Category: Flavors

  • Flavor Ban Risks Lives, Warns Cardiologist

    Flavor Ban Risks Lives, Warns Cardiologist

    Photo: Tobacco Reporter archive

    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.

  • Report: Flavored Vapes Remain Widely Available

    Report: Flavored Vapes Remain Widely Available

    Photo: kurgu128

    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.

  • Denver: Mayor Vetoes Flavored Tobacco Ban

    Denver: Mayor Vetoes Flavored Tobacco Ban

    Photo: Blanca

    Denver Mayor Michael Hancock vetoed a bill that would have banned the sale of most flavored tobacco and vaping products in 2023.

    In a letter to the city council, Hancock stated that such a ban would not be effective due to surrounding counties continuing to sell the products, and he added that a ban would harm small businesses. He offered a compromise, though, including boosting enforcement of existing laws, and stated that a statewide ban would be more effective. He has encouraged the city’s legislators to draft a bill that would outlaw flavors across Colorado.

    The city council will discuss whether to override the veto at their Monday night meeting.

    “I believe in passing and implementing effective policies,” Hancock said in an interview with The Denver Post. “I didn’t see that this bill singling Denver out would do anything to keep nicotine and vaping products from our young people.”

    Public health advocates criticized Hancock’s decision.

    “There is no excuse for Mayor Hancock vetoing this critical ordinance, siding with Big Tobacco over Denver’s kids and the 100-plus organizations who support this policy,” said Jodi Radke, regional director for the Campaign for Tobacco-Free Kids, in a statement.

    Vape show owners welcomed the veto.

    “I can say we are breathing a sigh of relief today,” Monica Vandrusko, owner of Cignot, a vape shop in northwest Denver, said. “We are happy to hear Hancock wants to work with us instead of just putting us out of business.”

    The Denver City Council approved the ban on most flavored tobacco, including menthol cigarettes, and vaping products on Dec. 6, and the ban would have been effective in July 2023. Under the law, adults in Denver only would be able to buy flavored smoking products in hookah lounges and cigar and pipe shops.

     

  • IEVA: Risk of EU Flavor Ban Remains

    IEVA: Risk of EU Flavor Ban Remains

    Dustin Dahlmann (Photo: IEVA)

    The Independent European Vape Alliance (IEVA) welcomed the decision of MEPs to recognize tobacco harm reduction as a tool in beating cancer; but remains concerned that the report approved today by the European Parliament leaves the door open to a flavor ban in the EU.

    The Special Committee on Beating Cancer (BECA) recently voted on the amendments and the draft of the Beating Cancer report by Rapporteur Véronique Trillet-Lenoir. The authors of the report identify smoking as one of the main causes of cancer and IEVA agrees that everything should be done to significantly reduce the smoking rate in Europe.

    “There is little scientific doubt that tobacco harm reduction is a key tool in achieving this goal,” the IEVA wrote in a press note. “Even those skeptical of tobacco harm reduction concede that vaping is many orders of magnitude less harmful than continuing to smoke. According to Public Health England, e-cigarettes are 95 percent less harmful than tobacco and the risk of cancer drops by 99.6 percent.”

    The reports’ compromise amendment on vaping includes the recognition of vaping as a tool to help some smokers quit smoking and the need for further research on vaping to be done in relative terms (i.e. in comparison to combustible tobacco).

    But the final text of the report also includes a mention of further assessment of flavors “particularly attractive to minors and non-smokers” and a possible ban on them in the context of the review of the Tobacco Products Directive.

    “European Parliament reports like this are necessarily a compromise,” said IEVA President Dustin Dahlmann. “IEVA notes that the variety of flavors is one of the most important reasons for smokers to switch to e-cigarettes and for vapers not to go back to smoking. A ban on flavors would eliminate one of the main advantages of the e-cigarette over the tobacco cigarette—an improved taste.”

    “We also see that the importance of the e-cigarette for quitting smoking is recognized and that the risks of vaping are planned to be assessed even more in relation to the risks of smoking in the future. This approach must be pursued, and not undermined by banning most products on the market today.”

  • Draft Menthol Standards Expected by April

    Draft Menthol Standards Expected by April

    Photo: Tobacco Reporter archive

    The U.S. Food and Drug Administration is on track to issue proposed product standards that could ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors in cigars by April 2022, reports CSP, citing FDA Center for Tobacco Products Director Mitch Zeller.

    Speaking on a webinar held on Dec. 2 by the National Association of Tobacco Outlets, Zeller said the effort is based on the clear scientific evidence related to the addictiveness and harm of menthol products.

