California Governor Gavin Newsom signed into law two bills to strengthen enforcement of California’s law ending the sale of flavored tobacco products. On Jan. 1, 2023, California implemented one of United States’ strongest laws prohibiting the sale of flavored tobacco products, including flavored e-cigarettes and menthol cigarettes.
The new laws are designed to thwart those initiatives.
One bill (AB 3218) requires the state Attorney General to establish and maintain a list of unflavored tobacco products, putting the onus on the tobacco industry to demonstrate that a product does not have a flavor and can be legally sold in California.
The bill also updates the definition of a prohibited “characterizing flavor” to include products that impart a menthol-like cooling sensation, thereby making it illegal to sell the menthol-like cigarettes that tobacco companies introduced to evade California’s prohibition on the sale of menthol cigarettes.
The second bill (SB 1230) authorizes the California Department of Tax and Fee Administration to seize illegal, flavored tobacco products discovered during routine tobacco tax inspections.
Menthol cigarettes and menthol-flavored heated tobacco sticks are strictly banned in multiple countries, including Canada, Ethiopia, the European Union, Moldova, Turkey, the United Kingdom, and specific regions of the United States like California, the District of Columbia, and Massachusetts.
In an effort to satisfy menthol consumers, Dekang Biotech Co. Ltd., an established player in the vaping industry, developed the DKiss menthol flavor roll-on. According to the company, the innovative product is set to transform the smoking experience in several ways.
“It is the easiest way to flavor cigarettes. The DKiss Menthol Flavor Roll-On is distinguished by its innovative roll-on design, ensuring a clean and convenient application process while allowing users to adjust the intensity based on their preferences,” a Dekang representative said.
The DKiss menthol flavor roll-on can be used with both traditional cigarettes and heated tobacco sticks for heat-not-burn nicotine delivery systems. It caters to a diverse audience by providing a wide variety of flavor options, including flavors specifically designed for individuals sensitive to cigarette odors.
DKiss menthol roll-on allows smokers to flavor their own cigarettes. In addition to menthol, the Dkiss line offers several other mixed flavors derived from plant extracts, such as loquat and ginseng, blended with menthol. This helps remove the bad breath caused by smoking. It brings the most satisfying fragrance to add a new dimension to your inhalation experience, according to Dekang.
“This product effectively eradicates cigarette odors and bad breath caused by smoking, serving as a discreet solution for smokers,” the representative said. “Mint enthusiasts will appreciate the refreshing mint flavor variant, which cleverly balances the taste of the cigarette and the unpleasant smell it creates, making it an ideal choice for menthol cigarette lovers.”
Dekang will showcase its DKiss menthol roll-on brand and its other innovative product lines during the Intertabac industry trade show (booths 5.D14 and 1B.A28), which will be held in Dortmund, Germany, from Sept. 19 – 21, 2024.
The California legislature has passed two bills to strengthen enforcement of the state’s law ending the sale of flavored tobacco products. The legislation must still be signed into law by Governor Gavin Newsom.
On Jan. 1, 2023, California implemented one of the strongest laws in the United States prohibiting the sale of flavored tobacco products, including flavored e-cigarettes and menthol cigarettes. In response, tobacco companies have developed alternative products that provide a similar cooling sensation with a less pronounced flavor. While tobacco companies insisted the such “mimic menthols” complied with state law, critics said they were designed to circumvent California’s rules.
One of the new bills (AB 3218) requires the state Attorney General to establish and maintain a list of unflavored tobacco products, putting the onus on the tobacco industry to demonstrate that a product does not have a flavor and can be legally sold in California. The bill also updates the definition of a prohibited “characterizing flavor” to include products that impart a menthol-like cooling sensation, thereby making it illegal to sell tobacco companies’ menthol-like cigarettes.
The second bill (SB 1230) authorizes the California Department of Tax and Fee Administration to seize illegal, flavored tobacco products discovered during routine tobacco tax inspections.
Anti-tobacco activists advocates welcomed the move. “We applaud the California leaders who have championed these bills,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, in a statement. “They are ensuring that California’s law works as intended to protect kids from tobacco addiction, advance health equity and save lives.”
