Category: Flavors

  • Governor to Veto ‘No Flavor Bans’ Bill

    Governor to Veto ‘No Flavor Bans’ Bill

    Image: Dmitry | Adobe Stock

    Ohio Governor Mike DeWine appears primed to veto a bill just passed by the state legislature that would prohibit cities like Columbus from regulating vaping and other tobacco products.

    DeWine told ABC 6 On Your Side he supports the Columbus ordinance passed Monday banning the sale of flavored vaping and other tobacco products.

    “Making a decision not to have flavored cigarettes is a logical decision that will save many, many lives and will save taxpayers a lot of money,” DeWine said. “Smoking costs the citizens of Ohio hundreds and hundreds of millions of dollars every single year.”

    The day after the Columbus tobacco ban passed, Republicans who control the legislature added a proposal to an unrelated bill mandating that only the state can regulate tobacco products in Ohio. The bill would wipe out attempts by local governments, such as that in Columbus, to rein in the use of tobacco products.

  • Ohio Passes Ban on Cities’ Flavor Bans

    Ohio Passes Ban on Cities’ Flavor Bans

    Image: Tobacco Reporter archive

    The Columbus City Council in the U.S. state of Ohio voted unanimously in favor of banning the sale of flavored tobacco and vaping products within city limits on Monday, Dec. 12. On Wednesday, the Ohio Senate approved a bill that would make what the Columbus City Council did illegal.

    The Ohio Senate passed H.B. 513 by a vote of 23-8. It includes an amendment that will prohibit local governments in Ohio from enacting any laws regarding tobacco or vaping products that are stricter than state law, a mechanism known as preemption, according to Halfwheel.

    Because of this amendment, the bill now heads back to the Ohio House of Representatives, where it must be approved before heading to the desk of Governor Mike DeWine. Reports indicate that the House vote is expected this week.

    If approved, the state law will effectively void the law passed by the Columbus City Council on Monday. The Columbus city law is set to take effect on Jan. 1, 2024.

    Preemption clauses have been a successful tool in blocking bans on the sales of flavored vaping products and other tobacco products. The city of Philadelphia lost a federal lawsuit that overturned its flavored tobacco ban due to Pennsylvania’s preemption clause.

  • Top Court Clears Way for California Flavor Ban

    Top Court Clears Way for California Flavor Ban

    Photo: Oleksii

    The U.S. Supreme Court on Dec. 12 refused to block California’s ban on flavored tobacco, clearing the way for the law to take effect next week, reports The New York Times. Consistent with its practice when ruling on emergency applications, the court gave no reason for its decision.

    Originally passed by lawmakers in 2020, California’s flavor ban was put on hold after opponents gathered enough signatures to force a referendum on the measure.

    After Californians voted to uphold the law on Nov. 8, tobacco companies challenged it in court, arguing that only the federal government can ban tobacco flavors, as the Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug Administration authority to regulate tobacco.

    State officials responded that the federal law was meant to preserve the longstanding power of state and local authorities to regulate tobacco products and to ban their sale.

    The tobacco companies also argued that they would suffer “irreparable harm” from being shut out of one of the country’s largest markets. Small retailers, they argued, would potentially have to lay off employees and close. The plaintiffs further noted that menthol cigarettes make up about a third of the cigarette market and are disproportionally smoked by people of color, suggesting that that group would suffer disproportionally from a flavor ban.

    In their Supreme Court brief, state officials urged the justices not to delay the law any longer. “The unsuccessful referendum campaign has already delayed the implementation” of the law for nearly two years, they wrote, “allowing children and teenagers across the state to be initiated into the deadly habit of tobacco use via flavored tobacco products throughout that period.”

    Previously, the 9th Circuit Court of Appeals denied the tobacco companies’ request to block the law pending appeal.

    Industry critics welcomed the Supreme Court ruling. “The tobacco companies’ battle against the California law shows once again that they haven’t changed and are lying when they claim to care about anything other than their bottom line,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement.

    The California flavor ban applies to flavored e-cigarettes, menthol cigarettes and flavored cigars but exempts loose-leaf tobacco, premium cigars and shisha tobacco.

