Tag: menthol

Bentley: Banning Menthol is a High-Risk Strategy
Guy Bentley
The U.S. Food and Drug Administration’s plan to ban menthol cigarettes may have unintended consequences, such as increased black market sales and more incarceration, while doing little to advance public health, according to Guy Bentley, director of consumer freedom at the Reason Foundation.
Writing on the organization’s website, Bentley says the desired public health gains could also be achieved by applying the harm reduction model to tobacco policy.
In his article, Bentley examines the experiences of Canada, the European Union and Massachusetts, which have already banned menthol cigarettes, and finds the results to be underwhelming.
“In the aggregate, the experience of menthol bans in the real world, as opposed to forecasts about them, is that the bans have minimal effects on tobacco consumption but do engender unintended consequences, even in markets where menthol is relatively unpopular,” he writes.
According to Bentley, banning menthol cigarettes is a radical policy with significant implications for the criminal justice system and personal autonomy. “Rather than resorting to the failed policies of the past, the FDA and the Biden administration should apply the harm reduction model to tobacco policy,” he writes.
“Educating the public and taking a harm reduction approach has been successful in the fields of sexual health and drug addiction, and it would be far more effective in reducing smoking than banning menthols.”
April 18, 2022
More Ads for Menthol E-Cigarettes

When the U.S. Food and Drug Administration banned flavored tobacco products, email and mailed advertisements for those products fell; however, ads for menthol-flavored products more than doubled, according to the Truth Initiative citing a Tobacco Control study.
The study showed that partial flavor bans may not deter consumers, including youth, away from tobacco products. “Rather, manufacturers and consumers are adapting to new FDA regulations,” the study authors write. “The restriction of some flavored e-cigarette products has resulted in a shift of the sales and marketing of restricted flavored e-cigarette products toward other available flavored e-cigarette products.”
“A more comprehensive approach that includes the consideration of disposables, refillable devices and other flavored e-cigarettes not covered by the current FDA guidance is needed to offer the most benefit for prevention efforts among youth and young adults,” the authors write.
The FDA is expected to ban menthol-flavored products sometime this year.
April 1, 2022
FDA Submits Menthol Ban for Review

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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 (OMB), 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 nontobacco 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.
March 1, 2022
FDA Menthol Cigs and Flavored Cigars Plans on Track

Photo: Yulia Usikava
The U.S. Food and Drug Administration is on track to propose rules prohibiting menthol as a characterizing flavor in cigarettes and prohibiting all characterizing flavors (including menthol) in cigars by spring.
The FDA’s actions “are an important opportunity to achieve significant, meaningful public health gains and advance health equity,” said FDA Center for Tobacco Products Director Mitch Zeller in a statement. “For far too long, specific populations have been targeted and disproportionately impacted by tobacco use, especially when it comes to characterizing flavors that entice them to start and keep smoking.”
In April 2021, the FDA announced its commitment to advancing these two tobacco product standards. Then in November, attorneys for the FDA appeared in court as anti-tobacco groups accused the agency of failing to implement a ban on menthol cigarettes.
The National Association of Convenience Stores (NACS) cautioned that banning menthol in cigarettes and all characterizing flavors in cigars would boost black market sales.
“Menthol makes up more than 37 percent of the tobacco market,” Lyle Beckwith, NACS senior vice president of government relations, said in an article published on the association’s website. “That demand will not go away due to a ban. NACS is on record opposing menthol bans as we believe illicit vendors will quickly source and begin selling foreign and counterfeit menthol cigarettes. Illicit vendors do not verify age, do not collect and remit taxes, and they sell other illegal products beyond just menthol cigarettes.”
In the convenience retailing channel, cigarettes contributed 27.79 percent of in-store sales in 2020, according to the NACS State of the Industry Report of 2020 Data. Other tobacco products, a category which includes cigars, accounted for 6.9 percent of in-store sales in 2020.
After reviewing and considering comments to its proposed rules, the FDA could then proceed to issue final product standards, which would become enforceable once in effect.
January 31, 2022
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.
November 21, 2021
‘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.”
October 14, 2021
‘Menthol Ban Would Save 650,000 Lives’

