Menthol, Flavored Cigar and Nicotine Cap Rules Withdrawn (2025)

Table of Contents

1. What Happened in January 2025
2. The Nicotine Cap Proposal: What It Would Have Required
3. Which Products the Nicotine Cap Would Have Covered
4. The FDA’s Model Projections for the Nicotine Cap
5. The Menthol Cigarette Rule
6. The Flavored Cigar Rule
7. January 21: The Final Rules Withdrawn From White House Review
8. The Regulatory Agenda’s “Withdrawn” Listings
9. What the Withdrawals Did Not Do
10. Dates and Legal Status as of 11 October 2026
11. How These Actions Fit Earlier FDA Tobacco Rulemaking
12. Primary Documents
13. Key Research Papers
14. Connections

1. What Happened in January 2025

Three separate rulemakings are covered here. All three were proposed “tobacco product standards” — rules the FDA may write under section 907 of the Federal Food, Drug, and Cosmetic Act to set requirements for how tobacco products are made, such as limits on an ingredient or a constituent. A product standard must go through the ordinary rulemaking steps: a proposed rule published in the Federal Register (the government’s daily journal of rules and notices), a public comment period, and then a final rule.

• Nicotine cap, proposed 16 January 2025. The FDA announced the proposal in a press release dated 15 January 2025 and published it in the Federal Register the next day, titled “Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products” (90 FR 5032–5144, Docket FDA-2024-N-5471, Regulation Identifier Number 0910-AI76).
• Menthol cigarette and flavored cigar final rules, withdrawn from review 21 January 2025. Both rules had been proposed on 4 May 2022. The FDA sent the final versions to the Office of Management and Budget (OMB) for review on 13 October 2023. OMB’s review records show both reviews concluded on 21 January 2025 with the decision “Withdrawn”.
• Regulatory agenda listings. The Spring 2025 Unified Agenda moved all three rulemakings to “Completed Actions”: the nicotine cap with the entry “Withdrawn 04/21/2025”, and the menthol and cigar rules with the entry “Withdrawn 07/25/2025”.

No FDA or HHS press release announcing either withdrawal was found, and no Federal Register notice withdrawing any of the three rules was found for 2025 or 2026. The withdrawals are documented in the OMB and Unified Agenda records listed in section 12.

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2. The Nicotine Cap Proposal: What It Would Have Required

The proposed rule would have set a maximum nicotine content of 0.70 milligrams of nicotine per gram of total tobacco in the products it covered. The FDA’s stated aim, in the words of its press release, was to reduce nicotine “to minimally or nonaddictive” levels. For comparison, the proposal states that the average nicotine content of the 100 top-selling cigarette brands in 2017 was 17.2 milligrams per gram of tobacco.

The rule’s title speaks of nicotine “yield” — the amount of nicotine in the smoke a person can inhale. The proposal explains that yield measured by smoking machines can be raised by how a person smokes (deeper inhalation, larger puffs, blocking filter vents), which is called compensatory smoking. Nicotine “content” — the nicotine present in the tobacco itself — is not affected by smoking behavior, so the FDA proposed to limit yield by capping content, which places an absolute ceiling on the nicotine available in the smoke.

Other elements the proposal describes:

• One step, not a gradual phase-down. The FDA proposed an immediate reduction to the single target level. It states that studies of gradual reduction showed more compensatory smoking, while studies of immediate reduction to very low nicotine content showed very little or none.
• Not zero. The proposal notes that the law (section 907(d)(3)) does not allow the FDA to require that nicotine yields be reduced to zero.
• Testing and records. Manufacturers would have had to test products with a validated laboratory method before sale, follow a sampling plan for each batch, handle nonconforming products under written procedures, mark products with a manufacturing code, and keep testing records.
• Effective date. Any final rule would have taken effect two years after publication. After that date, covered products above the limit could not be distributed or sold in the United States; before it, retailers and wholesalers could sell existing stock.
• Who would be bound. The proposal states that the FDA’s enforcement would address manufacturers, distributors, wholesalers, importers and retailers, and that the FDA “cannot and will not enforce against individual consumers” for possession or use.

The FDA’s press release adds: “The proposed rule would not ban cigarettes or any other tobacco products.” The proposal states that smoked products with minimally addictive or nonaddictive nicotine levels would remain on the market for people who wish to continue smoking.

