Regulatory Counsel

0910-AI28 202110 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 Characterizing Flavors in Cigars

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.

]]> Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Yes No 21 CFR 1166 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 ... 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 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.

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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 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.

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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

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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.

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]]> ANPRM 03/21/2018 83 FR 12294 ANPRM Comment Period End 07/19/2018 NPRM 04/00/2022 Yes Businesses Undetermined Undetermined Yes No Laura Chilaka 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 G355, Silver Spring MD 20993