The government in Spain has approved a decree that equates the regulation of heated tobacco products with that of traditional cigarettes, prohibiting products with flavorings. The rules do not apply to all vaping products, such as e-cigarettes.
In addition, it will now be mandatory for labels to contain warnings for heated tobacco products that they products are harmful to health, according to Catalan News.
The country’s Ministry of Health is considering further regulations.
“The ban will cover tobacco products with an aroma or flavor in their components (such as filters, papers, packaging, or capsules) or any other technique that allows modifying the smell or taste of the products or intensify the smoke. Filters, papers and capsules cannot contain tobacco or nicotine,” the report states.
Heated tobacco products must include the following informative message on their outer packaging: “Tobacco smoke contains more than 70 carcinogenic substances,” with relevant accompanying photographs.
This decree will enter into force three months after its publication in the official state gazette (Boletín Oficial del Estado).
Virginia has long been the epicenter of the tobacco industry; now, two bills that would ban flavored vaping products have been filed with the state’s General Assembly.
Sponsors say Virginia should step in where Washington has been ineffective in blocking unregulated flavored e-cigarettes, such as Elf Bar disposables, off of store shelves.
The bills, House Bill 1069 and Senate Bill 550, call for a fine of $1,000 a day for each product sold that the U.S. Food and Drug Administration has not authorized to be marketed in the U.S.
The Attorney General would maintain a directory of legal products, much like Alabama and Louisiana. Products not listed in that directory could not be legally sold in Virginia.
The bill states any retailer and wholesaler that sells or distributes any liquid nicotine or nicotine vapor product in the state is subject to scheduled or unscheduled compliance checks carried out by the Attorney General’s Office for enforcement purposes.
Manufacturers must certify, in a filing with the Attorney General, that an FDA marketing authorization order covers their product or is exempt from that because it was sold in the U.S. before 2016 or subject to a premarket tobacco product application dating from before 2020.
“It’s a public health issue,” said Del. Rodney Willett, who sponsored the House of Delegates bill.
“They’re targeting kids with the flavors,” he said, according to media reports. “When I walk into a convenience store, I’m just stunned by the number of these products that are for sale.”
The Singapore government said that the potential loss in revenue from tobacco tax was not a factor in its decision to ban the use of e-cigarettes in 2018.
In his reply to a question by a Workers’ Party and Sengkang member of Parliament, Deputy Prime Minister Lawrence Wong, who is also the Minister for Finance, said, “The Government’s decision to ban the use of e-cigarettes in 2018 was based on public health considerations, to protect our population from the harms of these products. The potential loss in tobacco tax revenue from the reduced consumption of tobacco products was not a factor in this decision.”
… our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans.”
Lawrence Wong
Wong added that if the government were to legalize and tax e-cigarettes “the challenges would be similar to those we encounter for cigarettes and other tobacco products today,” according to a Yahoo news report.
“In any case, the government has no plans to change our current approach, as our priority is to protect the health of our population and prevent e-cigarettes from causing harm to our people, especially to younger Singaporeans,” he said.
U.S. Senate Majority Whip Dick Durbin has again decried the Food and Drug Administration on its unacceptable failure to “protect children from the dangers of vaping” as the agency continues to miss and delay critical deadlines.
In a press release, Durbin stated that he has repeatedly criticized theFDA for its long-overdue review of premarket tobacco product applications (PMTAs) from e-cigarette manufacturers, which originally had a federal court deadline of September 9, 2021.
FDA has missed that court-ordered deadline by 28 months as unauthorized e-cigarettes flood the market.
During his speech, Durbin also called on the Biden Administration to swiftly implement a proposed public health rule to prohibit the production and retail sale of menthol cigarettes and flavored cigars.
“I know this President cares deeply about the toll of cancer. It has touched his family personally, as it has mine,” the Senator said. “If we want to make a difference in the health of Americans—and set a legacy for future generations—then the Administration must finalize this public health measure to end Big Tobacco’s predatory promotion of menthol cigarettes. Lives hang in the balance.”
The FDA stated in prior status reports for PMTAs that the agency would complete a review of 100 percent of the applications by the end of 2023. The agency is now estimating that completion of the reviews may be delayed as the FDA considers the D.C. Circuit’s opinion in Fontem US v. FDA, affirming in part and vacating and remanding in part marketing denial orders for certain vaping products.