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3. Which Products the Nicotine Cap Would Have Covered

The proposal would have applied to cigarettes, cigarette tobacco, roll-your-own tobacco, cigars (little cigars, cigarillos and large cigars, but not premium cigars) and pipe tobacco. It would not have applied to:

• e-cigarettes and other electronic nicotine delivery systems;
• nicotine pouches and smokeless tobacco;
• heated (noncombusted) tobacco products that legally count as cigarettes;
• waterpipe (hookah) tobacco;
• premium cigars.

The FDA’s reasoning, as stated in the proposal: cigarettes cause the largest share of tobacco-related harm (it gives about 28 million adults and 380,000 young people in the United States as current cigarette smokers); covering only cigarettes could lead people to move to similar smoked products; and smoked products are responsible for most tobacco-related death and disease. For waterpipe tobacco, the proposal cites the roughly one-hour session time and bulky equipment as reasons it saw little risk of people switching to it. For noncombusted products, it describes tobacco products as lying on “a continuum of risk”, with smoked cigarettes the deadliest, and asks for comments and data on all of these scope choices.

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4. The FDA’s Model Projections for the Nicotine Cap

The proposal and the FDA press release give estimates from the agency’s population health model. They are model projections, built from published evidence and from formal expert-elicitation exercises the FDA conducted in 2015 and 2018 (the proposal says a further elicitation was under way). As reported by the FDA:

• about 48 million young people and young adults who would otherwise have taken up regular smoking would not do so by the year 2100;
• more than 12.9 million additional people who smoke would quit cigarettes one year after the rule took effect, rising to 19.5 million within five years (counting both quitting tobacco entirely and switching completely to a noncombusted product);
• 1.8 million tobacco-related deaths averted by 2060, and 4.3 million by 2100;
• 19.6 million life-years gained by 2060 and 76.4 million by 2100.

The proposal bases the 0.70 mg/g level on its review of studies of very low nicotine content cigarettes, which it describes as showing reduced addiction measures, fewer cigarettes per day and more quit attempts, without increased toxicant exposure, craving, withdrawal or compensatory smoking. Some of that research is listed under Key Research Papers. The proposal also acknowledges that “questions remain” about the precise nicotine level that would be minimally addictive or nonaddictive for particular individuals or groups.

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5. The Menthol Cigarette Rule

The menthol rule, “Tobacco Product Standard for Menthol in Cigarettes”, was proposed on 4 May 2022 (87 FR 26454, Docket FDA-2021-N-1349, Regulation Identifier Number 0910-AI60). It would have prohibited menthol as a characterizing flavor in cigarettes and their components and parts.

What the 2022 proposal states as its background:

• A 2009 law, the Family Smoking Prevention and Tobacco Control Act, already banned cigarettes with characterizing flavors other than tobacco or menthol, so menthol cigarettes were the only flavored cigarettes still sold in the United States.
• In 2019 there were more than 18.5 million current smokers of menthol cigarettes aged 12 and older in the United States.
• The FDA wrote that menthol’s flavor and sensory effects increase appeal and make menthol cigarettes easier to use, particularly for young people, and that the standard was expected to reduce starting, increase quitting, and reduce tobacco-related health disparities.

The proposed effective date was one year after a final rule. As with the nicotine cap, the proposal states that the FDA’s enforcement would address manufacturers, distributors, wholesalers, importers and retailers, and that it “cannot and will not enforce against individual consumers for possession or use of menthol cigarettes.” The comment period, first set to close on 5 July 2022, was extended (87 FR 36786, 21 June 2022) and closed on 2 August 2022.

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6. The Flavored Cigar Rule

The cigar rule, “Tobacco Product Standard for Characterizing Flavors in Cigars”, was proposed the same day, 4 May 2022 (87 FR 26396, Docket FDA-2021-N-1309, Regulation Identifier Number 0910-AI28, planned as 21 CFR part 1166). It would have prohibited characterizing flavors other than tobacco in all cigars and their components and parts. Unlike the 2025 nicotine cap, it did not exempt premium cigars.

The proposal and the regulatory agenda abstract state that:

• flavors such as strawberry, grape, orange, cocoa and fruit punch increase appeal and make cigars easier to use, particularly among youth and young adults;
• over half a million young people in the United States use flavored cigars;
• an estimated 9,000 premature deaths each year are attributed to regular cigar smoking (defined as smoking cigars on 15 or more of the past 30 days).

Its proposed effective date was also one year after a final rule, with the same statement that enforcement would not be directed at individual consumers. Its comment period followed the same extended timetable, closing on 2 August 2022.

