June 6, 2022.
National Center for Health Research’s Comments on the FDA’s Proposed Regulation to Establish Tobacco Product Standards for Menthol in Cigarettes and Characterizing Flavors in Cigars
We are writing to express our views on the Food and Drug Administration’s (FDA) proposed regulations to establish tobacco product standards for menthol in cigarettes and characterizing flavors in cigars.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which products, prevention strategies, and treatments are safest and most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We strongly support the proposed tobacco product standards that would prohibit menthol in cigarettes and prohibit characterizing flavors in all cigars. We concur with FDA that these regulations will have a profound impact on public health, saving lives by helping prevent youths from lifelong addiction as well as advancing health equity. As has been clearly established, Black Americans have been specifically targeted by the tobacco industry and have had disproportionately suffered from the adverse health effects of menthol cigarettes. We thus urge FDA to finalize and implement these regulations with utmost urgency.
These regulations are supported by overwhelming scientific evidence and are long overdue. In fact, in 2013 FDA’s own evaluation of the public health effects of menthol cigarettes pointed out that it is “likely that menthol cigarettes pose a public health risk above that seen with non-menthol cigarettes.” 1 Since menthol can mask the harshness of tobacco smoke as it cools and numbs the throat, it makes it easier for kids, young adults, and other non-smokers and new smokers to start smoking or experimenting with tobacco products. Research has shown that flavored tobacco products are particularly attractive to youth and are harder to quit, leading not only to increased smoking initiation, but also potentially lifelong use of tobacco products.
In recent years, menthol cigarettes accounted for 33% of cigarette sales, including in 2021.2 Recent research has shown that from 1980 to 2018 menthol cigarettes were responsible for “10.1 million extra smokers, 3 million life years lost and 378 000 premature deaths”3 and that in the same time period Black Americans were disproportionately harmed by menthol cigarettes, causing 157,000 premature deaths in this group alone.4 In addition, as the proposed rule points out, many cigar flavors include kid-friendly flavors such as “strawberry, grape, cocoa, and fruit punch”. It is thus not surprising that cigars are now the second most popular tobacco product among high school children,5 with Black youths at particular risk.
This disproportionate risk and the unique barriers to smoking cessation in racial, ethnic, and sexual minority populations (e.g., lack of financial and social support for prevention) have been ignored for far too long and the proposed product standards finally have the potential to reduce the tobacco-related health burden in minority communities in a meaningful way. Let us also be clear – this proposed prohibition only applies to industry, not consumers. Thus, by focusing on industry and not penalizing individual consumer possession of menthol cigarettes, this regulation is uniquely powerful in both promoting health and ensuring equity.
While the proposed product standards are an important first step, we also urge FDA to prohibit menthol in all e-cigarettes and related products, in addition to enforcing efforts to prohibit fruit, dessert, and some other flavored cartridge-based sales. E-cigarettes and similar products are very popular among youth and minority populations and companies are still circumventing regulations to aggressively market many types of flavored e-cigarettes and related products, including loopholes around flavored e-cigarettes that are disposable. These products are marketed as being benign compared to tobacco, but recent studies have highlighted the link between flavored e-cigarettes and inflammation in the gut and brain.5
In summary, we strongly support FDA’s proposed regulations, but urge their expansion to cover the wide variety of tobacco and nicotine products that are marketed to young people and minorities. Through such efforts, there is a significant opportunity to reduce nicotine addiction in the United States, particularly among young people who increasingly suffer from that addiction as they grow older.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.
- FDA. Preliminary Scientific Evaluation of the Possible Public Health effects of Menthol versus Nonmenthol Cigarettes. Published 2013. Accessed June 2, 2022. https://www.fda.gov/media/86497/download
- Ali FRM, Seaman EL, Schillo B, Vallone D. Trends in Annual Sales and Pack Price of Cigarettes in the US, 2015-2021. JAMA Network Open. 2022;5(6):e2215407. doi:10.1001/jamanetworkopen.2022.15407
- Le TT, Mendez D. An estimation of the harm of menthol cigarettes in the United States from 1980 to 2018. Tob Control. Published online February 25, 2021:tobaccocontrol-2020-056256. doi:10.1136/tobaccocontrol-2020-056256
- Consequences of a match made in hell: the harm caused by menthol smoking to the African American population over 1980–2018 | Tobacco Control. Accessed June 2, 2022. https://tobaccocontrol.bmj.com/content/early/2021/09/16/tobaccocontrol-2021-056748
- Moshensky A, Brand CS, Alhaddad H, et al. Effects of mango and mint pod-based e-cigarette aerosol inhalation on inflammatory states of the brain, lung, heart, and colon in mice. Elife. 2022;11:e67621. doi:10.7554/eLife.67621