Regulatory Counsel

0910-AI28 202310 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

This rule is a tobacco product standard that would prohibit 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. 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 these products easier to use. Over a half million youth in the United States use flavored cigars, placing these youth at risk for cigar-related death and disease.

]]> Section 3(f)(1) Significant Previously Published in The Unified Agenda Final Rule Stage Yes State, local, or tribal governments Private Sector 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 will prohibit 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 will reduce the appeal of cigars, particularly to youth and young adults, and thereby decrease the likelihood of experimentation, development of nicotine dependence, and progression to regular use. This product standard will improve public health by increasing the likelihood of cessation among existing cigar smokers; this product standard will also improve health outcomes within groups that experience disproportionate levels of tobacco use, including certain vulnerable populations.

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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. 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 906(d) of the FD&C Act authorizes the Secretary to issue regulations requiring restrictions on the sale and distribution of a tobacco product, including restrictions on the access to, and the advertising and promotion of, the tobacco product, if the Secretary determines that such regulation would be appropriate for the protection of the public health. 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 product standard, FDA will assess the costs and benefits of, among other things, a different effective date for the rule, and including pipe tobacco in the product standard.

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The anticipated benefits of the product standard include those coming from reduced death and disease that are the result of cigar use among adult cigar smokers, reduced death and disease from secondhand smoke, and reduced death and disease among youth who are deterred from initiating under the product standard. The anticipated costs of the product standard are those to firms to comply with the rule, to consumers impacted by the rule, and to the government.

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]]> ANPRM 03/21/2018 83 FR 12294 ANPRM Comment Period End 07/19/2018 NPRM 05/04/2022 87 FR 26396 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 03/00/2024 Yes Businesses Federal Local State Tribal Yes Yes No Nathan Mease Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov 10903 New Hampshire Avenue, Center for Tobacco Products, Document Control Center, Building 71, Room G335, Silver Spring MD 20993