U.S. tobacco companies have been using a synthetic coolant originally developed for shaving products to replace menthol cigarettes, according to an article in Chemical & Engineering News.
California and Massachusetts ban menthol cigarettes, and the U.S. Food and Drug Administration would like to prohibit them at the federal level, arguing that menthol makes it easier to start smoking and harder to quit.
In the 1970s, the British shaving product company Wilkinson Sword began altering menthol in search of analogs for its shaving products. It sought molecules that would provide the same cooling effect but without the skin and eye irritation sometimes associated with menthol.
Cigarette companies took note and created products using similar molecules to mimic the cooling sensation provided by menthol.
In 2020, the FDA determined that cigarettes with nonmenthol cooling agents, developed by R.J. Reynolds Tobacco Co., are substantially equivalent to menthol cigarettes, basically permitting the marketing of them.
Critics contend that the vague legal definition of flavors has allowed tobacco companies to develop and market substitute menthol products.
In challenging fines received in Massachusetts for selling their menthol replacement products, R.J. Reynolds testified that these cigarettes scientifically cannot be a flavored product because they do not activate the taste or olfactory receptors, but only thermoreceptors.
Reynolds also has a lawsuit pending against the attorney general of California based on similar arguments regarding what constitutes characterizing flavor.
Public health advocates have argued for legislation that considers a molecule’s chemical structure and function.
They point to Germany, which bans multiple cooling agent in cigarettes. Belgium and the Netherlands consider molecules’ function in their bans. Canada has a list of approved additives that doesn’t include menthol or any other coolant.
Michael Chaiton, director of research at the Ontario Tobacco Research Unit, which studies the province’s tobacco strategy, told Chemical & Engineering News that problems arise when lawmakers attempt to regulate things they don’t understand. A better appreciation for how tobacco additives interact with the body would help mitigate their harmful consequences without reliance on semantic arguments about flavor, aroma, and taste, he says.
When the U.S. Food and Drug Administration authorized the marketing of four Njoy brand menthol e-cigarette products, Senator Dick Durbin was disappointed. He said the agency should have done better. The move marks the first nontobacco-flavored e-cigarette products to be authorized by the FDA.
“Flavors like menthol are used by Big Tobacco companies to mask the harsh taste of their dangerous products. FDA knows this from its own experience seeking to ban the production of menthol cigarettes to protect the public health,” Durbin stated. “We’ve seen that children begin nicotine use with menthol. Today’s authorization of menthol-flavored vapes will create an opening for more children to become addicted to harmful products.”
Earlier this month, Durbin, chair of the Senate Judiciary Committee, held a committee hearing titled “Combatting the Youth Vaping Epidemic by Enhancing Enforcement Against Illegal E-Cigarettes.” The hearing underscored the alarming level of youth e-cigarette use and the role that flavors—such as menthol—play in youth use of tobacco products and examined how federal agencies have failed to enforce laws designed to protect children from a lifetime of nicotine addiction.
Tony Abboud, executive director of the Vapor Technology Association, who also spoke at Durbin’s hearing, said he applauds the FDA’s decision to “finally follow the massive body of science” that shows flavored e-cigarettes help people quit smoking. However, Abboud said the move does little to address the massive problems surrounding the regulatory agency’s authorization process.
“The reality is that this news, while a tiny step in the right direction, again reveals a more troubling pattern—the FDA acting only in self-interest to quell political pressure rather than acting in the interest of the American people,” said Abboud. “The only vapes authorized today are all owned by the biggest cigarette companies.
“Today’s authorizations once again demonstrate Brian King and the FDA’s hypocritical allegiance to those cigarette companies whose deadly cigarettes and other combustible products that the FDA continues to flood the market with at a record pace.”
Vapes are a powerful tool for adult smokers making the transition from cigarettes to reduced-risk products (RRP). The category is governed by market-specific regulation, often influencing public perception and, therefore, uptake.
Last week, following an extensive scientific review, the U.S. Food and Drug Administration authorized the marketing of four menthol-flavored e-cigarette products for Altria-owned vaping company Njoy. This is a watershed moment for the sector and one which will have a huge and significant impact on the global RRP market.
