“…When determining whether a new tobacco product is appropriate for the protection of the public health, TCA §910(c)(4) requires FDA to consider the risks and benefits to the population as a whole including users and nonusers of the tobacco product, and taking into account (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products. 77 Halpern et al 16 Hajek et al 73 Lee et al 76 Lucchiari et al 18 Walker et al 19 Hatsukami et al 74 Holliday et al 75 Bullen et al 17 Lee et al 77 Halpern et al 16 Hajek et al 73 Lee et al 76 Lucchiari et al 18 Walker et al 19 Hatsukami et al 74 Holliday et al 75 Bullen et al 17 1 extent that people who smoke simply add e-cigarettes to their cigarette smoking (becoming so-called dual users), their risk of heart disease, [80][81][82][83] lung disease, 84,85 and cancer 86 disease, [80][81][82][83]92 lung disease, 84,85,93,94 and cancer. 86,95,96 By contrast, the RCTs suggest that however, also requires that they be "safe," meaning that the benefit-to-risk ratio must be favorable.…”