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HHS/FDA RIN: 0910-AI28 Publication ID: Fall 2021 
Title: Tobacco Product Standard for Characterizing Flavors in Cigars 
Abstract:

Evidence shows that flavored tobacco products appeal to youth and also shows that youth may be more likely to initiate tobacco use with such products. Characterizing flavors in cigars, such as strawberry, grape, orange, and cocoa, enhance taste and make them easier to use. Over a half million youth in the United States use flavored cigars, placing these youth at risk for cigar-related disease and death. This proposed rule is a tobacco product standard that would ban characterizing flavors (other than tobacco) in all cigars. We are taking this action with the intention of reducing the tobacco-related death and disease associated with cigar use.

 
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: Yes  Unfunded Mandates: No 
CFR Citation: 21 CFR 1166   
Legal Authority: 21 U.S.C. 331    21 U.S.C. 333    21 U.S.C. 371(a)    21 U.S.C. 387b and 387c    21 U.S.C. 387f(d) and 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 characterizing flavors (other than tobacco) in all cigars.  Characterizing flavors in cigars, such as strawberry, grape, cocoa, and fruit punch, increase appeal and make the cigars easier to use, particularly among youth and young adults. This product standard would reduce the appeal of cigars, particularly to youth and young adults, and is intended to decrease the likelihood of experimentation, progression to regular use, and potential for addiction to nicotine. In addition, most of the users of flavored cigars are from under served communities and/or at risk populations, including racial/ethnic minorities, lesbian, gay, bisexual, transgender and queer (LGBTQ+) persons, those of lower socioeconomic status, and youth. As such, reducing the appeal and use of cigars by eliminating characterizing flavors is also expected to decrease tobacco-related disparities and promote health equity across population groups.

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 the public health. Section 907 also authorizes FDA to include in a product standard a provision that restricts the sale and distribution of a tobacco product to the extent that it may be restricted by a regulation under section 906(d) of the FD&C Act. Section 701(a) of the FD&C Act authorizes the promulgation of regulations for the efficient enforcement of the FD&C Act.

Alternatives:

In addition to the costs and benefits of the proposed rule, FDA will assess the costs and benefits of changing the effective date of the rule, and including pipe tobacco in the proposed standard

Anticipated Costs and Benefits:

The anticipated benefits of the proposed rule stem from diminished exposure to tobacco smoke for users of cigars from decreased experimentation, progression to regular use, and consumption of cigars with characterizing flavors other than tobacco.  The diminished exposure and use is expected to reduce illness and improve health.

Risks:

None

Timetable:
Action Date FR Cite
ANPRM  03/21/2018  83 FR 12294   
ANPRM Comment Period End  07/19/2018 
NPRM  04/00/2022 
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: Undetermined 
Small Entities Affected: Businesses  Federalism: Undetermined 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: Yes 
Agency Contact:
Samantha LohCollado
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
Email: ctpregulations@fda.hhs.gov