Irish Health Minister Stephen Donnelly proposed bans on non-tobacco vape flavors and advertising in non-specialized shops, reports The Irish Times. He tabled the suggestions as Ireland’s cabinet approved restrictions on disposable vapes on Sept. 9.
Donnelly said the proposals are aimed at protecting children, who he believed were “very cynically” targeting children. The proposed legislation, he said, would see just one flavor, tobacco, being sold.
“We live in a country where around 13 percent of people between the ages of 12 and 17 have vaped in the last 30 days,” said Taoiseach Simon Harris, who described vaping as “the revenge of the tobacco industry.”
Minister of State for Public Health Colm Burke said the regulations are necessary because “many people who used vaping products subsequently moved on to smoking.”
San Francisco is cracking down on the online sale of flavored nicotine pouches. The new lawsuit targets a handful of online retailers that the city says are violating its prohibition on flavored tobacco products.
Unflavored versions of the product, which are sold at corner stores and tobacco shops in the city, will remain available for online purchase.
“The tobacco industry has gone to tremendous lengths to reinvent their products to addict young people,” said City Attorney David Chiu. “We aren’t going to allow these companies to disregard the law and unravel decades of progress on preventing youth from using tobacco.”
The Standard obtained a draft of the complaint, which was filed Tuesday in San Francisco County Superior Court. The suit alleges that Northerner Scandinavia, Lucy Goods, Rogue Holdings, and Swisher International sell flavored nicotine pouch products online to San Franciscans despite the ban.
“Tobacco companies market nicotine pouches as discreet — the ‘perfect way to enjoy the nicotine you love without getting noticed, and without the risk of staining your teeth’; and claim that they are smoking cessation devices that help users ‘focus better, think deeper, chill out smoother, and inspire creativity,’” the complaint states.
Illinois Senator Dick Durbin strongly condemned top health and law enforcement officials for their inadequate efforts in combating the surge of illegal disposable e-cigarettes among young people in the U.S.
Industry analysts estimate disposable vapes make up 30 percent to 40 percent of the roughly $7 billion vaping market. The two best-selling disposables—Breeze and Elf Bar—generated more than $500 million in sales last year, according to Nielsen retail sales data analyzed by Goldman Sachs, according to media reports.
Both brands have been sanctioned by FDA regulators but remain widely available, in some cases with new names, logos, and flavors. More than half of the 2.8 million U.S. teens who vaped last year said they used Elf Bar.
Overall, teen vaping has fallen 60 percent since its all-time high in 2019, following the COVID-19 pandemic and new age restrictions and flavor bans on e-cigarettes and other tobacco products.
“Nearly all e-cigarettes are sold in violation of federal law, yet 2 million kids report vaping,” Durbin tweeted.
Using its own authorities, the FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years. But the letters have done little to dissuade companies from flouting FDA rules and introducing new vapes.
Welcome to Golden sign along Washington street in Golden, Colorado (Credit: PaBrady63)
Lawmakers in Golden, Colorado, dropped the hammer on more than two dozen retail outlets last year when they banned the sales of all flavored tobacco and nicotine products in the city.
The move is costing the businesses thousands of dollars in revenue.
Now, this city on the western edge of the Denver metro area is setting up a one-time $100,000 relief fund for smoke and vape shops, gas stations, and convenience stores to soften the financial hit they’ve taken since Golden’s prohibition went into effect on Jan. 1, according to media reports.
The City Council earlier this month directed staff to create a competitive grant program for businesses to apply for funds. No single store can receive more than $10,000, and the money must be allocated before the end of the year.
About 30 businesses in Golden are affected by the city’s prohibition.
“The City Council is trying to say they’ve heard the concerns of local businesses and they want to be responsive to local businesses that were impacted by an ordinance they weren’t anticipating,” said Rick Muriby, Golden’s community development director.
While several Colorado municipalities, including Boulder, Aspen, Glenwood Springs, and Edgewater, have passed similar flavored tobacco sales bans in recent years to combat youth nicotine product consumption, Golden appears to be the first willing to backfill revenues lost to a law it passed.
Muriby said the $100,000 figure wasn’t based on sales data from city businesses but was a figure the council and city manager “felt was a reasonable amount for the city to spend.” While Golden wants to ensure its businesses remain healthy, he said, it has no intention of taking a second look at its flavored nicotine ban.
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.
Illinois lawmakers have decisively passed a law that forbids vaping companies from targeting teens with their advertising, particularly by promoting electronic cigarettes that resemble school supplies such as highlighters, markers, or erasers.
The changes come at a time when lawmakers from both sides of the aisle in Springfield have been bombarded with complaints about students bringing vapes into schools that could easily be mistaken for such common items, according to media.
Seilback argues that none of the deception should come as a surprise.
“The industry is always needing to replace those that quit using their products,” he adds. “They’re always looking for the next generation. They’re going to keep saying what they say and we need to make sure that our elected officials stand with the public health community.”
The new law will be enforced by the Illinois Department of Revenue, the Attorney General’s office, and local law enforcement. At the same time, Senate Bill 3098, which will ban electronic cigarette companies from allowing anyone under 21 to order vaping products online or by mail, is also slated to soon take effect.
Illinois Senate Bill 3098, signed into law Aug. 9, prohibits e-cigarettes purchased by mail, online or through other remote sale methods from being shipped to anyone in the state other than a distributor or retailer. Senate Bill 3098 goes into effect Jan. 1, 2025.
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.
A county district attorney in California wants to keep vapes, tobacco products and other prohibited items off of store shelves out of the hands of children.
Monterey County is handing down civil penalties to Rubystar Gems and Gifts, a local business accused of doing just that. The Monterey County District Attorney’s Office says they received word in late 2023 from the Monterey Police Department and Monterey Sheriff’s Department about complaints against the store for selling tobacco products to minors.
The store was also allegedly selling flavored tobacco products, which are illegal in California, hallucinogenic mushroom gummies containing a substance that is illegal to sell in California and illegal weapons like “metal knuckles.”
The mushroom gummies contain psilocybin, which is a hallucinogenic controlled substance that is illegal to sell in California. The packaging was counterfeit and did not indicate the actual product and its true manufacturer on the label, according to media reports.
The store’s owner agreed to a civil settlement and has to pay a $25,000 penalty for the violations. In 2022 and 2023, two sales clerks were prosecuted in a criminal court for selling tobacco products to minors. Continued complaints prompted the Monterey District Attorney’s Office to investigate further.
The store is currently closed, but Emily Hickok, a chief deputy district attorney at the Monterey County District Attorney’s Office, says it can legally continue to operate. The store owner didn’t want to go on camera but did say the store is closed because of personal health reasons and that he is retiring.
The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary.
The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.
“These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.
Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey.
The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.
For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.
These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.
To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.
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?
