FDA Bans Menthol and Flavored Cigars Through New Product Standards
The authority to adopt product standards is one of the most powerful tobacco regulatory tools that the U.S. Congress gives the U.S. Food and Drug Administration (FDA). In April 2021, FDA took full advantage of that authority, announcing two new standards (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers) to add menthol to the banned flavor list and ban all flavored cigars.
“Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products,” Acting FDA Commissioner Janet Woodcock, MD, said (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers). “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 (https://www.hhs.gov/about/news/2021/04/29/statement-hhs-secretary-xavier-becerra-fda-tobacco-actions-menthol-cigarettes-flavored-cigars.html), we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the United States.”
If implemented, the menthol ban would only affect manufacturers, distributors, wholesalers, importers, and retailers, not individual consumers. It would restrict any unlawful tobacco products from the market and drastically reduce access to those specifically targeted by Big Tobacco (https://voice.ons.org/advocacy/nurses-obliged-to-end-racism-tobacco-industrys-manipulative-marketing), including minorities, LGBTQ+ individuals, and low-income communities.
Through several congressional pieces of legislation in the past decade, FDA has received stronger authority over the marketing, sales, and distribution of tobacco products. However, the Tobacco Control Act of 2009 (https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/family-smoking-prevention-and-tobacco-control-act-overview) didn’t include menthol in the list of restricted flavors because of insufficient research on that specific additive at the time.
Since then, new research findings have validated the flavor’s addictive properties, particularly in minority populations. One study (https://tobaccocontrol.bmj.com/content/early/2021/03/31/tobaccocontrol-2020-056259) suggested that banning menthol cigarettes would help 923,000 smokers quit, including 230,000 African Americans, in the first 13–17 months after a ban went into effect. An earlier study (https://ajph.aphapublications.org/doi/full/10.2105/AJPH.2011.300179) projected that about 633,000 deaths would be averted, including about 237,000 deaths of African Americans.
Flavored cigars are disproportionately popular (https://voice.ons.org/news-and-views/first-time-smoking-age-increases-among-young-adults) among younger and minority audiences. Nearly 74% (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers) of youth cigar smokers (aged 12–17) say they smoke because of the enjoyable flavors. Among youth who have ever tried a cigar, 68% of cigarillo users and 56% of filtered cigar users report (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers)ed that their first product was flavored.
In 2020, more young people tried a cigar every day than those who tried a cigarette, and non-Hispanic Black high school students reported (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers) smoking cigars within the last month twice as often as their White counterparts.
“These flavor 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,” Mitch Zeller, JD, director of FDA’s Center for Tobacco Products, said (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers). “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.”
FDA plans to issue these proposed product standards within a year. The next step is to publish proposed rules in the Federal Register (https://www.federalregister.gov/) and open the conversation to public comment. FDA will also work with agency partners to ensure those trying to quit have access to supportive resources. Smokers interested in quitting today should visit smokefree.gov (https://smokefree.gov/) or call 1-800-QUIT-NOW to learn about the cessation services available in their state.
“For far too long, certain populations, including African Americans, have been targeted and disproportionately affected by tobacco use,” Zeller said (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers). “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 (https://voice.ons.org/news-and-views/cdc-outlines-racial-ethnic-cigarette-smoking-rates).”
ONS is an active member of the Campaign for Tobacco Free Kids (https://www.tobaccofreekids.org/) and publicly supported (https://www.ons.org/sites/default/files/2021-05/ONS%20Statement%20on%20FDA%E2%80%99s%20Decision%20in%20Restricting%20Menthol-Flavored%20Products%20and%20Electronic%20Nicotine%20Delivery%20Systems.pdf) FDA’s decision. Tobacco is the leading cause of preventable death (https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers) in the United States, and at least a dozen different cancers (https://www.cancer.gov/about-cancer/causes-prevention/risk/tobacco) are attributed to tobacco use. Oncology nurses must advocate (https://voice.ons.org/advocacy/get-involved-in-onss-health-policy-advocacy) for policy restrictions on these products and educate their patients (https://voice.ons.org/advocacy/resource-helps-explain-the-potential-dangers-of-e-cigarettes-to-providers-and-patients) about smoking cessation.