iOn May 4, 2022, the U.S. Food and Drug Administration (FDA) initiated a notice and comment rulemaking process to ban menthol-flavored cigarettes and all characterizing flavors in cigars and cigarillos.[1] Recently, Health and Human Secretary Xavier Becerra announced the ban on menthol-flavored cigarettes will be delayed indefinitely. This article explores the long history of the proposed ban on menthol-flavored cigarettes.
A. Cigarette Characterizing Flavor Ban in Tobacco Control Act
The availability of menthol combustible cigarettes has long been a subject of controversy due to the checkered history of menthol use in cigarettes. When it passed the Family Smoking Prevention and Tobacco Control Act (TCA) in 2009, Congress explicitly excluded menthol and tobacco flavored cigarettes from the TCA’s ban on the sale of cigarettes with characterizing flavors.[2] Thus, absent a tobacco product standard from FDA, menthol and tobacco flavors are permitted for use under the TCA’s flavored cigarette ban.[3]
Instead of including menthol in the cigarette flavor ban, Congress directed the Tobacco Products Scientific Advisory Committee (TPSAC) to review and report on the “issue of the impact of menthol in cigarettes on the public health, including such use among children, African-Americans, Hispanics, and other racial and ethnic minorities,” and gave FDA the authority to regulate the use of menthol in cigarettes through its rulemaking procedures.[4]
In 2011, TPSAC published its long-awaited report on menthol cigarettes.[5] The report concluded that menthol cigarettes have an adverse impact on public health and do not provide any health benefit or reduced risk compared to non-menthol cigarettes.[6] Consequently, TPSAC voted to remove menthol cigarettes from the marketplace.[7] But the Committee also identified a number of negative consequences that could result from a menthol cigarette ban, including consumer evasion, aftermarket mentholation, and proliferation of black market products.[8]
Following the TPSAC report, FDA issued an advance notice of proposed rulemaking (ANPRM) requesting information on whether it should take action to regulate menthol cigarettes, published its preliminary scientific evaluation of the possible public health effects of menthol compared to non-mentholated cigarettes, and commissioned several menthol-related scientific studies.[9] In 2013, a group of public health advocates filed a citizen petition urging FDA to take immediate action to prohibit menthol as a characterizing flavor in cigarettes.[10]
In 2018, then-FDA Commissioner Dr. Scott Gottlieb announced that the Agency would soon begin the rulemaking process to ban menthol in cigarettes as part of the Agency’s Comprehensive Plan for Tobacco and Nicotine Regulation.[11] But in 2020, having still received no response from FDA, the citizen petitioners filed a federal lawsuit to compel the Agency to respond to the eight-year-old petition alleging, in part, that FDA’s failure to initiate the rulemaking process and prohibit menthol in cigarettes despite having sufficient evidence constituted an “unreasonable delay” of Agency action under the Administrative Procedure Act.[12]
The call to ban all characterizing flavors in cigars and menthol cigarettes received increasing support leading up to FDA’s April 2021 announcement. On January 22, 2021, approximately two dozen attorneys general submitted a comment to the citizen petition asking FDA to initiate rulemaking to prohibit menthol cigarettes.[13] In addition, Health and Human Services Secretary Xavier Becerra expressed support for FDA’s menthol and cigar product standards and indicated that addressing tobacco-related death and disease is a priority for the Biden Administration.[14]
B. FDA Rulemaking to Ban Menthol and Characterizing Flavors
On April 29, 2021, FDA announced that it would initiate the notice and comment rulemaking process to not only ban menthol as a characterizing flavor in cigarettes, but also all characterizing flavors in cigars and cigarillos (including menthol).[15]
With respect to menthol cigarettes, FDA explained that, based on its understanding of the available science and evidence, menthol increases the appeal, potential for initiation, and addictiveness of cigarettes.[16] Banning the flavored product that nearly 18.6 million American smokers use could save hundreds of thousands of lives, according to FDA, thereby significantly reducing tobacco-related disease and death in the United States.[17]
With respect to cigars, FDA indicated that the continued availability of flavored cigars and cigarillos undermines the TCA’s characterizing flavor ban for cigarettes.[18] After the TCA prohibited characterizing flavors in cigarettes, use of flavored cigars increased dramatically, according to the Agency.[19] Since cigars and cigarillos are combusted tobacco products, they pose the same public health problems as cigarettes “and are disproportionately popular among youth.”[20] According to FDA, in 2020, more young people first tried a cigar every day than tried a cigarette, and “74% of youth aged 12–17 who use cigars said they smoke cigars because they come in flavors they enjoy.”[21]
