25 months from submission to decision

27 months from submission to decision

The applicant compared NJOY ACE products with JUUL and Vuse Alto. NJOY ACE and Vuse Alto have comparable design parameters such as e-liquid volume (ml), e-liquid pH, battery cell capacity (mAh), atomizer resistance (O), and the same atomizer type. Although not all design parameters are comparable with comparison products, the applicant's rationale for selection of these comparison products is acceptable from an engineering perspective.

In the applicant's NJOY User Study, the estimates of complete switching from combusted cigarettes to ENDS at three months was 32%, which is higher than what is typically seen in the literature for estimates of complete switching from combusted cigarettes to ENDS (3.4%- 5.9%) (Coleman et al., 2019; Stanton et al., 2020; Piper et al., 2020). Furthermore, the applicant's data suggests there was a decrease in complete switching (measured by 30-day point prevalence abstinence (PPA)) between two months and three months. These high estimates of complete switching in the applicant's NJOY User Study are possibly inflated due to use of a convenience sample with a low enrollment rate and considerable loss to follow-up.

Overall, reported curiosity and intention to try the new product was low (<2%) among adult never and former smokers. These data suggest that former and never smoking adults are not interested in trying the new products.

The applicant's Adult Prevalence Study on NJOY DAILY use among adults showed use was more common in current than former and never smokers. Complete switching from combusted cigarettes to NJOY DAILY was estimated in the applicant's NJOY User Study with 39% of 2,533 adults using the tobacco flavored products at 6 months, a rate that is much higher than typically seen (3-6%) in the published literature. Based on data presented by the applicant, dual use of the new products with combusted cigarettes was also observed (78.6% baseline) which is higher than other ENDS productsreported in the literature (44-54%).

The applicant submitted youth prevalence studies and although these studies had small sample sizes, the data suggest that 40.5% of youth who reported ever ENDS use started with "something other" than tobacco or menthol flavored products, and 45.6% of ever NJOY DAILY youth users reported starting with non-tobacco/non-menthol flavored NJOY DAILY products.