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7. January 21: The Final Rules Withdrawn From White House Review

Before a significant federal rule can be published, it goes to the Office of Information and Regulatory Affairs (OIRA), part of the White House Office of Management and Budget, for review under Executive Order 12866. OIRA publishes a record of each completed review, including the date the rule arrived, the date the review ended, and the outcome.

OIRA’s 2025 list of completed reviews shows:

• Menthol in Cigarettes (0910-AI60) — stage: Final Rule; received 13 October 2023; completed 21 January 2025; decision: “Withdrawn”.
• Characterizing Flavors in Cigars (0910-AI28) — stage: Final Rule; received 13 October 2023; completed 21 January 2025; decision: “Withdrawn”.

A withdrawal from OIRA review means the final rule was pulled back before publication; it was never issued. Both rules had sat at OIRA for about 15 months. The same OIRA list records the nicotine cap’s earlier passage through review as a proposed rule: received 10 December 2024 and cleared on 3 January 2025 as “Consistent with Change”, two weeks before it was published.

No FDA or HHS press release on the 21 January withdrawal was found. The OIRA records are the primary source for the date.

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8. The Regulatory Agenda’s “Withdrawn” Listings

The Unified Agenda of Regulatory and Deregulatory Actions is published twice a year and lists every rule each federal agency is working on, with a timetable of its steps. An entry moves to “Completed Actions” when a rulemaking ends — by a final rule or by withdrawal.

In the Spring 2025 Unified Agenda:

• the nicotine cap (0910-AI76) is listed under Completed Actions with the timetable “NPRM 01/16/2025 90 FR 5032; Withdrawn 04/21/2025”;
• the menthol rule (0910-AI60) and the flavored cigar rule (0910-AI28) are listed under Completed Actions, each ending “Withdrawn 07/25/2025”.

Two different withdrawal dates therefore appear in the record for the menthol and cigar rules: 21 January 2025, when the final rules were pulled from OIRA review, and 25 July 2025, the date the agenda gives for withdrawal of the rulemakings themselves.

For the nicotine cap, the agenda entry is the only primary record of withdrawal found. The Federal Register record of the proposal still shows its comment period running until 15 September 2025, and no Federal Register withdrawal notice was found. Stated plainly: the federal regulatory agenda lists the proposal as withdrawn (21 April 2025).

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9. What the Withdrawals Did Not Do

• They did not change anything on the market. None of the three rules ever took effect, so the products they addressed were sold under the same rules before and after.
• No nicotine limit applies to any tobacco product. The proposal itself noted that there were no existing tobacco product standards regulating nicotine; that remained the case.
• The 2009 flavored-cigarette ban was not touched. The ban Congress set in the Tobacco Control Act on cigarettes with characterizing flavors other than tobacco or menthol is a statutory “special rule” and stands independently of these rulemakings.
• No replacement rule was proposed. No new menthol, flavored-cigar or nicotine-level proposal appears in the Federal Register for 2025–2026.
• The nicotine cap would not have covered other nicotine products in any case. E-cigarettes, nicotine pouches and smokeless tobacco were outside its proposed scope.

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10. Dates and Legal Status as of 11 October 2026

No Federal Register document on any of the three rules was found for 2025–2026 beyond the January 2025 nicotine proposal, and the site has no 2026 follow-up page on these rules. The FDA’s own “Tobacco Product Standards” web page, as read on 11 October 2026, still described the menthol and cigar rules as under OMB review and the nicotine proposal as open for comment; the OIRA and Unified Agenda records above are the later and more specific sources.

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11. How These Actions Fit Earlier FDA Tobacco Rulemaking

The three rules were the end points of more than a decade of steps recorded in the Federal Register and the Unified Agenda:

• 2009 — the Family Smoking Prevention and Tobacco Control Act gives the FDA authority over tobacco products, including the power to set product standards, and bans flavored cigarettes other than tobacco and menthol.
• 24 July 2013 — advance notice of proposed rulemaking (an early request for information) on menthol in cigarettes, 78 FR 44484.
• 2016 — a “deeming” rule (81 FR 28974) brings cigars, pipe tobacco and other products under the FDA’s tobacco authority.
• 16 March 2018 — advance notice on nicotine in combusted cigarettes, 83 FR 11818; the FDA’s 2025 press release cites 2018 as when it first announced its intent to propose a nicotine standard.
• 21 March 2018 — advance notice on flavors, including menthol, in tobacco products, 83 FR 12294.
• 4 May 2022 — menthol and flavored cigar proposed rules; comments closed 2 August 2022.
• 13 October 2023 — both final rules sent to OIRA.
• 16 January 2025 — nicotine cap proposed.
• 21 January 2025 — menthol and cigar final rules withdrawn from OIRA review.
• 21 April and 25 July 2025 — withdrawal dates listed in the Unified Agenda.

