A newly published critical umbrella review in Tobacco Use Insights found that there were no statistically significant changes in respiratory function for e-cigarette (EC) users. Conducted by researchers from the Center of Excellence for the Acceleration of Harm Reduction (CoEHAR), the study highlights the absence of significant short- or medium-term respiratory changes associated with e-cigarette use, regardless of usage patterns.
Led by Giusy Rita Maria La Rosa, Riccardo Polosa, and Renée O’Leary, the review analyzed 12 systematic reviews on e-cigarette effects, categorizing users into three groups: dual users (who smoke and vape), exclusive users (former smokers who switched to vaping), and naïve users (those who have never smoked but use e-cigarettes).
“Studies on the latest products on the market have shown reductions in chemical emissions,” said O’Leary. “Across all user categories, there were no statistically significant changes in respiratory function. The five systematic reviews in our analysis concluded that there is no definitive evidence of harm or benefit regardless of the pattern of EC use”
“Current data do not show significant respiratory variations associated with e-cigarette use in the short or medium term,” La Rosa added. “However, due to the lack of adequate longitudinal studies, no definitive conclusions can be drawn.”
The researchers said their results, which vary from many others around the industry, can be explained by considering several important factors: acute studies provide data on short-term exposure to e-cigarettes and cannot be used to assess long-term effects; studies do not always account for participants’ smoking history; and individuals with low-frequency e-cigarette use are often grouped together with those who use e-cigarettes more frequently.
Regarding the quality of the included studies, only five out of 12 reviews were rated as having high or moderate confidence in their findings. Reporting issues were common.
“The study highlights the importance of distinguishing between different vaping behaviors in future research, as well as addressing methodological weaknesses and biases observed in many previous studies on the topic,” Polosa said. “But it allows us to state once again that vaping cannot be associated to significant changes in respiratory function.”
E-cigarettes do not increase smoking cessation and are associated with reduced tobacco abstinence, says researchers at the Herbert Wertheim School of Public Health and Human Longevity Science and Moores Cancer Center at the University of California San Diego. The study, among smokers in the U.S. and published March 5 in JAMA, “refutes the common misperception among tobacco users and e-cigarette proponents” that e-cigarettes can help people quit smoking.
“Most smokers think vaping will help you quit smoking,” John P. Pierce, Ph.D., a distinguished professor at the school and study’s co-author said. “However, this belief is not supported by science to date. While some researchers have suggested that smokers who switch to daily vaping will be more successful in quitting smoking, we studied quitting success among both daily and non-daily vapers and came up with a quite definitive answer.”
The study analyzed data from 6,000 U.S. smokers from the Population Assessment of Tobacco and Health Study. There were 943 smokers who also vaped and by matching and comparing these to similar smokers who didn’t vape, they found smoking cessation was 4.1% lower among smokers who vaped daily and 5.3% lower among smokers who vaped occasionally.
Researchers said that while e-cigarettes don’t have the same health consequences as smoking, they are not harmless.
“The adverse health effects of cigarette smoking become obvious after people have smoked for 20 years,” said Pierce. “While vapes generally don’t contain the same harmful chemicals as cigarette smoke, they have other risks, and we just don’t yet know what the health consequences of vaping over 20 to 30 years will be.”
This study was supported by the Tobacco-Related Disease Research Program of the University of California Office of the President.
Today, Taiwan’s Health Promotion Administration (HPA) proposed an amendment to the Tobacco Hazards Prevention Act (THP) to strengthen regulations against e-cigarettes and heated tobacco products. The proposal allows the direct confiscation and destruction of these products and enhances online supervision, Tobacco Control Division head Lo Su-ying said.
The THP was amended in 2023 to prohibit the manufacture, import, sale, display, advertisement, and use of e-cigarettes and unapproved heated tobacco products. Since then, more than 600,000 fines totaling $11.2 million have been issued, however, currently, the contraband items cannot be confiscated but are instead returned to the owner. The proposed amendment would fill in this loophole, facilitating the accelerated confiscation and destruction of e-cigarettes and heated tobacco products, Lo said.
The new proposal would also stipulate that internet service providers must remove illegal tobacco advertisements and restrict access to related content.
A new study from researchers at the University of Rochester Medical Center published in Scientific Reports suggests an elevation of carcinogenic cellular signaling pathways with e-cigarette users when compared to non-users. Dongmei Li, the director of Translational Science Statistical Support Services for the Clinical and Translational Science Institute, said little is known about how exclusive e-cigarette use affects exosomal microRNAs, which regulate genes that influence cancer-causing pathways.
By comparing exosomal microRNA profiles between exclusive e-cigarette users and non-users, the researchers identified several exosomal microRNAs that are upregulated—more active than normal—in exclusive e-cigarette users. These overactive microRNAs are involved in cancer pathways, suggesting an elevation of carcinogenic cellular signaling pathways in exclusive e-cigarette users.
“Our results contribute significantly to understanding the potential health risks of e-cigarette use and should be considered by medical professionals and the public to protect public health,” Li said. “Our study results will spark further investigations into the impact of exclusive e-cigarette use on plasma exosomal miRNAs and other biomarkers related to cancer risks, which will help us better understand the toxicity of e-cigarette use.”
This study was funded by an R21 grant from the National Institutes of Health
China’s e-cigarette exports declined to $11 billion in 2024 according to the nation’s General Administration of Customs, a decline of 1.1% from the previous year.
The United States accounted for 36% of China’s exports ($3.7 billion), followed by the U.K. ($1.2 billion), South Korea ($717 million), and Germany ($677 million).
Chinese exports peaked at $19 billion in 2021 but have declined each year since due to comprehensive worldwide regulations.
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.
Ireland Minister for Health Stephen Donnelly and Minister for Public Health Frank Feighan received government approval to introduce additional restrictions on the sale and advertising of nicotine inhaling products such as e-cigarettes, according to Gov.ie.
Under the new proposals, the sale of e-cigarettes and related vaping products will be prohibited from self-service vending machines, from temporary or mobile premises and at places or events for children. In addition, advertisements for e-cigarettes will be prohibited on public transport, in cinemas and near schools.
“These measures are designed to protect our children and young people from starting to vape,” said Donnelly. “We recognize that nicotine is a highly addictive drug, and we are acting today to make these products less accessible to our young people and to remove the advertising for these products from our children’s everyday lives.”
The proposals will be incorporated into the Public Health (Tobacco and Nicotine Inhaling Products) Bill, which is currently being drafted. The bill is expected to be finalized and published by year end. The legislation will be designed to regulate any product that can be used for the consumption of nicotine-containing vapor or any component of that product.
The bill already contains measures to ban the sale of nicotine inhaling products to those under the age of 18 and to introduce a licensing system for the retail sale of tobacco products and nicotine inhaling products. Other measures contained in the bill include:
prohibiting the sale of tobacco products and nicotine inhaling products by persons under 18 years of age;
prohibiting the sale of tobacco products from self-service vending machines, from temporary or mobile units and at events or locations for children;
introducing minimum suspension periods for retailers convicted of offenses; and
introducing fixed penalty notices for offenses.
Feighan welcomed the government’s approval of the measures.
“Tobacco smoking continues to kill approximately 4,500 people in our country each year,” he said. “We recognize that nicotine inhaling products are used by some adult smokers to assist them to quit tobacco smoking. However, we are clear that these products are of no benefit to our children and young people or to nonsmokers, and that is why we are taking this action today.”
