Tag: menthol

  • U.S. FDA Publishes Proposed Ban on Menthol as a Flavor

    U.S. FDA Publishes Proposed Ban on Menthol as a Flavor

    By Timothy S. Donahue

    The ban on menthol cigarettes is closer to becoming a reality. After years of discussion, the U.S. Food and Drug Administration has instituted a proposed rule to place a ban on menthol combustible cigarettes and flavored cigars. Whether the menthol ban will also cover next-generation tobacco products, such as e-cigarettes, has not yet been clarified.

    “The authority to adopt tobacco product standards is one of the most powerful tools Congress gave the FDA and the actions we are proposing can help significantly reduce youth initiation and increase the chances that current smokers quit. It is clear that these efforts will help save lives,” said FDA Commissioner Robert M. Califf, M.D. “Through the rulemaking process, there’s an important opportunity for the public to make their voices heard and help shape the FDA’s ongoing efforts to improve public health.”

    When finalized, the FDA states that the proposed menthol product standard will:

    • reduce the appeal of cigarettes, particularly to youth and young adults, decreasing the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking; and
    • improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation. 

    The FDA states that the proposed product standards are based on clear science and evidence establishing the addictiveness and harm of the products. Many organizations were quick to condemn the regulatory agency for proposing the rule that is opposed by all major law enforcement, civil rights and criminal justice reform organizations. Opponents of the menthol ban say that evidence clearly shows that banning menthol products will do nothing to reduce combustible cigarette smoking rates but will lead to an increase in people purchasing products on the black market.

    Credit: FDA

    “This misguided proposal will have disastrous impacts on public health and public safety. It will do nothing to reduce smoking rates and instead make the United States less safe.” said Tim Andrews, director of Consumer Issues for Americans for Tax Reform (ATR). “It is unfortunate that as violent crime rates rise across the country, the FDA chooses to divert valuable police resources to pursue an unnecessary ban on menthol products.”

    Andrews argues that a menthol ban exposes “vulnerable members of minority communities to conflict with law enforcement, and their purchases could also fund sophisticated international criminal syndicates.” According to the U.S. Department of State, illicit tobacco’s links to funding terrorist organizations already present a “serious threat” to national security. “This policy would worsen the problem while also depriving state governments of excise revenue, putting state government programs at risk,” says Andrews.

    Richard Marianos, a senior law enforcement consultant who has served more than 27 years at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and who is now a consultant and adjunct lecturer at Georgetown University, says that in many foreign markets, such as Asia, companies are creating products to make mentholated cigarettes, because those types of products are not covered by the rule.

    “They are flavor packets you just slide into a pack of cigarettes. You buy your cigarettes, you put that in there and by the time you get home, the whole pack is mentholated. They also have these – it’s like a little Tic Tac box with a round, small, little mint … but what it does is you put it into the filter, shake, crush and now it’s a menthol cigarette,” said Marianos. “Are we eventually going to be asking border protection to now start looking for minty flavor packets or Tic Tac boxes when they have to concentrate on biological and nuclear threats? When you overlook public safety surrounding this matter, you’re creating an unhealthy situation, not just for smokers, but anybody who’s out there.”

    Marianos says that a menthol ban will create a greater level of diversion and criminal activity with high-value targets overseas, it’ll bring more organized crime into the United States. It’ll also create a greater market for border countries to begin manufacturing menthol and bring it into the United States.

    “There was one investigation in particular, I remember, where the individual said on a wire that once they banned menthol cigarettes in the United States, you can pave the roads in gold because of the boost in sales of black market and DIY menthol cigarettes,” he said. “Prohibition doesn’t work. Your quality of police work goes down; they can’t concentrate on violent crime as much and it creates a greater wedge between themselves and the community.”

