Lithuania will ban the sale of flavored e-cigarettes and e-liquid cartridges starting in July, reports LRT. Tobacco flavors will remain legal.
The move is aimed at reducing sales of e-cigarettes that are growing increasingly popular in Lithuania.
On Jan. 18, Lithuanian lawmakers adopted amendments to the Law on Control of Tobacco, Tobacco Products and Related Products with 92 votes in favor, nine against and nine abstentions.
Lithuania already bans vaping hardware and cartridges containing vitamins and other additives that create an impression that they are good or do less damage to health.
The country also prohibits imports of e-cigarettes and e-liquid cartridges containing caffeine and other stimulating compounds linked to energy and vitality.
Restrictions on flavors in vaping products would be a drastic setback in the battle to reduce the 48,000 Canadian lives lost every year to smoking, according to a new independent study released on Jan. 11.
The review, covering more than 340 articles of evidence on e-cigarette flavorings, concludes that they are “inextricably linked” to smoking cessation and should be made more accessible and affordable to adults trying to quit.
“Well-regulated use of flavors can and should be considered as a valuable tool to help prevent disease and save the lives of adult smokers who cannot or will not quit by themselves or with other approved methods,” says report author Konstantinos Farsalinos, a cardiologist with a career devoted to tobacco harm reduction.
Farsalinos released his review at a webinar on Dec. 15, 2021.
The report, which examines the science, consumer insights, risks and regulatory considerations related to e-cigarettes, comes as Health Canada seeks to implement a ban on flavored vapes.
“We’re at a crossroads where policymakers are about to turn away from the evidence showing flavors help smokers transition to products that carry only a fraction of the risk of combustible cigarettes, thereby preventing disease and saving lives,” said Farsalinos.
“If bans were allowed, it would ultimately drive consumers to tampering, illicitly traded products, towards the black market, or back to traditional cigarettes.”
Electronic nicotine delivery systems (ENDS) are now the overriding method of choice for smokers who want to quit, says the report. Studies show users of flavored e-cigarettes are up to three times more successful.
The review highlights the work of David Levy, who developed the Smoking and Vaping Model, which allows researchers to calculate the life-saving potential if all adult cigarette smokers were to switch to nicotine vaping products. Applied to Canada, 130,000 deaths could be avoided between 2012 and 2052 if Canadian smokers switched to vaping. This would save 2.5 million life years.
The report points out that flavors are used to improve the efficacy of nicotine replacement therapy products, such as lozenges and gums, which feature on the World Health Organization’s list of essential medicines.
“Surely, if the WHO considers flavorings an essential anti-smoking tool in nicotine lozenges, the same should apply for consumer acceptance in nicotine vaping products” said Farsalinos.
“Vaping is already delivering results in Canada by helping long-term smokers who have struggled to quit to finally give up the habit. To misguidedly deny desperate smokers their best chance of quitting is needlessly putting their health at risk.”
The report recommends better access and affordability for quitting tools such as flavored vapes “through proportionate, risk-based regulation and robust monitoring.”
Concerns about underage use of vapes would be best addressed by focusing on youth access at the point of sale and the elimination of flavor descriptors clearly targeting the young, it adds.
Three months after a court-ordered deadline for the U.S. Food and Drug Administration to decide what e-cigarette products can stay on the market, FDA delays have left e-cigarettes in kid-friendly flavors widely available across the country, according to a new report released by the Campaign for Tobacco-Free Kids (CTFK).
Under a federal court order, e-cigarette manufacturers were required to submit marketing applications to the FDA by Sept. 9, 2020, and products that were the subject of timely applications were allowed to stay on the market for up to one year while the FDA reviewed the applications, a period that expired Sept. 9, 2021. The CTFK and other public health groups have urged the FDA to deny marketing applications for all flavored e-cigarettes because of “the clear evidence that flavored products have fueled an epidemic of youth e-cigarette use and nicotine addiction.”
The FDA has denied marketing applications for more than 1 million flavored e-cigarette products. However, the FDA has yet to issue decisions about the e-cigarette brands that have the largest market share or are most popular with kids, such as Juul, most Vuse products, NJOY, Blu, Smok and Suorin.
The FDA is also considering whether to authorize any menthol-flavored e-cigarettes despite the popularity of menthol products with kids, according to the CTFK.
In addition, more than 40 e-cigarette companies have filed lawsuits challenging the FDA’s marketing denial orders, and other companies—including Puff Bar, the flavored disposable e-cigarette that is now the most popular brand among kids—have started using synthetic nicotine because that substance is currently not regulated by the agency.
