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HHS/FDA RIN: 0910-AI60 Publication ID: Fall 2023 
Title: Tobacco Product Standard for Menthol in Cigarettes 

This rule is a tobacco product standard to prohibit the use of menthol as a characterizing flavor in cigarettes.

Agency: Department of Health and Human Services(HHS)  Priority: Section 3(f)(1) Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: Yes  Unfunded Mandates: State, local, or tribal governments; Private Sector 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 387g    21 U.S.C 371    21 U.S.C 387f   
Legal Deadline:  None

Statement of Need:

The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), authorizes FDA to adopt tobacco product standards under section 907 if the Secretary finds that a tobacco product standard is appropriate for the protection of the public health. This product standard would prohibit menthol as a characterizing flavor in cigarettes. The 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 cigarette smoking. In addition, the 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.

Summary of the Legal Basis:

Section 907 of the FD&C Act authorizes the adoption of tobacco product standards if the Secretary finds that a tobacco product standard is appropriate for the protection of public health.


In addition to the costs and benefits of the rule, FDA will assess the costs and benefits of extending the effective date of the rule, creating a process by which some products may apply for an exemption or variance from the product standard, and prohibiting menthol as an intentional additive in cigarette products rather than prohibiting menthol as a characterizing flavor.

Anticipated Costs and Benefits:

The rule is expected to generate compliance costs on affected entities, such as one-time costs to read and understand the rule and alter manufacturing/importing practices.  The quantified benefits of the rule stem from improved health and diminished exposure to tobacco smoke for users of cigarettes from decreased experimentation, progression to regular use, and consumption of menthol cigarettes.  The qualitative benefits of the rule include impacts such as reduced illness for smokers and non-smokers.  



Action Date FR Cite
ANPRM  07/24/2013  78 FR 44484   
ANPRM Comment Period End  09/23/2013 
NPRM  05/04/2022  87 FR 26454   
NPRM Comment Period Extended  06/21/2022  87 FR 36786   
NPRM Comment Period End  07/05/2022 
NPRM Comment Period Extended End  08/02/2022 
Final Rule  03/00/2024 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Federal, Local, State, Tribal 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Beth Buckler
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335,
Silver Spring, MD 20993
Phone:877 287-1373