FDA Proposes Banning Menthol Cigarettes and Flavored Cigars (2022)

Table of Contents

1. What the FDA Proposed in April and May 2022
2. The Menthol Cigarette Proposal
3. The Flavored Cigar Proposal
4. What the FDA Says Menthol Does
5. The Figures the FDA Gave
6. Who Would Have Been Bound: Enforcement and Equity
7. Comments, Listening Sessions and the Extended Deadline
8. What the Proposals Did Not Do
9. Dates and Legal Status as of October 18, 2026
10. How the Proposals Fit Earlier and Later FDA Tobacco Actions
11. Primary Documents
12. Key Research Papers
13. Connections
14. Featured Videos

1. What the FDA Proposed in April and May 2022

The FDA’s news release of April 28, 2022 announced “proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars.” A tobacco product standard is a rule that sets requirements for how a tobacco product is made — in these two cases, which flavors a cigarette or cigar may have. The FDA’s Commissioner, Robert M. Califf, M.D., described the power to adopt such standards as “one of the most powerful tools Congress gave the FDA.”

The two proposals were published as separate documents in the Federal Register, the U.S. government’s daily publication of rules and official notices, on May 4, 2022:

• “Tobacco Product Standard for Menthol in Cigarettes” — 87 FR 26454 (49 pages), Docket No. FDA-2021-N-1349, Regulation Identifier Number (RIN) 0910-AI60, to become a new part 1162 of title 21 of the Code of Federal Regulations.
• “Tobacco Product Standard for Characterizing Flavors in Cigars” — 87 FR 26396 (56 pages), Docket No. FDA-2021-N-1309, RIN 0910-AI28, to become a new part 1166 of title 21.

A proposed rule is the first formal step of federal rulemaking: the agency publishes the text it is considering, the public comments, and the agency then decides whether to issue a final rule. The FDA’s release put it this way: “Once all the comments have been reviewed and considered, the FDA will decide whether to issue final product standards.” A Federal Register docket is the public file for an action, where the documents and comments are kept on regulations.gov.

The Secretary of Health and Human Services, Xavier Becerra, said in the release that “The proposed rules would help prevent children from becoming the next generation of smokers and help adult smokers quit,” and that they “represent an important step to advance health equity by significantly reducing tobacco-related health disparities.”

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2. The Menthol Cigarette Proposal

The Federal Register summary states that the FDA was “proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes.” It opens with the agency’s premise: “Tobacco use is the leading preventable cause of death and disease in the United States.”

The summary gives two aims for the standard:

• to “reduce the appeal of cigarettes, particularly to youth and young adults, and thereby decrease the likelihood that nonusers who would otherwise experiment with menthol cigarettes would progress to regular smoking”; and
• to “improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation.”

It adds that the proposed standard “also is expected to reduce tobacco-related health disparities and advance health equity.” The summary counts “over 18.5 million menthol cigarette smokers ages 12 and older in the United States”; the FDA’s release dates that count to 2019 and describes “particularly high rates of use by youth, young adults, and African American and other racial and ethnic groups.”

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3. The Flavored Cigar Proposal

The second proposal would “prohibit characterizing flavors (other than tobacco) in all cigars and their components and parts.” The Federal Register summary names the kinds of flavors involved — “strawberry, grape, cocoa, and fruit punch” — and states that they “increase appeal and make the cigars easier to use, particularly among youth and young adults.” It reports that “Over a half million youth in the United States use flavored cigars.”

The FDA’s fact sheet issued with the announcement explains what the rule meant by a cigar: “a roll of tobacco wrapped in leaf tobacco or in a substance that contains tobacco,” ranging from little filtered cigars and cigarillos to “large so-called premium cigars.” The proposal covered all of them.

The summary states the aims as reducing the appeal of cigars to young people, which would “decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use,” and reducing “the tobacco-related death and disease associated with cigar use.” The release adds that the standard would “improve public health by increasing the likelihood that existing cigar smokers may quit.” Like the menthol proposal, the cigar proposal states it is expected to reduce tobacco-related health disparities.

