Is the FDA's cigarette ban just smoke and menthols? – MedPage Today op-ed

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Dr Kenneth Warner of the University of Michigan School of Public Health argues in a MedPage Today op-ed that a ban on menthol cigarettes and cigars by the US Food and Drug Administration is an important step in the fight against smoking deaths and inequality – but it could take years to implement.

The open access op-ed, published on 3 May 2021, follows below:

Cigarette smoking annually claims the lives of 480,000 Americans, accounting for a sixth of all deaths (a seventh in the extraordinary pandemic year of 2020). That is more – a lot more – than the combined total of deaths caused by all licit and illicit drugs, alcohol, homicide, suicide, motor vehicle collisions, HIV-AIDS, and fires.

Cigarettes are not an equal opportunity killer, however. Notably, African Americans’ death rates from smoking exceeds that of white Americans, despite the fact that African Americans smoke fewer cigarettes and start smoking at a later age.

One potential factor is a far larger percentage of African American smokers use menthol cigarettes than do the smokers in any other racial or ethnic group. More than 80% of African American adult smokers smoke menthol cigarettes; less than a third of whites do.

Why does this matter? asks MedPage Today? Because menthol makes it easier to start smoking, more likely to progress to established smoking, and harder to quit.

As a consequence, menthol cigarettes were responsible for 10.1 million extra smokers and an additional 378,000 premature deaths from 1980 to 2018. A disproportionate number of those additional premature deaths were experienced by African Americans.

Menthol cigarettes are especially popular among new initiates to smoking of all racial-ethnicity groups. Creating a cooling sensation, menthol reduces the harshness of inhaled smoke, making it easier to start smoking.

More than half of all youth smokers, ages 12 to 17, use menthol cigarettes, including 95% of African American youth and 51% of whites, MedPage Today reports.

Now, after a multi-year fight over these products, the FDA announced last week a proposal to ban menthol in cigarettes and cigars. But even after the long and bumpy road to get to where we are today, there's much more work to be done.

The recent history of menthol in the US

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, giving the FDA responsibility to regulate tobacco products. Among its provisions, the Act prohibited the use of flavours in cigarettes – except for menthol.

It did, however, require the newly-established Tobacco Products Scientific Advisory Committee (TPSAC) to review the effects of the use of menthol in cigarettes on public health, including use by children, African Americans, and other racial and ethnic minorities.

TPSAC issued its report in 2011. The committee concluded that "removal of menthol cigarettes from the marketplace would benefit public health", according to MedPage Today. In 2013, FDA produced a report on its internal scientific investigation.

Similarly to TPSAC, FDA found "it likely that menthol cigarettes pose a public health risk above that seen with non-menthol cigarettes." In particular, the agency noted the problem menthol posed for African Americans regarding smoking cessation. However, the report emphasised: "This document does not constitute a decision about what regulatory action, if any, FDA might take with respect to menthol in cigarettes."

That was eight years ago, MedPage Today reports. At the time, 20 medical and health organisations, including two African American tobacco control organisations, petitioned the FDA to remove menthol cigarettes from the market.

In 2018, FDA Commissioner Dr Scott Gottlieb proposed a ban, but the Trump administration rejected the idea following substantial tobacco state political opposition. Last year, two organisations sued to force FDA to respond to the petition.

The court required the FDA to respond by 29 April 2021. On that day last week, the FDA announced that it would issue “proposed product standards within the next year: one to ban menthol as a characterising flavour in cigarettes and another to ban all characterising flavours (including menthol) in cigars". The latter is important, explains MedPage Today, because many young people smoke flavoured small cigars, a behaviour as dangerous as smoking cigarettes.

Matthew Myers, president of the Campaign for Tobacco Free Kids, responded to the announcement by saying, "The Administration's new policy has the potential to be the strongest action our nation has ever taken to drive down the number of kids who start smoking and the number of Americans who are sickened and killed by tobacco."

The statement reflects the enthusiasm with which the public health community greeted the announcement.

The fight isn’t over yet

Dr Kenneth Warner’s article continues:

The move is definitely encouraging – but before we fall head-over-heels in a rapturous response, we need to recognise that the actual implementation of the regulations, should it ever occur, is years into the future.

There are two major time-consuming impediments. One is the complex and lengthy bureaucratic maze that the FDA must traverse. The second is the protracted tobacco industry legal challenges that invariably follow any proposed regulation that might actually decrease cigarette sales.

Responding to the announcement, industry analysts uniformly concluded that, for these reasons, any outcome will take many years. Tellingly, the cigarette companies' stock prices hardly budged in response to the news.

Throughout the process, the political battle over the proposal will be intense, the MedPage Today article concludes.

The move has had consistent support from African American medical and public health organisations. It has garnered increasing political support, including recently from prominent African Americans in Congress.

But other prominent African Americans have expressed their opposition. Notably, the Reverend Al Sharpton has labeled the policy discriminatory and said it could exacerbate tensions between police and African Americans who were smoking smuggled menthol cigarettes. Arguments like these contributed to the defeat of a menthol ban in New York City in 2019.

But FDA considers the concern about police interactions unwarranted as the regulations would have legal ramifications only for the manufacturers and distributors of cigarettes, not individual consumers.

A ban on menthol cigarettes would serve the interests of social justice. The burden of disease and death wrought by smoking clearly falls disproportionately on African Americans, as well as other minority groups. Ultimately, a ban would reduce the significant disparity in life expectancy between blacks and whites in our society. As well, it almost certainly would reduce smoking among adolescents.

With 37 other countries having banned menthol in cigarettes, the US is a laggard. People have died as a consequence. Massachusetts and California have banned menthol, as have more than 100 US cities and towns. That the FDA may one day extend this protection to the entire country is welcome news, if long overdue.

* Dr Kenneth E Warner is the Avedis Donabedian Distinguished University Professor Emeritus and Dean Emeritus at the University of Michigan School of Public Health.


FDA commits to evidence-based actions aimed at saving lives and preventing future generations of smokers

FDA news release published on 29 April 2021

Efforts to ban menthol cigarettes and flavoured cigars build on a previous flavour ban and mark significant steps to reduce addiction and youth experimentation, improve quitting, and address health disparities, said the FDA material.

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.

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,” said Acting FDA Commissioner Janet Woodcock, MD.

“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 Mitch Zeller, JD, director of the FDA’s 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 recognizes 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. Smokers interested in quitting today should visit or call 1-800-QUIT-NOW to learn about cessation services available in their state.

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.


MedPage Today op-ed – Is FDA's cigarette ban just smoke and menthols? (Open access)

FDA news release – FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers (Open access)




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