The Czech Health Ministry is drafting an amendment to a decree that could significantly impact the e-cigarette industry. The proposed changes would prohibit all flavors except tobacco, as well as sweeteners and other additives commonly used in e-liquids.
These regulations would apply solely to vaping products, leaving traditional cigarettes and other nicotine alternatives unaffected. Industry representatives have responded with alarm, warning that this move could lead to the collapse of the entire sector.
“We are stunned. Without any prior consultation, the ministry is essentially planning to ban e-cigarettes in the Czech Republic,” said Robert Hrdlička, chairman of the Chamber of Electronic Vaping (KEVAP).
He argued that without the now-banned ingredients, tobacco-flavored e-liquids would be unsellable. “The ministry is imposing an amateurish and uninformed view on what tobacco should taste like,” Hrdlička added.
In addition, a new excise tax on e-cigarettes is set to take effect in September, with further increases planned in the coming years, according to media reports. “The government’s approach is entirely illogical. First, they encourage e-cigarettes as a tool to reduce smoking, and now they’re essentially banning them,” Hrdlička criticized.
Experts in the e-cigarette field warn that such a ban could push users back to conventional cigarettes or encourage smuggling of e-liquids from abroad.
While FDA menthol market authorizations are rightly seen as a victory, they may be pyrrhic.
By Rich Hill
The flavored electronic nicotine-delivery systems (ENDS) road has been a bumpy ride. Going back to pre-deeming days, flavored ENDS were ubiquitous, as were unquantified, anecdotal reports of their cigarette-smoking cessation efficacy. Following the accelerated premarket tobacco product application (PMTA) submission timeline, as everyone knows, the Center for Tobacco Products’ (CTP) decisions decimated flavored ENDS. Likewise, even the most sophisticated companies were receiving marketing denial orders (MDOs) for menthol ENDS. Throughout this bloodbath, the CTP oft repeated that flavored products need to demonstrate a cessation benefit to adult smokers weighed against the risk of youth initiation. Until recently, this had not played out.
Njoy’s marketing granted orders (MGOs) for menthol Ace and Daily products was a watershed moment demonstrating that an ENDS product with a flavor other than tobacco could be granted marketing authorization status. However, the authorization does leave some questions unanswered.
CTP’s Menthol Positioning
In 2022, the CTP staked out its position on menthol in the cigarette context with the product standard prohibiting menthol in cigarettes. The center asserted that menthol reduces irritation and harshness of smoking, increases appeal and makes cigarettes easier to use—especially for youth, increases nicotine’s sensory effects in the brain and makes it more difficult to quit smoking. While the first points on irritation and harshness are unique to cigarettes, the CTP’s other points arguably apply to menthol and nicotine more generally—a dour omen for ENDS and other products.Given this position, particularly on youth initiation, it came as little surprise that several menthol ENDS products received MDOs over the past several years.
An About Face?
The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?
Beyond Njoy’s successful showing of product characterization, toxicology and abuse liability data, according to the Njoy Ace Technical Project Lead Review (TPLR), behavioral studies and marketing restrictions appear to have made the difference. Alongside other behavioral studies, Njoy simply did what the CTP required and conducted a longitudinal study comparing cigarette smoking cessation efficacy between tobacco and menthol ENDS products. Per the TPLR, “[t]he applicant’s findings and additional analyses conducted by statistics demonstrate a statistically significant added benefit of using menthol-flavored Njoy Ace compared to classic tobacco flavor … in achieving past-30-day [combustible cigarette] smoking cessation ….” Among other data in the TPLR, Table 3 reports that in the Intention to Treat Analysis, initial flavor at baseline analysis resulted in 26.6 percent past-30-day abstention rates for menthol versus 19.3 percent for tobacco at 6 months. When analyzed by flavor at time of switching, past-30-day cessation rates of 27.1 percent for menthol versus 19.3 percent for tobacco at 6 months were reported.