This announcement signifies the FDA’s acknowledgment that menthol vaping products have the potential to be an important and effective tool for adult smokers looking for reduced-risk alternatives. This is significant for the wider sector in a number of ways; above all, it sets a precedent for other markets, paving the way for other regulators, particularly those looking at bans, to consider flavors in the context of public health.
Across the globe, we are seeing an increasing number of markets introduce bans on flavors on a precautionary basis in a bid to mitigate youth uptake. At Plxsur, we have long advocated against the ban of flavors on vape products, arguing that it has the potential to negatively impact those making the transition from conventional cigarettes, who often are drawn to vapes for their flavor, amongst other factors such as price and convenience. There are also arguments and emerging evidence that flavor bans drive the black market sale of unregulated, dangerous products.
There will be many that, understandably, say this decision is “too little, too late,” but it is nonetheless encouraging to see the FDA, with its extensive science and evidence-based review, validating that with effective regulation and enforcement, flavored vape products are “in the interest of public health.” Those countries that have considered flavor bans should look to the U.S. and conclude that it can’t be justified from a scientific review perspective.
While this is the first authorization of a “characterizing flavor” by the FDA for vaping products, two of the major regulatory influencing bodies, the FDA and the Medicines and Healthcare Products Regulatory Agency (MHRA), now acknowledge that there is value in non-tobacco-flavored vaping products.
This decision has the potential to impact the world. The U.S. has long influenced international markets, so it sets a benchmark that we expect other, less vape-supportive governments and regulatory bodies will follow.
Rob Burton
In Italy, tobacco-flavored vapes constitute 40% of the vape market, while menthol represents 21%.[1] This demonstrates the significance of flavored products in the market as a whole. If such flavors were to be banned, this would act as a barrier for smokers to move to reduced-risk alternatives and potentially lead vapers to return to cigarettes.
In some geographies, it is great to see that vapes are being accepted as an effective alternative to conventional cigarettes, even this week’s news from Australia announcing that vapes – which until now have only been available through prescription – will soon be available for sale within pharmacies without the need for a prescription, offering an effective pathway to end the smoking epidemic in the country.
As we anticipate the potential revision of the Tobacco Product Directive Review next year, the justification for banning flavors, from a scientific point of view, simply isn’t there. In the case of Njoy, this has been shown through closed-system pod-based devices, which offer a more cost-effective avenue for existing smokers and disposable systems while incorporating child lock systems that will restrict access to children, as is already applied by a Plxsur company, ProVape, in its SALT and KUBIK brands.
While the FDA’s authorization is specific to these four products made and sold by Njoy and does not apply to any other menthol-flavored e-cigarettes, our expectation is this will open a channel for other such products to achieve authorization by providing the necessary framework and the potential for knowledge-sharing and guidance. With the weight of data-led evidence, the category can advocate for the democratization of this framework, enabling further regulatory authorizations for products produced by responsible vaping companies in the interest of the adult smoker.
At Plxsur, we have a clear purpose – to facilitate adult smokers to make positive health decisions by transitioning away from cigarettes to reduced-risk products. Flavor is a key factor in supporting smokers moving completely to such alternatives, and we look forward to seeing a more science and data-led approach being adopted across all markets as we work to save the lives of those impacted by smoking, mitigate the risk of youth uptake, and do so sustainably and responsibly.
We view this FDA decision as a significant step forward in broadening the pathway for adult smokers, and previously lacking “off-ramp” for U.S. menthol smokers looking to make the switch, which, according to Public Health England, is 95% less harmful and, therefore, undeniably, “in the interest of public health.”[2]
Robert Burton is Group Scientific and Regulatory director for Plxsur.
The Biden administration has again delayed its decision on whether to ban menthol cigarettes in the United States.
“This rule has garnered historic attention, and the public comment period has yielded an immense amount of feedback, including from various elements of the civil rights and criminal justice movement,” said Secretary of Health and Human Services Xavier Becerra in a statement. “It’s clear that there are still more conversations to have, and that will take significantly more time.”
Government officials declined to provide a new target date for the measure, saying they needed more time to hear from outside groups, especially civil rights activists.
Menthols account for more than a third of all cigarettes sold in the U.S. each year and are predominantly used by Black and Latino smokers.
