless, ECigIntelligence expects to see a significant increase in the number of pre-filled and open pod category product launches as companies start to develop pod versions of disposable devices in line with incoming regulations in areas such as battery waste.
This will lead to some growth in user numbers in these categories—though the majority of that will only be down to cannibalizing off existing disposable category numbers.
This could potentially lessen the reliance of the sector on Chinese manufacturing—though it should be noted that the opinion of Chinese industry members is that such growth is more overspill from a crowded Shenzhen manufacturing scene rather than wholesale relocation of business to other markets due to factors like increased domestic regulations and duties in China.
Freddie Dawson is the managing editor for news at ECigIntelligence, a provider of detailed global market and regulatory analysis, legal tracking and quantitative data.
