Consumer representatives are urging European policymakers to adopt science-based tobacco harm reduction strategies as EU health ministers gather in Brussels for a two-day meeting to discuss Europe’s Beating Cancer Plan, among other topics.
The Beating Cancer Plan presents several legislative initiatives to address cancer risk factors, including measures to reduce tobacco and alcohol consumption and improve healthy diets.
“This meeting should mark the beginning of driving the EU towards a smoke-free future,” said Michael Landl, director of the World Vapers Alliance, in a statement. “Health ministers should take inspiration from Sweden, poised to become the first smoke-free country in the world, thanks largely to the adoption of safer and less harmful alternatives. It remains vital that the EU follow their example and enforce sensible regulation.”
However, according to Landl, the EU Commission has thus far been “deaf” to the science of tobacco policies. “It is crystal clear that safer nicotine alternatives such as vaping or pouches are significantly less harmful than smoking and effectively aid in smoking cessation,” he said.
“EU health ministers have a critical opportunity this week to advocate for sensible regulations that could prevent 700,000 unnecessary deaths annually due to smoking. The Beating Cancer Plan acknowledges that vaping can help smokers quit. Politicians must act accordingly. ”
Frequent social media use is linked to an increased risk of youth using any tobacco product—including e-cigarettes—for the first time after one year, according to a new study led by Boston University School of Public Health (BUSPH) researchers.
Published in Addictive Behaviors, the study found that youth with no prior tobacco use who used social media daily were 67 percent more likely to begin smoking after one year, compared to youth who used these platforms less frequently. The results also showed that youth who actively engaged with tobacco marketing by liking or following content by major tobacco brands developed an even greater risk of first-time tobacco use.
“Our results add to a growing body of literature documenting the harms of social media use for this age group, as well as how commercial interests such as the tobacco industry are targeting kids on these platforms,” said study lead and corresponding author Lynsie Ranker, assistant professor of community health sciences at BUSPH, in a statement.
While the U.S. Food and Drug Administration expanded its regulatory authority over the marketing of new and emerging tobacco products in 2016, restrictions on tobacco advertising on social media is largely at the discretion of the social media companies, rather than government officials. The researchers also note that these restrictions primarily apply to paid promotional content with the platforms, leaving loopholes for branded accounts and marketers’ collaborations with influencers.
“Based on our research, social media platforms lack self-regulation,” says study coauthor Jessica Fetterman, assistant professor of medicine at Boston University Chobanian & Avedisian School of Medicine. “They have their own policies against tobacco marketing, yet many leading tobacco companies are able to maintain their own branded accounts to market their products. The government must step forward to regulate tobacco marketing on social media, just as they have done for other forms of media such as TV and print ads.”
While U.S. cigarette smoking rates have declined substantially among US youth since the mid-1990s, an estimated 10 percent of middle and high school students—2.8 million people—currently use at least one tobacco product, and many also engage in dual use, particularly with e-cigarettes.
Kenya’s Ministry of Health has invited the public to comment on 13 proposed large graphic warnings for tobacco products, reports The Star.
If the changes are approved, graphic warning depicting impotence, cancerous growths and sick fetuses will also be printed on new tobacco and nicotine products sold in Kenya. Currently, only cigarette packets are required to display such warnings. The law requires a combined picture and text health warning to occupy at least 30 percent of the front and 50 percent of the back of smoked tobacco products. Among the proposed labels is also a message indicating that nicotine pouches are not a safe alternative.
“These warnings are very important because they speak even to those who can’t read and they attract attention. They also scare people and pass information more clearly and immediately compared to text,” said Joel Gitali, head of the Kenya Tobacco Control Alliance.
Health warnings were introduced in Kenya as part of the 2007 Tobacco Control Act, which came into force in July 2008 and included requirements for 13 rotating text-only health warnings in Kiswahili and English.
In 2014, the government introduced 15 new images for smoked and smokeless tobacco packages. The regulations were to be implemented in June 2015 but were delayed due to a legal challenge by cigarette manufacturers, who lost the case at the Supreme Court. The images were introduced beginning September 2016.
The 2014 regulations require tobacco manufacturers to rotate the picture and text warnings in a 12-month period.
However, the law does not state how frequently the health minister must update the warnings. The World Health Organization advises governments to change tobacco health warnings every 12 to 36 months.
Gijs Lambert Johan de Best will take over as president of Philip Morris Fortune Tobacco Co. (PMFTC) in the Philippines, succeeding Denis Gorkun who has been the company’s president since September 2019, reports The Philippine Star.