According to The Wall Street Journal, lawmakers have been weighing the potential public health benefits of banning minty smokes against the political risk of angering Black voters in an election year.
A November poll commissioned by Altria Group found that 54 percent of “core” Biden voters—defined as minority voters or non-conservative white voters under age 45—oppose the proposed ban.
Anti-tobacco groups were aghast by the latest delay. “It is unacceptable and deeply harmful to public health that the Biden administration today has once again delayed issuing the final rule to prohibit menthol cigarettes,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, in a statement. “This decision prioritizes politics over lives, especially Black lives.”
The FDA formally proposed the ban in April 2022, saying there were 18.5 million smokers who preferred menthol brands in the United States.
Anti-smoking activists say the cooling sensation of the menthol flavor makes it easier to start smoking and harder to quit. The FDA estimates that the menthol ban could reduce smoking by 15 percent in 40 years. Studies project that as many as 650,000 smoking-related deaths could be avoided.
Researchers looking at similar moves in other nations estimated that a ban could result in nearly a quarter of smokers quitting, with the rest moving to nonmenthol cigarettes or managing to keep smoking menthols.
In recent months, dozens of groups have met with administration officials to discuss the proposal. Among other concerns, opponents of the measure cite job losses and aggressive police targeting of Black smokers. An estimated 85 percent of U.S. Black smokers prefer menthol brands, according to market data. The FDA insists that enforcement would be against manufacturers rather than consumers.
Critics, however, contend that tobacco companies are financing and fueling those fears. Richardson said she was disturbed to see the administration “parrot the false claims of the tobacco industry about support from the civil rights community.”
“The fact is the menthol rule is overwhelmingly supported by Black civil rights, faith, public health, medical and other organizations,” she said.
While other jurisdictions, including the European Union, have banned menthol cigarettes, the impact of such a measure would likely be greater in the U.S. because of their large market share. Reynolds American Inc. (RAI), which makes the market-leading Newport brand, earns about $7 billion from menthol cigarette sales a year, research by Goldman Sachs shows.
Convenience store, gas station and wholesaler groups predict a loss of $34 billion in sales from menthol cigarettes and snacks and drinks purchased by customers. Some House Republicans have sent letters to the administration warning that the ban could have a disastrous effect on small businesses and that it could encourage cigarette smuggling that would benefit terrorist groups.
Altria spokesman David Sutton said the company was also concerned about illicit sales as well as lost tax revenue and jobs.
U.S. health groups filed a second a second lawsuit against the Food and Drug Administration for the agency’s inaction on banning menthol cigarettes. The case comes more than seven months after the FDA’s initial date for finalizing the new rule.
“The relentless and racist tobacco industry targeting has killed too many members of the Black community,” said Carol McGruder, co-chair of the African American Tobacco Control Leadership Council, which filed the suit along with Action on Smoking and Health and the National Medical Association. “If Black lives truly matter, then we must end the sale of menthol cigarettes and do it now.”
The plaintiffs’ first lawsuit was filed on June 17, 2020. The initial complaint sought to compel the FDA to act on its earlier conclusions that removing menthol cigarettes from the marketplace would benefit public health. The lawsuit asked the court to compel the FDA’s determination on whether to add menthol to the list of prohibited characterizing flavors—a determination that the FDA delayed making for over 10 years. The joint lawsuit followed the 2013 Citizen Petition from the Public Health Law Center, which called on the FDA to prohibit the sale of menthol cigarettes.
“We’re extremely disappointed to be forced to file this second lawsuit against the FDA in support of protecting Americans from menthol cigarettes,” said Laurent Huber, executive director of Action on Smoking and Health, in a statement. “The FDA’s own research confirms that a menthol ban would save lives; there is no scientific reason to delay finalizing this rule.”
In 2011, the FDA’s scientific advisory committee concluded that the “Removal of menthol cigarettes from the marketplace would benefit public health in the United States.”
As a result of the plaintiffs’ first lawsuit, the FDA made the landmark determination to add menthol to the list of banned characterizing flavors in cigarettes. To begin that rulemaking process, the FDA issued a Notice of Proposed Rulemaking to ban the sale of menthol cigarettes in the marketplace. In response, the plaintiffs voluntarily dismissed their initial lawsuit.
