The Food and Drug Administration (FDA) in the United States recently proposed a ban on menthol-flavoured cigarettes. Professor Clifford E Douglas, of the University of Michigan School of Public Health, is concerned about calls for the menthol ban be expanded to other products, including e-cigarettes.
Douglas, who is also director of the University of Michigan Tobacco Research Network, wrote an opinion piece on the menthol ban that was published in MedPage Today on 2 May 2022. The article in MedPage Today, below, is followed by the FDA announcement regarding the proposed ban.
How far should the menthol ban go?
On 28 April, the FDA announced regulations to prohibit menthol as a characterising flavour in cigarettes and all characterising flavours (other than tobacco) in cigars. The agency said the proposals “have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the US, by reducing youth experimentation and addiction, and increasing the number of smokers that quit”.
Between 4 May and 5 July, the public can provide comments to the FDA, after which it will issue final rules. Once the final rules are issued, the industry is expected to sue to block them.
Much media attention has been devoted to FDA's announcement, but another close look is warranted, particularly focusing on concerns about unintended consequences and the demand by some that the menthol ban be extended to all ‘tobacco products’ including e-cigarettes.
Why ban menthol in cigarettes?
Douglas continues in MedPage Today:
First, the basics: menthol is a regulated drug when used in products like cough medicine and topical pain relievers, but in cigarettes and cigars it is used as a non-medicinal ‘flavour’ additive with a minty aroma and taste that makes it less irritating to inhale smoke. Menthol also interacts with nicotine in the brain to increase addiction.
FDA has explained that the new regulations are based on evidence of the greater addictiveness and harms of these products, expanding the restrictions legislated in 2009 by the Family Smoking Prevention and Tobacco Control Act, which prohibited all characterising flavours (other than tobacco and menthol) in cigarettes.
The elimination of menthol cigarettes is a social justice and child protection issue. In 2019, there were more than 18.5 million current menthol cigarette smokers ages 12 and older in the US, with especially high rates of use by youth, young adults and African American and other racial and ethnic groups. Over 80% of African Americans who smoke use menthols, compared to 30% of white smokers. Menthols are the favoured starter product for youth.
The fact that African Americans suffer disproportionately is no accident. The cigarette industry has aggressively targeted African American communities for decades.
The companies misappropriated black culture and bought allegiance and silence through heavy marketing investments in black publications and sponsorship of events like the Kool Jazz Festival, while cynically saturating black community, health, and educational organisations with philanthropic contributions.
Modelling studies, including ours from the FDA-funded Center for the Assessment of Tobacco Regulations, estimate as many as 654,000 smoking-attributable deaths, including 238,000 among African Americans, would be avoided over a 40-year period if menthol cigarettes were no longer available and adult smokers were offered effective nicotine alternatives.
Will there be unintended consequences?
Douglas continues in MedPage Today:
In opposition, cigarette manufacturers and their allies argue that the menthol ban will be used as a pretext for police to target black communities and result in a black market for menthol cigarettes and additives.
The FDA has made clear, however, that the regulations are directed at manufacturers, distributors, wholesalers, importers and retailers, and do not prohibit individual possession or use.
The FDA has acknowledged, however, “concerns related to how state and local law enforcement may enforce their own laws in a manner that may impact equity and community safety, particularly for underserved and underrepresented communities”, and requested public comments.
When it comes to black market concerns, data from Canada suggest little likelihood of a significant illicit market for menthol cigarettes. Surveys have also shown that a ban would encourage African Americans to quit using menthol cigarettes rather than pursue illicit products. Since no country with as large a menthol market as ours has banned menthol cigarettes, we can't be certain what the illicit market impact will be.
But there are things we can do to manage that risk, and that includes not banning menthol in all products.
Should the menthol ban extend to non-combustible products?
Douglas continues in MedPage Today:
This is why I am concerned that some menthol ban supporters are using this moment to urge, without scientific basis, that FDA expand the menthol ban to other ‘tobacco’ products, including e-cigarettes (which don’t contain or burn tobacco).
A 22 April letter to FDA Commissioner Dr Robert Califf, from a coalition of health groups led by the Campaign for Tobacco-Free Kids provides impressive scientific documentation supporting the proposed rules, while saying nothing about e-cigarettes or other non-combustible products…that is, until the last line of the letter, which states, without elaboration: “Finally, FDA's issuance of these rules should be the first step toward a broader set of product standards prohibiting all non-tobacco flavours in all tobacco products.”
The premature demand that menthol be banned in all tobacco products, if implemented, risks handing almost the entire tobacco marketplace over to cigarettes, which kill half of long-term users.
Science has demonstrated that a variety of non-combustible products offer reduced-risk alternatives for adult smokers who are either unable or unwilling to quit using nicotine completely.