To assess the impact of the FDA’s actions to date on the availability of flavored e-cigarettes, the CTFK scanned five top online e-cigarette retailers and 43 brick-and-mortar stores in eight cities across the U.S. The group notes that the scan provides a snapshot of the current e-cigarette market and is not intended to be a representative sample of stores nationwide or online.
Key findings include that kid-friendly flavored e-cigarettes and nicotine e-liquids are still widely available; that the bestselling e-cigarette brands remain available for purchase; and that the most popular e-cigarette brands among youth are still available in flavors that appeal to youth, according to the CTFK.
The group has called on the FDA to act quickly on all remaining e-cigarette applications and deny authorization to all flavored e-cigarettes, including menthol-flavored products.
New research suggests that flavored vaping products are much less harmful to young people than combustible cigarettes. They also have the potential to help current teen cigarette smokers quit.
Credit: Haiberliu
A new study from researchers at the University of East Anglia (UEA) reported the views and experiences of more than 500,000 youth under the age of 18. Lead researcher, Caitlin Notley, from UEA’s Norwich Medical School, said the study was conducted because there was a lot of concern that young people may start vaping because they are attracted to e-liquid flavors, and that it could potentially lead them to start smoking tobacco.
“We wanted to find out more about the links between vape flavors, the uptake of vaping among young people, and whether it leads to regular vaping and, potentially, tobacco smoking,” she said in a statement, adding that he research team studied all available evidence (58 studies) on the youth use of e-liquid flavors. “We found that flavored e-liquids are an important aspect of vaping that young people enjoy. This suggests that flavored products may encourage young people to switch away from harmful tobacco smoking towards less harmful vaping.”
Flavored vaping products also did not cause vapers to move on to combustible products, according to the study. may be an important motivator for e-cigarette uptake – but we found no evidence that using flavored e-liquids attracted young people to go on to take up tobacco smoking. “And we also found no adverse effects or harm caused by using liquid vape flavors,” Notley said. “However, there is also a need to monitor flavor use to ensure that young people who have never smoked are not attracted to taking up vaping.”
The team found that the overall quality of the evidence on use of e-cigarette flavors by young people was low. In particular, many studies did not clearly define e-liquid flavors and could not therefore be included within the review. The study was led by UEA in collaboration with researchers at University College London, the University of Bristol and University Hospitals Bristol and Weston NHS Foundation Trust.
The city of Bangor, Maine has banned flavored vaping products, including e-cigarettes. The Bangor City Council voted 7-1 in favor of the ban, which will not go into effect until after the Maine Legislature reconvenes next year. The ordinance bans the sale and marketing of all flavored tobacco products in the city — including menthol cigarettes and e-cigarette flavors that have a taste or smell besides tobacco — beginning on June 1, 2022.
Credit: Ianm35
While the amended ordinance falls short of the pre-session ban that advocates hoped would spur the Legislature to action on a statewide prohibition on the sale of flavored tobacco, it is a strong gesture for a council with many members who believe the flavored tobacco issue was better solved at the state level, according to Maine Public Radio.
Opponents and supporters saw the Bangor vote as an important step in the fight to ban the sale of flavored tobacco at the state level. That bill, LD 1550, was reported out of committee earlier this year but had not come to a vote before the end of this year’s legislative session.
Many opponents brought up the contents of messages the National Association of Tobacco Outlets requested under Maine’s Freedom of Access Act that they said showed an effort by Bangor councilors, especially Councilor Sarah Nichols, to not include the voices of merchants in the process of crafting and debating the ordinance. Many of the exchanges are text messages between Nichols and Matt Moonen, who had brought the proposal to ban flavored tobacco to her. Moonen is the executive director of Equality Maine.
Earlier Monday, the New England Convenience Store and Energy Marketers Association had called for the council to suspend decisions on the tobacco ban and evaluate how councilors had acted. Sprague, one of several councilors to turn back those arguments, said such allegations had ultimately hurt the opponents’ case.
“The comments about the process and how the city has not supported open dialogue are insulting, if not repulsive,” Sprague said. City Council Chair Dan Tremble was the only councilor to vote against the ordinance. Nichols did not directly respond to statements about her during the meeting, though she referenced them in her remarks on why she supported the ordinance.
Retailers who continued to sell or market flavored tobacco products after the ordinance took effect would first face a warning, and then a $50 to $100 fine for their next offense within a two-year period after the warning. A fine of $300 to $1,000 would then be levied for each additional offense within that two-year period.