David Levy
Banning menthol flavors in cigarettes could reduce smoking by 15 percent by having smokers giving up tobacco products altogether or switching to e-cigarettes and other nicotine vaping products—avoiding 16,250 tobacco-related deaths per year by 2060, according to a new University of Michigan study.
The report supports the April 2021 announcement by the U.S. Food and Drug Administration of its intention to ban menthol cigarettes and cigars nationwide. The menthol ban would not affect e-cigarettes or other flavored products. Published in Tobacco Control, the study notes that additional measures such as increasing taxes on cigarettes and cigars could further reduce smoking and related deaths.
“This work is the culmination of a series of sequential projects aimed to assess the impact that a menthol ban could have on smoking, tobacco use and downstream health effects,” said Rafael Meza, one of the authors of the study and a professor of epidemiology at the University of Michigan’s School of Public Health. “Our findings show that a menthol ban could result in considerable health gains and highlight the urgency for final approval and implementation of the ban.”
The study is based on the data analysis and computational modeling infrastructure that the researchers have assembled as part of the Center for the Assessment of Tobacco Regulations. Researchers used the Smoking and Vaping Model, a simulation model they had previously developed to reflect recent cigarette and vaping products and incorporated current trends in the use of menthol and nonmenthol cigarettes.
Then, the researchers developed a scenario with a menthol ban starting in 2021, informed by expert assessment of the potential impacts, and estimated the public health impact as the difference between smoking and vaping attributable deaths and life-years lost in the current and the menthol ban scenarios, between 2021–2060.
They found that with a menthol ban, combined menthol and nonmenthol cigarette smoking would decline by 15 percent by 2026. Deaths attributable to smoking and vaping were estimated to fall by about 5 percent and life-years lost by 8.8 percent—translating to 16,250 deaths per year averted and 11 million life-years gained (almost 300,000 per year) over a 40-year period.
“Recent evidence finds that a menthol ban would likely increase smoking cessation, with more limited evidence of reducing smoking initiation and switching from smoking to other products like e-cigarettes,” said David Levy, professor of oncology at Georgetown University and lead author of the paper.
The researchers said that the effects of a menthol ban will also depend on other tobacco control policies. In particular, higher cigarette taxes would reduce smoking initiation and increase cessation, and increased enforcement of age 21 purchase laws would likely reduce smoking initiation. However, a menthol ban is likely to be very effective as a standalone policy, they said.
The work was conducted by the Center for the Assessment of Tobacco Regulations, one of nine Tobacco Centers for Regulatory Science funded by the FDA/NIH.
September 6, 2021
‘FDA Unlikely 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.
August 27, 2021
U.K. Retailers “Missed” in Menthol Buyback

Photo: Miriam Doerr | Dreamstime.com
U.K. retailers say tobacco companies have “missed” significant volumes of now-illicit menthol cigarettes during the initial returns phase following the country’s ban on such cigarettes.
The U.K. prohibited sales of menthol cigarettes on May 20, 2020. Prior to the ban, tobacco companies pledged to take back and credit retailers for any noncompliant stock remaining once the legislation came into force.
However, six retailers across England told Better Retailing that they still have menthol brands from Philip Morris Limited (PML) and British American Tobacco U.K., with some holding stock with a combined value worth several hundreds of pounds.
BAT U.K. said it carried out a significant menthol pack return exercise from September to December 2020. “Despite our best efforts, some of our retail partners appear to have been missed in this initial returns phase; we are sorry for any inconvenience caused,” a BAT spokesperson said, adding that a second returns phase would be introduced at the end of this year.
PML said it introduced a nationwide “buy-back” scheme from May to July 2020, which covered all plain packaging products with duty paid.
August 10, 2021
That Fleeting Scent

