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

迄今为止，大多数实验性烟草监管科学（TRS）都特别关注 关于单一烟草使用的可能的烟草产品标准（例如对电子烟调味剂的限制） 标准针对的产品（例如电子烟）在主要或仅使用目标产品的个人中 产品（例如电子烟）。尽管这种“单一目标”方法产生了大量可操作的 证据，这也导致了监管科学证据基础的重大差距，两个相互关联的 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， 可能的新产品标准对烟草制品（MTP）使用者的影响， 烟草使用人口的40%（美国成年人口的10%）。电子烟的双重使用者（EC）和 燃烧的香烟（CC）占MTP使用人群的40%。第二，我们的初步证据 表明任何两种烟草产品在相互替代的程度上是不同的， 针对一种烟草产品的可能的新产品标准可能会对烟草产品的吸引力和使用产生影响， 其他烟草产品。在拟议的研究中，我们将通过评估影响来填补上述空白 限制EC电子液体口味的烟草-只有上诉，和偏好，CC在成人双重样本 EC和CC的用户。除了评估限制电子液体风味对CC使用的影响之外， 现有的（目标1），我们还将研究限制EC液体对CC偏好的影响， 其消除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，已经成为拟议规则制定的主题，或 在文献中有过争论。在每个实验中，成人双EC/CC用户将经历偏好 他们将在EC和CC之间做出选择。我们假设， 只有烟草味的EC，将增加对CC的偏好（目标1）;薄荷醇吸烟者，限制EC 相对于当EC是优选的香料时，或者当EC是优选的香料时， 参与者使用自己的电子商务设备（目标2）;将电子商务限制为仅限烟草将增加VLNC的选择 香烟相对于EC是首选口味或参与者自己的设备（目标3）。拟议 研究将为FDA提供关于可能的产品标准对一个人的影响的可操作信息。 烟草产品的吸引力和使用其他烟草产品。这项研究将在 经常使用一种以上烟草产品的人，因此最容易受到 新产品目标产品特性发生变化后非目标产品的使用模式 标准我们的目标是高度响应RFA-OD-18-002中列出的FDA研究优先事项， 评估“烟草产品特性的变化（如口味.）如何影响烟草使用 行为包括.双重/多用途，过渡到非调味产品，和.”（成瘾优先领域）。

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).