After setting an initial date of August 2023 to issue its menthol rule, the FDA has unreasonably and unlawfully delayed this life-saving rule, according to the plaintiffs.
“As African American physicians, we are deeply disturbed at the continuing delays in FDA’s finalizing of the ban on menthol cigarettes,” said Yolanda Lawson, president of the National Medical Association. “Our patients, more than any other group, become disabled and die prematurely due to the continued use of these cigarettes,” she said.
The plaintiffs accuse the Biden Administration of falling for “disinformation and fear-mongering” by the tobacco industry. “The industry is sowing doubt and confusion and taking advantage of real issues in our country and claiming that removing menthol will harm Black lives, when just the opposite is true,” the groups wrote in a statement. “We remain disheartened to be forced to call on the Biden Administration to prioritize human life.”
A total of 123 civil rights, public health, medical, faith, youth-serving and other organizations placed a full-page ad in The Washington Post and issued a joint statement urging the Biden administration to issue final rules this month to prohibit cigarettes and flavored cigars to meet a deadline the administration set in December, according to the Campaign for Tobacco-Free Kids.
The ad and joint statement underscore the support across the nation for the U.S. Food and Drug Administration’s proposed rules to eliminate menthol cigarettes and flavored cigars, including from organizations representing populations that have been targeted by the tobacco industry and disproportionately harmed by these products.
“President Biden, we stand united,” the ad reads. “Act now to eliminate menthol cigarettes.”
“These rules are supported by overwhelming scientific evidence, they will have enormous benefits for our nation’s health and they are critical to achieving top priorities of the Biden administration, especially the president’s Cancer Moonshot and the administration’s commitment to promoting health equity,” the joint statement reads.
“We were deeply disappointed in December when the administration delayed issuing these long-overdue rules. As tobacco use is the leading cause of preventable death in the United States, killing nearly half a million Americans every year, any further delay in issuing the final rules will result in needless disease, suffering and deaths. The administration must stand up to the tobacco industry and act now to save lives.”
Is a menthol ban appropriate for the protection of public health? Hopes, concerns and a reality check
By Cheryl K. Olson
Is a U.S. menthol ban finally coming? The 2009 Tobacco Control Act exempted menthol cigarettes from its blanket ban on candy and fruit flavors. Menthol was left out, according to CNN, due to “serious lobbying from the industry.”
As the Washington Postreported, plans to finalize the rule have been made—and postponed—multiple times by the Biden administration. The announcement of a finalized rule was planned for this month.
The Food and Drug Administration first announced its “proposed product standards to prohibit menthol as a characterizing flavor in cigarettes” back in April 2022. The stated purpose? To reduce appeal to and experimentation by youth that will lead to regular smoking addiction and to reduce disease and death among adults via fewer cigarettes smoked and more quitting. A ban is also “expected to reduce tobacco-related health disparities.” The ban would target making and selling not individual possession or use.
Concerns that banning menthol could exacerbate waning enthusiasm for Biden among Black voters appears to be one factor behind the delay. (Hoping to capitalize on this, one conservative group is reportedly testing menthol-focused ads on Black South Carolina primary election voters.) Four in five Black adults who smoke report choosing menthols.
The National Association for the Advancement of Colored People, a venerable advocacy organization for Black Americans, supports a federal menthol ban. In a Jan. 12 press release, its senior vice president of global policy called out “the relentless predatory marketing of menthol-flavored cigarettes, [which] has inflicted devastating consequences on Black communities.” This included ads in Black-oriented media, such as Ebony magazine, and sponsored events, such as the Kool Jazz Festival.
Other organizations, such as Reverend Al Sharpton’s National Action Network, have argued against singling out menthol for a ban. Sharpton has expressed concern that a menthol focus could increase over-policing of Black communities, pointing to the New York City police killing of Eric Garner, who was suspected of selling “loosie” untaxed cigarettes.
“The illicit market is always open and doesn’t check IDs.”
Why Menthol?
In the U.S., menthol has been added to cigarettes for at least 100 years, at times promoted as throat-soothing for coughs and colds. National governmentsurveys find that, as smoking rates overall trend down, the proportion of menthols smoked has crept up.