Per FDA, “[c]haracterizing flavors in cigars, such as strawberry, grape, cocoa and fruit punch, increase appeal and make cigars easier to use, particularly among youth and young adults.”[22] “More than a half million youth in the U.S. use flavored cigars, and in recent years more young people tried a cigar every day than tried a cigarette.”[23] The goals of the new product standard prohibiting the use of characterizing flavors are to:
- “reduce the appeal of cigars, particularly to youth and young adults, and decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use; and
- improve public health by increasing the likelihood that existing cigar smokers may quit.”[24]
C. Comments on Menthol Ban and Characterizing Flavor Ban
On August 2, 2022, the comment period closed on proposed regulations that would ban the use of menthol in cigarettes and as a characterizing flavor in cigars.[25] FDA indicated in an August 10, 2022, announcement that it “received a very large number of comments – nearly 250,000 comments, including approximately 175,000 for the menthol cigarettes proposed rule and approximately 71,000 for the flavored cigars proposed rule.”[26]
Multiple groups have noted in the comments:
- Non-tobacco flavored ENDS should be permitted on the market as a viable alternative to combusted menthol cigarettes;[27]
- Youth smoking of combustible cigarettes is at an all-time historic low and concerns over youth smoking are conflated by FDA;[28]
- FDA’s focus should be on transitioning combusted menthol cigarette smoker to less harmful ENDS products;[29]
- Adult smokers prefer non-tobacco flavored ENDS;[30] and
- FDA must institute an effective off ramping mechanism for menthol cigarette smokers and develop plausible smoking reduction and cessation plans, which would include continuing to allow non-tobacco flavored ENDS to remain on the market.[31]
The Agency is required to read each of the comments and has indicated it will continue to update the public on the status of the comment review and rulemaking process. Although officials targeted to finish rulemaking on menthol cigarettes and flavored cigars by the end of 2023, FDA extended the deadline to March 2024.[32] However, by April 2024, the Agency had not promulgated the rules for menthol cigarette or characterizing flavors in cigars. On April 2, 2024, the African American Tobacco Control Leadership Council, Action on Smoking and Health, and National Medical Association filed suit against the U.S. Department of Health and Human Services (HHS) and FDA claiming violations of the Tobacco Control Act and Administrative Procedure Act for FDA’s failure to implement a ban on menthol cigarettes within a reasonable time.[33] The complaint requests that the court order HHS and FDA to promulgate the proposed rule banning menthol in combustible cigarettes within a reasonable timeframe, among other things.[34]
D. Secretary Becerra Delays Finalizing the Menthol Ban Without a New Deadline
After passing the 2023 end-of-year deadline, the extended March 2024 deadline, the Biden Administration – with an election on the horizon – has again delayed finalizing the rule banning menthol in combustible cigarettes. In a statement on April 26, 2024, HHS Secretary Xavier Becerra said that finalizing the rule “will take significantly more time” and noted the “historic attention” and “immense amount of feedback” that the proposed rule has received.[35] Secretary Becerra did not provide any new deadlines or timeframes by which the rule will be finalized. Further, Secretary Becerra’s statement expressly applies only to the proposed ban on menthol in cigarettes, though, at the time of his statement, the proposed ban on characterizing flavors in cigars still has yet to be finalized.
Kelsey Anliker also contributed to this article.
[1] Tobacco Product Standard for Characterizing Flavors in Cigars, 87 Fed. Reg. 26,396 (May 4, 2022); Tobacco Product Standard for Menthol in Cigarettes, 87 Fed. Reg. 26,454 (2022)
[2] 21 U.S.C. § 387g(a)(1)(A).
[3] Id.
[4] Congress authorized the creation of the TPSAC from a diverse array of technically qualified individuals trained and experienced in medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products, in order to advise FDA on tobacco product regulation based on safety, dependence, and health issues related to the use of tobacco products, including the public health impact of menthol cigarettes. See U.S. Food & Drug Admin., Tobacco Products Scientific Advisory Committee, (Sep. 20, 2023), https://www.fda.gov/advisory-committees/committees-and-meeting-materials/tobacco-products-scientific-advisory-committee#:~:text=The%20Tobacco%20Products%20Scientific%20Advisory%20Committee%20(TPSAC)%20advises%20the%20FDA,the%20regulation%20of%20tobacco%20products.
