United States Food and Drug Administration
Department of Health and Human Services
via https://www.regulations.gov
Re: Docket Nos. FDA-2021-N-1349 and FDA-2021-N-1309
On behalf of our 25,000 physician, resident, and medical student members, the Massachusetts Medical Society (MMS) appreciates the opportunity to submit comments to the United States Food and Drug Administration (FDA) regarding the “Tobacco Product Standard for Menthol in Cigarettes” and “Tobacco Product Standard for Characterizing Flavors in Cigars” published in the Federal Register on May 4, 2022 (87 FR 26454 and 87 FR 26396).
The preventable health risks posed by tobacco and nicotine, and the flavor tactics used by Big Tobacco to enable addiction, have been present for far too long. For years, the Massachusetts Medical Society has advocated for tobacco control at the state
and federal levels to prohibit all flavored nicotine products and, since 2001, has urged the Massachusetts Congressional delegation to support legislative efforts to authorize the FDA’s regulation of nicotine and nicotine delivery products.
Relative to Docket No. FDA-2021-N-1349, “Tobacco Product Standard for Menthol in Cigarettes”, the MMS has encouraged the American Medical Association (AMA), the national physician membership organization, to “advocate, that the FDA extend the ban
on sale or distribution of any flavored cigarettes to include menthol and mint flavors and electronic nicotine delivery systems by any retailer, retail establishment, or other person or entity to any consumer.” (MMS House of Delegates, 5/4/2019)
The Commonwealth of Massachusetts passed landmark legislation in November 2019, which prohibited Big Tobacco’s targeting of youth, LGBTQ+, and Indigenous people, and communities of color by restricting the sale of menthol cigarettes and vaping products.
As of January 1, 2020, Massachusetts commercial health insurance plans and the state’s Group Insurance Commission and MassHealth are required to cover smoking cessation counseling and FDA-approved smoking cessation products, such as gum, lozenges, and
patches, without cost sharing. On June 1, 2020, sale of flavored combustible cigarettes and other flavored tobacco products, including menthol cigarettes and flavored chewing tobacco, was restricted in the Commonwealth to licensed smoking bars for
on-site consumption only. Also beginning on June 1, 2020, was an additional 75 percent excise tax on the wholesale price of nicotine vaping products, in addition to the state’s 6.25 percent sales tax. The MMS was and is a proud partner in the passage
of that law and continues to work with the AMA and Tobacco Free Mass, the state’s largest anti-tobacco and nicotine coalition, to create a united front against Big Tobacco.
As the FDA rightly states, tobacco use is the leading preventable cause of death and disease in the United States. Combining tobacco with menthol additives is known to make tobacco use more easily tolerated – and more addictive – by reducing the body’s
response to irritants found in smoke. Menthol makes it harder to quit tobacco use, and menthol cigarettes are more addictive and may be more dangerous. Studies from the FDA and other scientific entities conclude that menthol cigarettes are associated
with increased nicotine dependence and reduced success in smoking cessation.
It is well documented that tobacco companies have targeted Black, Indigenous, Latinx, and LGBTQ+ communities with their flavored products, including menthol. Youth are also targeted, particularly with flavors including menthol, through vaping products
and little cigars. The MMS and other public health-related organizations, both state-wide and nationally, have pushed back against the tobacco industry’s newest tactic to promote themselves as defenders of public health through deceitful advertising
and disinformation campaigns. A local example of this tactic is recent image polishing by Phillip Morris International (PMI) in The Boston Globe. The Globe accepted sponsored content from PMI, which included articles on ‘innovation”
and touted PMI products as solutions to those addicted to tobacco and nicotine products. Similar sponsored content has also run in The New York Times and other newspapers across the country.
The 2020 Surgeon General’s Report on smoking cessation found that Black Americans are less likely to quit smoking due to a higher use of menthol cigarettes. More than half of all high school students who smoke use menthol cigarettes, and over 90% of African
American youth who smoke use menthol cigarettes. According to Truth Initiative, because African Americans use menthol cigarettes at higher rates, menthol also contributes to health inequities.
In 2018, the National Medical Association, the largest and oldest national organization representing African American physicians and their patients, passed policy in support of banning menthol cigarettes. The NAACP also strongly supports a ban on menthol
flavoring.
Carol McGruder, Co-Chair of the African American Tobacco Control Leadership Council, states that “Big Tobacco is now using race as an excuse to keep products on the market saying if menthol products are taken away, more police violence against Black Americans
will ensue.” The MMS notes, however, that the FDA proposal will only address manufacturers, distributors, wholesalers, importers, and retailers, not individual consumers.
Tobacco companies have advertised at sexual- and gender-diverse community events, have contributed to HIV/AIDS organizations, and are visible at gay pride festivals, evidencing their targeting of these communities. The American Lung Association details
that, according to the CDC, approximately 36% of LGBTQ+ smokers report smoking menthol cigarettes compared to 29% of heterosexual smokers.
Relative to Docket No. FDA-2021-N-1309, “Tobacco Product Standard for Characterizing Flavors in Cigars”, flavors make it easier for kids to start using tobacco products, as those grape, watermelon, and other additives mask the harsh taste of tobacco.
As the FDA did with flavored electronic cigarettes (with the exclusion of menthol flavoring), the MMS supports banning these flavors to decrease the number of youth and young adults who try and quickly become addicted to nicotine.
The benefits of reducing tobacco-related health disparities and advancing health equity to historically marginalized people and protecting all young people from tobacco are compelling. The MMS applauds the FDA’s proposal of a tobacco product standard
that would prohibit characterizing flavors (other than tobacco) in all cigars and their component parts, as well as the proposal to prohibit menthol as a characterizing flavor in cigarettes. As these proposals are intended to reduce uptake of tobacco
use, we urge the FDA to similarly prohibit menthol as a characterizing flavor in electronic nicotine delivery systems, while also considering enforcement mechanisms and messaging that will promote equity.
The Massachusetts Medical Society appreciates the opportunity to provide comments to the FDA in our shared goal of providing the highest quality health and health care to patients. The MMS’ comments and recommendations are guided by our policies, our
membership, and our commitment to providing high quality, equitable care to all patients. Should you have any questions, please contact Casey Rojas, Federal Relations and Health Equity Manager, at crojas@mms.org or (781) 434-7082.
View a PDF version of these comments here.