The chairman of the Consumer Protection Authority states that a fine of up to OMR2,000 ($5,196) for multiple violations will be imposed on anyone who trades in e-cigarettes, shisha, and their accessories in the Sultanate of Oman.
His Excellency Sulayem bin Ali Al-Hakmani issued Ministerial decision No. 756/2023 on Sunday, January 7, 2024, creating the ban, according to media reports.
Article One stipulates that the circulation of e-cigarettes, shisha, and their accessories is prohibited.
Article Two states that, “without prejudice to the penal penalties stipulated in the aforementioned Consumer Protection Law, an administrative fine not exceeding OMR1,000 shall be imposed on anyone who violates the provisions of this decision, and the fine shall be doubled in the event of a repeat violation.
Credit: Helga Bragina
“If this violation continues, an administrative fine of OMR 50 will be imposed for each day that the violation continues, provided that its total does not exceed OMR 2,000. The seized quantities of electronic cigarettes, shishas, and their accessories will be destroyed in accordance with the controls in force at the Consumer Protection Authority.”
The new bill also repealed an earlier Resolution (No. 698/2015), as well as any laws or rules that contravene the current resolution or conflict with its provisions.
It also stipulates that the decision “shall be published in the Official Gazette, and shall be effective from the day following the date of its publication.”
A new University of Louisville study shows the nicotine in certain types of electronic cigarettes can increase the risk for an irregular heartbeat, according to a press release.
Tests in mice showed that nicotine salts used in pod-based e-cigarettes led to heart arrhythmias and could trigger a fight-or-flight response in higher doses.
“This suggests the nicotine is harmful to the heart and counters popular claims that the nicotine itself is harmless,” Alex Carll, an assistant professor in UofL’s Department of Physiology who led the study, said in a news release Thursday. “Our findings provide new evidence that nicotine type and concentration modify the adverse cardiovascular effects of e-cigarette aerosols, which may have important regulatory implications.”
Researchers state that regulating nicotine salts could help mitigate the health risks of vaping.
The research also suggests choosing e-cigarettes with freebase nicotine instead of nicotine salts, or using e-cigarettes with a lower nicotine content could reduce the risk of harm.
Examining the impact of flavored e-cigarettes on adult smokers: insights from a three-month experimental study
By Jessica Zdinak
Much ink has been devoted to the dichotomy presented by electronic nicotine-delivery systems (ENDS)—are they a friend or a foe?
For several years now, we have seen a surge of a variety of different e-cigarette products, overrunning the U.S. commerce both legally and illegally. The question remains for some, including our regulator: Do they serve as an alternative to traditional combustible cigarettes, or do they serve as an initiator for youth and young adults? This dichotomy revolves heavily around the authorization of and use of flavored e-cigarette/e-liquid products.
Continuously, and in my opinion, rightfully so, the U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) presents manufacturers with marketing denial orders that state things like “… your PMTA lacks sufficient evidence demonstrating that your flavored ENDS will provide a benefit to adult users that would be adequate to outweigh the risks to youth.” To demonstrate this, a reliable and robust study must be conducted. “Reliable and robust” means different things with each of the different scientific areas contained within an application. For the behavioral sciences, it means using a design that inherently has a level of methodological and statistical control, such as a randomized control trial, known in our scientific area as a “between-subjects experimental design.”
To address the CTP’s concerns and gain a better understanding of the effects of flavored e-cigarettes, the research team at Applied Research and Analysis Company (ARAC) conducted a three-month randomized experimental study. This study was sponsored by Accorto Regulatory Solutions, in conjunction with Freenoms, an e-liquid manufacturer and subsidiary of Lotus Vaping Technologies, creator of the Nomenons e-liquid. In this article, we will explore the key findings and insights from this study, shedding light on how flavored e-cigarettes may influence adult smokers’ habits and vapes’ potential as a smoking cessation tool.
Study Context
The study, conducted by a team of experts led by ARAC Chief Research Officer Jessica Zdinak, was designed to provide evidence related to the public health impact of flavored e-cigarette products on adult smokers. The study’s design played a crucial role in ensuring the validity and reliability of the results. Expertise in behavioral science and research methodologies were instrumental in crafting the study’s plan, design and analysis. After a recent meeting with the CTP, it is acknowledged that ARAC’s key behavioral science framework meets the mark from a scientifically rigorous perspective. Here are just a few key aspects of ARAC’s study designs that underscore the importance of such expertise:
Statistical power: The study’s design took into account statistical power, ensuring that there were enough participants to detect significant effects should differences or effects exist and not to detect such differences or effects should they not exist. (Think, “Can you generalize your results?”)
