The FDA moves to ban menthol cigarettes

What was proposed, and what happened to it

On 28 April 2022 the FDA announced two proposed product standards. One would prohibit menthol as a characterizing flavor in cigarettes. The other would prohibit all characterizing flavors except tobacco in cigars. Both proposed rules were published in the Federal Register on 4 May 2022.

Neither was ever finalized.

The official regulatory record makes this plain. The Unified Agenda entry for the menthol rule, RIN 0910-AI60, lists the proposal in May 2022, a comment period that closed on 2 August 2022 after an extension, and then a single word: Withdrawn, dated 25 July 2025. The cigar rule, RIN 0910-AI28, shows the same withdrawal date.

So the headline is accurate for 2022 and out of date now. Menthol cigarettes remain legal to sell in the United States.

Who the proposal would have reached

FDA was explicit on one point, and it was widely misread at the time.

The agency stated that it cannot and will not enforce against individual consumers for possession or use of menthol cigarettes or flavored cigars. Enforcement would have applied to manufacturers, distributors, wholesalers, importers and retailers. FDA also noted that state and local police do not enforce the Federal Food, Drug and Cosmetic Act on its behalf.

Why menthol specifically

The case against menthol is about chemistry and habit, not taste alone.

Menthol produces a cooling sensation that masks the irritation and harshness of cigarette smoke. NCI's researchers describe two consequences. Smoke that hurts less is easier to start on. And menthol interacts with nicotine in the brain in a way that strengthens nicotine's addictive effect, which makes quitting harder.

FDA cited an estimate that in 2019, 18.5 million people in the United States aged 12 and over smoked menthol cigarettes, with high rates among youth, young adults, and Black Americans. NCI notes that 85% of African Americans who smoke use menthol cigarettes, and that the tobacco industry marketed these products to Black communities for decades.

What smoking does to lung tissue

This is the medical reason a flavor additive is a cancer story.

The lungs are two cone-shaped organs that bring oxygen in and push carbon dioxide out. Air travels down the windpipe, splits into two bronchi, then into smaller bronchioles, ending in tiny sacs called alveoli where the gas exchange happens. Cigarette smoke passes over every one of those surfaces.

Lung cancer is the leading cause of cancer death in the United States. NCI estimates that smoking accounts for about 30% of all cancer deaths in the country.

The American Cancer Society projects about 229,410 new lung and bronchus cancer diagnoses in the United States in 2026 and about 124,990 deaths, and SEER, NCI's surveillance program, publishes both. SEER's own measurement puts median age at diagnosis at 71.

Stage at diagnosis dominates the outlook, on cases diagnosed from 2016 through 2022. Twenty-four percent of cases are found while confined to the lung, with five-year relative survival of 65.5%. Twenty-one percent have reached nearby lymph nodes, at 38.2%. Fifty-one percent are found after distant spread, at 10.5%. Across all stages the figure is 29.5% for people diagnosed from 2016 through 2022.

Those are group averages from a registry. They describe a population, not any individual, and they lag current treatment by years.

Screening, and who it is for

Low-dose CT screening is the one test with randomized evidence behind it in lung cancer.

NCI's clinical summary reports two trials. One screened higher-risk people aged 55 to 74 with a 30 pack-year history, either currently smoking or having quit within 15 years, three times at yearly intervals. It cut lung cancer deaths by 20% compared with chest x-rays, with an updated estimate of 16%. The other found a 24% reduction in men screened four times against no screening.

NCI summarizes the effect as roughly a 20% to 24% relative reduction in lung-cancer-specific deaths.

Screening also carries harms, including findings that turn out not to be cancer and lead to further tests. Our page on the benefits and harms of screening covers that trade-off, and cancer screening explains how eligibility is set.

Whether screening fits any one person depends on age and smoking history, and it is a conversation with a clinician rather than a rule that can be printed on a page.

What this does not mean

• The title describes 2022 accurately. It does not describe 2026. Both proposed rules were withdrawn on 25 July 2025 according to the Unified Agenda, and no menthol ban took effect.
• The deaths-avoided figures quoted at the time were modeled projections of a policy that was never implemented. FDA cited published models estimating 324,000 to 654,000 smoking-attributable deaths avoided over 40 years. Those are estimates of what a finalized rule might have done, not observations of anything that occurred.
• A withdrawn proposal changes nothing about what menthol does to a smoker. The pharmacology described above is unaffected by the rulemaking.
• Nothing here is advice about quitting, which is an individual matter and better supported by a clinician than by a policy page. Our overview of lung cancer covers the disease itself.

Sources

• FDA: FDA Proposes Rules Prohibiting Menthol Cigarettes and Flavored Cigars
• NCI Cancer Currents: FDA Proposes Rule Prohibiting Menthol Cigarettes
• Unified Agenda RIN 0910-AI60: Tobacco Product Standard for Menthol in Cigarettes
• Unified Agenda RIN 0910-AI28: Tobacco Product Standard for Characterizing Flavors in Cigars
• NCI PDQ: Lung Cancer Screening (Health Professional Version)
• NCI SEER Stat Facts: Lung and Bronchus Cancer

How this article was prepared

An AI-assisted editorial system helped prepare this page. No named medical reviewer has reviewed it unless one is listed.

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