Durbin, Duckworth Join Merkley, Colleagues In Call To Ban Menthol Cigarettes

Dear OMB Director Shalanda Young:
We write to you regarding the Biden administration's recent indication in the Unified Agenda of
Regulatory and Deregulatory Actions that it would delay finalizing a long-overdue federal rule to
prohibit the manufacture and retail sale of menthol as a characterizing flavor in cigarettes. We are extremely concerned that the rule is now expected to be released in March 2024, which is two years after the Food and Drug Administration's (FDA's) April 2022 announcement of the proposed rule Likewise, we are also awaiting a final rule to ban all flavors in cigars, a proposed rule that was also announced in April 2022. We write today to urge the FDA and OMB to act with urgency to solidify and enforce the bans on these harmful products as soon as possible. Simply put, delays in finalizing these rules will only bring more addiction and death.

The harmful effects of these products on public health have been well-understood for several
years and cannot be overstated. In 2013, the FDA released a report that found that menthol
cigarette use is associated with increased smoking initiation among youth and young adults,
greater signs of nicotine dependence, and less success in smoking cessation. This report collectively indicated that menthol cigarettes pose a greater public health risk than non-menthol cigarettes.
Flavored cigars also present a pressing public health risk--particularly for youth-- with nearly 74 percent of youth cigar users aged 12-17 choosing to smoke cigars because of their flavors.

These findings are also reinforced by more recent data. In 2019, nearly 18.6 million Americans
smoked menthol cigarettes. Youth who smoke are more likely to smoke menthol cigarettes than
older smokers, with almost half of the cigarette smokers ages 12-18 choosing to smoke menthol
cigarettes. Big Tobacco has also aggressively targeted minority communities, particularly the
African American community, through efforts at the point of sale, branding, and sponsorship to
push these products. As a result, among individuals who smoke, nearly 85 percent of African
Americans use menthol cigarettes, compared to 47.7 percent of Hispanics, 41.1 percent of
Asians, and 30.3 percent of whites.

We are also aware of additional delay in the comment period for these rules, with the original
comment deadline falling from July 5, 2022, to August 2, 2022. In addition, the unified federal agenda indicated that the rules were supposed to be finalized in August 2023, and then
administration officials indicated that they would finish by December 2023. While we appreciate
the need for thorough, well-informed rulemaking, it is clear that these products pose significant
and persistent threats to public health, and the longer these products are allowed on the market,
the more harm consumers and the American public will face.

Because of these scientific findings, concerning statistics, and slipping deadlines, the need to act
swiftly in finalizing and enforcing these regulations is critical. However, past rulemaking
processes have shown a concerning trend of inaction from the FDA. More than a decade ago, in
2013, the FDA published an advance notice of proposed rulemaking (ANPRM) to obtain
information related to the potential regulation of menthol in cigarettes, and again in 2018 related
to the regulation of broad flavors in tobacco products. In March 2019, the FDA announced that
it was considering removing flavored cigars that were on the market as of August 8, 2016. And
almost two years ago, in April 2022, the FDA announced its intention to ban menthol as a characterizing flavor in cigarettes, and all flavored cigars. Despite these repeated overtures, the
FDA has yet to issue a final rule on these topics, much less begin enforcement--which the FDA
has been clear would only fall upon manufacturers, distributors, wholesalers, importers, and
retailers for violations of the Federal Food, Drug, and Cosmetic Act, and would not take place
against individuals either by the FDA or by state and local law enforcement.

The data uncovered over the last decade is more than clear. Menthol cigarettes and flavored
cigars have contributed to a public health crisis, and the administration must center those
impacted and finalize these rules immediately.

Thank you for your attention to this critical public health concern. We look forward to your
responses and working with your agency to advance public health in our country.

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