Effect size considerations: Researchers considered effect size, an important factor in determining the practical significance of findings. (Think, “How generalizable are your results?”)
Hypothesis generation: The study involved the formulation of hypotheses that guided the research, enabling a systematic investigation of the impact of flavored e-cigarettes on smoking behaviors.
Awareness of behavioral factors: Researchers were keenly aware of the behavioral factors at play behind nicotine consumption, adding depth to the study’s approach.
Study Design
The study was conducted using a between-subjects randomized experimental design, which involved two conditions: one with flavored e-liquids and another with tobacco-tasting e-liquids. The primary dependent variables were cigarettes per day (CPD) and candidate product usage. The use of a randomized experimental design is a rigorous and reliable approach to investigate the effects of flavored e-cigarettes on smoking behaviors, as it minimizes bias and allows for causal inferences.
Following Institutional Review Board approval, participants were recruited from several locations across the U.S. They were then randomly assigned to one of two conditions: flavored candidate e-liquids or tobacco-tasting candidate e-liquids. Over a three-month time period, participants returned to facilities each month to select additional products as needed and to complete follow-up surveys. The follow-up surveys asked participants to specify their CPD over the past 30 days and the past 24 hours as well as their use of the candidate e-liquids. These responses were used for the primary analyses in which reduction and cessation were defined and analyzed as:
computed reduction of 50 percent or more of cigarette stick usage from baseline to follow-up
complete elimination of cigarette sticks
Results: Descriptive Insights
At the end of the three-month study, a total of 382 participants completed the final follow-up survey (n=181 in flavor condition; n=157 in tobacco-tasting condition). Using this data, we conducted both descriptive and inferential statistics. Coupled together, but with a focus on the inferential statistics, this study’s results offer valuable insights into the impact of flavored e-cigarettes on smoking behaviors.
Flavors over time: The study tracked how participants’ preferences for specific e-liquid flavors did (or did not) change over the three-month study period.
2. CPD between conditions over time: The results show the descriptive differences in cigarettes smoked per day between the flavored and tobacco-tasting conditions over the course of the study.
3. CPD between conditions over time: The results show the inferential statistics assessing the experimental effect of flavors on CPD compared to tobacco-tasting. Specifically, the study found that the portfolio of flavored e-liquids led to a significant reduction in CPD compared to tobacco-tasting products. This suggests that flavor plays a role in encouraging smokers to cut down on their cigarette consumption.
4. Switching rates: The research examined the rates at which participants switched from smoking cigarettes to using e-cigarettes, with specific attention to the flavored e-liquids, which led to a higher quit/cessation rate than tobacco-tasting e-liquids.
5. Individual flavor assessments: The study explored how individual flavors affected CPD reduction and cessation, providing insights into the specific flavors that had the most significant impact. Specifically, different flavors had varying effects on CPD reduction and cessation, with some flavors showing statistically significant differences. This highlights the complexity of the relationship between flavor and smoking behaviors, such as reduction in CPD and cessation of combustible cigarettes.
Summary of Findings
In summary, the study found that flavored e-liquids had a positive impact on smoking behaviors among adult smokers. Specific findings include:
CPD reduction: The portfolio of flavored e-liquids were associated with a statistically significant reduction in cigarettes smoked per day compared to tobacco-tasting products, suggesting that flavors encourage smokers to cut down on their cigarette consumption.
Variability among flavors: The impact of flavored e-liquids on CPD reduction and smoking cessation varied among different flavors. Certain flavors had a more pronounced effect, highlighting the need to consider the specific flavor profiles when evaluating their impact on smoking behavior.
Preference changes over time: Some participants’ preferences for specific flavors changed throughout the study, indicating that flavor appeal may evolve and influence its effectiveness in encouraging smokers to switch to e-cigarettes.
Qualitative insights: Open-ended questions provided valuable qualitative insights into how flavors influenced participants’ perceptions and decisions to quit or reduce cigarette consumption. These insights offer a more comprehensive understanding of the relationship between flavor and smoking behavior.
Overall, the study’s findings underscore the complex interplay between flavored e-cigarettes and smoking behaviors among adult smokers. While some flavors show promise in reducing cigarette consumption and promoting switching, there is no one-size-fits-all approach, and individual preferences and perceptions play a significant role.