    The state joins Massachusetts and the District of Columbia in ending the sale of flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars. Three other states—New Jersey, New York and Rhode Island—prohibit the sale of flavored e-cigarettes. With local laws included, 25 percent of the U.S. population will now be covered by laws ending the sale of flavored e-cigarettes.

  • Netherlands Flavor Ban Effective Next Year

    Netherlands Flavor Ban Effective Next Year

    Image: and.one | Adobe Stock

    The Netherlands will ban all e-cigarette flavors except tobacco effective Oct. 1, 2023, reports NL Times, citing a government amendment to the Staatscourant. The ban extends to pre-filled e-cigarettes and disposable vapes as well.

    The ban was announced in 2020, and will also include banning packaging that depicts anything other than tobacco and restricting rules for naming products.

    The RIVM, a public health institute, created a list of 16 ingredients that manufacturers can use to make tobacco flavors.

  • Flavor Ban Didn’t Stop Vapers

    Flavor Ban Didn’t Stop Vapers

    Image: eldarnurkovic | Adobe Stock

    The U.S. Food and Drug Administration ban on flavored tobacco products, except for menthol and tobacco flavors, did not stop consumers from vaping, reports EurekAlert!, citing a study published in Tobacco Control.

    The study showed that less than 5 percent of the 3,500 adult e-cigarette users surveyed quit using e-cigarettes in response to the ban. The remaining respondents switched to other forms of tobacco products or flavors of e-cigarettes that are not covered by the ban. 

    “An increasing body of literature shows that e-cig flavors themselves cause damage when inhaled, so it makes sense to ban flavors,” said Deborah J. Ossip, a tobacco research expert and professor in the Department of Public Health Sciences and Center for Community Health and Prevention at the University of Rochester Medical Center (URMC) who co-authored the study. “But the ban doesn’t appear to be working. People—including youth—can still get flavored products and are still using them.”

    Lead study author Dongmei Li, associate professor of clinical and translational research, obstetrics and gynecology and public health sciences at URMC, stated that a big issue is that the ban did not cover products such as disposable e-cigarettes and e-cigarettes that use tanks rather than cartridges or pods.

    “Other forms of flavored e-cigs, especially disposable e-cigs, have become very popular after the FDA policy,” Li said. “The FDA policy also did not ban menthol[-flavored] or tobacco-flavored products—and our study shows many people switched to menthol-flavored e-cigs after the ban. It seems many people find menthol to be a nice flavor.”

    Of the survey respondents, nearly 30 percent switched to tank or disposable flavored e-cigarettes and another 30 percent switched to menthol-flavored or tobacco-flavored pods; 14 percent switched to combustible products, like cigarettes, and 5 percent switched to smokeless tobacco. Less than 5 percent quit using e-cigarettes following the ban.

  • A Taste of Things to Come?

    A Taste of Things to Come?

    Nveed Chaudhary | Photo Courtesy of the Broughton Group

    What the recent marketing denial order for Logic’s menthol vapes implies for flavored e-cigarettes

    By Stefanie Rossel

    On Oct. 26, the U.S. Food and Drug Administration wrote a new chapter in the story of electronic nicotine-delivery systems (ENDS) regulation. That day, the agency for the first time rejected a premarket tobacco product application (PMTA) for a menthol e-cigarette. Logic Technology Development received marketing denial orders (MDOs) for its Logic Power Menthol E-Liquid Package and its Logic Pro Menthol E-Liquid Package.

    In a press release accompanying its decision, the FDA said the rejection was based on a full scientific review. The applications, the FDA argued, “lacked sufficient evidence to demonstrate that permitting the marketing of the products would be appropriate for the protection of the public health.” The evidence provided within the application, it said, did not demonstrate that these menthol-flavored e-cigarettes were more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.

    In its statement, the agency also referred to the 2022 National Youth Tobacco Survey (NYTS), which had been released shortly before the Logic MDO. “For nontobacco-flavored e-cigarettes, including menthol-flavored e-cigarettes, existing evidence demonstrates a known and substantial risk with regard to youth appeal, uptake and use,” the FDA wrote.

    Tobacco harm reduction advocates were dismayed. The MDO shattered their hopes that mentholated vapor products would be allowed to remain on the market as a less risky alternative to mentholated cigarettes, which the FDA wants to prohibit. They were also surprised given that the FDA in late 2021 authorized 22nd Century Group to market its reduced-nicotine VLN Menthol King brand as a modified-risk tobacco product.

