FDA Commits to Banning Menthol Cigarettes and Flavored Cigars (2021)
On April 29, 2021, the U.S. Food and Drug Administration (FDA) granted a citizen petition asking it to prohibit menthol in cigarettes and announced that it was working toward two proposed rules: one to ban menthol as a characterizing flavor in cigarettes and one to ban all characterizing flavors, including menthol, in cigars. The announcement banned nothing on its own; it was a commitment to start rulemaking. The substance behind the products is described on the site’s Nicotine page.
This page reports what the FDA’s own documents say: what the agency announced and why, the petition it granted, what the two standards would have changed, the history of menthol regulation the FDA gave, the evidence and figures it cited, who enforcement would and would not reach, what the announcement did not do, its status as of October 18, 2026, and how it fits the FDA’s earlier and later tobacco actions. No company, brand or petitioner is named here.
Table of Contents
- What the FDA Announced on April 29, 2021
- The Citizen Petition the FDA Granted
- What the Two Product Standards Would Change
- Background: Menthol After the 2009 Flavor Ban
- The Evidence the FDA Cited on Menthol
- Who Smokes Menthol Cigarettes: The FDA’s Figures
- The Case the FDA Made on Flavored Cigars
- Who Enforcement Would and Would Not Reach
- Quit Support and E-Cigarette Oversight in the Same Release
- What the Commitment Did Not Do
- Dates and Legal Status as of October 18, 2026
- How It Fits Earlier and Later FDA Tobacco Actions
- Primary Documents
- Key Research Papers
- Connections
- Featured Videos
1. What the FDA Announced on April 29, 2021
The FDA news release of April 29, 2021, titled “FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers,” states that the agency was “committing to advancing two tobacco product standards to significantly reduce disease and death from using combusted tobacco products, the leading cause of preventable death in the U.S.”
In the release’s words, the FDA was “working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars.” It described the power to set product standards as “one of the most powerful tobacco regulatory tools Congress gave the agency.”
A tobacco product standard is a rule that sets requirements every product of a given kind must meet; the FDA’s later proposals describe these two standards as rules that “would prohibit” menthol in cigarettes and characterizing flavors in cigars. A characterizing flavor is a flavor that gives a product its distinctive taste; the FDA’s 2022 cigar proposal gives “strawberry, grape, cocoa, and fruit punch” as examples. Combusted tobacco products are ones that are burned and smoked, such as cigarettes and cigars.
The release named the next step: “the next step will be for the agency to publish proposed rules in the Federal Register allowing an opportunity for public comment.” The Federal Register is the U.S. government’s daily publication of proposed and final rules and official notices.
Acting FDA Commissioner Janet Woodcock was quoted as saying that “Banning menthol—the last allowable flavor—in cigarettes and banning all flavors in cigars will help save lives, particularly among those disproportionately affected by these deadly products.” She added that the actions would, in the agency’s view, “help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ+ individuals.”
2. The Citizen Petition the FDA Granted
A citizen petition is a formal written request from members of the public or organizations asking the FDA to take, or not take, a particular action. The April 2021 release states: “Today, the FDA granted a citizen petition requesting that the agency pursue rulemaking to prohibit menthol in cigarettes, affirming its commitment to proposing such a product standard.”
Granting the petition meant the FDA agreed to the request to begin rulemaking. It did not itself prohibit anything; the prohibition would have had to come through a proposed rule, public comment and a final rule. The petition was filed by public-health groups; its own text, docket number and filing date were not available for this page and are not given here.
3. What the Two Product Standards Would Change
The release described two separate standards:
- Menthol in cigarettes. A ban on menthol as a characterizing flavor in cigarettes. Menthol was, in the release’s words, “the last allowable flavor” in cigarettes.
- Flavors in cigars. A ban on all characterizing flavors, including menthol, in cigars. The release describes “flavored mass-produced cigars and cigarillos” as combusted tobacco products that “can closely resemble cigarettes, pose many of the same public health problems, and are disproportionately popular among youth and other populations.”
Center for Tobacco Products (CTP) Director Mitch Zeller was quoted as saying: “These flavor standards would reduce cigarette and cigar initiation and use, reduce health disparities, and promote health equity by addressing a significant and disparate source of harm.” The CTP is the part of the FDA that regulates tobacco products.