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4. What the FDA Says Menthol Does

The FDA’s fact sheet describes menthol as “a flavor additive with a minty taste and aroma that is widely used in consumer and medicinal products due to its reported cooling or painkilling properties.” The April 28 release sets out the agency’s account of why it matters in cigarettes:

• menthol “reduces the irritation and harshness of smoking,” which “increases appeal and makes menthol cigarettes easier to use, particularly for youth and young adults”;
• menthol “interacts with nicotine in the brain to enhance nicotine’s addictive effects”;
• the combination of flavor, sensory effects and this interaction “increases the likelihood that youth who start using menthol cigarettes will progress to regular use”;
• menthol “also makes it more difficult for people to quit smoking.”

The release describes the proposals as “based on clear science and evidence establishing the addictiveness and harm of these products.” Among its related documents it lists the FDA’s earlier “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes.” Some of the independent research on menthol and flavored tobacco is listed under Key Research Papers; how nicotine dependence works is described on the site’s Nicotine Addiction and Withdrawal page.

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5. The Figures the FDA Gave

The release and fact sheet give the following numbers. The projections are estimates from published modeling studies, which is how the FDA itself attributes them.

Menthol cigarettes

• Projected effect of removing menthol cigarettes: “Published modeling studies have estimated a 15 percent reduction in smoking within 40 years if menthol cigarettes were no longer available in the United States.”
• Projected deaths avoided: the same studies estimate that “324,000 to 654,000 smoking attributable deaths overall (92,000 to 238,000 among African Americans) would be avoided over the course of 40 years.”
• Who uses menthol cigarettes: the fact sheet states that “Nearly 85% of all non-Hispanic Black smokers use menthol cigarettes, compared to 30% of non-Hispanic White smokers,” and that from 2011 to 2018 declines in menthol cigarette use were seen among non-Hispanic White youth “but not among non-Hispanic Black or Hispanic youth.”

Cigars

• Youth use: according to the 2020 National Youth Tobacco Survey cited in the fact sheet, an estimated 3.5% (960,000) of middle and high school students had smoked a cigar, cigarillo or little cigar in the preceding 30 days; 58.3% of youth cigar smokers, about 550,000 young people, reported using a flavored one.
• Who tries cigars: the fact sheet states that in 2019 more young adults tried a cigar for the first time each day than tried a cigarette for the first time (3,163 cigar versus 2,640 cigarette initiates per day). The release puts it as “in recent years more young people tried a cigar every day than tried a cigarette.”
• Deaths: “Each year, an estimated 9,000 premature deaths are attributed to regular cigar smoking,” about 5,200 of them in cigar smokers who do not also currently smoke cigarettes.
• Differences between groups: in the 2020 survey data, 6.5% of non-Hispanic Black middle and high school students reported past-30-day cigar use, compared with 2.8% of non-Hispanic White students.

Cancer

The release tied both proposals to the federal Cancer Moonshot, which it described as aiming “to reduce the death rate from cancer by at least 50 percent over the next 25 years,” and stated that “approximately 30 percent of all cancer deaths in the United States are caused by smoking.” Smoking-related diseases are described on the site’s Lung Cancer and COPD pages.

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6. Who Would Have Been Bound: Enforcement and Equity

Both the release and the fact sheet make the same statement about individual smokers: “the FDA cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars.” If the rules were finalized, FDA enforcement “will only address manufacturers, distributors, wholesalers, importers and retailers who manufacture, distribute, or sell such products within the U.S. that are not in compliance.” The documents add: “These proposed regulations do not include a prohibition on individual consumer possession or use.”

