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HHS/FDA RIN: 0910-AH88 Publication ID: Fall 2020 
Title: Premium Cigars 

The notice requests information on how premium cigars should be defined, the health effects of these products, and their patterns of use. In the proposed deeming rule, FDA had requested scientific information that would support consideration of exempting premium cigars from regulation. FDA received comments claiming that the health risks associated with cigar use generally, or with the use of premium cigars in particular, are not significant because of the way these products are used. Specifically, commenters claimed that these products are not used by youth and young adults, they are not used frequently, and they are not always inhaled. However, the information in the comments did not provide an adequate scientific basis or public health rationale to support excluding these products from regulation.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: Other 
CFR Citation: Not Yet Determined     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 U.S.C. 387a(b)   
Legal Deadline:  None
Action Date FR Cite
ANPRM  03/26/2018  83 FR 12901   
ANPRM Comment Period End  07/25/2018 
RFI  01/00/2021 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Federalism: No 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: No 
Agency Contact:
Nathan Mease
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