    Guy Bentley

    Guy Bentley, director of Consumer Freedom Research for the Reason Foundation, said that similar bans have had minimal effects on tobacco consumption in other countries such as Canada and the U.K., adding that a menthol ban is likely to lead to more policing in minority communities, more incarceration, boost black market sales and undermine criminal justice reforms in the U.S.

    In an email to Vapor Voice, Bentley explained that a recent study funded by the Norwegian Cancer Society in partnership with the Polish Health Ministry found that in Poland – the EU state with the largest pre-ban menthol share – found “mixed evidence” that the ban is working as intended.

    Bentley argues the FDA and Biden administration should apply a harm reduction model, educating the public about safer alternatives to conventional cigarettes and the latest smoking cessation options. Andrews concurs with Bentley, adding that the proposed rulemaking will inevitably lead to further growth of illicit markets, put members of minority communities in danger and divert law enforcement resources away from real crime.

    “It ignores best practice expert recommendations on how to reduce smoking rates through proven harm reduction technologies, is a disaster for public health, and will make all Americans less safe,” Andrews said. “If the Biden Administration truly cared about the American people, they would junk this anti-science and genuinely harmful proposal immediately.”

    Beginning May 4, 2022, the public can provide comments on these proposed rules, which the FDA will review as it considers future action. The agency also will convene public listening sessions on June 13 and June 15 to expand direct engagement with the public, including affected communities.

    The public will have the opportunity to submit either electronic or written comments directly to the dockets on the proposed rules through July 5, 2022. Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards. 

    The FDA also states that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. If the proposed rules are finalized and implemented, FDA enforcement will only address manufacturers, distributors, wholesalers, importers and retailers who violate the rules.

  • FDA Submits Menthol Ban to White House for Review

    FDA Submits Menthol Ban to White House for Review

    Credit: New Africa

    The U.S. Food and Drug Administration is a step closer to a complete ban on menthol-flavored cigarettes and cigars.

    The ban is not expected to impact vaping products, although many experts predict a menthol combustible ban could possibly transition some menthol smokers to e-cigarettes. It is predicted to be similar to what happened in the U.K. when it banned menthol cigarettes in 2020.

    Thursday the agency submitted its proposal to the White House’s Office of Management and Budget, according to news reports.

    In 2020, the regulatory agency enacted a “flavor ban” on e-cigarettes because they targeted middle and high school students. Now, public health officials argue banning menthol, the last allowable flavor in cigarettes, will save lives.

    In its proposal, the FDA provides evidence that menthol tobacco products are heavily marketed to racial minorities. The U.S Centers for Disease Control and Prevention reports more than 85-percent of menthol smokers are black, taking a disproportionate toll on their health.

    FDA officials say the proposed menthol ban will still need to be opened to public comment before a final review.

  • FDA Not Expected to Include ENDS in Menthol Ban

    FDA Not Expected to Include ENDS in Menthol Ban

    Photo: makcoud

    The U.S. Food and Drug Administration is unlikely to incorporate electronic nicotine-delivery devices (ENDS) into its proposed rulemaking to ban menthol cigarettes and flavored cigars, according to Azim Chowdhury and Neelam Gill.

    Azim Chowdhury

    Writing on the Food and Drug Law Institute’s website, the Keller and Heckman attorneys say that doing so would only further complicate a rulemaking that is already poised to receive hundreds of thousands of comments and will likely be litigated once final.

    On April 29, 2021, the FDA announced that it will initiate a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos within the next year.

    In its announcement, the FDA did not mention ENDs, which come in a wide variety of nontobacco flavors and have been the subject of much debate.

    Chowdhury and Gill believe Congress is more likely to defer to the premarket tobacco product application (PMTA) process rather than intervene and legislate a flavored ENDS ban. All ENDS products require FDA marketing authorization through that process.

    But while a federal ban on flavored ENDS seems unlikely while FDA reviews the science and the manufacturers’ arguments, these products continue to face the threat of prohibition at the local level, according to the attorneys.