    According to data by the Centers for Disease Control and Prevention, menthol-flavored products accounted for 37 percent of all cigarette sales in the U.S. in 2019 and 2020.

    Misplaced Priorities

    Critics also lambasted the agency’s focus on the risk of youth uptake at the expense of the opportunity to move adult smokers to lower risk products. Christopher Russell, director at Russell Burnett Research and Consultancy, made up a quick calculation based on recent NYTS data. Of the 2.55 million U.S. students who had used an e-cigarette in the past 30 days according to the survey, 84.9 percent had used flavored vapes. Of the current flavor vapers, 26.6 percent consumed menthol ENDS, which corresponded to 2.12 percent of U.S. youth having vaped menthol in the past 30 days. “MDOs for menthol e-cigarettes,” he concluded, “equals banning menthol to 100 percent of adults in order to protect under 3 percent of youth.”

    Neil McKeganey, co-director of the Centre for Substance Use Research, went a step further, quoting a Scottish study carried out by his institution that looked at ENDS use among representative samples of U.S. youth and adults in 2021 and 2022. Out of the 1,215 youth aged 13 to 17 surveyed in 2022, he said, 0.2 percent had ever used a Logic Power and 0.5 percent had ever used a Logic Pro.

    When the Scottish researchers looked at youth e-cigarette use over the last 30 days, the levels of Logic use shrank to 0.1 percent of youth reporting having used the Logic Power during that period whereas the level of Logic Pro use was so low that it was not even recorded.

    “In dispatching the MDOs for these two products,” he stated, “the FDA seems to have set aside a commitment to review the data around individual devices and liquids and to formulate a response in terms of the brand of products being used and justify the denial orders issued by reference to the NYTS data.”

    Jim McDonald of Vaping360 predicted a rise in illicit trade if the FDA blocks the legal path to market for menthol vape products. The FDA, he said, ignored the fact that most youth vapers use unauthorized gray market flavored disposable vapes, many of which are menthol flavored. “They will continue using these products, too, while the FDA pursues its goal of eliminating legal vaping, locked into the belief that its ‘authority’ has some effect on the market,” wrote McDonald.

    In March, the FDA authorized Logic devices with tobacco-flavored refills. To date, the agency has not approved a single vapor product with nontobacco flavors.

    Shortly after receiving its MDO, Logic Technology Development secured a stay of the FDA order in court, allowing retailers and wholesalers to continue selling Logic menthol products for the duration of the stay. Even if the court requires the FDA to reevaluate the evidence, this does not guarantee a more favorable outcome for Logic and the future of menthol vape in the United States.

    Understanding the FDA’s Requirements

    Despite Logic Technology Development’s travails, Nveed Chaudhary, chief scientific and regulatory officer at Broughton Group, is confident the recent MDOs do not mark the beginning of the end for menthol and other nontobacco-flavored e-liquids in the U.S.

    While he agrees with McKeganey that the FDA’s positions are being driven in large part by the data from cross-sectional studies like the NYTS, Chaudhary believes the fundamental issue is how the PMTA studies were designed, how the data has been interpreted and how the arguments have been presented to the FDA. “Based on the original PMTA guidance and then the Final Rule, many, if not all, of the applications for menthol and nontobacco-flavored products were considered to be ‘equal,’” he says. According to Chaudhary, the relative benefits of all the ENDS flavors together were compared with the risks of smoking combustible cigarettes. The youth access measures introduced were the same across all flavors of a given platform.

    “What has become very clear from the FDA’s recent communications, especially through the MDOs, is that they do not consider all flavors of ENDS to have the same risk profile—in this case, the risk of promoting on-ramping amongst youth,” says Chaudhary.

    “Therefore, the expectation from the FDA has evolved. Given the data from studies such as NYTS, the FDA are now saying that the PMTA applications need to demonstrate that there is additional benefit of the menthol over tobacco flavors for current smokers—essentially that the additional benefit outweighs the continued risk of youth finding menthol more attractive. Over time, as the industry presents this data to FDA and FDA begin to approve menthol-flavored products, I can imagine a situation where the same would apply to other nontobacco and nonmenthol flavors—only that, for these flavors, an additional benefit for smokers compared with menthol that outweighs the risk on youth use would be required.”