One of the most powerful aspects of science is replicability. If industry is serious about getting new products, including flavors, authorized for market, replicability of studies such as this one is fundamental to success. Let’s hope this study is just the first of many at building that library of rigorous scientific evidence that the CTP has been looking for.
Jessica Zdinak is a U.S. Eastern Shore Virginia native with almost 20 years’ experience leading psychological research across a variety of domains, including a decade of which serving in tobacco harm reduction. She leads a team focused on product development and behavioral science consumer research supporting innovation, “next-generation” products and regulatory applications, including investigational tobacco products, premarket tobacco product applications, modified-risk tobacco product applications and substantial equivalence applications. Zdinak has substantial experience within the U.S. federal government sector, leading research evaluation teams with a focus on the Centers for Disease Control and Prevention, the National Institutes of Health, the National Science Foundation, the Food and Drug Administration, and other large-scale grants and projects.
A new tax will hit vapers in the United Kingdom despite warnings it will punish people who have switched to e-cigarettes after quitting smoking.
The plans for the levy, which will likely increase the cost of vaping liquid by at least a quarter, will be unveiled in the Budget in March.
A government source told The Mirror it was now almost inevitable that a tax on vaping will be introduced as part of the Spring Budget, which Chancellor Jeremy Hunt will announce on March 6.
Ministers are looking to copy European countries such as Germany and Italy that already have levies on vapes.
A 10ml bottle of e-liquid, which a typical vaper would get through in a week, costs around £4 at present. In Germany, a £1.40 vape tax is slapped on 10ml bottles, with plans to double this to £2.80 in 2026.
Italy, which in 2014 became the first country to tax e-cigarette fluid, charges a £1.10 levy on 10ml bottles.
Regulatory challenges and misinformation continued to test the vaping industry in 2023.
By TR staff
It remains a frustrating business environment. The vaping segment has survived despite setbacks in 2023 and continues growing as a global market. However, divergent regulatory perspectives on vaping’s harm reduction potential continue to hinder its uptake by cigarette smokers. The past 12 months could also be labeled the year of the great exodus as several vaping retailers and manufacturers went out of business. Despite the challenges, more and more former smokers continue to switch.
While several countries banned, enacted regulations or continued heavily regulating vaping products, the United States’ denials of numerous premarket tobacco product applications (PMTAs) had the greatest impact on the industry this year. The U.S. Food and Drug Administration’s ban on most products has allowed a black market of disposable vapes to become a multibillion-dollar industry. Disposable e-cigarettes account for almost 40 percent of the global vape sector, according to ECigIntelligence.
Critics have accused the industry of avoiding responsibility for the environmental damage caused by disposable vaping products while federal regulators have failed to pass measures that would make vaping components easier to recycle or more eco-friendly. Some regulations have been proposed to lessen the products’ environmental impact. For example, standards could be put in place requiring them to be reusable or mandating that manufacturers fund collection and recycling programs.
Disposable e-cigarettes currently account for about 53 percent of the multibillion-dollar U.S. vaping market, according to the Centers for Disease Control and Prevention, more than doubling in size since 2020. Several states, including New York and California, have extended product responsibility laws in place for computers and other electronics, but those rules don’t apply to vaping products. At the federal level, there are no regulations specifically for the disposal of vaping products. Without action, some experts say the devastating environmental impact could last for centuries.
Misinformation surrounding the vaping industry also continued to spread in 2023. Nearly half of cigarette smokers and young adult nonsmokers think that nicotine-based e-cigarettes have the same amount or even more harmful chemicals than regular tobacco-based cigarettes, according to a Rutgers study.
Another study found that there are also a lot of exaggerations and misinformation about vaping on social media. Some tweets exaggerate or distort claims about nicotine and addiction while others misinterpret scientific studies to promote vaping. There are also tweets that downplay the harmful effects of nicotine and promote its benefits, which are potentially problematic. Below is a month-by-month recap of the vaping industry’s biggest headlines in 2023.
January
Credit: Cerib
The upscale U.K.-based grocer Waitrose halts sales of single-use vaping products due to environmental concerns. The FDA says it will “decide within months” how to regulate legal cannabis (it still hasn’t). Vaporesso becomes the first open-system vaping device brand to obtain the ability to sell in the United Arab Emirates. The Netherlands bans flavors, and Belgium says it plans to restrict flavor names and vape devices. A 2022 article that claimed e-cigarette users faced the same cancer risk as combustible cigarette smokers is retracted by the World Journal of Oncology. Lawmakers in Taiwan ban vaping products. A U.S. district judge preliminary approves a $255 million settlement resolving consumer claims that Juul Labs deceptively marketed e-cigarettes.