    Many state and local authorities and attorneys general are pushing for bans or have requested the FDA to deny PMTAs for flavored ENDS. New York, New Jersey, Rhode Island and Massachusetts have already banned the sale of flavored ENDS while Maryland, California and Connecticut are considering similar measures.

  • Demand for Menthol Liquid up After Menthol Cigarette Ban

    Demand for Menthol Liquid up After Menthol Cigarette Ban

    Photo: Max

    A year to the day since menthol cigarettes were banned in the U.K. more than two thirds of vapor retailers are reporting a rise in sales of menthol flavored e-liquids according to a study by the U.K. Vaping Industry Association (UKVIA).

    The ban last year, which also prevented menthol filters, papers and skinny cigarettes from being produced or sold in the U.K., followed a four-year phasing-out period which saw smaller packs of rolling tobacco and 10 packs of cigarette banned in 2017.

    The study revealed that more than 70 percent of owners of bricks and mortar stores and online retail operations said they had seen an uptake in demand for menthol vape products.

    And, while fruit e-liquids remained the customer favorite, menthol was the second most popular flavor according to the survey.

    “What we have witnessed in the U.K. is that menthol as an ingredient in vape e-liquids has continued to increase following the combustible menthol ban and is now one of the most important components of all e-liquids,” said Tim Phillips, independent analyst at ECigIntelligence.

    Menthol as an ingredient in vape e-liquids has continued to increase following the combustible menthol ban and is now one of the most important components of all e-liquids.

    Tim Phillips, analyst, ECigIntelligence

    UKVIA Director-General John Dunne said the survey results were a clear indication of the importance e-cigarettes have in helping smokers to quit their habits in favor of vaping which Public Health England acknowledges is far less harmful than combustible tobacco.

    “Our survey of retailers clearly shows that, as menthol cigarettes were removed from sale, vape stores witnessed an increase in sales of the same flavor in e-liquid form,” he said.

     “It is not unreasonable to surmise that the majority of menthol e-liquid sales above retailers’ baseline pre-ban were to those who would have previously smoked cigarettes.”

  • FDA ‘Intends’ to Ban Menthol Cigarettes, Excludes E-Liquids

    FDA ‘Intends’ to Ban Menthol Cigarettes, Excludes E-Liquids

    Photo: esser

    The U.S. Food and Drug Administration has stated its intent to ban menthol as a characterizing flavor in cigarettes and all characterizing flavors (including menthol) in cigars. In a statement released today, the agency said it is working toward issuing proposed product standards within the next year. The plan does not include noncombustible products, such as e-cigarettes.

    “This decision is based on clear science and evidence establishing the addictiveness and harm of these products and builds on important previous actions that banned other flavored cigarettes in 2009,” the FDA wrote in its press release.

    “Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said acting FDA Commissioner Janet Woodcock.

    “With these actions, the FDA will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers and address health disparities experienced by communities of color, low-income populations and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.”

    According to the FDA, there is strong evidence that a menthol ban will help people quit. “Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults,” the agency stated. “Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using. Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine.”

    One study cited by the FDA suggests that banning menthol cigarettes in the U.S. would lead an additional 923,000 smokers to quit, including 230,000 Black Americans in the first 13 to 17 months after a ban goes into effect. An earlier study projected that about 633,000 deaths would be averted, including about 237,000 deaths of Black Americans.

    These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm.

    Mitch Zeller, Director, CTP

    “For far too long, certain populations, including African Americans, have been targeted and disproportionately impacted by tobacco use. Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

    “These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities and promote health equity by addressing a significant and disparate source of harm. Taken together, these policies will help save lives and improve the public health of our country as we confront the leading cause of preventable disease and death.”

    The FDA stressed that, if implemented, enforcement of any ban on menthol cigarettes and all flavored cigars will address only manufacturers, distributors, wholesalers, importers and retailers. “The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product,” the agency stated.

    Racial justice groups have expressed concern that by outlawing menthols, the FDA would set the stage for more negative interactions between law enforcement and people of color, who smoke a disproportionate share of menthol cigarettes.