Gorkun will step down at the end of this month, concluding a nearly 30-year career at PMI.
De Best is currently Philip Morris International’s vice president strategy and program delivery for South and Southeast Asia, the Commonwealth of Independent States and Middle East and Africa.
After starting as a financial analyst at PMI’s Netherlands office in August 2004, he held managerial positions in Belgium, Spain, Switzerland, Germany, eventually becoming director of business development during his time in Hong Kong.
PMFTC is a partnership between PMI and LT Group’s Fortune Tobacco Corp., which owns 49.6 percent of PMFTC. In 2023, the firm held 55.2 percent share of the Philippines’ tobacco market.
PMFTC’s net income declined 26 percent last year to PHP11.38 billion ($198.05 million). LT Group attributed the drop to an industry-wide price increase in the first quarter of last year, which depressed sales.
Rising illicit cigarette trade incidence and trade inventory movements also contributed to the lower income, according to LT Group.
The U.S. Food and Drug Administration today announced the issuance of complaints for civil money penalties (CMPs) against 20 brick-and-mortar retailers and two online retailers for selling unauthorized e-cigarettes, including Elf Bar, a popular youth-appealing brand.
The regulatory agency previously issued warning letters to these retailers for selling unauthorized tobacco products. However, according to an FDA release, follow-up inspections revealed that the retailers had failed to correct the violations.
Accordingly, the agency is now seeking a CMP of approximately $20,000 from each retailer.
The approximately $20,000 CMP sought from each retailer is consistent with similar CMPs sought against retailers for the sale of unauthorized Elf Bar products over the last few months, including in Sept., Nov., Dec. and Feb.
The retailers can pay the penalty, enter into a settlement agreement, request an extension to respond, or request a hearing. Retailers that do not take action within 30 days after receiving a complaint risk a default order imposing the full penalty amount.
The board of directors for the Brazilian Health Surveillance Agency (Anvisa) voted unanimously on April 19 to maintain a ban on the sale of e-cigarettes and other vaping products, reports Brazil Reports.
Manufacturing, selling, importing and advertising vapes has been banned in the country since 2009, but e-cigarettes remain widely available in small shops and online stores across Brazil.
According the Brazilian Institute of Geography and Statistics, 16.8 percent of students aged 13 to 17 said they had tried vaping at least once in their lives. An estimate 4 million Brazilians vape, according to Covitel, which carries out health-related surveys.
Anvisa’s vote follows a public consultation on the measure. Anvisa justified its position based on the rise in underage vaping in countries that permit e-cigarettes, the addictive properties of nicotine and the lack of long-term studies on the effects of vaping on health, along with the potential impact of allowing vaping on Brazil’s overall tobacco control policies, which have been praised internationally.
In July 2019, Brazil became the second country to fully implement all measures set out by the World Health Organization with the aim of reducing tobacco consumption and protecting people from chronic non-communicable diseases.
The Brazilian Tobacco Industry Association, ABIFUMO, said that banning vapes is “ignoring the learnings of more than 80 countries that have already authorized their sale with clear rules for control, restriction of points of sale and taxation of manufacturers.”
Philip Morris Brasil said that “maintaining the ban on vapes is out of step with the uncontrolled growth of the illicit market, proven to be accessible to around 4 million Brazilians who use a product daily without any control of quality.”
Meanwhile, the Senate is debating a bill that would authorize the production, import, export and consumption of e-cigarettes in Brazil. The proposal is still in its early stages and does not have a date for voting.
E-cigarettes represent a valuable aid in smoking cessation, but more can and should be done to reduce their appeal, availability and affordability to nonsmokers and reduce environmental harms, according to a new report by the Royal College of Physicians (RCP) in the United Kingdom.
The results are summarized in over 50 recommendations, which explore trends in combustible tobacco use and vaping products; the differences in health effects of vaping in people who smoke, vape or do neither; ethical dilemmas presented by e-cigarette environmental damage; and the role of the tobacco industry in the rising use of e-cigarettes.
The RCP report concludes that:
since the 2016 RCP report, the evidence of the effectiveness of e-cigarettes as an aid to quitting has become much stronger;
use of e-cigarettes by young people and nonsmokers has increased substantially in recent years;
prompt remedial measures are needed to curb youth vaping without undermining use by adult smokers as an aid to quitting; and
the government should commission a series of regular evidence updates on the use and effects of nicotine products to guide policy.