These range from e-cigarettes and oral nicotine lozenges and pouches to such products as a very low-nitrosamine smokeless tobacco called snus. Research to date suggests that retaining menthol in some or perhaps all of them could help adults quit smoking.
Douglas continues in MedPage Today:
To their credit, Califf and Michele Mital, the acting director of FDA's Center for Tobacco Products, made clear that the agency is considering exempting certain products from the menthol ban.
The agency has already authorised mentholated versions of a nonaddictive, very low nicotine cigarette and a heated tobacco product called IQOS, which produces fewer harmful chemicals, determining these products are “appropriate for the protection of public health”.
As I've written previously, FDA has a profound responsibility to make evidence-based decisions. It is inappropriate for cigarette companies or health organisations to pressure the agency to make predetermined decisions, disregarding the agency's expertise and the impact such decisions will have on the lives of tens of millions of addicted adult smokers.
The best thing we can do now as healthcare practitioners, policy experts and concerned citizens is to support FDA’s life-saving efforts, trust the agency's scientific expertise, refrain from prejudging the science, and continue to work to drive down smoking as quickly as possible.
The opinions expressed are the author's and do not necessarily reflect the views of any organisation with which he is affiliated.
FDA commits to evidence-based actions aimed at saving lives and preventing future generations of smokers
The following announcement was made by the FDA on 29 April 2022.
Today, the US Food and Drug Administration announced it is committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the US.
The FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterising flavour in cigarettes and ban all characterising flavours (including menthol) in cigars; the authority to adopt product standards is one of the most powerful tobacco regulatory tools Congress gave the agency.
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 flavoured cigarettes in 2009.
“Banning menthol – the last allowable flavour – in cigarettes and banning all flavours in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” said Acting FDA Commissioner Dr 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 colour, low-income populations, and LGBTQ+ individuals, all of whom are far more likely to use these tobacco products.
“Together, these actions represent powerful, science-based approaches that will have an extraordinary public health impact. Armed with strong scientific evidence, and with full support from the Administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the US.”
The agency is taking urgent action to reduce tobacco addiction and curb deaths. 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.
Menthol masks unpleasant flavours 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 suggests that banning menthol cigarettes in the US would lead an additional 923,000 smokers to quit, including 230,000 African 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 averted for African Americans.
“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 Dr Mitch Zeller, director of the FDA Center for Tobacco Products.
“These flavour 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.”
If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavoured cigars will only address 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 FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.
These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity. The FDA is working expeditiously on the two issues, and the next step will be for the agency to publish proposed rules in the Federal Register allowing an opportunity for public comment.
The agency also recognises the importance of ensuring broad and equitable access to all the tools and resources that can help currently addicted smokers seeking to quit, including those who smoke menthol cigarettes and would be impacted by these public health measures.
The FDA will work with partners in other federal agencies to make sure the support is there for those who are trying to quit…
The FDA also remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS).
The Center for Tobacco Products recently provided an update on its ongoing work of conducting the premarket review of ENDS and other tobacco product applications, and has issued warning letters to ENDS product manufacturers and retailers who continue to sell products that are illegally on the market.
The FDA has also made a significant investment in a multimedia e-cigarette public education campaign. The campaign targets nearly 10.7 million youth aged 12-17 who have ever used e-cigarettes or are open to trying them, and highlights information about the potential risks of e-cigarette use.
Background on the actions
Today, the FDA granted a citizen 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 characterising flavours in cigarettes, leaving menthol cigarettes as the only flavoured combusted cigarettes still marketed in the US. 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 Tobacco Control Act, 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 non-menthol cigarettes and the impact of menthol on population health.
In the US, 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% smoke menthol cigarettes, compared to 30% 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.
Cigar flavour product standard
After the 2009 statutory ban on flavours in cigarettes other than menthol, use of flavoured cigars increased dramatically, suggesting that the public health goals of the flavoured cigarette ban may have been undermined by continued availability of these flavoured cigars.
Flavoured mass-produced cigars and cigarillos are combusted tobacco products that 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% of youth aged 12-17 who use cigars say they smoke cigars because they come in flavours they enjoy. Among youth who have ever tried a cigar, 68% of cigarillo users and 56% of filtered cigar users report that their first cigar was a flavoured product. Moreover, in 2020, more young people tried a cigar every day than tried a cigarette.
MedPage Today story – How Far Should the Menthol Ban Go? (Open access)
See also from the MedicalBrief archives
Is the FDA's cigarette ban just smoke and menthols? – MedPage Today op-ed
Impact of e-cigarette non-menthol flavours on perceptions and use
Menthol makes smokers want more