It could be some time before the U.S. Food and Drug Administration issues marketing orders for flavored vapor products.
By Chris Howard
For the past 10 years, we have ridden a rollercoaster together. We have experienced the same highs and lows and shared the hope that harm reduction will prevail in the end. Then, over the course of the past several weeks, the journey ended abruptly with marketing denial orders (MDOs) for so many. Not surprisingly, several question whether the vapor industry can ever recover.
The FDA’s Recent Actions
For what it’s worth, the recent actions of the U.S. Food and Drug Administration should not have been a surprise to anyone in the vapor industry. We have known for several years that being part of a highly regulated segment would not be easy. In fact, the FDA made its expectations clear in its 2016 Draft Guidance entitled Premarket Tobacco Product Applications for Electronic Nicotine-Delivery Systems (ENDS). In sum, this document revealed that obtaining a marketing order for vapor products would require scientific expertise, extensive data development and very deep pockets.
That said, the FDA’s rationale for such broad-based denials has raised questions among many. More specifically, the FDA provided the following rationale in its Aug. 26, 2021, news release:
In light of the public health threat posed by the well-documented, alarming levels of youth use of flavored ENDS, the agency has reviewed the applications subject to this action to determine whether there is sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth. Based on existing scientific evidence and the agency’s experience conducting premarket reviews, the evidence of benefits to adult smokers for such products would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.
Chris Howard
The primary question we are left to ponder is whether this balancing of interests exceeds the FDA’s standard for assessing whether a product is appropriate for the protection of public health. Based on Section 910 of the Tobacco Control Act, which describes the appropriate standard of review, it appears that this balancing is one of many facets of an application that the FDA is required to consider.
Appropriate for the Protection of Public Health
Section 910 of the Tobacco Control Act provides the FDA’s standard of review for new tobacco products:
…whether the marketing of a tobacco product for which an application has been submitted is appropriate for the protection of the public health shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account—
(A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and
(B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.
So clearly, the risk of initiation of flavored ENDS products by youth is relevant as is the likelihood of ceasing use by smokers generally. Without a doubt, the FDA has determined that evidence related to part (A)—cessation—must outweigh part (B), initiation. This risk balancing, in the FDA’s own words, is reflected in data from clinical studies or longitudinal studies demonstrating that adult use of flavored ENDS leads to cessation (or switching) outcomes that exceed the risk of youth initiation of tobacco product use. And yet, despite this seeming clarity, many questions surround this analysis. For example, by how much must adult cessation exceed youth initiation? What if both tobacco varieties and flavored varieties show the same or similar cessation rates? Has the FDA considered the reduction in use by youth resulting from the recent change in the age to purchase tobacco products to 21 when examining the balancing of risks versus benefits?
These questions are likely to remain unanswered for quite some time. Many committed companies are already beginning efforts to satisfy the FDA’s outstanding requests for clinical studies and/or longitudinal data, but the development of data will take several months. Obviously, this is likely to do significant damage to an already fractured market—and even more potential damage to smokers seeking an alternative to combustible cigarettes.
Flavors Are Critical for Harm Reduction
Despite these tumultuous past few weeks, the FDA is arguably the biggest advocate for harm reduction. Given the agency’s desire to provide options to adult smokers to move away from traditional combustible cigarettes, it seems clear that a pathway for flavors to return does indeed exist.
Along with the rest of the industry and many public health researchers, I believe that the removal of all flavored products would negatively impact harm reduction efforts in the United States. Some vapers will undoubtedly return to smoking combustible cigarettes. And smokers who might have transitioned to ENDS products may now elect not to do so. In the studies conducted at my company, E-Alternative Solutions, we demonstrated that adults prefer flavors and that flavors assist adults in transitioning from combustible cigarettes to potentially less harmful alternatives. Existing literature documenting the research conducted by others also supports this proposition. Moreover, anecdotal reports are easy to find on Twitter and multiple other social media forums.
While it may not be apparent from the FDA’s recent actions, I do not believe that flavored ENDS are finished in the United States. While the bar appears high, I hope and expect, for the sake of adult smokers in this country, that we will see flavored ENDS on the U.S. market again. That said, it could take time until the agency issues market orders for flavored vapor products.
What’s Next?