These surveys show that menthol smoking is disproportionately higher among subgroups of people regulators consider disadvantaged or vulnerable. This includes Black and Hispanic adults who smoke, young adults, women and persons reporting serious psychological distress.
Concern that menthol may be a drag on cessation rates has boosted support for a ban. Because it reduces irritation, menthol may make it easier to start smoking. It’s used more often by people who smoke intermittently or experimentally. Researchers have called for more studies to parse and prove a causal role for menthol in increasing smoking and deterring quitting.
In this century, smoking rates have been stagnant among African-American adults who smoke. A 2020 analysis of U.S. studies did not find an overall effect of menthol on smoking cessation but did find that among African-Americans who smoked, use of menthol was linked to 12 percent lower odds of quitting.
Can bans help people quit smoking? To some degree, yes. Pooled results from a 2024 systematic review and meta-analysis of English-language menthol ban studies found that 24 percent of those who smoked menthols had quit cigarettes a year or two later. But results varied widely; bans took place under a variety of conditions, and most of the studies included had small or unrepresentative samples.
For example, a survey of San Francisco’s ban of menthol and other flavors in all tobacco products found decreased flavored e-cigarette and cigar use and a slight uptick in smoking. The study used a small convenience sample of 247 young adults. Even rigorous economic studies of bans admit to trouble tracking illicit and cross-border sales and other workarounds.
Regulators are aware of the need for better research. The FDA recently awarded a $3.6 million grant to researchers at the Medical University of South Carolina to study whether banning menthol in cigarettes (and e-cigarettes) would increase quitting or switching. Meanwhile, Rutgers University received two grants totaling $7 million via the National Institutes of Health to study anticipated “disinformation” from industry, aimed at Black and Hispanic young adults, that could “undermine the impact of a ban on menthol cigarettes and flavored cigars.”
What Could Go Wrong?
The FDA expects minimal illegal trade in event of a ban. Richard Marianos disagrees. He is a retired assistant director at the U.S. Bureau of Alcohol, Tobacco, Firearms and Explosives and a faculty member at Georgetown University. Marianos says banning products creates crime.
Illicit sales of individual cigarettes and contraband packs are already problematic, in part because taxes have driven up costs. Marianos showed me photos of several men, one with a gun in his waistband, at an illegal sales spot outside of a Washington, D.C., Metro station.
“People come off the train, buy four loosies from the spot, then ration them out during the day,” he says. “You can get your marijuana, your cocaine and your Newports.”
The flavor ban in California has sparked increased robberies of convenience stores across the border in Arizona, according to Marianos. “A pack of menthol cigarettes that they can steal and sell for $2 apiece at the spot derives a greater profit than a cash register robbery,” he says. “I have videos of crews hitting a Circle K or Wawa, jumping over the counter, sticking up the clerk and—like Santa—putting the cigarettes into a gigantic tarp and taking off.”
A Canadian study of intended and unintended effects of their menthol ban found that many people purchased menthols on First Nations reserves, where the ban did not apply. Marianos expects that Native American reservations in the U.S. would similarly help meet demand.
The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction.
Menthol Workarounds
The assumption by many tobacco control advocates that Big Tobacco will sabotage menthol bans overlooks the likely ingenuity of individuals. Marianos described one case he ran across: “A guy was going on eBay and buying menthol crystals, spraying regular cigarettes in his basement and then selling them on the corner as menthols.”
Noting that products to alter cigarette characteristics are illegal under the proposed rule, “FDA does not anticipate a substantial number of individuals would utilize such products.”
Researchers have documented sales of flavor cards and menthol drops in Canada and various flavor accessories in the European Union to circumvent their menthol bans—predictably leading to calls to ban those items too.
“The illicit market is always open and doesn’t check IDs,” notes Nicholas “Grimm” Green, a YouTuber and tobacco harm reduction advocate. “As long as $10 ‘menthol injectors’ exist on Amazon, the idea of a menthol ban is silly.”
That’s not to say that companies won’t do their part to circumvent a menthol ban. “Tobacco companies have already introduced nonmenthol-menthol cigarettes into the market in California,” says Green. Further, enforcement is lax. “Menthol disposable vapes are available at almost every gas station and head shop in the state,” he adds.
