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HHS/FDA RIN: 0910-AI60 Publication ID: Fall 2021 
Title: Tobacco Product Standard for Menthol in Cigarettes 

This proposed 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: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Undetermined 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 387g   
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 ban menthol as a characterizing flavor in cigarettes. The standard would reduce the availability of menthol cigarettes and thereby decrease the likelihood that nonusers who would experiment with these products would progress to regular cigarette smoking. In addition, among current menthol cigarette smokers, the proposed tobacco product standard is likely to improve the health of current menthol cigarette smokers by decreasing 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 proposed 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 proposed product standard, and prohibiting menthol as an additive in cigarette products rather than prohibiting menthol as a characterizing flavor.

Anticipated Costs and Benefits:

The proposed 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 proposed 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 proposed rule include impacts such as reduced illness for smokers.  



Action Date FR Cite
ANPRM  07/24/2013  78 FR 44484   
ANPRM Comment Period End  09/23/2013 
NPRM  04/00/2022 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: Undetermined 
Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
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