    Remediating Deficiencies

    Chaudhary believes that “with the addition of a few relatively inexpensive studies and an overhaul of the dossier to build the arguments that FDA want to see,” Logic Technology Development should be able to convince the agency of the additional benefits of nontobacco flavors.

    Attempts at rectification, however, may prove futile. In January 2020, the FDA banned all flavors except tobacco and menthol in cartridge-based e-cigarettes. In September 2020, the agency signaled that it would not authorize flavored products without extraordinary evidence. With Logic Technologies Development being part of Japan Tobacco International, one of the world’s leading players, it may furthermore be assumed that the company submitted a very comprehensive application.

    While acknowledging that many of the applicants are large multinationals with the financial power to conduct large complex studies, Chaudhary says this does not mean that the studies that the FDA is now looking for were in fact conducted. “It all goes back to the industry’s understanding of the PMTA guidance and final rule back in September 2020 and the way in which the FDA have chosen to enforce the rule today,” he says. “The ongoing view of FDA is that that NYTS illustrates a preference for menthol flavors amongst youth. Therefore, since the original studies were designed to compare all flavors of ENDS to combustible cigarettes; they are not geared to demonstrate additional benefit of menthol flavors compared with tobacco flavors. I would say for any new applications, that has to be a central question to which the application must provide answers.”

    Chaudhary deems it likely that much of the data required to build these arguments already exists in the comprehensive PMTA applications—perhaps with some gaps that could be potentially filled with relatively inexpensive studies. He expects the FDA to apply the same logic to flavored disposable products, which are exempt from the agency’s 2020 flavor ban and have recently experienced a surge in sales. “I would imagine that unless any company has constructed their PMTAs to show the additional benefit of flavors compared to menthol and menthol compared with tobacco flavor, they will also receive MDOs,” says Chaudhary.

    “I think we all agree that this is awful news for U.S. smokers who will be denied the wide range of options that they need to stop smoking,” he continues. “It seems that the only way to re-offer smokers these critical choices is to ensure that we as an industry are responsible. We must ensure that we understand the evidence the FDA want to receive and provide this data to them so that menthol and ultimately other flavors can be authorized back into the marketplace, and all smokers can continue their off-ramping journeys.”

    Chaudhary says the industry needs to move forward, put aside grievances that have arisen as a result of how the FDA has enforced the PMTA final rule and provide the agency with the data it wants to see to ensure that smokers can have these products in their hands at the earliest opportunity.

    “Any integrated technology that can minimize or even eliminate underage use of e-cigarettes would lower the risk of youth use and therefore lower the bar for the additional benefit data that the FDA are now asking for,” he says.

  • Supreme Court Asked to Stop California Ban

    Supreme Court Asked to Stop California Ban

    Photo: kuosumo

    Tobacco companies have asked the U.S. Supreme Court to stop California from enforcing a ban on flavored tobacco products set to go into effect on Dec. 21, reports CBS News Bay Area.

    On Nov. 8, Californians voted to uphold a state law ending the sale of most flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    Originally passed by lawmakers in 2020, the measure was put on hold after opponents gathered enough signatures to force a referendum on the ban.

    Following the Nov. 8 ballot, tobacco companies challenged the law in court, arguing that only the federal government can ban tobacco flavors, as the Family Smoking Prevention and Tobacco Control Act gives the U.S. Food and Drug Administration authority to regulate tobacco.

    The Supreme Court filing states that the companies would suffer “irreparable harm” from being shut out of one of the country’s largest markets. Small retailers, they argued, would potentially have to lay off employees and close.

    Previously the Ninth Circuit Court of Appeals denied the tobacco companies’ request to block the law pending appeal.

  • Vapor Group Files Amicus Brief

    Vapor Group Files Amicus Brief

    Photo: David

    The Vapor Technology Association (VTA) has filed an amicus brief with the U.S. Supreme Court in support of a petition for writ of certiorari in a case against L.A. County’s ordinance banning flavored tobacco products.

    Citing the substantial impact on America’s economy created by the sale of tobacco products, the trade group says Supreme Court review of the flavor ban is critical.