    Earlier this week, the National Newspaper Publishers Association (NNPA), representing more than 200 African American-owned community newspapers from around the United States, and leading Black and Hispanic law enforcement executives, too, sent a letter urging the FDA to keep menthol cigarettes legal.

    In acting on menthol, the FDA granted a citizen’s petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes, affirming its commitment to proposing such a product standard.

    The 2009 Tobacco Control Act (TCA) did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only flavored combusted cigarettes still marketed in the U.S. The law instructed the FDA to further consider the issue of menthol in cigarettes.

    Since then, the FDA sought input from an independent advisory committee as required by the TCA, and further demonstrated its interest by issuing an Advance Notice of Proposed Rulemaking, undertaking an independent evaluation and supporting broader research efforts—all to better understand the differences between menthol and nonmenthol cigarettes and the impact of menthol on population health.

    In the U.S., it is estimated that there are nearly 18.6 million current smokers of menthol cigarettes. But use of menthol cigarettes among smokers is not uniform: Out of all Black smokers, nearly 85 percent smoke menthol cigarettes compared to 30 percent of white smokers who smoke menthols. In addition, among youth, from 2011 to 2018, declines in menthol cigarette use were observed among non-Hispanic white youth but not among non-Hispanic Black or Hispanic youth.

    After the 2009 statutory ban on flavors in cigarettes other than menthol, use of flavored cigars increased dramatically, suggesting that the public health goals of the flavored cigarette ban may have been undermined by continued availability of these flavored cigars, according to the FDA.

    Flavored mass-produced cigars and cigarillos can closely resemble cigarettes, pose many of the same public health problems and are disproportionately popular among youth and other populations. In 2020, non-Hispanic Black high school students reported past 30-day cigar smoking at levels twice as high as their white counterparts.

    Nearly 74 percent of youth aged 12 to 17 who use cigars say they smoke cigars because they come in flavors they enjoy, according to the FDA. Among youth who have ever tried a cigar, 68 percent of cigarillo users and 56 percent of filtered cigar users report that their first cigar was a flavored product. Moreover, in 2020, more young people tried a cigar every day than the number of young people who tried a cigarette.

    Pamela Kaufman

    Pamela Kaufman and Sanath Sudarsan of Morgan Stanley said that while the absence of a proposed rule in today’s statement was “somewhat better than the market had feared,” the FDA’s plan is likely to remain an overhang for the sector. They also noted the agency did not indicate plans to ban menthol in noncombustible products such as e-cigarettes, heat-not-burn products and nicotine pouches, which could help incentivize smokers to move away from cigarettes and toward reduced-risk alternatives.

    Menthol regulation will have to follow the FDA’s multi-step/multi-year rulemaking process. The next step is a preliminary rule that would be subject to a comment and review period, typically lasting 90 days. The FDA would then review stakeholder responses and publish a final rule, which would require review from the Department of Health and Human Services and the Office of Management and Budget. Once a rule is finalized, the industry would have additional time to implement the change.

    Kaufman and Sudarsan expect the tobacco industry to challenge a final rule, questioning its scientific basis and stressing the risk of creating an illicit market for menthol cigarettes.

     

  • Biden Likely To Ban Menthol, News Reports Suggest

    Biden Likely To Ban Menthol, News Reports Suggest

    Photo: kasetch

    The Biden administration is likely to announce its intention to ban menthol cigarettes tomorrow, people familiar with the plan told CBS News. It is unknown if the law would impact menthol and ice flavored e-liquids in vaping products.

    Such a move would have considerable impact on the tobacco industry, however, because menthol cigarettes account for roughly one-third of the U.S. cigarette market. Approximately 20 million Americans smoke menthols, according to the Food and Drug Administration.