When the two proposals were published a year later, on May 4, 2022, their Federal Register summaries described the menthol standard as one that “would prohibit menthol as a characterizing flavor in cigarettes” and the cigar standard as one that “would prohibit characterizing flavors (other than tobacco) in all cigars and their components and parts.”
4. Background: Menthol After the 2009 Flavor Ban
The release traces the history this way. The 2009 Tobacco Control Act (TCA) “did not include menthol in its ban on characterizing flavors in cigarettes, leaving menthol cigarettes as the only flavored combusted cigarettes still marketed in the U.S.” It states that “The law instructed the FDA to further consider the issue of menthol in cigarettes.”
The release lists the steps the FDA took after that:
- it “sought input from an independent advisory committee as required by the TCA”;
- it issued an advance notice of proposed rulemaking (ANPRM), an early notice that asks the public for information before any rule is drafted. That notice, “Menthol in Cigarettes, Tobacco Products; Request for Comments,” appeared in the Federal Register on July 24, 2013 (78 FR 44484; Docket No. FDA-2013-N-0521), with comments due September 23, 2013;
- it undertook an independent evaluation and supported broader research, “all to better understand the differences between menthol and non-menthol cigarettes and the impact of menthol on population health.”
The 2013 notice’s summary states that the FDA was also making available “its preliminary scientific evaluation of public health issues related to the use of menthol in cigarettes,” and that “The preliminary scientific evaluation indicates there is likely a public health impact of menthol in cigarettes.” That evaluation is titled “Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes”; its chapters cover smoke chemistry and toxicology, physiology, biomarkers, patterns of use, marketing and perception of risk, initiation and progression to regular use, dependence and cessation.
A Federal Register docket is the public file for an action, where its documents and the public comments on it are kept on regulations.gov.
5. The Evidence the FDA Cited on Menthol
The release states that “There is strong evidence that a menthol ban will help people quit” and summarizes the research it relied on:
- “Studies show that menthol increases the appeal of tobacco and facilitates progression to regular smoking, particularly among youth and young adults.”
- “Menthol masks unpleasant flavors and harshness of tobacco products, making them easier to start using.”
- “Tobacco products with menthol can also be more addictive and harder to quit by enhancing the effects of nicotine.”
The release then cites two modeling and survey-based estimates, attributed here to the studies the FDA linked:
- one study, published in Tobacco Control in 2021, “suggests that banning menthol cigarettes in the U.S. would lead an additional 923,000 smokers to quit, including 230,000 African Americans in the first 13 to 17 months after a ban goes into effect”;
- an earlier study, published in the American Journal of Public Health, “projected that about 633,000 deaths would be averted, including about 237,000 deaths averted for African Americans.”
Both papers are listed under Key Research Papers. The release calls the agency’s decision “based on clear science and evidence establishing the addictiveness and harm of these products.” Projections of this kind are estimates from models and surveys, not counts of observed outcomes.
6. Who Smokes Menthol Cigarettes: The FDA’s Figures
The release gives these figures for the United States:
- “it is estimated that there are nearly 18.6 million current smokers of menthol cigarettes”;
- “out of all Black smokers, nearly 85% smoke menthol cigarettes, compared to 30% of White smokers who smoke menthols”;
- “among youth, from 2011 to 2018, declines in menthol cigarette use were observed among non-Hispanic White youth but not among non-Hispanic Black or Hispanic youth.”
The FDA’s 2022 menthol proposal gives a slightly different total, “over 18.5 million menthol cigarette smokers ages 12 and older in the United States”; each figure belongs to its own document and year.
CTP Director Mitch Zeller was quoted on the disparities: “For far too long, certain populations, including African Americans, have been targeted, and disproportionately impacted by tobacco use. Despite the tremendous progress we’ve made in getting people to stop smoking over the past 55 years, that progress hasn’t been experienced by everyone equally.”
7. The Case the FDA Made on Flavored Cigars
On cigars, the release states that after the 2009 statutory ban on flavors in cigarettes other than menthol, “use of flavored cigars increased dramatically, suggesting that the public health goals of the flavored cigarette ban may have been undermined by continued availability of these flavored cigars.”
It gives these youth figures:
- “Nearly 74% of youth aged 12-17 who use cigars say they smoke cigars because they come in flavors they enjoy.”
- “Among youth who have ever tried a cigar, 68% of cigarillo users and 56% of filtered cigar users report that their first cigar was a flavored product.”
- “in 2020, more young people tried a cigar every day than tried a cigarette.”
