Tobacco Product Standard for Menthol in Cigarettes (Proposed Rule), Preliminary Regulatory Impact Analysis

The Food and Drug Administration (FDA) is proposing a tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes. Tobacco use is the leading preventable cause of death and disease in the United States. Menthol’s flavor and sensory effects increase appeal and make menthol cigarettes easier to use, particularly among youth and young adults. There are over 18.5 million menthol cigarette smokers ages 12 and older in the United States. This proposed product standard would 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. In addition, the proposed tobacco product standard would improve the health and reduce the mortality risk of current menthol cigarette smokers by decreasing cigarette consumption and increasing the likelihood of cessation. FDA is taking this action to reduce the tobacco-related death and disease associated with menthol cigarette use. The proposed standard also is expected to reduce tobacco-related health disparities and advance health equity.

Regulatory Impact Analysis

Tobacco Product Standard for Menthol in Cigarettes (Proposed Rule), Preliminary Regulatory Impact Analysis (PDF- 2.43MB)

Federal Register: 87 FR 26454, May 4, 2022

Docket: FDA-2021-N-1349