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FDA on Track to Take Actions to Address Tobacco-Related Health Disparities

Infographic showing arrow coming from left side. Top line - Menthol Cigarettes. Bottom line - Flavored Cigarettes. Merging into arrow - Product Standards. Right top - Reduce tobacco related disease and death. Right bottom - Advanced health equity.

By: Mitch Zeller, J.D., Director, Center for Tobacco Products

In April 2021, the U. S. Food and Drug Administration announced its intent to take significant action toward dramatically reducing tobacco-related disease and death in the U.S. The agency remains on track to advance two proposed tobacco product standards – one prohibiting menthol as a characterizing flavor in cigarettes and another prohibiting all characterizing flavors (including menthol) in cigars – by spring. 

Dr. Mitch Zeller
Mitch Zeller, J.D.

Given that each year nearly half a million people in the U.S. die prematurely from tobacco-related diseases, reducing the appeal of cigarettes and cigars will have an extraordinary public health impact.

These actions are an important opportunity to achieve significant, meaningful public health gains and advance health equity. 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.

Over the last 55 years, adult smoking rates have declined from 43% to 14%, but that progress hasn’t been experienced by everyone equally. Data from multiple national studies show that:

  • In the U.S., 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: Nearly 85% of all non-Hispanic Black smokers smoke menthol cigarettes, compared to 30% of non-Hispanic white smokers who use menthols. 
  • 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.
  • In 2020, non-Hispanic Black high school students reported past 30-day cigar smoking at levels twice as high as their non-Hispanic white counterparts. 

It’s a core part of the FDA’s mission to protect and advance public health by helping to reduce harm from regulated tobacco products. This includes striving to advance health equity by taking targeted steps to prevent youth from starting to smoke, helping more current smokers to quit for good, and addressing tobacco-related health disparities experienced by communities including, but not limited to, certain racial and ethnic populations, low-income populations, and LGBTQ+ individuals. 

We know the important role of flavors in facilitating initiation and addiction, especially for populations with disproportionate use of and harm from these products. We also have seen the benefits of prohibition of other flavored cigarettes. One of the most powerful ways to address these inequities is to advance these two product standards, which are expected to have enormous health benefits to these populations. And we remain on track to do just that.

Studies show that menthol increases the appeal of tobacco products and facilitates initiation and progression to regular smoking among youth and young adults. Cigarettes with menthol as a characterizing flavor can also be more addictive than non-menthol cigarettes and harder to quit by enhancing the effects of nicotine. Menthol cigarette smokers, particularly Black or African American smokers, are less likely to successfully quit smoking than non-menthol smokers. One modeling study estimates that prohibiting menthol in cigarettes and cigars could prevent 650,000 premature tobacco-related deaths and reduce life-years lost by 11 million over a 40-year period.

Flavors in cigars, such as fruit and sweet flavors, also facilitate initiation and progression to regular cigar smoking among young people. Beginning in 2019, cigars surpassed cigarettes as the most commonly reported combustible tobacco product used by youth. In 2019, more young people tried a cigar for the first time every day than tried a cigarette. And 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 flavored product. Certain cigars can closely resemble cigarettes and cigars pose many of the same harms as cigarettes.

Product standards are one of the most powerful tools Congress gave the FDA when it enacted the Tobacco Control Act. Much like it sounds, a product standard is a rule that sets requirements for a tobacco product; in this case, the product standards being proposed would prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors (including menthol) in cigars. 

As the next step in this process, we expect to issue proposed rules for these two product standards in the spring. At that point, the public will see the specifics of the proposed product standards and will have the opportunity to comment. In general, comments to proposed rule dockets may be helpful in determining what changes, if any, might be made from the proposed rule to a final rule. 

After reviewing and considering comments, the FDA could then proceed to issue final product standards, which would become enforceable once in effect.

If implemented, the FDA’s enforcement of any prohibition on menthol cigarettes and flavored cigars would 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 other tobacco product. 

As these changes are made, in partnership with partners across the U.S. Department of Health and Human Services and the federal government, the FDA will make sure the support is there for the millions of smokers who are trying to quit. Smokers interested in quitting today are encouraged to visit smokefree.gov or call 1-800-QUIT-NOW to learn about cessation services available in their state. 

Together, the product standards will help save hundreds of thousands of lives, with an especially pronounced benefit for certain racial and ethnic populations, low-income populations, and LGBTQ+ individuals. These actions are based on extensive scientific evidence establishing the addictiveness and harm of these products and they build on important previous actions to protect public health and advance health equity. 

For more quitting resources: Quitting Smoking and Other Tobacco Public Health Resources and Want to Quit Smoking? FDA-Approved Products Can Help

For more information on the FDA’s work on minority health and health equity: Office of Minority Health and Health Equity 


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