- “In 2020, non-Hispanic Black high school students reported past 30-day cigar smoking at levels twice as high as their White counterparts.”
Because the cigar standard would cover all characterizing flavors, menthol cigars would have been covered along with other flavors such as the “strawberry, grape, cocoa, and fruit punch” named in the FDA’s 2022 cigar proposal.
8. Who Enforcement Would and Would Not Reach
The release sets out the scope of enforcement in plain terms: “If implemented, the FDA’s enforcement of any ban on menthol cigarettes and all flavored cigars will only address manufacturers, distributors, wholesalers, importers and retailers. The FDA cannot and will not enforce against individual consumer possession or use of menthol cigarettes or any tobacco product.”
It adds that “The FDA will work to make sure that any unlawful tobacco products do not make their way onto the market.” In other words, a standard of this kind would govern what may be made and sold, not what an individual smoker has or uses.
9. Quit Support and E-Cigarette Oversight in the Same Release
Quit support. The release states that the agency “recognizes the importance of ensuring broad and equitable access to all the tools and resources that can help currently addicted smokers seeking to quit, including those who smoke menthol cigarettes and would be impacted by these public health measures,” and that “The FDA will work with partners in other federal agencies to make sure the support is there for those who are trying to quit.” It pointed smokers interested in quitting to smokefree.gov and the 1-800-QUIT-NOW line for information on cessation services in their state. That is the FDA’s information; decisions about quitting methods and medicines belong with a clinician.
E-cigarettes. The release states that the FDA “also remains focused on its regulatory oversight of e-cigarettes and other electronic nicotine delivery systems (ENDS),” noting its ongoing premarket review of ENDS applications, warning letters to makers and retailers of products “illegally on the market,” and a public education campaign that “targets nearly 10.7 million youth aged 12-17 who have ever used e-cigarettes or are open to trying them.” The menthol and cigar commitments themselves did not cover e-cigarettes; the FDA’s 2021 e-cigarette decisions are reported on their own pages (section 12).
The release also linked a same-day statement by the Secretary of Health and Human Services on the actions; that statement could not be retrieved for this page.
10. What the Commitment Did Not Do
- It banned nothing. The April 2021 step was a commitment to propose rules and the grant of a petition. Proposed rules have no legal effect until they are made final, and no final rule followed (section 11).
- It did not take menthol cigarettes or flavored cigars off the market. Both remained legal to sell after the announcement.
- It did not reach individual smokers. The FDA stated it “cannot and will not enforce against individual consumer possession or use.”
- It did not address e-cigarettes. The two standards concerned cigarettes and cigars only.
- It did not set a text for the rules. The details of what would be prohibited were left to the proposals published in May 2022.
11. Dates and Legal Status as of October 18, 2026
- 2009: the Tobacco Control Act bans characterizing flavors other than menthol in cigarettes.
- July 24, 2013: the FDA’s advance notice on menthol in cigarettes, with its preliminary scientific evaluation (78 FR 44484; Docket No. FDA-2013-N-0521).
- April 29, 2021: the FDA grants the citizen petition and commits to proposing a menthol-cigarette standard and a flavored-cigar standard within the next year.
- May 4, 2022: the two proposed rules are published: “Tobacco Product Standard for Menthol in Cigarettes” (87 FR 26454; Docket No. FDA-2021-N-1349; RIN 0910-AI60) and “Tobacco Product Standard for Characterizing Flavors in Cigars” (87 FR 26396; Docket No. FDA-2021-N-1309; RIN 0910-AI28). Comments were first due July 5, 2022.
- June 21, 2022: the FDA extends the comment period on both proposals to August 2, 2022, “in response to requests for an extension” (87 FR 36786).
- January 2025: the final versions of both rules are withdrawn from White House review at the Office of Management and Budget, as reported on the site’s 2025 withdrawal page.
Status as of October 18, 2026: no ban in effect. The April 2021 step was a commitment only. The rules it led to were proposed in 2022 but never finalized, and their final versions were withdrawn from White House review in January 2025. A check of the Federal Register through October 18, 2026 found no FDA final rule on menthol in cigarettes or flavors in cigars. A RIN (Regulation Identifier Number) is the tracking number a rulemaking carries through the federal regulatory agenda.
12. How It Fits Earlier and Later FDA Tobacco Actions
The April 2021 commitment sits between the 2009 law and the later rulemaking:
- 2009. The Tobacco Control Act bans other flavored cigarettes and leaves menthol for the FDA to consider further.