    Mentholated cigarettes have been marketed in the U.S. since the 1920s. Critics want to see them banned because they believe that, by masking the harshness of tobacco smoke, menthol makes it easier to start smoking and harder to quit. While overall smoking has trended downward in recent years, menthol declines have dragged behind other products. The tobacco industry insists that menthol cigarettes are no more harmful to health than nonmenthol cigarettes.

    Cigarette manufacturers have also come under fire for marketing menthol cigarettes disproportionately to Black Americans, highlighting racial inequities. More than 85 percent of Black smokers report using menthol products, as do more than half of all youth who smoke, according to government data.

    The 2009 Family Smoking Prevention and Tobacco Control Act empowered the FDA to regulate cigarette ingredients. The agency duly banned characterizing flavors in cigarettes. However, it exempted mentholated cigarettes, citing concerns about illicit sales, among other considerations.

    In 2011, the FDA’s Tobacco Products Scientific Advisory Committee concluded that “removal of menthol cigarettes from the marketplace would benefit public health in the United States,” but the additive remained on the market. In early 2020, the Trump administration again gave menthol a pass when it banned characterizing flavors in vapor products.

    While the U.S. wavered, other jurisdictions charged ahead. Brazil outlawed menthol along with all flavored cigarettes in 2012, followed by Turkey in 2015 and the European Union and the United Kingdom in 2020.

    Tired of what they perceived as FDA foot-dragging, anti-smoking and racial justice groups sued the agency. The judge in the case instructed the FDA to respond to this citizens’ petition by April 29.

    There is no factual basis to assert that a menthol cigarette ban will stop people of color from smoking.

    Benjamin Chavis, president and CEO, NNPA

    Advocates of the ban say the decision about whether to move ahead is ultimately President Biden’s. Banning menthol cigarettes has Democratic support in Congress too. Senator Dick Durbin, Representative Raja Krishnamoorthi and Representative Bobby Rush recently argued that the FDA has a “duty” to ban menthols. “These failures to protect children, particularly African American children, from a path to addiction are inexcusable,” they told the administration. 

    If enacted, a ban would not take effect overnight. Industry analysts expect the implementation of any plan to remove menthol cigarettes from the U.S. market to take years.  The FDA, which does not yet have a permanent commissioner in place, would have to go through a lengthy rulemaking process, consider potential consequences, such as illegal sales and racial injustice, and solicit public input.

    “In essence, such an announcement would simply be a way to tell the public, as well as the tobacco industry, that the agency intends to ban the flavoring in cigarettes,” Pebbles Fagan, the director of the Center for the Study of Tobacco at the University of Arkansas for Medical Sciences, told NBC News. “The rulemaking process would likely take several years to finalize and implement. That would provide time to boost smoking cessation programs targeting menthol smokers.”

    The American Civil Liberties Union and dozens of other criminal justice groups warned the White House and Health and Human Services Secretary Xavier Becerra that a ban on menthol cigarettes would have “serious racial justice implications.” 

    The National Newspaper Publishers Association (NNPA), representing more than 200 African American-owned community newspapers from around the United States, and leading Black and Hispanic law enforcement executives, too, have urged the FDA to keep menthol cigarettes legal.

    “It is clear that there is no factual basis to assert that a menthol cigarette ban will stop people of color from smoking,” says Benjamin Chavis, president and CEO of the NNPA. “In fact, the unintended consequences of such a racially discriminatory ban will set the stage for more negative and more likely counterproductive interactions between law enforcement and people of color.”

    Supporters of barring menthol products say that a federal ban would focus on retailers selling products and would not criminalize personal use or possession. But critics say that it could be inevitable as a black market grows for illegal cigarettes.

    Biden has pledged to address racial inequities in both criminal justice and healthcare, setting up for what could be an intense balancing act with critics arguing that a ban could increase police brutality and the incarceration of Black Americans.