Along with the adult cessation data, Njoy agreed to a long list of marketing restrictions—beyond what is observed in other applications. The restrictions included limitations on advertising means including no radio, television, outdoor, print, search engine advertising, social media promotions, product placements, engagements or activations or influencers, sponsors, etc., among others. Talent portrayals would be limited to models over 45 years of age. Njoy identified a range of sales restrictions as well.
Ultimately, after assessing the youth data and risks, the TPLR executive summary states, “[t]he PMTAs contain sufficient evidence to show that the new products have the potential to benefit adults who smoke combustible cigarettes and who switch completely or significantly reduce their combustible cigarettes use …. The applicant also proposed robust marketing plans that include restrictions beyond those required with PMTA authorization. The Office of Health Communication and Education has determined that these restrictions may help further limit youth exposure to the new product, the products’ labeling, advertising, marketing, and/or promotion, and the potential for youth initiation.”
Questions Remain from the Njoy Decision
The MGO, however, raises two interesting questions. First, how much adult benefit is enough to overcome youth uptake? And second, what impact do marketing restrictions have on marketing authorization decisions?
The Math on Youth Use vs. Adult Cessation – How Much Differential is Enough?
The TPLR reports youth Njoy use data from both applicant data and national surveys and concludes that “[w]hile ENDS with nontobacco flavors and high nicotine delivery may help adults who smoke switch from CC to ENDS, these same characteristics may facilitate initiation and continued nicotine use by youth.” The cost-benefit analysis is troubling because CTP provides no real quantitative measure comparing youth use rates to adult cessation rates. Rather than a numerical comparison, the analysis seems to rely upon the totality of the evidence. As the TPLR states, “the totality of evidence provided by the applicant suggests that the menthol-flavored [product] … is associated with significantly higher smoking cessation rates than tobacco-flavored Njoy Ace products, and epidemiology concluded that the new products are highly beneficial to adults who smoke CC.” The close of the TPLR user population synthesis states that menthol-flavored new products pose a risk to youth but went on to assert that the data “demonstrate added benefit of using menthol-flavored compared to classic tobacco-flavored … Njoy Ace in achieving past-30-day smoking cessation—a showing required to outweigh the risks associated with flavored ENDS among youth.”
For some time, many in industry have wondered how much cessation difference between tobacco and flavored ENDS would be enough to outweigh risk to youth. While the balancing test is not numerically quantified, this marketing decision does provide some level by which to assess menthol products.
Are Marketing Plans Back on the Table?
In the White Lion Investments dba Triton Distribution v. FDA5th Circuit Court of Appeals decision from January 2024, the majority opinion found that the FDA ignored marketing plans in the Triton PMTAs: “[w]orse, after telling manufacturers that their marketing plans were ‘critical’ to their applications, FDA candidly admitted that it did not read a single word of the 1 million plans.”
Njoy’s marketing plan, however, seems to have an effect on the outcome. Reviewers remarked that the Njoy plan was “robust and is expected to limit youth exposure” to marketing materials. Interestingly, the TPLR states that the marketing plan was “not considered in the APPH assessment,” but then goes on to refer to the plan positively, stating, “the applicant’s approach to marketing may help further limit youth exposure to the new products.”In Njoy’s case, the marketing plans may not have moved the APPH needle but were considered as a net positive in youth prevention.
Are marketing plans important to your application? Beyond being a required part of the PMTA submission, it appears that in this case, the restrictions at least supplemented the adult benefit data to good effect.
Will Menthol MGOs Have an Impact in This Market?
While the menthol market authorizations are rightly seen as a victory, such a victory may be a pyrrhic one.
The presence and consumer acceptance of flavored disposable ENDS products looms over this seminal marketing authorization. The fact is that many menthol-flavored ENDS products with pending PMTAs remain on the market. Even in the face of the availability of menthol ENDS, flavored disposable ENDS sales have skyrocketed.