February
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Hong Kong begins enforcing its ban on CBD, labeling it as a “dangerous drug” and imposing harsh penalties for its possession. Bloomberg Philanthropies commits $420 million over four years to the Bloomberg Initiative to Reduce Tobacco Use. Australia reschedules the psychedelics psilocybin and MDMA to provide access to people with post-traumatic stress disorder. Connecticut sues five companies for selling delta-8 products. Alex Norcia resigns from Filter for a job at Altria. RAI Services Co. submits a citizen petition asking the FDA to adopt a new enforcement policy directed at “illegally marketed disposable electronic nicotine-delivery system [ENDS]” products. Matthew Farrelly, former chief scientist and director of the Center for Health Analytics at RTI International, is named director of the FDA’s Center for Tobacco Products’ (CTP) Office of Science. The FDA files the first civil money penalties for illicit sales of ENDS products.
March
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Altria Group exchanges its entire investment in Juul Labs for a nonexclusive, irrevocable global license to certain of Juul’s heated-tobacco intellectual property. Altria also agrees to acquire Njoy Holdings for approximately $2.75 billion and asks the U.S. Federal Trade Commission (FTC) to drop its 2020 challenge to the company’s 2018 acquisition of a 35 percent share in Juul Labs. The FDA proposes new requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of vaping and other tobacco products. RLX Technology reveals that its 2022 financial performance was heavily impacted by new industry regulations and e-cigarette taxes, along with Covid-related disruptions, in China. A U.S. federal judge throws out a tobacco industry lawsuit against California’s statewide ban on the sale of flavored vaping and other tobacco products. The FDA updates its definition of “tobacco products” to include nontobacco nicotine products. Two menthol Vuse flavors that received a marketing denial order (MDO) can continue to be marketed by R.J. Reynolds Vapor Co. after the federal 5th Circuit Court of Appeals issues a stay. Argentina bans imports and sales of ENDS products. Former CTP Director Mitch Zeller joins the advisory board of Qnovia, a “platform pharmaceutical” company that is developing a prescription inhaled smoking cessation therapy.
April
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Malaysia removes e-liquid containing nicotine used in e-cigarettes and other vaping products from the country’s Poisons List of controlled substances. Greentank Technologies closes a Series B financing round worth $16.5 million with a “strategic investor group” that includes BAT-funded Canadian cannabis producer Organigram Holdings. Vuse’s U.S. market share rises from 41.5 percent while Juul’s declines to 26.1 percent. Altria’s youth marketing suit in California begins. The U.K. announces plans to give 1 million smokers free vaping starter kits to encourage them to give up tobacco products. Juul Labs settles youth marketing lawsuits with six states, bringing the total of state settlements to 45 states, with a combined price tag of more than $1 billion. Panama rejects a proposal to regulate vaping products. The High Court of Justice in London rules that Philip Morris Products’ patents protecting its tobacco-heating technology are valid. Delaware becomes the 22nd U.S. state to pass a recreational marijuana bill. Altria’s youth marketing suit in California begins.
May
Credit: MdIqbal
Australia announces that it will ban the importation of all nonprescription vaping products, including those that do not contain nicotine. R.J. Reynolds sends letters to several small vape shops threatening to sue them if the shops do not stop selling flavored vaping products. A U.K. report shows inmates are spending more than £7 million ($8.5 million) a year on e-cigarettes. Logic Technology challenges the FDA’s marketing denial of its menthol vape products. Altria strikes a $235 million deal to end a California lawsuit alleging that the company marketed vaping products to youth. Flonq launches the world’s first fully recyclable vape device—the Flonq Plus-E. Yolonda Richardson succeeds Matthew Myers as president of Tobacco-Free Kids. The FDA issues “Import Alert 98-06” detaining new tobacco products such as e-cigarettes without marketing authorization at the border. Altria completes its purchase of Njoy.
June
Credit: Timothy S. Donahue
Hawaiian law makes shipping of vaping and other tobacco products valued at more than $10,000 a misdemeanor. ANDS launches Slix, a disposable vape that it says is 99.29 percent recyclable.
