31 months from submission to decision

The applicant submitted information for the eight new tobacco products listed on the cover page and with more detail in Appendix A, sold under the brand names Logic Vapeleaf, Logic Pro, and Logic Power. Briefly, the applicant stated that the new products are “designed for adult combusted tobacco smokers”, and their user guides state that the new products are not smoking cessation products. - Page 7

The BCP review considered the five applicant-sponsored clinical studies in adult smokers. Three studies investigated the abuse liability of Logic Power Tobacco (PM0000540.PD1; LP001), Logic Vapeleaf Regular (PM0000529.PD1; LP002), and Logic Pro Tobacco (PM0000535.PD1; LP003) products under controlled laboratory conditions, compared to usual brand CC smoking, representative ENDS, and nicotine gum or inhaler. Nicotine exposure and exposure to non-nicotine BOE, as well as subjective effects, were evaluated in forced-switch, 60-day ad libitum use studies(PM0000529.PD1, PM0000540.PD1; LP004 and PM0000535.PD1; LP005); BOE were compared to continued CC smoking and, in one study, complete tobacco cessation (although NRT was provided, if requested). - Page 21

The applicant-submitted data do not suggest that the new products will promote CC cessation, at least in the 60 days assessed in LP004, LP005. But because they may facilitate incomplete switching (i.e., dual use) and decrease CPD, the new products may still promote CC quit attempts and, ultimately, CC cessation. In addition, there is no evidence to suggest that CC smokers will increase their overall tobacco use when initiating use of these new products. - Page 34

The applicant-submitted data do not suggest that CC smokers will completely switch to the new products and indicate instead that dual use is the most likely use behavior. Because the greatest potential health benefit to CC smokers is associated with cessation, the population health model may overestimate the impact actual use of these products has on population health. - Page 47