The FDA’s recent decisions will likely prompt many to appeal and some to resort to litigation [at least two suits are known to have been filed already]. The FDA appears prepared to address these initiatives and is prioritizing enforcement of those failing to comply with MDOs and/or who are selling vapor products that have not undergone premarket review. While these activities are ongoing, many will begin longitudinal studies and the hard work to identify alternative methods to show the FDA that flavors are determinative in adult smokers’ efforts to switch from combustible cigarettes.
Ultimately, we will have to wait while the remainder of the story unfolds. Hopefully, the FDA will be prepared to work directly with sophisticated manufacturers to ensure that flavored ENDS can continue to play a role for adult smokers seeking alternatives.
Chris Howard is the vice president, general counsel and chief compliance officer of E-Alternative Solutions, an independent, family-owned innovator of consumer-centric brands.
A study released by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention (CDC) found that youth use of e-cigarettes fell sharply in 2021, the second consecutive year of major declines, according to the government’s annual National Youth Tobacco Survey (NYTS). An estimated more than 2 million U.S. middle and high school students reported currently using e-cigarettes in 2021, with more than 8 in 10 of those youth using flavored e-cigarettes.
The study shows that an estimated 11.3 percent (1.72 million) of high school students and an estimated 2.8 percent (320,000) of middle school students reported current e-cigarette use, lower than the 19.6 percent (high school) reported in 2020 and substantially lower than the 27.5 percent reported in 2019 (high school), according to previous FDA statements. Middle school vaping fell to 2.8 percent this year from 4.7 percent in 2020—a 40.4 percent decline. Middle school past 30-day vaping in 2020 fell 55.2 percent from 2019.
The report, published in the CDC’s Morbidity and Mortality Weekly Report, was based on data from the 2021 NYTS, a cross-sectional, self-administered survey of U.S. middle (grades 6–8) and high (grades 9–12) school students. The study assessed current (used on one or more of the past 30 days) e-cigarette use; frequency of use; and use by device type, flavors and usual brand.
Credit: CASAA
Among youth who currently used e-cigarettes, the study found the most commonly used e-cigarette device type was disposables (53.7 percent), followed by prefilled or refillable pods or cartridges (28.7 percent), and tanks or mod systems (9.0 percent). Some in the industry have pointed out that “for the record, past-30-day ever use was 7.6%. The real numbers are: Disposables: 4.1%, Pods or cartridges: 2.2%, Tanks or mod systems: 0.7%,” a vaping advocate (@phil_w888) tweeted.
The FDA and CDC are also being accused of using the data to further an anti-vaping agenda. The Consumer Advocates for Smoke-free Alternatives Association (CASAA) tweeted that “Past-month HS vaping declines dramatically–down 47% from 3.6 million to 1.72 million–with daily vaping down from 4.4% to around 3%. Yet the general public wouldn’t know that from the negative spin made by Public Health.”
Administered Jan. 18- May 21, 2021, thus NYTS was the first to be fully conducted during the Covid-19 pandemic. Data were collected using an online survey to allow eligible students to participate in the classroom, at home or in some other place to account for various school settings during this time. Prior to the pandemic, the survey was conducted in person, inside the school classroom. Because of the changes in the way the survey was conducted this year, the FDA claims results of the 2021 NYTS cannot be compared to findings from previous surveys.
Robin Koval, president and chief executive of Truth Initiative, a nonprofit anti-nicotine advocacy group, emphasized that the sharp drop in youth vaping may be attributable to pandemic restrictions that kept youth at home. “Kids were not in school, they were not seeing friends,” Koval said. There was no mention of the drop from 2019 numbers that were measured before the Covid-19 pandemic began.
“These data highlight the fact that flavored e-cigarettes are still extremely popular with kids. And we are equally disturbed by the quarter of high school students who use e-cigarettes and say they vape every single day,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The FDA continues to take action against those who sell or target e-cigarettes and e-liquids to kids, as seen just this year by the denial of more than one million premarket applications for flavored electronic nicotine delivery system products. It is critical that these products come off the market and out of the hands of our nation’s youth.”
The Canadian government has proposed restrictions on flavored vape products, which Health Canada acknowledges will result in increased combustible cigarette smoking. The justification for the flavor ban is that flavor restrictions will lessen youth vaping rates, according to the Canadian Vaping Association (CVA). However, youth rates are already in decline.
Credit: Kristina Blokhin
The Canadian Tobacco and Vaping Survey, 2020, found that youth vaping has declined since 2019. Currently, youth daily vaping is 4.7 percent and Health Canada expects the recently implemented nicotine ceiling will further reduce use and experimentation.