Photo: kasetch
The FDA’s proposed ban on menthol cigarettes and cigars remains highly controversial.
By Stefanie Rossel
Almost exactly a year after the European Union imposed a ban on the manufacture and sale of menthol cigarettes, the U.S. Food and Drug Administration said it would ban menthol as a characterizing flavor in cigarettes and cigars at the federal level. With the move, the agency hopes to significantly reduce youth initiation to smoking, 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 more likely to use these tobacco products, according to acting FDA Commissioner Janet Woodcock.
The proposed ban, announced on April 29, has been under discussion for more than a decade. While the 2009 Family Smoking Prevention and Tobacco Control Act (TCA), which gave the FDA regulatory authority over tobacco products, banned all characterizing flavors in cigarettes, it allowed the continued use of menthol cigarettes but instructed the agency to consider what to do about the additive. The FDA’s recent decision was forced by a federal lawsuit brought by public health groups in 2020 after the agency failed to respond to their 2013 petition, which called on the FDA to ban menthol products.
Menthol can be extracted from mint plants or made synthetically. In tobacco, it is used to mask the harshness and irritation caused by cigarette smoke. The minty flavor creates a cooling, slightly anesthetic sensation, which, according to a 2013 FDA report, makes cigarettes more appealing to new smokers, thus getting them more easily addicted. The substance is also believed to increase the degree of addiction; menthol smokers are reportedly less likely than nonmenthol smokers to successfully quit smoking despite having a higher urge to end their tobacco dependence. Around the globe, mentholated smokes account for about 10 percent of cigarette consumption, according to the World Health Organization.
In the U.S., menthol cigarettes represented 36 percent of all cigarette sales in 2018, according to the Centers for Disease Control and Prevention. Although U.S. smoking prevalence has dropped below 40 million, the share of mentholated cigarettes has risen significantly after the TCA prohibited all other characterizing flavors.
What makes the FDA’s proposed ban controversial is the fact that menthol cigarettes are also considered a racial justice issue in the U.S. According to the 2019 National Survey on Drug Use and Health, 85 percent of African American smokers smoke menthol cigarettes compared to 30 percent of white smokers and compared to less than 10 percent of African American smokers in the 1950s—a situation that critics attribute to racially targeted marketing strategies by the tobacco industry. African Americans typically smoke fewer cigarettes and start smoking at an older age than white smokers, but they die from tobacco-related illnesses at much higher rates, CDC data indicates.
Menthol cigarettes also appeal to Hispanic (48 percent) and Asian (41 percent) smokers, according to the survey, whereas about half of smokers aged 12–17 smoke menthols compared with about 40 percent for smokers aged 18 and older. With a market share of 49 percent, menthol cigarettes also featured prominently in in the LGBTQ+ community.

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Great Expectations
The FDA expects its proposed ban to have a significant impact. A Canadian study quoted by the agency suggests that the measure would prompt an additional 923,000 U.S. smokers to quit, including 230,000 African Americans, in the first 13 months to 17 months after taking effect. According to an earlier study, such a measure would avert 633,000 premature deaths, including 237,000 African American deaths.
While many public health and civil rights groups welcomed the FDA’s decision, lauding it as a win for both public health and racial justice, critics cast doubt on the health effects and warned that it could create more problems for minorities.
“In this country, we have found out that prohibition doesn’t work,” says Jeff Stier, senior fellow at Taxpayers Protection Alliance. “The ban is supposed to protect African American smokers, but they are likely to switch to a different, nonmenthol combustible cigarette brand or buy their mentholated cigarettes on the black market. We already have a pretty active illicit market; a ban would make it even worse.”
In the view of some civil rights organizations, a ban on menthol would create new, unwelcome opportunities for negative interactions between law enforcement and Black Americans.
The FDA plans to implement its ban by 2022, but experts expect a flood of lawsuits from the tobacco industry. Apart from a long fight regulators may face in court, along with resistance in Congress, most notably from tobacco-state lawmakers, the process of shaping respective legislation is likely to take time as it will comprise two detailed proposals that are open to public comments and will then be reviewed by the White House. When the FDA last proposed to ban menthol cigarettes in 2013, it received 174,000 public comments. The agency is obliged by law to read every single one and consider them carefully.
Questionable Effect
While several countries, including Brazil and Turkey, have banned menthol cigarettes over the past decade, data on the impact of the measure remains scarce. Studies from Canada show that smokers of menthol cigarettes were considerably more likely to quit their habit altogether after that country banned menthol cigarettes nationwide in 2017. A more recent study by the National Bureau of Economic Research in Cambridge, Massachusetts, USA, however, concludes that there was “almost no direct evidence on [the] effects” of a menthol cigarette ban “using real-world policy variation.” The study also found that many youths switched to nonmenthol cigarettes and that many adults started buying their menthol cigarettes from Native Canadian reserves, which are exempted from the ban. With a pre-ban market share of 5 percent, the Canadian menthol cigarette market is also more like that of the EU, where menthol cigarettes account for 7 percent of all cigarette sales, than that of the U.S.
The EU prohibited the manufacture and sale of menthol cigarettes in May 2020. The ban extends to the sale of rolling tobacco with mentholated filters or papers. Exempted from the ban are menthol-flavored e-liquids for vape products, separately available mentholated smoking accessories, menthol-flavored oral nicotine pouches and cigarillos. Outside of Germany, mentholated consumables for heated-tobacco products (HTPs) also remain legal.
Cigarette manufacturers responded with innovative solutions to the ban. Apart from broadening their portfolios of menthol-flavored and mint-flavored reduced-risk products (RRPs), they introduced mentholated flavor cards, which smokers could buy separately to mentholate conventional cigarettes. Tobacco companies also started offering cigarillos with mentholated filter capsules. Cigarillos are exempt from the EU ban as they are wrapped in tobacco leaf.