     “Were these proposed product standards to be finalized and to go into effect, this will help to significantly reduce initiation by kids, increase smoking cessation among current smokers and, very importantly, address some profound health disparities when it comes to the use of these types of products by communities of color, low-income populations and the LGBTQ+ population,” he said.

    After the FDA publishes the proposed new rules, there would be a review and public comment period, meaning the bans wouldn’t take effect for between one to two years, if ever.

  • Down to the Wire

    Down to the Wire

    Photo: kurgu128

    Uncertainty lingers about the future for vaping as the FDA decides the fate of the remaining marketing applications.

    By Stefanie Rossel

    Two months after the Sept. 9, 2021, deadline for the U.S. Food and Drug Administration to determine the fate of millions of premarket tobacco product applications (PMTAs), uncertainty continues to prevail, and the fate of e-liquids with flavors other than tobacco remains unclear. The agency’s approach to e-cigarette regulation to date, alternatingly labeled a “fiasco” or “bureaucratic chaos” by critics, suggests that the U.S. may be heading toward a de facto ban of all nontobacco flavors.

    The 2009 Tobacco Control Act (TCA) gave the FDA authority to regulate cigarettes, smokeless tobacco, cigarette tobacco and roll-your-own tobacco. The “deeming rule” of Aug. 8, 2016, extended the agency’s authority to electronic nicotine-delivery systems (ENDS), cigars, pipe tobacco, nicotine gels and hookah tobacco. As a result, deemed products are now subject to all TCA rules, including the requirement that any new tobacco product must receive premarket authorization from the FDA to be legally marketed.

    Following litigation by anti-tobacco groups, a court set the deadline for manufacturers to submit their applications by Sept. 9, 2020, and gave the agency one year to decide on them. The time frame presented a daunting challenge to the chronically understaffed agency. The FDA received more than 6.5 million marketing applications for newly deemed tobacco products alone. At press time, the agency had acted on more than 98 percent of these applications. Its actions included refuse-to-accept letters to more than 200,000 applications, a refuse to file order for approximately 4.5 million products submitted by a single company and marketing denial orders (MDOs) for more than 1 million nontobacco-flavored ENDS. Only three new tobacco products received marketing granted orders. The FDA still needs to rule on applications covering about 80,000 products, including those submitted by market leaders such as Juul and NJOY.

    David Sweanor

    Retroactive Change of Requirements

    Most of the MDOs were directed at vape products with flavors other than tobacco, including menthol. The manufacturers, the agency claimed in its MDO letters, had failed to provide sufficient evidence that their nontobacco-flavored products deliver a net public health benefit for adult smokers compared with the “threat posed by the well-documented, alarming levels of youth use” of flavored vapes through either a randomized controlled trial in which a specific group of people is examined through intervals of time, or a longitudinal cohort study, which tracks large groups of people over an extended period of time.

    “It appears that the FDA is planning to significantly hobble the vaping category and thus protect lethal cigarettes from what is perhaps the greatest threat that business has ever faced,” says David Sweanor, adjunct professor of law at the University of Ottawa. “But how far this succeeds depends on many factors, not least what the courts will say about the process.”

    The requirement is now part of the PMTA rules, which the agency finalized in October 2021, and which took effect in November. However, it had not been in the original guidance for PMTA applications, according to critics.

    For most smaller vape manufacturers, the FDA’s ruling has meant the end of their business activities. “Like most vape companies, we cannot remain financially viable with only two [tobacco-flavored] products, and we will most certainly be forced to close our business after eleven years,” California-based Kai’s Virgin Vapor states on its website.

    Paul Blair

    Temporary Stays Granted

    Others have taken legal action. Arguing that the FDA moved the goalpost by retroactively changing the PMTA requirements, MDO recipients filed more than 40 petitions for review and stay on the grounds that the FDA had acted in an “arbitrary and capricious manner.” At the time of writing, at least five companies had been granted a temporary stay either by the FDA or the courts, and their products were back under review.

    Among them was Turning Point Brands, which may now continue to market its vapor products while its PMTAs are being reassessed. “We’re encouraged that the agency has acknowledged the robust nature of our PMTAs for a wide range of tobacco, menthol and other flavored vapor products,” Paul Blair, vice president of government affairs at Turning Point Brands, told Tobacco Reporter. “These open system e-liquids, sold predominantly in vape shops across the U.S., play an important role in providing reduced-risk options to more than 30 million adult smokers who may be looking for alternatives to combustible cigarettes. It is our hope that at the end of the PMTA review process, the agency will preserve the important off-ramp from cigarettes to a wide range of vapor products used by adults. Preserving these options will ensure that the diverse vapor marketplace can help ultimately achieve a more significant reduction in smoking rates across the U.S.”

