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项目摘要/摘要 2016年5月,美国食品和药物管理局(FDA)发布了最终规则,将电子产品 尼古丁递送系统(END)和其他符合法定定义的产品 其授权范围内的烟草产品。联邦法律明确禁止五类标签 烟草产品的广告包括:(1)虚假和/或误导性的;(2)FDA批准的或 FDA认可,未经FDA批准;(3)未经FDA批准的风险烟草产品 批准。此外,END不能作为戒烟或戒烟的产品销售。 (五)未经美国食品药品监督管理局药物中心批准的其他治疗用途 评估和研究(CDER)。尽管这些类型的终止索赔一直是 在网上和印刷媒体上记录,可能很难识别被禁止的索赔 通常是含蓄的。FDA的任务是考虑消费者对此类声明的看法 在确定它们是否被禁止时;然而,文献中有一个显著的空白 关于消费者对健康声明的看法。此外,还没有进行过任何研究 关于电子烟商店的广告主张,这是终端增长最快的部分 零售商。这项研究将建立在一项试点赠款的基础上,该赠款开发了以下方法 使用可穿戴成像技术,通过照片记录Vape商店的索赔。在……里面 在拟议的研究中,我们将使用这种方法来进行另一波数据 收集以记录电子烟商店中的索赔。飞行员和新浪潮的声明 将结合数据收集,以创建一份未经证实的索赔的全面清单 在调查中使用,该调查将调查消费者对它们的看法。这将是此类产品中的第一款 为了评估消费者如何解读这些现实世界,零售商做出了健康声明。在… 在这项研究的结论中,我们将开发出用于捕获索赔的可靠方法 在Ends零售环境中;扩展了Ends索赔类型的知识 并制定了评估消费者对这些产品的看法的措施 索赔,所有这些都将帮助FDA确定此类索赔是否属于 这是他们禁止的类别之一。这一重点项目由一名新调查员领导,与 国家认可的合作者团队,将为未来更大规模的研究奠定基础 将增加关于目的的证据,并直接告知过程中 FDA对被禁止的广告主张进行识别和分类。
英文摘要
PROJECT SUMMARY/ABSTRACT In May 2016, the Food and Drug Administration (FDA) issued a Final Rule, bringing electronic nicotine delivery systems (ENDS) and other products that meet a statutory definition of a tobacco product under its authority. Federal law explicitly prohibits five categories of labelling and advertising for tobacco products including: (1) false and/or misleading; (2) FDA-approved or FDA-endorsed, without FDA approval; and (3) modified risk tobacco product, without FDA approval. Additionally, ENDS cannot be marketed as a product for (4) smoking cessation or for (5) other therapeutic purposes, without prior approval from the FDA's Center for Drug Evaluation and Research (CDER). Although these types of ENDS claims have been documented online and in print media, it can be difficult to identify prohibited claims as they are often implicit. The FDA has been tasked with considering consumer perceptions of such claims when determining if they are prohibited; however, there is a significant gap in the literature regarding consumer perceptions of health claims. Additionally, no research has been conducted on advertising claims made in vape shops, which are the fastest growing segment of ENDS retailers. This study will build upon a pilot grant that developed the methodology to photographically document ENDS claims in vape shops using wearable imaging technology. In the proposed study, we will use this methodology to conduct an additional wave of data collection to document claims in vape shops. The claims from both the pilot and the new wave of data collection will be combined to create a comprehensive list of unsubstantiated claims for use in a survey, which will investigate consumer perceptions of them. It will be the first of its kind to assess how consumers interpret these real-world ENDS health claims made by retailers. At the conclusion of this study, we will have developed robust methodologies for capturing claims in the ENDS retail environment; expanded the knowledge of the types of ENDS claims being made to consumers; and developed measures for assessing consumer perceptions of those claims, all of which will aid the FDA in making determinations of whether such claims fall into one of their prohibited categories. This focused project, led by a New Investigator working with a nationally recognized team of collaborators, will lay the groundwork for future, larger studies that will increase the body of evidence regarding ENDS and directly inform the process in which the FDA identifies and classifies prohibited advertising claims.
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Core 2 - ARSC
The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior
The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior
The Impact of Cannabidiol (CBD) Health Claims at Point-of-Sale on Consumer Perceptions and Behavior
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