- 2013. The FDA asks for public comment on menthol and publishes its preliminary scientific evaluation.
- April 2021. The petition is granted and the two standards are promised.
- August–October 2021. In separate actions, the FDA issues its first marketing denials for flavored e-cigarettes and its first e-cigarette marketing authorization.
- May 2022. The two proposals are published; their content is reported on the 2022 menthol and flavored cigar proposals page.
- January–July 2025. The final rules are withdrawn from review and later listed as withdrawn, as reported on the 2025 page on the withdrawn tobacco standards.
Later FDA actions on e-cigarettes are reported on the pages about the 2022 denial and stay for a leading e-cigarette maker and the 2023 youth e-cigarette enforcement actions. The health effects of smoking are covered on the site’s Lung Cancer, COPD and Secondhand Smoke pages.
13. Primary Documents
- U.S. Food and Drug Administration. FDA Commits to Evidence-Based Actions Aimed at Saving Lives and Preventing Future Generations of Smokers. News release, April 29, 2021 (content current as of April 29, 2021) — fda.gov news release
- 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
- U.S. Food and Drug Administration. Preliminary Scientific Evaluation of the Possible Public Health Effects of Menthol Versus Nonmenthol Cigarettes. Made available with the 2013 advance notice — fda.gov PDF
- Food and Drug Administration, HHS (2022). Tobacco Product Standard for Menthol in Cigarettes. Proposed rule. Federal Register 87 FR 26454, May 4, 2022. Docket No. FDA-2021-N-1349; RIN 0910-AI60 — FR Doc. 2022-08994
- Food and Drug Administration, HHS (2022). Tobacco Product Standard for Characterizing Flavors in Cigars. Proposed rule. Federal Register 87 FR 26396, May 4, 2022. Docket No. FDA-2021-N-1309; RIN 0910-AI28 — FR Doc. 2022-08993
- 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
- Public docket FDA-2021-N-1349 (menthol in cigarettes) — regulations.gov FDA-2021-N-1349
- Public docket FDA-2021-N-1309 (flavors in cigars) — regulations.gov FDA-2021-N-1309
Key Research Papers
- 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
- Chung-Hall J, Fong GT, Meng G, Cummings KM, Hyland A, O’Connor RJ, Quah ACK, Craig LV (2022). Evaluating the impact of menthol cigarette bans on cessation and smoking behaviours in Canada: longitudinal findings from the Canadian arm of the 2016-2018 ITC Four Country Smoking and Vaping Surveys. Tobacco Control 31(4):556-563 — PubMed PMID: 33820856
- Fong GT, Chung-Hall J, Meng G, Craig LV, Thompson ME, Quah ACK, Cummings KM, Hyland A, O’Connor RJ, Levy DT, Delnevo CD, Ganz O, Eissenberg T, Soule EK, Schwartz R, Cohen JE, Chaiton MO (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
- 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
- Soule EK, Dubray J, Cohen JE, Schwartz R, Chaiton M (2021). Smoking cessation strategies used by former menthol cigarette smokers after a menthol ban. Addictive Behaviors 123:107046 — PubMed PMID: 34311185
- Rostron BL, Cheng YC, Gardner LD, Ambrose BK (2020). Prevalence and Reasons for Use of Flavored Cigars and ENDS among US Youth and Adults: Estimates from Wave 4 of the PATH Study, 2016-2017. American Journal of Health Behavior 44(1):76-81 — PubMed PMID: 31783934
The first two papers are the studies the FDA’s April 2021 release linked for its projections (the second was published online in 2021 and in print in 2022). The third pools Canadian data on quitting after Canada’s menthol ban and projects the effect for the United States. The fourth is a systematic review of research on menthol cigarettes. The fifth describes how former menthol smokers in Ontario quit after a ban there. The sixth reports national survey estimates of flavored cigar and e-cigarette use and the reasons given for it.
PubMed Topic Searches
Connections
- FDA Actions of 2021
- FDA and Regulation
- Menthol and Flavored Cigar Proposals (2022)
- Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)
- First Flavored E-Cigarette Denials (2021)
- First E-Cigarette Authorization (2021)
- E-Cigarette Denial and Stay (2022)
- Youth E-Cigarette Enforcement (2023)
- Nicotine
- Lung Cancer
- COPD
- Secondhand Smoke