  • Menthol Sales up After U.S. Flavor Ban

    Menthol Sales up After U.S. Flavor Ban

    Photo: Photo: Miriam Doerr | Dreamstime.com

    Sales in menthol e-cigarettes have risen since the U.S. Food and Drug Administration (FDA) guidance banning flavors has gone into effect, according to an article in Tobacco Control.

    Since Juul Labs has taken mint flavors off the market and the FDA has banned flavors other than menthol and tobacco, market shares of menthol-flavored e-cigarettes increased.

    After Juul’s actions, there was a 59.4 percent increase in the market share of menthol products after four weeks, and after the FDA guidance, there was a 54.5 percent increase after four weeks and an 82.8 percent increase after eight weeks.

  • U.K. Menthol Ban Could Drive Smokers Towards Vapor

    U.K. Menthol Ban Could Drive Smokers Towards Vapor

    bridge

    More smokers could turn to reduced-risk products like e-cigarettes after the U.K.’s menthol ban becomes enforceable today, new research suggests.

    The study by TobaccoIntelligence shows that many retailers are planning to use the shelf space previously occupied by menthol cigarettes for alternatives such as vapour and heated tobacco products.

    David Palacios, from TobaccoIntelligence, said: “The opportunities to convert menthol smokers to less risky alternatives are substantial.

    “In the UK alone, for example, it is estimated that 1.3 million people currently using menthol cigarettes will need to find an alternative product.”

  • EU Menthol Ban Could Help Smokers Switch

    EU Menthol Ban Could Help Smokers Switch

    Photo: VPZ

    U.K. vapor industry representatives are hoping that the EU ban on menthol cigarettes that comes into force today will encourage more smokers to transition to less-hazardous vapor products.

    The ban of menthol cigarettes comes from the EU Tobacco Products Directive (TPD), banning all cigarettes and rolling tobacco with “characterizing flavor” other than traditional tobacco.

    The ban originates from a range of tobacco control measures approved by the European Parliament in 2013, with revisions including mandating the banning of menthol cigarettes by 2022.

    In the U.K. there are an estimated 1.3 million menthol cigarette smokers.

    Research by the U.K. Vaping Industry Association, the largest trade domestic body representing the sector, shows that menthol vapor products sold by its retail and wholesale members represent an average of 16.5 percent of all sales and nearly double this number, at 30.75 percent, for manufacturers producing such products.

    The data suggests that menthol cigarettes are used by up to 12.4 percent of smokers in England, while global sales in 2018 exceeded $80bn. Currently, some 14.4 percent of the adult population in England smoke and there are some 7m smokers across the UK.

    Doug Mutter

    “I think in normal circumstances this move could have had the potential to significantly reduce smoking rates in the U.K.,” said Doug Mutter, director of manufacturing and compliance at VPZ, a leading vapor company in the U.K.

    “However, with vaping stores closed and stop smoking services shut, it remains to be seen how we can engage menthol smokers and encourage them to make the switch.

    “This is the biggest change to tobacco law since plain packing was introduced.

    “For the vaping industry it presents an opportunity to help smokers finally make the switch, and whilst that will be harder with stores still closed, we believe that vaping presents the best opportunity to stamp out cigarettes for good.

    “VPZ has built a digital platform for advice and guidance on smokers switching to vaping for the first time as well as how to pick the best products to help them quit.

    “We are expecting a growth in the number of new vapers in the U.K, so it was important to us to use our expert staff to help create a guide for menthol smokers looking to quit through vaping.

    “From which device best suits your needs to what strength of nicotine is required, we have tried to cover as many questions as possible. We have even put together some starter kits covering all categories to help with any first-time decision as we appreciate the first step can be daunting, without the opportunity to visit one of our stores.

    “It will be difficult for many people just now because vape stores are closed and the temptation to go back to traditional cigarettes is everywhere.  We are talking about over one million people in the UK will now not have their menthol cigarettes available and we hope that they are beginning to research which stop smoking products can best help them quit.

    “Our message to smokers across the country is that the best time to quit cigarettes is now.”