    According to an economic impact report prepared by John Dunham and Associates, the independent vapor industry comprises more than 10,000 companies across the United States and is responsible for generating more than 130,000 jobs and more than $22 billion in economic activity for the U.S. economy.

    In its amicus brief, the VTA argues that this industry would be devastated by unrestricted flavor bans given its unique and substantial reliance on the sale of flavored vapor products to adult consumers.

    The trade group also notes that since the passage of the L.A. County Ordinance, leading tobacco control scientists have challenged the notion of banning e-cigarette flavors and have warned that decreasing availability of flavored vaping products harms the ability of adult smokers to quit smoking cigarettes.

    Instead of blanket bans, these tobacco control scientists endorse alternative time, place and manner restrictions for the sale of flavored vaping products, the VTA notes in its amicus brief.

    Permitting local and state governments to implement unscientific bans that directly interfere with the fundamental purpose of the Tobacco Control Act and would overrule the Food and Drug Administration’s decision-making for products deemed appropriate for the protection of public health is not only unlawful but is dangerous from a public health perspective, the VTA wrote.

    Tobacco and vape flavor bans have gained momentum in the U.S. On Nov. 8, Californians voted to uphold a state law ending the sale of most flavored tobacco products.

  • California Sued Following Flavor Poll

    California Sued Following Flavor Poll

    Photo: niroworld

    Tobacco companies filed a lawsuit against California in federal court over the state’s ban on flavored tobacco one day after voters backed the ban in a Nov. 8 referendum, reports the Courthouse News Service.  

    Though more than half the state’s ballots have yet to be counted, media outlets have declared that the referendum will pass. Unless a judge agrees to intervene, the ban is set to go into effect no later than Dec. 21, 2022.

    In their suit, the tobacco companies argue that the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 allows states and municipalities to regulate tobacco products but not to ban their use or sale.

    “The ban falls under the TCA’s express preemption clause, which preempts ‘any [state] requirement’ that is ‘different from, or in addition to,’  a federal requirement about a tobacco product standard,” the suit reads. “A flavor ban is a paradigmatic tobacco product standard.”

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Tobacco companies already sued California over the flavor ban in 2021. But a federal judge dismissed the case, telling the plaintiffs to wait for the voters to weigh in before suing.

  • Californians Uphold Flavored Tobacco Ban

    Californians Uphold Flavored Tobacco Ban

    Photo: PX Media

    Californians voted to uphold a state law ending the sale of most flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars.

    Proposition 31, the ballot referendum to uphold the law, was ahead by a margin of 65 percent to 35 percent on Nov. 9. The Associated Press called the race, though official results will take longer to finalize. The state mailed ballots to all active voters. Ballots postmarked by election day have a week to arrive.

    In 2020, California lawmakers passed a ban on all flavored nicotine products except hookah, loose leaf tobacco (for pipes) and premium cigars. Menthol products are also covered by the legislation.

    Opponents of the ban collected more than 1 million signatures and forced the state to hold a referendum on the ban. Originally scheduled to take effect Jan. 1, 2021, the legislation was then suspended until the Nov. 8 vote.

    Advocates for Proposition 31 argued the restrictions would deter tobacco use among kids by eliminating youth-friendly flavors, such as bubblegum, cotton candy and cherry.

    Opponents said the ban would remove flavored electronic nicotine-delivery systems as an effective tool to quit traditional cigarettes and that some communities were unfairly targeted by the law. Black smokers, for example, are more likely to use menthol cigarettes.

    Supporters of the ban outspent opponents by a significant margin in the runup to the ballot. By mid-October, the billionaire anti-smoking and anti-vaping activist Michael Bloomberg had provided $15.3 million of the $17.3 million raised by the committee in favor of the ban, according to the San Francisco Chronicle. By contrast, the opposition had raised just over $2 million, almost entirely comprised of donations from Philip Morris USA ($1.2 million) and R.J. Reynolds ($743,000).

    California joins Massachusetts and the District of Columbia in ending the sale of flavored tobacco products, including flavored e-cigarettes, menthol cigarettes and flavored cigars. Three other states—New Jersey, New York and Rhode Island—prohibit the sale of flavored e-cigarettes. With local laws included, 25 percent of the U.S. population will now be covered by laws ending the sale of flavored e-cigarettes.