Impact of new standards for tobacco products among dual e-cigarette/combusted cigarette users

到目前为止，大多数实验性烟草管制科学(TRS)都专门专注于影响 关于单一烟草使用的可能的烟草产品标准(例如，限制电子烟调味品) 标准所针对的产品(例如，电子烟)主要或仅使用目标产品的个人 产品(如尿布)。鉴于这种“单一目标”的方法已经产生了大量可操作的 证据，这也导致了监管科学证据基础上的巨大差距，这两个 原因：首先，对单一烟草产品(STP)使用者的狭隘关注导致很少有证据表明 可能的新产品标准在多个烟草产品(MTP)用户中的影响，这些用户组成了30- 40%的烟草使用人口(占美国成年人口的10%)。电子烟的双重使用者(EC)和 燃烧香烟(CC)占MTP使用人口的40%。第二，我们的初步证据 表明任何两种烟草产品在它们相互替代的程度上存在差异，并且 针对一种烟草产品的可能的新产品标准可能会影响对 其他烟草产品。在拟议的研究中，我们将通过评估效果来填补上面确定的空白 将EC电子液体口味限制在烟草中--仅基于对CC的吸引力和偏好，在一组成年双胞胎样本中 EC和CC的用户。除了评估限制电子液体风味对CC使用的影响，因为它们 现在存在(目标1)，我们还将按照标准检查限制EC液体对CC偏好的影响 消除CC中的薄荷醇(目标2)并降低CC尼古丁含量(目标3)。我们选择了这些可能的政策 已经在地方一级颁布的行动，已成为拟议的规则制定的主题，或 在文献中都有过争论。在每个实验中，成年双重EC/CC用户将经历偏好 会议期间，他们将在EC和CC之间做出选择。我们假设，限制 EC只对烟草有味道，会增加对CC的偏好(目标1)；在薄荷醇吸烟者中，限制EC 相对于EC何时是首选口味，或者何时为非薄荷醇CC，纯烟草将增加选择 参与者使用自己的EC设备(目标2)；将EC限制为仅限烟草使用将增加VLNC的选择 香烟相对于EC是首选的味道，还是参与者自己的设备(目标3)。建议数 研究将为FDA提供关于一种可能的产品标准影响的可行信息 对烟草制品的诉求和使用其他烟草制品。这项研究将在 经常使用一种以上烟草产品的个人，因此最容易受到 随着新目标产品特性的变化，非目标产品的使用模式 标准。我们的目标是高度响应FDA在RFA-OD-18-002中列出的研究优先事项 评估烟草产品特性的变化(如香精…)对烟草使用的影响 包括…在内的行为两用/多用，过渡到非调味品，以及…“(成瘾优先区)。

The majority of experimental tobacco regulatory science (TRS) to date has focused specifically on the impacts of possible tobacco product standards (e.g. limit on e-cigarette flavoring) on the use of the single tobacco product targeted by the standard (e.g. e-cigarettes) among individuals who primarily or solely use the targeted product (e.g. vapers). Whereas this “single target” approach has yielded a large amount of actionable evidence, it has also resulted in a significant gap in the regulatory science evidence base for two interrelated reasons: First, the narrow focus on single tobacco product (STP) users has resulted in very little evidence on the impact of possible new product standards among multiple tobacco product (MTP) users who make up 30- 40% of the tobacco using population (10% of the U.S. adult population). Dual users of e-cigarettes (EC) and combusted cigarettes (CC) make up 40% of the MTP using population. Second, our preliminary evidence suggests that any two tobacco products vary in the degree to which they substitute for one another and that possible new product standards targeting one tobacco product may have an impact on the appeal and use of other tobacco products. In the proposed research, we will fill the gaps identified above by evaluating the effects of limiting EC e-liquid flavors to tobacco-only on the appeal of, and preference for, CC in a sample of adult dual users of EC and CC. In addition to evaluating the impact of limiting e-liquid flavor on the use of CC as they exist now (Aim 1), we will also examine the effects of limiting EC liquid on CC preference following standards that eliminate menthol in CC (Aim 2) and reduce CC nicotine content (Aim 3). We chose these possible policy actions as they have already been enacted at local levels, have been the subject of proposed rulemaking, or have been debated in the literature. In each experiment, adult dual EC/CC users will undergo preference sessions during which they will make choices between an EC and a CC. We hypothesize that restricting the flavor of EC to tobacco only, will increase preference for CC (Aim 1); that among menthol smokers, limiting EC to tobacco-only will increase choices for non-menthol CC relative to when EC are a preferred flavor, or when participants use their own EC device (Aim 2); and limiting EC to tobacco-only will increase choices for VLNC cigarettes relative to when EC are a preferred flavor, or the participant's own device (Aim 3). The proposed research will provide the FDA with actionable information on the impact of possible product standards for one tobacco product on the appeal and use other tobacco products. This research will be conducted among individuals who regularly use more than one tobacco product, and as such, are most vulnerable to changes in patterns of use of non-targeted products following changes in the characteristics of products targeted by new standards. Our aims are highly responsive to FDA research priorities as listed in RFA-OD-18-002 by evaluating how “changes in tobacco product characteristics (such as flavors…) impact on tobacco use behaviors including… dual/poly use, transition to non-flavored products, and …” (Addiction Priority Area).