Bidi Vapor sends the initial shipment of Bidi Sticks to over 900 Kwik Trip and Mapco locations.
A federal appeals court rules that the FDA acted reasonably in denying Magellan Technology’s application to market flavored vaping products.
The FDA issues warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars brands. Zanzibar bans the use and imports of vape products. The CTP announces that it has made significant strides in putting its Reagan-Udall Foundation recommendation-based plan for improvement into action.
July
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Juul Labs asks the U.S. International Trade Commission (ITC) to block sales and imports of the Njoy Ace vapor device, claiming that the product infringes several Juul patents. The FTC dismissed the complaint against Njoy parent Altria Group for its purchase of a 35 percent stake in Juul Labs after Altria’s pullout. New York City accuses Magellan Technology Inc., Ecto World LLC (Demand Vape), Mahant Krupa 56 LLC (Empire Vape Distributors) and Star Vape Corp. of racketeering for selling illegal flavored vapes. Jason Carignan moves to Chemular. The FDA gives the Ohio State University Comprehensive Cancer Center a $3.9 million grant to evaluate the effects of e-cigarette flavors on the smoking behaviors of current adult smokers. Philip Morris International acquires Syqe Medical, an Israeli company, for an estimated $650 million. Juul Labs submits a PMTA to the U.S. FDA for the Juul2 system. China’s State Tobacco Monopoly Administration releases the guidelines for vape exports. A study linking nicotine vapes to liver disease was retracted from Gastroenterology Research. The FDA sends more warning letters for Esco Bars and Elf Bar sales. China vape exports top $3.36 billion for the first half of 2023.
August
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Ukraine imposes a consumption tax on disposable vapes. Venezuela bans all vaping products. The Philippines passes a law forcing importers of raw materials for vaping products to seek special clearances to release shipments. High Light Vape, which sells a vape pen disguised as a highlighter, is lambasted by the media. Njoy asks the ITC to ban the import and sale of certain Juul products. New Zealand imposes new regulations to limit youth vaping. The Coalition of Asia Pacific Tobacco Harm Reduction Advocates launches its shadow report on the World Health Organization’s failing tobacco harm reduction strategy. Juul Labs announces a company restructuring aimed at reducing operating costs. Romania bans flavors for heated-tobacco products. Suriname bans the sale of all vaping products. The U.S. Court of Appeals for the D.C. Circuit sides with Fontem U.S. in a ruling that the FDA failed to conduct a proper analysis before rejecting some vaping product marketing applications.
September
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The U.K. Vaping Industry Association announces that it will exclude tobacco companies from its membership. Indonesia legalizes vaping. Esco Bars’ manufacturer files a lawsuit challenging the FDA’s import ban of its products. Vaporesso becomes the first licensed company to sell open systems in the UAE. New York opens state cannabis licensing to the public. The FDA sends warning letters to 15 companies that market products under the brand names Elf Bar, EB Design, Lava, Cali, Bang and Kangertech. A massive fire destroys U.K. e-liquid and hardware brand Dinner Lady’s factory. Ispire announces that its fiscal year 2023 saw a 100.4 percent and a 10.9 percent surge in cannabis and tobacco vaping product revenues, respectively. Healthier Choices Management Corp. sues R.J. Reynolds Vapor Co. seeking royalties from sales of its Vuse Alto vape pens, chargers and pre-filled liquid pods, alleging the products infringe a patent. The FDA imposes civil money penalties on 22 retailers for the illegal sale of Elf Bar/EB Design products.
October
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Philip Morris International unveils LEVIA, a zero-tobacco stick for use with its IQOS heat-not-burn device. A new study, E-Cigarette Flavor Restrictions’ Effects on Tobacco Product Sales, finds that flavor bans boost sales of traditional combustible cigarettes. U.K. Prime Minister Rishi Sunak proposes a tobacco endgame plan. The U.S. Supreme Court declines to hear Avail Vapor’s arguments against the FDA’s regulatory authorization process. ECigintelligence reports that disposable e-cigarettes account for almost 40 percent of the global vape sector. The American Vaping Association ends operations; Greg Conley joins the American Vaping Manufacturers Association. The FDA declines to issue a marketing order for flavored Vuse Alto pods. Elf Bar changes its name to defy a U.S. import ban. Njoy files lawsuits against 34 foreign and domestic manufacturers, distributors and online retailers of illicit disposable vaping products. Logic Technology Development loses a court appeal to halt the FDA’s ban on the company’s menthol-flavored pods. Czechia bans flavors for heated-tobacco products. Altria says a booming illegal disposable flavored vape market is causing a major decline in the sales of its authorized vaping products.