[5] U.S. Food and Drug Admin., Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes, (July 1, 2011), https://www.fda.gov/media/86497/download.
[6] Id. at 6.
[7] Id. at 3.
[8] Id.
[9] See Menthol in Cigarettes, Tobacco Products; Request for Comments, 74 Fed. Reg. 44484 (July 24, 2013) (to be codified at 21 C.F.R. 1140).
[10] See generally Tobacco Control Legal Consortium et al., Citizen Petition to Food & Drug Admin., Prohibiting Menthol as Characterizing Flavor in Cigarettes (Apr. 12, 2013), https://www.publichealthlawcenter.org/sites/default/files/resources/tclc-fdacitizenpetition-menthol-2013.pdf.
[11] See FDA Statement, Scott Gottlieb, M.D., Statement from FDA Commissioner Scott Gottlieb, M.D., On Proposed New Steps to Protect Youth by Preventing Access to Flavored Tobacco Products and Banning Menthol in Cigarettes (Nov. 15, 2018), https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-proposed-new-steps-protect-youth-preventing-access; U.S. Food and Drug Admin., FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation, https://www.fda.gov/tobacco-products/ctp-newsroom/fdas-comprehensive-plan-tobacco-and-nicotine-regulation.
[12] See generally African Am. Tobacco Control Leadershipv. U.S. Dep’t of Health & Human Servs., 571 F.Supp. 3d 1144 (N.D. Cal. 2021).
[13] Att’ys Gen., Docket No. FDA-2013-P-0435, Comments on Tobacco Control Legal Consortisum, et. al., Citizen Petition to the Federal Food and Drug Administration Related to Prohibiting Menthol as a Characterizing Flavor in Cigarettes (Apr. 12, 2013), https://www.regulations.gov/comment/FDA-2013-P-0435-0101.
[14] Dep’t of Health and Human Servs., Statement by HHS Secretary Xavier Becerra on FDA Tobacco Actions on Menthol Cigarettes and Flavored Cigars (Apr. 29, 2021)https://www.hhs.gov/about/news/2021/04/29/statement-hhs-secretary-xavier-becerra-fda-tobacco-actions-menthol-cigarettes-flavored-cigars.html.
[15] U.S. Food and Drug Admin., FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers (Apr. 29, 2022), https://www.fda.gov/news-events/press-announcements/fda-commits-evidence-based-actions-aimed-saving-lives-and-preventing-future-generations-smokers.
[16] See id.
[17] Id.
[18] Id.
[19] Id.
[20] Id.
[21] Id.
[22] U.S. Food and Drug Admin., FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death (Apr. 28, 2022), https://www.fda.gov/news-events/press-announcements/fda-proposes-rules-prohibiting-menthol-cigarettes-and-flavored-cigars-prevent-youth-initiation.
[23] Id.
[24] Id.
[25] See generally Tobacco Product Standard for Menthol in Cigarettes, 87 Fed. Reg. 26,454 (2022); Tobacco Product Standard for Characterizing Flavors in Cigars, 87 Fed. Reg. 26,396 (2022).
[26] U.S. Food & Drug Admin., Comment Period Closed for FDA Proposed Rules Prohibiting Menthol Cigarettes and Flavored Cigars (Aug. 10, 2022), https://www.fda.gov/tobacco-products/ctp-newsroom/comment-period-closed-fda-proposed-rules-prohibiting-menthol-cigarettes-and-flavored-cigars.
[27] See id.
[28] See id.
[29] See id.
[30] See id.
[31] See id.
[32] See Off. of Info. & Regul. Affs., Tobacco Product Standard for Menthol in Cigarettes, https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI60; See Off. of Info. & Regul. Affs., Tobacco Product Standard for Characterizing Flavors in Cigars, https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI28.
[33] Plaintiff’s Complaint, Afr. Am. Tobacco Control Leadership Council v. U.S. Dep’t Health Hum. Servs., No. 4:2024cv01992 (N.D. Cal. Apr. 2, 2024).
[34] Id. at 48.
[35] U.S. Dept. of Health and Human Services, Secretary Becerra Statement on the Proposed Menthol Cigarette Rule, (April 26, 2024), https://www.hhs.gov/about/news/2024/04/26/secretary-becerra-statement-proposed-menthol-cigarette-rule.html.