The FDA also addressed the role of police. State and local law enforcement agencies, the release states, “do not independently enforce the Federal Food, Drug and Cosmetic Act and do not, and cannot, take enforcement actions against any violation of FDA’s tobacco authorities, including its regulations, on the FDA’s behalf.” At the same time the agency said it “recognizes concerns related to how state and local law enforcement may enforce their own laws in a manner that may impact equity and community safety, particularly for underserved and underrepresented communities.”

For that reason the FDA asked the public for comment on, among other things, how it could “best make clear the respective roles of the agency and state and local law enforcement,” and on “policy considerations related to the potential racial and social justice implications of the proposed product standards.”

The release also stated that the FDA and HHS were working with other federal agencies on access to help for people trying to quit, noted that many insurance plans cover tobacco cessation services such as medication and counseling without out-of-pocket cost, and pointed to the federal smokefree.gov site and the 1-800-QUIT-NOW line. These are the FDA’s statements; decisions about quitting aids belong with a clinician.

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7. Comments, Listening Sessions and the Extended Deadline

• Original deadline. Both proposed rules asked for electronic or written comments by July 5, 2022.
• Listening sessions. A separate Federal Register notice published the same day (87 FR 26311, covering both dockets) announced virtual listening sessions on June 13 and 15, 2022, where the FDA would present information on the proposals and the public could make open comments; requests to speak were due by June 6, 2022. The release said the sessions would be recorded and submitted to the dockets, and described them as a way “to expand direct engagement with the public, including affected communities.”
• Extension. On June 21, 2022, the FDA extended the comment period on both proposals to August 2, 2022 (87 FR 36786), “in response to requests for an extension to allow interested persons additional time to submit comments.”
• The count. An FDA Center for Tobacco Products newsroom item of August 10, 2022 reports that the comment period, extended from 60 to a total of 90 days, closed on August 2, and that the FDA received “nearly 250,000 comments on these two proposed rules combined, including approximately 175,000 for the menthol cigarettes proposed rule and approximately 71,000 for the flavored cigars proposed rule.”

The same newsroom item said the agency had begun reviewing the comments, data and expert opinions submitted, that it was “committed to completing the rulemaking process as quickly as possible,” and that it “will need ample time to comprehensively review and analyze all of the comments.”

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8. What the Proposals Did Not Do

• They did not ban anything. A proposed rule has no legal effect, and because no final rule was ever issued, no federal ban on menthol cigarettes or flavored cigars took effect.
• They would not have penalized individual smokers. The FDA stated that it “cannot and will not enforce against individual consumers for possession or use”; enforcement would have been aimed at makers, distributors, importers and sellers.
• They did not cover e-cigarettes. The menthol proposal addressed cigarettes, and the flavor proposal addressed cigars. FDA actions on e-cigarettes and other nicotine products are reported on separate pages (section 10).
• They did not change the 2009 flavor ban. The ban Congress set in 2009 on cigarettes with characterizing flavors other than tobacco and menthol was already in force and was not part of these rulemakings.
• They did not limit nicotine. A separate proposal on nicotine levels in cigarettes and some other smoked products came only in January 2025, as the 2025 page reports.

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9. Dates and Legal Status as of October 18, 2026

• April 28, 2022: the FDA announces the two proposed product standards.
• May 4, 2022: both proposed rules (87 FR 26454 and 87 FR 26396) and the listening-session notice (87 FR 26311) are published.
• June 13 and 15, 2022: virtual public listening sessions.
• June 21, 2022: comment period extended to August 2, 2022 (87 FR 36786).
• August 2, 2022: comment period closes; nearly 250,000 comments received.
• October 13, 2023: the final versions of both rules are sent to the White House Office of Management and Budget (OMB) for review.
• January 21, 2025: both final rules are withdrawn from OMB review before publication.
• July 25, 2025: the date the Spring 2025 federal regulatory agenda gives for the withdrawal of both rulemakings.