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Choosing Alternatives
To determine whether the EU ban met its objective of discouraging people from smoking or encouraging them to quit, Euromonitor International, on behalf of the Foundation for a Smoke-Free World, surveyed more than 6,000 adult menthol cigarette smokers in eight EU countries before and after the menthol cigarette ban. While the pre-ban surveys queried awareness and intention to quit or switch, the post-ban surveys queried behavior.
Main takeaways of the surveys included a lower rate of quitting smoking completely (8 percent) than indicated in the pre-ban survey (12 percent) and higher use of products that allow consumers to manually add a flavor to regular tobacco products. Thirteen percent of respondents said they had started buying products such as menthol flavor cards or menthol filter tips after the ban as opposed to 8 percent who had the pre-ban intention to do so.
Thirty percent of respondents said they had reduced consumption of menthol cigarettes after the ban. Twenty-eight percent indicated they had stopped smoking menthol cigarettes but continued to consume regular cigarettes (pre-ban intention: 35 percent). Twelve percent said they had stopped consuming menthol cigarettes after the ban but increased their consumption of nonmenthol cigarettes (pre-ban intention: 13 percent). Eighteen percent stated post-ban they had switched to other menthol products not affected by the ban, such as menthol cigars, cigarillos, e-cigarettes and HTPs (pre-ban intention: 19 percent).
Thirteen percent had started buying menthol cigarettes from other sources (pre-ban intention: 12 percent), more precisely from friends or family who had travelled to countries where menthol cigarettes were still legal or from online retailers shipping from other countries.
Interestingly, when unprompted, only 43 percent of respondents considered menthol cigarettes to be illegal in the post-ban surveys. While 10 percent were unsure of the legal status of menthol products, 27 percent still believed them to be legal or to be banned in the future (20 percent).
Harm Reduction Instead of Prohibition
Interestingly, the EU menthol ban appears to have nudged smokers a bit toward less hazardous forms of nicotine consumption. Of the 18 percent of respondents who said they had switched to other menthol products not affected by the ban, the majority chose RRPs. On average, 57 percent of respondents said they had switched to e-cigarettes, with the highest percentages being observed in Poland (67 percent) and the U.K. (57 percent), two markets with high vaping prevalence. Overall, 12 percent of switchers indicated they had switched to nicotine-replacement therapy products.
It’s a development Stier would like to see in the United States, which has yet to fully embrace the concept of tobacco harm reduction by promoting products such as e-cigarettes and snus as safer alternatives to combustible cigarettes. “Instead of going back to prohibition that will bring about unintended consequences, we should encourage smokers, as they do in the U.K., to quit smoking and switch to lower risk vape products. The FDA is sitting on applications to authorize these e-cigarettes now. Instead of banning products the African American community smokes, it should undo the misperceptions surrounding RRPs, offer better alternatives and be truthful about the risks,” he says.

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August 1, 2021