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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.