    “The cases look strong,” Sweanor states. “Administrative bodies, like referees in sporting competitions, are challenged when they seek to change the rules mid-game. This is supposed to be an example of transparent rule-making in a democratic society. There is also a history, in the U.S. and globally, of vaping companies using the courts to overturn laws and administrative rulings that have overly restricted their products and marketing.”

    However, a second review does not guarantee that the products will receive authorization. Critics fear that manufacturers who have received an MDO will continue to appeal the decisions to maximize the time to sell their products. THR advocates hope that legal challenges will force the FDA to make more careful decisions.

    Uncertain Future for Flavors

    There are many indications that the era of nontobacco vapor flavors is coming to an end in the U.S. After bombarding the vapor business with MDOs, the FDA on Oct. 12 approved R.J. Reynolds Vapor Co.’s Vuse Solo and accompanying tobacco-flavored e-liquid pods—the first-ever marketing granted order for an e-cigarette.

    Tobacco harm reduction advocates received the news with mixed feelings. While welcoming the agency’s acknowledgement that vape products can help adult smokers to quit cigarettes, they were disappointed that the order pertained to an outdated device with few users. Furthermore, while authorizing two Vuse tobacco-flavored e-liquid pods, the agency issued 10 MDOs for Vuse Solo nontobacco-flavored pods, claiming that Reynolds failed to demonstrate they were appropriate for the protection of public health.

    The agency is still evaluating Reynolds’ application for menthol-flavored products under the Vuse Solo brand. Menthol is another bone of contention: In late April, the FDA announced that it would initiate a notice and comment rule-making process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year. Vape manufacturers are hence unsure of whether their mentholated products will remain on the market.

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    Sloppy Assessment

    In its denial of providing marketing authorization to nontobacco-flavored e-liquids, the FDA referred to the most recent National Youth Tobacco Survey (NYTS), arguing the study had shown that among the estimated 2 million middle school and high school students that were using e-cigarettes in 2021, more than eight in 10 were using nontobacco-flavored vape products. It did not mention that, according to the same study, the use of e-cigarette among youths has more than halved over the past two years, from 27.5 percent in 2019 to 11.3 percent currently.

    Critics have accused the FDA of being “obsessed with youth vaping rates and flavors.” The online publication Filter revealed that, in order to cope with the unprecedented flood of PMTA submissions before the court-ordered deadline, the FDA relied on a database query to identify the top-12 manufacturers with the largest number of pending PMTAs for nontobacco-flavored e-liquid products not in the third of three FDA review phases.

    This approach allowed the agency to filter out 85 percent of all pending PMTA applications. It then introduced, apparently for the first time, a “fatal flaw” standard. The fatal flaw review is a simple review in which the reviewer examines the submission to identify whether or not it contains the necessary type of studies. “The fatal flaw review will be limited to determining presence or absence of such studies; it will not evaluate the merits of the studies,” according to an FDA Center for Tobacco Products Office of Science memorandum cited by Filter.

    With its attempt at speeding up matters, the agency has done itself no favors, say critics. The road to regulatory certainty in the U.S. vape market will likely become even longer. “At this point,” Sweanor suggests, “the solution could be to announce reasonable product standards aimed squarely at reducing harms—as is done with foods—rather than treat each subcategory of each product as if totally independent of other products.”

    Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.
  • FDA Rebuked Over Slow Progress Menthol Ban

    FDA Rebuked Over Slow Progress Menthol Ban

    Photo: New Africa

    On Nov. 17, Magistrate Judge Kandis A. Westmore of the United States District Court in the Northern District of California issued a ruling putting the Food and Drug Administration on notice that further delay in issuing a proposed rule on ending the sale of menthol-flavored cigarettes could be constructed as “undue delay” under the Administrative Procedure Act.

    In April 2021, the FDA announced that it would begin the rulemaking process in response to a citizen’s petition filed in 2013. The announcement followed a lawsuit filed by the African American Tobacco Control Leadership Council (AATCLC), Action of Smoking and Health, the American Medical Association, and the National Medical Association. Filed on June 17, 2020, the lawsuit asserted that the FDA had failed to act on menthol cigarettes contrary to the duties and mandate imposed by the 2009 Family Smoking Prevention and Tobacco Control Act.

    “We applaud District Court Judge Westmore for keeping the FDA’s feet to the fire,” explained AATCLC Co-Chair Phillip Gardiner. “The Black community has been waiting far too long for the FDA to act and protect the health of our people. Ending the sale of menthol cigarettes will be one of the most impactful steps this country can take to save African American lives and advance health equity.”