The California ban, approved by voter referendum, went into effect in December 2022. It covers not just menthol cigarettes but nearly all flavored nicotine products. Researchers have found synthetic cooling agents that give menthol-like effects in cigarettes sold in that state. A journalist from STAT News found widespread sales of flavored products, even in cities that had their own longstanding flavor bans.
Legal Hurdles
If the menthol rule comes to pass, store shelves aren’t immediately cleared. Flavor bans enacted by states can take effect within months. Because the proposed federal ban comes out of the FDA’s complex rule-making process, it could take years.
“If they publish that rule on a Monday, the next day, you’ll see a legal challenge filed to prevent it from ever going into effect,” says Jeffrey Weiss, partner at Flagstaff Ventures and formerly chief engagement officer and general counsel at Njoy.
He predicts a dead-end fate for the menthol ban, similar to that of the final rule requiring graphic health warnings on cigarette packs. Why?
U.S. law requires that adoption of tobacco product standards must be appropriate for the protection of public health. In supplementary information to the proposed menthol rule, the FDA cites research, including population models and expert opinions, on what is expected to happen after a menthol ban.
“They model that a certain percentage will switch to tobacco cigarettes, a percentage will buy black market menthol cigarettes, a percentage will quit and a percentage will switch to an e-cigarette, primarily menthol,” Weiss says. “But that model doesn’t actually exist—in the sense that there are no authorized menthol e-cigarettes for smokers to switch to.”
Post-ban, more menthol users are expected to switch to menthol e-cigarettes than to quit using tobacco. In sum, much of the health benefit from banning menthol is supposed to come via unauthorized product use. Products that are themselves banned in a growing number of states and localities.
Regulators are not unaware of this conundrum. FDA Commissioner Robert Califf has publicly expressed concern about the difficulties that people dependent on menthol cigarettes will face if the products are taken away. For example, he remarked at a 2023 Congressional budget hearing, “[W]here do they [menthol users] go to get help, coming off of a terrible addiction? Our healthcare systems are not set up to deal with that right now.”
What about evidence for a menthol ban preventing harm to youth? The respected nationally representative Monitoring the Future study found that past-month menthol and nonmenthol cigarette use by non-Hispanic black teens is now less than 1 percent. It’s fallen so low in recent years that “prevalence levels approach a floor effect.” Moreover, today’s Black adolescents use menthol cigarettes at lower levels than non-Black youth.
A Better Way?
Given the high risk of unintended effects and the limited certainty of benefits, is a menthol ban our best plan? “It would be best if the government would think first in the direction of ‘how can we affirmatively help people make positive change?’” Weiss says. “Because prohibitions are hard and costly to enforce.”
The lack of authorized reduced-harm menthol or mint products is just part of the problem. Another is the FDA’s limited and ambivalent reduced-risk communications.
Weiss points to the FDA’s routine tweeting of its one-page list of 23 authorized e-cigarette products. At the bottom of the page is a disclaimer: Being authorized “does not mean that these products are safe nor are they ‘FDA approved.’ All tobacco products are harmful.”
“If you want a current menthol smoker who can’t completely quit to switch to a regulated reduced-harm product—how are they going to do that when you’re telling them that none of these products are safe?” says Weiss. “If it’s an unsafe product, why is that a better choice for me” than a tobacco-flavored cigarette or an illicit menthol one?
Active promotion of reduced-harm menthol alternatives seems a sensible way to limit ban backfires. A rigorous laboratory study of adults who smoked menthol cigarettes daily found that menthol-flavored e-cigarettes outshone tobacco-flavored ones in reducing cigarette cravings—including urges to smoke for pleasure. According to the authors (affiliated with prominent universities), this is a known strong predictor of successful smoking cessation.
The practical path forward for advocates of an enforceable menthol cigarette ban is to actively promote harm reduction. “Encourage FDA to start authorizing menthol e-cigarettes, among other things, so that these smokers would have something to switch to,” says Weiss. “And to make it more likely that a menthol ban could withstand a legal challenge.”
Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors via McKinney Regulatory Science Advisors. She spent 15 years on the faculty of Harvard Medical School.
