Senior Regulatory Counsel

0910-AI60 202210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Tobacco Product Standard for Menthol in Cigarettes

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

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes State, local, or tribal governments Private Sector Not Yet Determined 21 U.S.C. 387g 21 U.S.C 371 21 U.S.C 387f Yes

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 among current menthol cigarette smokers, the tobacco product standard is likely to improve the health of current menthol cigarette smokers by decreasing consumption and increasing the likelihood of cessation.

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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.

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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.

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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.

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]]> 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 08/00/2023 Yes Businesses Federal Local State Tribal Yes Yes No Beth Buckler Senior Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993