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|Publication ID: Fall 2022
|Title: 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.
|Agency: Department of Health and Human Services(HHS)
|Priority: Economically Significant
|RIN Status: Previously published in the Unified Agenda
|Agenda Stage of Rulemaking: Final Rule Stage
|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
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 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.
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.
|Regulatory Flexibility Analysis Required: Yes
|Government Levels Affected: Federal, Local, State, Tribal
|Small Entities Affected: Businesses
|Included in the Regulatory Plan: Yes
|RIN Data Printed in the FR: Yes
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