The Centers for Disease Control and Prevention published a Morbidity and Mortality Weekly Report (MMWR) in 2023 assessing e-cigarette unit sales across the various categories of products and flavors using scan data from brick-and-mortar retailers only. The MMWR reported that “the percentage of disposable e-cigarette sales more than doubled, from 24.7 percent in January 2020 to 51.8 percent in December 2022.” The predominant disposable flavors reported were “flavors other than tobacco, menthol or mint” (71.4 percent in 2020 and 79.6 percent in 2022). At the same time, menthol ENDS sales overall did not significantly change, while tobacco and mint flavors declined. With half of the market occupied by flavors that consumers clearly want, the growth space for a couple of menthol products seems limited.
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While the FDA continues to publicize enforcement efforts, the flavored disposable ENDS trend will not abate anytime soon. Given that flavored disposables are crushing the category, it seems unlikely that the MGOs for Njoy’s menthol products will play a significant role in shifting market share in the near term.
Where Does This Leave Us?
Foremost, good on Njoy for cracking the code—most observers have been very skeptical that an ENDS product with any flavor would ever be granted marketing authorization. Ultimately, Njoy demonstrated what the industry knows to be true from ENDS consumers—flavors, including menthol, are a net positive for adults who smoke to transition away from higher-risk combustible cigarettes. However, questions remain about how the risk-benefit test will be applied—how that math actually works and who, other than the largest companies, can afford to produce such evidence.
Rich Hill is senior director and new product compliance counsel at E-Alternative Solutions.
The Ministry of Health and Welfare wants to ban 27 types of chemicals from being used in tobacco products, vapes and heat-not-burn devices, reports The Taipei Times.
The list includes vanillin, maltol and heliotropin among other chemical compounds commonly used as additives in flavored tobacco products. Without these substances, manufacturers would be unable to produce popular flavors such as caramel, butter, almond, rose, coconut, raspberry, vanilla and cheese,
The new proposal would enable the ministry to remove more than half of flavored tobacco products from the market, according to Lo Su-ying, who heads the Health Promotion Agency’s Tobacco Control Division.
Under the draft rule, manufacturers and importers of products containing the banned substances would risk fines of between NTD1 million ($30,846) and NTD5 million, while sellers would incur penalties of between NTD10,000 and NTD50,000.
The government will subject the proposal to a 60-day public consultation.
Anti-tobacco activists contend Philip Morris International is trying to circumvent the Dutch ban on flavored tobacco and vape products with its Levia heat sticks, reports Dutch News.
Made with cellulose rather than tobacco, Levia heat sticks are considered an herbal product and are thus not covered by country’s tobacco legislation. The sticks retail online for €6.60 ($7.21) per pack of 20 and are sold in two flavors—”island beat,” which is menthol, and berry-flavored “electro-rouge.”
The Netherlands banned menthol in cigarettes in May 2020 and outlawed flavored vape products in early 2024.
Campaign group Rookvrije Generatie says Levia “a trick” to keep on selling smoking products with flavor. “They might not contain tobacco but they are packed with addictive nicotine,” spokesman Dave Krajenbrink was quoted as saying.
Legislators are reportedly considering an amendment that would extend the flavor ban to tobacco-free nicotine products.
Leaders of Deschutes County, Oregon, are asking the state Legislature to ban flavored tobacco products to protect kids from smoking or vaping. “Nine out of ten adults who smoke reported that they started smoking before the age of 18,” Deschutes County Tobacco Prevention Specialist Jasmine Gerraty told Commissioners Monday.
Commissioner Tony DeBone was the lone ‘No’ vote, saying he doesn’t believe the county has much authority on the matter: “There’s a lot of good information here. There’s a legislative choice at the Legislature.” In 2020 and ’23, with the commissioners’ approval, Deschutes County public health officials testified in Salem in support of statewide bans that later failed.
Commissioner Phil Chang read part of a proclamation he approved Monday, saying, “Whereas ‘Big tobacco’s’ use of candy flavors like bubblegum, blue raspberry, root beer and minty menthol have an increased likelihood of attracting new and existing consumers – especially students and other targeted groups – on the massive hits of nicotine their tobacco products can deliver.”
Commission Chair Patti Adair also approved of the proclamation, reading in part, “Be it resolved that Deschutes County strongly encourages the Oregon Legislature to pass legislation ending the sale of flavored tobacco products. This action is necessary to protect our children, students and other targeted groups from starting or continuing the use of candy-flavored and minty-menthol tobacco products.”