November
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Italy’s Regional Administrative Court of Lazio (TAR) suspends a decree that would make CBD oil a narcotic substance until Jan. 16, 2024. The global vaping market will reach $93.94 billion in value by 2030, registering a CAGR of 16.27 percent from 2022 to 2030, according to Straits Research. BAT announces a $90.5 million investment in Organigram. Ohio becomes the 24th U.S. state to allow adult marijuana use for nonmedical purposes. Research from the United Nations suggests that toys are a much larger contributor to electronic waste than vaping products. The FDA again sends warning letters to online retailers for selling disposable products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava. The 10th Conference of the Parties (COP10) to the World Health Organization Framework Convention on Tobacco Control is postponed, officially due to unrest in the host nation, Panama.
Louisiana’s state Office of Alcohol and Tobacco Control releases a list of nearly 400 approved vape products for legal sale in the state. Juul Labs raises an estimated $1.3 billion in funding. Ispire Technology reports revenue of $42.9 million and gross profit of $6.9 million in the quarter that ended Sept. 30. The FDA increases the penalties for violations of federal nicotine product laws. PMI expands IQOS Iluma in the Middle East. New Zealand’s new coalition government announces a cancelation of the country’s controversial generational tobacco ban. The Foundation for a Smoke-Free World, which was originally funded by PMI, says it will no longer accept any monetary support from the nicotine industry. The WHO announces the dates for the resumed in-person sessions of COP10 for February 2024. Australia will ban imports of disposable vapes beginning Jan. 1, 2024. France plans to ban disposables by 2025.
December
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(Editor’s Note: This magazine went to press in December, so the month may be incomplete.) The FDA announces that it is now estimating that completion of PMTA reviews may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem U.S. v. FDA, affirming in part and vacating and remanding in part MDOs for certain vaping products. U.S. House lawmakers demand information from federal officials on what they are doing to stop the influx of kid-appealing electronic cigarettes from China. Mexico’s Supreme Court of Justice rules that the presidential decree banning the sale of e-cigarettes is unconstitutional. The FDA announces that it has filed civil money penalty complaints against 25 brick-and-mortar and online retailers for selling unauthorized Elf Bar, EB Design and other e-cigarette products. France’s National Assembly unanimously approves a bill to ban single-use electronic cigarettes. Vuse’s market share rose from 41.5 percent to 42 percent, surpassing No. 2 Juul which dropped from 24.7 percent to 24.3 percent. Guam proposes rules to stiffen the fees and penalties for vape sales to minors.
Looking ahead
It’s impossible to predict what the vaping industry will look like by the end of 2024. Industry insiders expect regulators to crack down on disposable vaping products, and misinformation will likely continue to run wild.
The U.S. will probably see a decline in product variety because the FDA is unlikely to approve many devices. However, globally, especially in the EU and the U.K., the industry should continue to thrive and expand. More importantly, innovation should continue to thrive outside the U.S.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, predicted at the end of 2022 that the FDA’s policy on vaping products would continue to be characterized by regulatory paralysis and the search for the least politically controversial regulatory option, and the industry wouldn’t hear rulings on many PMTAs until 2024 or later. He was correct on both counts.
Looking forward to 2024, Conley told Vapor Voice that the vaping industry should expect a turbulent ride, particularly in the United States. He predicts that the most significant hurdle remains the FDA’s CTP.
“Under the current leadership of Brian King, the agency’s stance toward vaping products has become even more antagonistic despite a drop in youth vaping to its lowest levels in a decade,” said Conley. “This tension is heightened by ongoing court cases that might force reforms within the CTP, but these changes are likely to be met with considerable internal resistance and intransigence.
“Those in the industry should not be naive. The regulatory landscape in the U.S. for vaping businesses, regardless of their size, is likely to get worse before it gets better. This is a hard truth we need to brace for.”
Beyond the federal level, a critical challenge will continue to come from state governments and major tobacco companies like Altria and R.J. Reynolds. The rise of synthetic nicotine-containing disposable vaping products, which are impacting cigarette sales and the vapor market shares of the major tobacco companies, is leading to a push for state-level PMTA registries, according to Conley.