Status as of October 18, 2026: proposed only, never finalized. The final rules were withdrawn from White House review in January 2025, and the government’s regulatory agenda lists both rulemakings as “Withdrawn.” No federal ban on menthol cigarettes or on flavored cigars is in effect. A check of the Federal Register through October 18, 2026 found no FDA document finalizing either rule and no formal withdrawal notice; the 2023–2025 steps come from OMB review records and the regulatory agenda, as set out on the site’s Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025) page.

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10. How the Proposals Fit Earlier and Later FDA Tobacco Actions

The documents place the 2022 proposals in a longer line of steps:

• 2009. The FDA release states that the Family Smoking Prevention and Tobacco Control Act “prohibited all characterizing flavors (other than tobacco and menthol) in cigarettes in 2009.” Menthol was the flavor that law left in place.
• July 24, 2013. The FDA publishes an advance notice of proposed rulemaking, “Menthol in Cigarettes, Tobacco Products; Request for Comments” (78 FR 44484, Docket No. FDA-2013-N-0521), together with its preliminary scientific evaluation of menthol. The notice’s summary states that the evaluation “indicates there is likely a public health impact of menthol in cigarettes.” An advance notice is an early request for information, before any rule text is proposed.
• April–August 2022. The two proposals reported on this page, their listening sessions and comment period.
• 2023–2025. The final rules go to OMB review in October 2023 and are withdrawn in January 2025 (section 9).

Other FDA tobacco and nicotine actions of the same years are reported on their own pages: in 2022, the FDA’s new authority over nicotine not made from tobacco and its denial and stay of marketing for a leading e-cigarette; in 2023, the youth e-cigarette crackdown; and in 2025, the nicotine pouch marketing authorization and the withdrawal of the menthol, flavored cigar and nicotine cap rules. The health effects of other people’s smoke are described on the site’s Secondhand Smoke page.

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11. Primary Documents

1. U.S. Food and Drug Administration (2022). FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars to Prevent Youth Initiation, Significantly Reduce Tobacco-Related Disease and Death. News release, April 28, 2022 (content current as of June 27, 2022) — fda.gov news release
2. U.S. Food and Drug Administration (2022). Fact Sheet: Proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and all characterizing flavors (other than tobacco) in cigars. Issued with the April 28, 2022 release — fda.gov fact sheet (PDF)
3. Food and Drug Administration, HHS (2022). Tobacco Product Standard for Menthol in Cigarettes. Proposed rule. Federal Register 87 FR 26454–26502, May 4, 2022. Docket No. FDA-2021-N-1349, RIN 0910-AI60 — FR Doc. 2022-08994
4. Food and Drug Administration, HHS (2022). Tobacco Product Standard for Characterizing Flavors in Cigars. Proposed rule. Federal Register 87 FR 26396–26451, May 4, 2022. Docket No. FDA-2021-N-1309, RIN 0910-AI28 — FR Doc. 2022-08993
5. Food and Drug Administration, HHS (2022). Proposed Regulations To Establish Tobacco Product Standards for Menthol in Cigarettes and Characterizing Flavors in Cigars: Listening Sessions; Public Meeting; Request for Comments. Federal Register 87 FR 26311, May 4, 2022. Docket Nos. FDA-2021-N-1349 and FDA-2021-N-1309 — FR Doc. 2022-09302
6. Food and Drug Administration, HHS (2022). Establishment of Tobacco Product Standards for Menthol in Cigarettes and Characterizing Flavors in Cigars; Extension of Comment Period. Federal Register 87 FR 36786, June 21, 2022. Dockets FDA-2021-N-1349 and FDA-2021-N-1309 — FR Doc. 2022-13209
7. FDA Center for Tobacco Products (2022). Comment Period Closed for FDA Proposed Rules Prohibiting Menthol Cigarettes and Flavored Cigars. CTP Newsroom, August 10, 2022 — fda.gov CTP newsroom item
8. Food and Drug Administration, HHS (2013). Menthol in Cigarettes, Tobacco Products; Request for Comments. Advance notice of proposed rulemaking. Federal Register 78 FR 44484, July 24, 2013. Docket No. FDA-2013-N-0521 — FR Doc. 2013-17805
9. Public dockets — regulations.gov FDA-2021-N-1349 (menthol) and regulations.gov FDA-2021-N-1309 (cigars)