Equipped with evidence showing that e-cigarettes are a proven smoking cessation tool, a majority of American voters become opposed to efforts to eliminate flavored e-cigarettes, according to a poll carried out by Kellyanne Conway, who previously served as a counselor to former President Donald Trump.
Conducted in Michigan, Wisconsin and Pennsylvania, the survey showed that a majority of registered voters support fair and reasonable regulations that would preserve flavored e-cigarettes as a smoking cessation tool for adults while also safeguarding youth through marketing and advertising restrictions.
“Americans continue to reject outright bans on popular, legal everyday consumables. Whether it’s social media apps, gas-powered cars, gas stoves, nicotine pouches, menthol cigarettes or flavored vaping products,” said Conway. “In this survey, we find voters favor common-sense reform over outright bans that put science over politics to reduce harm and protect vulnerable communities like youth.”
The polling also shows an “information underload” among the American public as only 12 percent believe that vaping is better than smoking cigarettes while 75 percent believe vaping is as bad as or worse than smoking.
In addition, the polling shows that voters question why their elected officials at the state and federal levels prioritize flavored e-cigarette bans and restrictions over more obvious and urgent concerns. Importantly, survey participants suggested that they are poised to reward those elected officials who reassess outright bans on flavored e-cigarettes and work toward science-based solutions that are less extreme and do not erode basic freedoms.
The Vapor Technology Association (VTA) welcomed the poll results.
“The latest polling conducted across Pennsylvania, Michigan and Wisconsin further reinforces what VTA has long maintained: When presented with factual information, American voters accept the importance of vaping as a harm reduction and smoking cessation tool and then question regulators’ constant derogation of flavored e-cigarettes,” said VTA Executive Director Tony Abboud in a statement.
“Voters are not stupid; they have just been negligently misinformed by FDA leaders for years. Today’s poll reveals not only the importance of changing public perceptions about vaping but also highlights the political dangers of continuing down the path the FDA is on. It’s clear that voters across party lines are receptive to evidence-based approaches that balance adult access to smoking cessation tools with youth protection measures.”
EU health ministers on June 21 discussed proposals to restrict flavors in consumer nicotine products, such as vapes and nicotine pouches.
The EU Employment, Social Policy, Health and Consumer Affairs Council will consider proposals from Latvia and Denmark to support an EU-wide flavor ban and a crackdown on cross-border sales, among other recommendations.
If the health ministers reach consensus support for these proposals, the next step would be to ask the European Commission to introduce draft legislation, which would eventually be voted on by the council and the European Parliament, according to Vaping360.
Denmark, Estonia, Finland, Hungary, Lithuania, the Netherlands and Slovenia already ban vape flavors. Spain recently completed a public consultation on a proposed flavor ban while Latvia reportedly is in the process of introducing flavor restrictions.
The Tobacco Products Directive allows the member states to set their own rules for flavors. The Latvian proposal asserts that individual bans don’t work due to cross-border sales, among other factors.
Vaping activists have urged the EU to keep e-cigarette flavors legal.
“By supporting a flavor ban, EU health ministers would push millions of adults back to smoking or into the black market, endangering lives and ignoring scientific evidence. A flavor ban would be a huge step backward for public health and harm reduction,” said Michael Landl, director of the World Vapers’ Alliance, in a statement.
“Scientific research consistently shows that flavors play a crucial role in helping smokers quit. The endorsement of the flavor ban ignores those findings and the clear will of the people, opting instead for a policy that will cause more harm than good. The World Vapers’ Alliance will continue fighting for reasonable, evidence-based policies that truly protect public health.”
Canada’s proposed list of permitted vapor product additives includes dangerous ingredients, according to Imperial Tobacco Canada (ITCAN).
“To put it bluntly, the list contains at least one known substance that could cause cancer,” said ITCAN Vice President, Corporate and Regulatory Affairs Eric Gagnon in a statement.