Other 2025 FDA tobacco actions went in a different direction: in January 2025 the agency authorized the marketing of a line of nicotine pouches, covered on the site’s Nicotine Pouch Marketing Authorization page. The site’s page on tobacco and nicotine bans reports one practitioner’s views on these policies.

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12. Primary Documents

1. Food and Drug Administration, HHS (2025). Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products. Proposed rule. Federal Register 90:5032–5144, 16 January 2025. Docket No. FDA-2024-N-5471, RIN 0910-AI76 — FR Doc. 2025-00397 (official PDF, govinfo.gov)
2. U.S. Food and Drug Administration (2025). FDA Proposes Significant Step Toward Reducing Nicotine to Minimally or Nonaddictive Level in Cigarettes and Certain Other Combusted Tobacco Products. Press release, 15 January 2025 — fda.gov press announcement
3. Office of Information and Regulatory Affairs, OMB. EO 12866 regulatory reviews completed in 2025 (entries for RIN 0910-AI60, 0910-AI28 and 0910-AI76) — reginfo.gov EO_RULE_COMPLETED_2025.xml
4. Spring 2025 Unified Agenda. Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products, RIN 0910-AI76, Completed Actions, “Withdrawn 04/21/2025” — reginfo.gov RIN 0910-AI76
5. Spring 2025 Unified Agenda. Tobacco Product Standard for Menthol in Cigarettes, RIN 0910-AI60, Completed Actions, “Withdrawn 07/25/2025” — reginfo.gov RIN 0910-AI60
6. Spring 2025 Unified Agenda. Tobacco Product Standard for Characterizing Flavors in Cigars, RIN 0910-AI28, Completed Actions, “Withdrawn 07/25/2025” — reginfo.gov RIN 0910-AI28
7. Food and Drug Administration, HHS (2022). Tobacco Product Standard for Menthol in Cigarettes. Proposed rule. Federal Register 87:26454, 4 May 2022. Docket No. FDA-2021-N-1349 — FR Doc. 2022-08994
8. Food and Drug Administration, HHS (2022). Tobacco Product Standard for Characterizing Flavors in Cigars. Proposed rule. Federal Register 87:26396, 4 May 2022. Docket No. FDA-2021-N-1309 — FR Doc. 2022-08993

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Key Research Papers

1. Benowitz NL, Henningfield JE (1994). Establishing a nicotine threshold for addiction. The implications for tobacco regulation. New England Journal of Medicine 331(2):123-125 — PubMed PMID: 7818638
2. Donny EC, Denlinger RL, Tidey JW, Koopmeiners JS, Benowitz NL, Vandrey RG, et al. (2015). Randomized trial of reduced-nicotine standards for cigarettes. New England Journal of Medicine 373(14):1340-1349 — PubMed PMID: 26422724
3. Hatsukami DK, Luo X, Jensen JA, al’Absi M, Allen SS, Carmella SG, et al. (2018). Effect of immediate vs gradual reduction in nicotine content of cigarettes on biomarkers of smoke exposure: a randomized clinical trial. JAMA 320(9):880-891 — PubMed PMID: 30193275
4. 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
5. 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
6. Chaiton M, Schwartz R, Cohen JE, Soule E, Zhang B, Eissenberg T (2021). Prior daily menthol smokers more likely to quit 2 years after a menthol ban than non-menthol smokers: a population cohort study. Nicotine & Tobacco Research 23(9):1584-1589 — PubMed PMID: 33693745

PubMed Topic Searches

1. PubMed: very low nicotine content cigarettes
2. PubMed: menthol cigarette ban
3. PubMed: flavored cigars and youth

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Connections

• FDA Actions of 2025
• FDA and Regulation
• Nicotine Pouch Marketing Authorization (2025)
• Nicotine: The Research
• Nicotine Addiction and Withdrawal
• Nicotine Toxicity, Poisoning and Safety
• Secondhand Smoke
• Tobacco and Nicotine Bans
• How Pyrazines Entered ‘Light’ Cigarettes
• Addiction and Substance Use Disorders
• Lung Cancer
• COPD

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