0910-AH88 201804 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Premium Cigars; Request for Scientific Information

The notice would request 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.

]]> Other Significant Previously Published in The Unified Agenda Prerule Stage No No Other Not Yet Determined 21 U.S.C. 387a(b) No ANPRM 05/00/2018 No None No No No Deirdre Jurand Regulatory Counsel 0910 Food and Drug Administration FDA 877 387-1373 ctpregulations@fda.hhs.gov 10903 New Hampshire Avenue, WO 71, Room G335, Silver Spring MD 20993