A study recently published in Tobacco Control journal says menthol cigarette smokers had a higher risk of dying from any health cause compared to non-menthol cigarette smokers, in what the researchers claim is the largest and most comprehensive study of its kind.
The report said, among former smokers, those who smoked menthol cigarettes showed:
12% higher risk of death from all causes
16% higher risk from cardiovascular diseases
13% higher risk from coronary artery disease
43% higher risk from other heart diseases
“Mortality risks were shown to be especially high for individuals who quit smoking or smoked 40 or more menthol cigarettes per day,” the study said. “In addition, Black Americans who currently smoke menthol cigarettes face an 88% elevated risk of mortality from some heart diseases compared to those smoking non-menthol cigarettes.”
While smoking rates have declined overall, the study said menthol cigarettes continue to rise in popularity with Blacks, women, and youth. “Menthol cigarettes represented 36% of the market among major manufacturers in 2022—the highest percentage since reporting began in 1963.” The popularity of menthol extends beyond cigarettes, with vape and flavored nicotine pouches also available.
For the report, researchers followed nearly a million people from the Cancer Prevention Study II, tracking their health over six years. Of the participants, 73,486 smoked menthol cigarettes and 281,680 smoked non-menthol cigarettes. In that time, 4,071 menthol smokers and 20,738 non-menthol smokers died.
In a two-page order, U.S. District Judge Haywood S. Gilliam granted a request filed last week jointly by both the government defendants and the public health advocates who filed the lawsuit, seeking a stay on the proceedings until mid-August. The lawsuit filed by anti-tobacco groups seeking to challenge the Food and Drug Administration’s delay to ban menthol cigarettes was paused by a federal judge in response to moves made by the Trump administration.
Judge Haywood S. Gilliam Jr. for the US District Court for the Northern District of California issued a stay in the case between the African American Tobacco Control Leadership Council and the FDA over whether the agency lawfully delayed a Biden-era final rule that would ban menthol cigarettes from store shelves.
Both parties in a joint submission proposed the stay on Feb. 18.
In late January, the FDA withdrew its proposed rules to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors in cigars.
“The recent withdrawal of both proposed federal flavor bans is compelling evidence that the Trump administration is taking a less aggressive rulemaking posture compared to the Biden administration,” Troutman Pepper Locke wrote on its Tobacco Law Blog. “The Office of Information and Regulatory Affairs withdrawal filings do not detail the reasoning behind the decision. However, several comments submitted during each proposed rule’s comment period detail ample justifications for withdrawing the proposals.
“With respect to the menthol cigarette ban, industry argued that illicit markets would proliferate, fed by consumer demand for menthol cigarettes despite the proposed prohibition.”
The Trump administration issued a setback to health regulators and anti-tobacco activists as it withdrew a plan to ban menthol cigarettes in the United States.
In April 2022, the U.S. Food and Drug Administration (FDA) proposed to ban the sale of flavored cigars and menthol cigarettes after several health advocacy groups said they were highly addictive and attractive to young people. A January 21, 2025, filing by the Office of Information and Regulatory Affairs shows that the proposal has now been “withdrawn.”
The FDA sent its final version of the regulation to the White House in October 2023, however, the administration allowed dozens of meetings with groups opposing the rule, including civil rights advocates, business owners, and law enforcement officials, according to Reuters, with the government missing deadlines in December 2023 and March 2024 to issue a final rule on the ban.
An estimated 18.5 million smokers consume menthol cigarettes, comprising one-third of the U.S. market share, meaning a ban would have cost billions of dollars in annual revenue for the industry.
With news of the proposal withdrawal, Tobacco companies saw their stocks rise today, with British American Tobacco gaining 1.3% and both Altria Group and Philip Morris International gaining 1%. The market’s response suggests investor relief at the removal of a significant regulatory risk for these companies.
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.