According to ITCAN, several ingredients on the flavor ban proposal list of permitted ingredients are substances that its parent company, British American Tobacco, categorically avoids in its vaping products.
The company says BAT’s toxicological risk assessment prevents the use of substances classified as having carcinogenic, mutagenic or reprotoxic (CMR) properties, as per the Globally Harmonized System for classification and labelling of substances.
“It is shocking that the government would include a proven and classified CMR substance in its lists of permitted additives for vaping products,” ITCAN wrote on its website. “The effect of a regulation that formally permits such ingredients is simply an encouragement to manufacturers—particularly smaller producers with limited access to scientific literature—to use an inherently unsafe substance in a product that is designed to be inhaled into the lungs.”
Gagnon cited isophorone as an example. “This substance is classified by the European Union as cancer-causing and acutely toxic. It is also banned by Canadian food and drug regulations from use in human cosmetics,” he said.
“We encourage Health Canada to reconsider the list and consult with experts to determine the best way forward.”
Two groups of e-cigarette distributors are urging a New York state court to dismiss claims from New York City alleging they’re violating city laws by selling flavored e-cigarettes. The defendants say the law in question only applies to retail sales, not distributor-to-distributor sales.
The 11 defendants – located in Brooklyn, Queens, Long Island, and upstate New York – are alleged to have distributed, and continue to distribute, flavored disposable e-cigarettes – such as Strawberry Colada, Mellow Mint, Blueberry Energize, and Frozen Creamsicle – to retail vape and smoke shops, convenience stores, and directly to consumers over the internet, in violation of federal, New York state, and New York City law.
The lawsuit seeks to block the defendants from further selling the items and seeks damages and penalties under state and city statutes. It is a companion to the city’s pending 2023 federal lawsuit, in which two defendants are already subject to court orders barring their sales and shipments of flavored e-cigarettes into the city.
Two vaping businesses joined forces in opening a vape shop that represents a “hypothetical” future store if the U.K. were to ban flavors and implement a newly proposed tax regime.
In a release, e-liquid manufacturer Riot Labs and the vape shop Right Vape opened “The Flavourless Vape Shop” in Northampton to draw attention to the implications of a looming tax rise and flavor ban proposal that Riot Labs states will have a “devastating impact on people trying to quit [combustible cigarettes].”
The group meticulously created their vision, from the signage to the interior decor, and illustrated every detail of what the “hypothetical future” would hold if the ban were in full effect to give vapers and smokers a taste of what might come.
Customers faced two choices: One side of the shop contained “less flavor, less value, and less choice.” Or they could step to the opposite side, where Right Vape would serve them at 2024 prices and allow access to current legal products that would be banned under the proposed rules, according to an emailed release.
The launch event featured a Rishi Sunak lookalike to help cut the “opening” ribbon and serve customers the proposed expensive and flavorless vapes.
“We’re committed to supporting smokers who want to quit and have already helped thousands to stop over the past 7 years,” said Ryan Michlig, owner of Right Vape shop. “The proposed vaping legislation is going to be so detrimental to everyone who wants to quit smoking. Partnering with Riot Labs to open the Flavourless Vape Shop and bring awareness to the new legislation was a no-brainer.
“We wanted to create an experience that showed what the legislation could be like in real-time and get invaluable feedback from customers about how it’ll impact them.”
A recent study conducted by One Poll and commissioned by the UKVIA found that 83 percent of surveyed vapers say flavored vapes helped them “pack in their smoking habit.”
It also found that 1 in 3 respondents (an estimated 1.5 million vapers) believe a ban on flavors would lead them back to conventional cigarettes.
“The reality of the new legislation is giving people less choice, less value and ultimately less reasons to quit smoking at all. Adults depend on flavors to support their quit-smoking journey, and this legislation is going to have a detrimental impact on smokers trying to quit,” said Ben Johnson, CEO for Riot Labs. “There are better ways to deal with youth vaping such as an enforceable licensing scheme for all retailers.”
The Njoy Ace and Daily menthol product MGOs were a surprise considering the CTP’s menthol position and flavored vapor product denials. What was different about Njoy’s applications that tipped the scales?