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Key Research Papers

1. Levy DT, Pearson JL, Villanti AC, Blackman K, Vallone DM, Niaura RS, Abrams DB (2011). Modeling the future effects of a menthol ban on smoking prevalence and smoking-attributable deaths in the United States. American Journal of Public Health 101(7):1236-1240 — PubMed PMID: 21566034
2. Villanti AC, Collins LK, Niaura RS, Gagosian SY, Abrams DB (2017). Menthol cigarettes and the public health standard: a systematic review. BMC Public Health 17(1):983 — PubMed PMID: 29284458
3. Villanti AC, Johnson AL, Ambrose BK, Cummings KM, Stanton CA, Rose SW, Feirman SP, Tworek C, Glasser AM, Pearson JL, Cohn AM, Conway KP, Niaura RS, Bansal-Travers M, Hyland A (2017). Flavored Tobacco Product Use in Youth and Adults: Findings From the First Wave of the PATH Study (2013-2014). American Journal of Preventive Medicine 53(2):139-151 — PubMed PMID: 28318902
4. Villanti AC, Johnson AL, Halenar MJ, Sharma E, Cummings KM, Stanton CA, Delnevo CD, Wackowski OA, et al. (2021). Menthol and Mint Cigarettes and Cigars: Initiation and Progression in Youth, Young Adults and Adults in Waves 1-4 of the PATH Study, 2013-2017. Nicotine & Tobacco Research 23(8):1318-1326 — PubMed PMID: 33159209
5. Chaiton MO, Nicolau I, Schwartz R, Cohen JE, Soule E, Zhang B, Eissenberg T (2020). Ban on menthol-flavoured tobacco products predicts cigarette cessation at 1 year: a population cohort study. Tobacco Control 29(3):341-347 — PubMed PMID: 31147474
6. Fong GT, Chung-Hall J, Meng G, Craig LV, Thompson ME, Quah ACK, Cummings KM, Hyland A, et al. (2023). Impact of Canada’s menthol cigarette ban on quitting among menthol smokers: pooled analysis of pre-post evaluation from the ITC Project and the Ontario Menthol Ban Study and projections of impact in the USA. Tobacco Control 32(6):734-738 — PubMed PMID: 35483720
7. Issabakhsh M, Meza R, Li Y, Yuan Z, Sanchez-Romero LM, Levy DT (2023). Public health impact of a US menthol cigarette ban on the non-Hispanic black population: a simulation study. Tobacco Control 33(1):126-130 — PubMed PMID: 35700999

The first and last papers are modeling studies of a U.S. menthol ban’s projected effects on smoking and deaths. The second is a systematic review of menthol cigarettes against the public health standard in U.S. tobacco law. The third and fourth report flavored and menthol tobacco use, including cigars, among youth and adults in a national U.S. cohort. The fifth and sixth evaluate quitting after Canada’s provincial and national menthol bans. Listing a paper here reports that it exists; it is not a claim that the FDA relied on it.

PubMed Topic Searches

1. PubMed: menthol cigarette ban
2. PubMed: flavored cigars and youth
3. PubMed: menthol, nicotine dependence and quitting

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Connections

• FDA Actions of 2022
• FDA and Regulation
• Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)
• Synthetic Nicotine Comes Under the FDA (2022)
• E-Cigarette Marketing Denial and Stay (2022)
• Youth E-Cigarette Crackdown (2023)
• Nicotine Pouch Marketing Authorization (2025)
• Nicotine: The Research
• Nicotine Addiction and Withdrawal
• Addiction and Substance Use Disorders
• Secondhand Smoke
• Lung Cancer
• COPD

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