Regarding the effectiveness of e-cigarettes as a cessation tool, researchers emphasize that e-cigarettes should be promoted as an effective means of helping smokers to quit smoking tobacco, particularly focusing on those population groups that could benefit the most, such as patients with mental disorders or those who experience socioeconomic disadvantage and people living in social housing.
Regarding potential health side effects resulting from vaping product use, researchers carried out a review of biomarkers of exposure to and harm from e-cigarettes using data published between 2021 and 2023 comparing people who vape, people who smoke, people who do both (dual use) and people who do neither.
Although lower levels of harmful substances were found in vapers compared to smokers for many of the biomarkers analyzed, researchers conclude that agreement needs to be reached on the methods for vaping health risks research, including which biomarkers are the most relevant to study regarding the relative and absolute risks of vaping, to draw accurate conclusions. Studies with larger samples are needed both on vapers with a history of smoking and on vapers who have never smoked.
The RCP report insists on finding a balance between preventing these categories from accessing vaping while not demonizing such products in the eyes of those who use them to quit smoking.
Regarding youth addiction specifically, RCP researchers concluded that standardized plain packaging combined with reduced flavor and brand descriptions together with retail display bans should be introduced to decrease youth interest in trying vaping.
E-cigarette price and taxation strategies should reduce the affordability of the cheapest products most commonly used by youth vapers (i.e., disposable e-cigarettes) while ensuring that the products most likely to be used by adults who smoke/quitters (i.e., rechargeable and refillable products), which are also less damaging to the environment, remain affordable.
The report also proposed to increase prices through the introduction of a consumption tax and a minimum unit price, prohibiting multiple purchases but ensuring that they remain a less expensive option for adults who use them to quit smoking, and limiting promotional materials in retail stores and product visibility, and restricting promotion on social media.
The authors of the report urge regulators to prevent cigarette manufacturers from playing a role in the development of national policies.
The New Civil Liberties Alliance (NCLA) has filed an amicus curiae brief in Cigar Association of America v. FDA, urging the U.S. Court of Appeals for the District of Columbia Circuit to reject the “remand without vacatur” legal doctrine. This practice allows administrative agencies to continue enforcing rules that the court has just declared unlawful.
In August 2023, the U.S. District Court for the District of Columbia concluded that the U.S. Food and Drug Administration’s final deeming rule regulating tobacco products was “arbitrary and capricious” with respect to premium cigars because the FDA failed to account for evidence regarding the potentially differential health effects between premium cigars and other tobacco products.
The court then set the rule aside to the extent that it addresses premium cigars. The FDA now asks the D.C. Circuit to either reverse the district court’s ruling or to at least allow it to continue enforcing the remaining unlawful rule under the “remand without vacatur” doctrine while it considers its options.
Without taking a position on whether the FDA’s conduct was arbitrary and capricious, the NCLA argues that the Administrative Procedure Act requires courts to set aside unlawfully promulgated rules completely. According to the group, this duty necessarily follows from basic principles underlying both the rule of law and the U.S. constitution.
Ivan Cahyadi (second from bottom left) will assume his new function on May 1. (Photo: Sampoerna)
Ivan Cahyadi will succeed Vassilis Gkatzelis as president director of Philip Morris International’s Sampoerna subsidiary in Indonesia on May 1.
Gkatzelis will join PMI’s executive leadership team as president of the East Asia, Australia and PMI duty-free region, overseeing strategic markets such as Japan, South Korea and China.
“Vassilis has successfully led Sampoerna through a stellar performance over the last two years, allowing it to continue to realize its commitment to creating value and multiplier effects for the society at large,” said Sampoerna President Commissioner John Gledhill in a statement. “I would like to thank Vassilis for his contributions to Sampoerna and congratulate him on his new global leadership role at PMI.”
Gledhill expressed confidence in Cahyadi’s leadership, praising his extensive experience and leadership.
Cahyadi joined Sampoerna in 1996 as a management trainee and progressed through many positions in Sampoerna, including organization development manager (1999–2000), manager of market intelligence (2000–2004), head of sales strategic development (2004–2005) and head of sales zone (2005–2009). He was named director of sales and distribution for PMI’s affiliate in Malaysia in 2009 before returning to Sampoerna in 2010 as head of zone and being appointed as a member of the board of directors in 2016.
In addition to approving Cahyadi’s appointment, Sampoerna shareholders also endorsed Yohan Lesmana as a director during the company’s annual meeting on April 23.
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.