    “We’re very pleased that Judge Westmore agreed that the FDA’s April 29 announcement is a beginning, not an end, for complying with the lawsuit,” said Laurent Huber, executive director of Action on Smoking and Health. “Unfortunately, when it comes to tobacco the FDA has rarely met a deadline, even a self-imposed one. Every delay costs lives.”

    Each year, more than 72,000 African Americans are diagnosed with a tobacco-related illness and more than 45,000 die from a tobacco-induced disease, according to the AATCLT. Eighty-five percent of all African American smokers smoke menthol cigarettes compared to 29 percent of White smokers. Menthol cigarettes increase addiction and make it harder to quit. More than 70 percent of African American smokers want to quit, and more than 60 percent made a quit attempt in the previous year. However, African American smokers are less likely than White smokers to successfully quit smoking.

  • ‘African Americans Bear Brunt of Menthol’

    ‘African Americans Bear Brunt of Menthol’

    Photo: New Africa

    African Americans represent 12 percent of the U.S. population but carried 41 percent of all menthol smoking-related premature deaths in the United States between 1980 and 2018, according to a new study researchers believe is the first to quantify the impact menthol cigarettes have had in Black communities across the country.

    “It is well known that tobacco companies, in the 1960s and 1970s, targeted menthol cigarettes to African American communities, and menthol cigarettes became ubiquitous in those communities,” said David Mendez, lead author of the study and an associate professor in the Department of Health Management and Policy at the University of Michigan School of Public Health.

    Menthol cigarettes were responsible for 1.5 million new smokers, 157,000 smoking-related premature deaths and 1.5 million life-years lost among African Americans between 1980 and 2018, according to the study. Relative to the general population, these figures represent, respectively, 15 percent, 41 percent and 50 percent of the total damage caused by menthol cigarettes during that period, despite African Americans constituting only 12 percent of the total U.S. population.

    For their analysis, published in Tobacco Control, researchers utilized a simulation model they had developed for a population-wide study published earlier this year. They also used data from the National Health Interview Survey to feed the model with information specific to the African American community.

    “Half of the life-years lost during this period due to menthol smoking occurred among African Americans, and our study results are likely to be conservative,” said study co-author Thuy Le. “Menthol cigarettes are an important contributor to health disparities in this country, and removing menthol cigarettes from the market will save thousands of lives, particularly among African Americans.”

  • Sales of Flavored Tobacco Products Spike in Korea

    Sales of Flavored Tobacco Products Spike in Korea

    Photo: Borgwaldt Flavor

    Sales of flavored tobacco products have increased significantly in South Korea, reports The Korea Bizwire, citing data from the Ministry of Economy and Finance.

    While overall domestic sales of tobacco products declined to 3.59 billion packs last year from 4.4 billion packs in 2011, sales of flavored tobacco products more than quintupled from 260 million packs to 1.38 billion packs during the same period.

    Accordingly, the share of flavored tobacco products among overall tobacco sales has risen to 40.3 percent in June 2021 from 38.5 percent last year and 5.8 percent in 2011.

    Among flavored tobacco products, sales of capsule-type cigarettes shot up to 1.09 billion packs last year, more than 15 times higher than the 70 million packs sold in 2011, with their share among overall tobacco sales rising to 32.4 percent in June 2021 from 1.7 percent in 2011.

    Sales of e-cigarettes also jumped from 80 million packs in 2017 to 380 million packs last year, with sales of flavored e-cigarettes surging from 50 million packs to 310 million packs.

  • EU Asked to Scrutinize Lithuania’s Flavor Ban

    EU Asked to Scrutinize Lithuania’s Flavor Ban

    Photo: sharafmaksumov

    The Independent European Vape Alliance (IEVA) has called on the European Commission to scrutinize Lithuania’s plan to ban all vapor flavors except tobacco.

    Lithuanian lawmakers want to amend the country’s tobacco control laws to reduce the attractiveness and demand for e-cigarettes. The legislators say they are worried about the growing popularity of vaping, especially among young consumers.

    The IEVA is particularly concerned by Article 1 of the draft law, which calls for a ban on sales of e-cigarettes and refill containers filled with liquids (both nicotine-containing and nicotine-free) containing flavors other than tobacco.

    The IEVA believes the proposed legislation is disproportionate to the objective. In a press note, the group said that, in drafting policies, EU member states should choose the means that least restrict the movement of goods. It noted that Lithuania already has a licensing law that regulates the market and prevents underage consumers from buying vapor products.

    The IEVA predicted that the law would eliminate more than 10,000 jobs and reduce tax revenues. It also warned that the ban would boost illicit sales.

    The IEVA’s full submission to the European Commission is available here.