“In essence, these bills seek to deputize state regulatory agencies to behave as mini-PMTA enforcement divisions. The true effect of these registries is to ban all products that submitted their PMTAs after September of 2020. In plain English, this means nearly every disposable vaping product on the market becomes illegal to sell,” Conley explains. “Such measures have already been implemented in Alabama, Oklahoma and Louisiana, leading to a disruption in the market dynamics. Law-abiding retailers and average adult consumers are suffering as a result.”
Globally, Conley predicts that the vaping industry will continue to go up against well-funded prohibitionist campaigns spearheaded by organizations bankrolled by Michael Bloomberg. However, there’s a silver lining: The evidence supporting regulation over outright bans continues to grow.
“I’m cautiously optimistic that we’ll see countries in Latin America and Southeast Asia begin to revisit their previous, misguided policies. Regrettably, however, the anti-disposable furor is likely to get even more heated in Europe,” said Conley. “For adult consumers looking for hassle-free nicotine consumption, there’s never been a better time than now. The market has evolved tremendously in terms of product quality and variety. However, the picture is starkly different for businesses in the vaping industry. Until there is real reform that regulates the products adults want, like flavored disposables, being successful in this industry may require risking your livelihood and potentially your freedom.”
Conley said the industry must remain vigilant because regulatory challenges, particularly in the U.S., coupled with global policy shifts and market dynamics suggest that the industry’s path will be rocky in the short term. “The hope is for a future where nicotine control policies are grounded in harm reduction principles rather than mirroring a drug war,” he said. “However, we’re currently seeing a trend that veers toward the latter.”
A former Altria executive has been promoted to CEO and resident of Kaival Brands Innovations Group, Inc. The company announced that it has expanded the role of Executive Chairman Barry Hopkins to include the additional positions.
Former CEO and president, Eric Mosser, has been appointed CEO and president of Kaival Brands International, a Kaival Brands Innovations Group’s subsidiary with an international licensing relationship with Philip Morris Products.
Niraj Patel, founder and chief science officer of Kaival Brands, said that from the beginning he has envisioned a diverse platform that could “capture the tailwinds” generated by the company’s core offering, the BIDI Stick electronic nicotine delivery system (ENDS) product.
“Barry understands this vision, the importance of regulatory compliance and youth access prevention, and has done an exceptional job since joining Kaival Brands. He has eagerly taken on increasing levels of responsibility, leveraging his decades of experience in management in our industry,” said Patel in a press release. “His appointment as Interim CEO and president was a natural progression, and we look forward to potentially expanding our excellent management team further during 2024 with a permanent CEO and/or president as our needs dictate.
“Having Barry in this position now is particularly important since we are at a significant inflection point, as we remain hopeful that FDA will soon complete its review of the pending premarket tobacco product application (PMTA) for the tobacco-flavored BIDI Stick Classic. If we receive a marketing granted order for this product, we will have significant momentum in the new year with the ability to continue to transition adult cigarette smokers, drive revenue and grow our company.”
According to a recent U.S. Food and Drug Administration announcement, the agency’s next status report regarding its review of the still-pending PMTAs for major brands and market share leading ENDS products is due to be filed by January 22, 2024 with the U.S. District Court in Maryland.
Although FDA has not indicated publicly which PMTAs it is prioritizing for review, Kaival Brands is hopeful that the BIDI Stick Classic will be included in the January status report. The company also anticipates the PMTAs for the other 10 BIDI-branded SKUs will remain in scientific review, according to Patel.
Recently, the Kaival Brands has been encouraged by the coordinated efforts of the FDA, U.S. Customs and Border Protection, and other government agencies to increase their coordinated focus on enforcement. The company believes it has been hurt by illicit vaping products flooding the market, and it is now preparing to scale along with other legal products, assuming increased enforcement continues alongside the January announcement by the FDA.
“Hopkins will spearhead the company under the direction of the Board of Directors with a continued focus on accelerating revenue growth, improving operational efficiencies and executing Kaival Brands’ strategic growth and diversification initiatives, while remaining in compliance with applicable state and federal regulations.
“The company, alongside BIDI Vapor (the maker of the BIDI Stick), is also continuing to focus on working with Philip Morris to accelerate the international distribution of ENDS products using BIDI technology (which Philip Morris markets under the brand name ‘VEEV Now’), as part of Philip Morris’s plan to deliver a smoke-free future.”