“Youth daily vaping and addiction rates are actually quite low and expected by tobacco control experts to continue to decline. Generally, youth vaping rates are discussed using data on the amount of youth that have tried vaping over the past 30 days,” said Darryl Tempest, executive director of the CVA. “This is a poor metric to base regulation on because it represents experimentation and not habitual use. Young people that try vaping once at a party are included in this figure. These surveys are also misleading because they include age of majority respondents. If these respondents were excluded from the survey, daily vaping among minors is around 2 percent.”
In a press release, Tempest stated that if other adult products were regulated consistently with the same concern as past 30-day vape use, both cannabis and alcohol would require severe restrictions, as both daily and past 30-day use prevalence are greater than nicotine vaping.
“Alcohol is considerably more harmful than nicotine vaping and despite its use being significantly more prevalent than vaping among youth, flavor restrictions have not been considered. This is likely because like vaping, youth are not drinking for flavors,” Tempest states. “Canada has set a goal to reduce tobacco use prevalence to 5 percent or less by 2035. Restricting flavors will push thousands of vapers back to smoking and jeopardize current smoking reduction targets. The CVA calls on Health Canada to forgo the flavor ban and instead focus on proven methods such as increased enforcement and education programs.”
The City Council for the District of Columbia (D.C.) voted Tuesday to ban the sale of flavored vaping and other tobacco products in the District, including menthol cigarettes. It was the council’s second vote in favor of the legislation and it now heads to the desk of Mayor Muriel E. Bowser, who supports the ban for health reasons. She has stated that she would sign it into law.
Credit: JHVE Photo
The 8-to-5 vote came after a lengthy debate in which legislators who opposed the ban — and even some who favored it — raised concerns that the law could create opportunities for Black smokers to be harrassed by police, and that the city would be unfairly targeting a smoking choice preferred by Black residents, according to the Washington Post. The Council voted 9-3-1 during the first reading at the June 15 legislative session.
In an attempt to avoid police interactions based on the use of flavored vapor products, the council approved a change to the bill Tuesday saying that the law does not give the city’s police authority to act on their own to enforce the vaping ban. The Department of Consumer and Regulatory Affairs, which can inspect D.C. stores to make sure they are not selling illegal products, could still call in police for assistance.
The council carved out one exception — any hookah bars in the city which already have an exemption from the city’s ban on indoor smoking in restaurants will be grandfathered in, and can continue offering flavored hookah for use on their own premises.
The Biden administration has vowed to eventually outlaw such flavored tobacco products, including menthol, nationwide. The council originally considered banning only e-cigarette products before expanding the bill to include menthol, a step that several legislators opposed.
“If the question is, ‘Is menthol bad for us?’ the answer certainly is yes. But if the question is, ‘Is smoking bad for us?’ the answer also is yes,” said Councilmember Robert White, who voted against the ban. “In the original bill, we were trying to get at things that were targeted toward youth, flavored items. Menthol to me seems like a different category…. I’m seeing this as paternalistic.”
The District joins the state of Massachusetts and some other cities across the country in banning menthol cigarettes, which are popular with Black smokers of all ages, alongside other flavored tobacco products such as the candy- and fruit-flavored e-cigarettes that advocates say are targeted toward inducing teenagers to smoke.
Acting FDA Commissioner Janet Woodcock is set to testify before a House subcommittee on Wednesday morning about youth vaping. Rep. Raja Krishnamoorthi, chair of the panel, plans to press Woodcock to do more to stop kids from vaping and becoming addicted to nicotine.
“We still have a youth vaping epidemic, even amidst our pandemic,” said Krishnamoorthi, in a story for Yahoo Finance.
Krishnamoorthi has been an advocate for cracking down on the vaping industry over the past several years. In 2019, amid an outbreak of vaping-related illness linked to black market THC products not nicotine, there was bipartisan support for a crackdown — leading the Trump administration to issue a vaping flavor ban in an effort to curb teenage use.
The ban covered flavors that critics argued targeted children — like fruit, mint and candy flavors — but allowed menthol and tobacco flavors to remain legal. The ban only applied to cartridges or pre-filled pod devices, like the ones sold by Juul, not disposable e-cigarettes. Some critics argued the move wasn’t enough.
“You’ve got to get rid of all the flavors. Secondly, you have to make sure that disposable cigarettes are subject to the same flavor ban that all other products are subject to — and then third, we have to regulate the nicotine content,” said Krishnamoorthi. “These vapes that are currently on the market are so addictive.”
