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HHS/FDA RIN: 0910-AH88 Publication ID: Fall 2017 
Title: ●Premium Cigars; Request for Scientific Information 

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.  FDA is aware that there is still interest in exempting these products from regulation or regulating them in a different manner from other cigars and, therefore, intends to issue an advance notice of proposed rulemaking requesting scientific information that might support such an action.  The notice would request information on how premium cigars should be defined, the health effects of these products, and their patterns of use.

Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage 
Major: Undetermined  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  12/00/2017 
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:
Deirdre Jurand
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, WO 71, Room G335,
Silver Spring, MD 20993
Phone:877 387-1373