Constitutional Compliance, Credibility, and FDA Regulated Tobacco Warning Labels

宪法合规性、可信度和 FDA 监管的烟草警告标签

• 批准号: 9081626
• 负责人: Sahara Elizabeth Byrne
• 金额: $ 57.3万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-06-09 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9081626
• 关键词: Address; Adult; Age; Amendment; Antismoking; Attention; Behavioral; Belief; Caucasians; Cessation of life; Cigarette; Color; Communication; Constitutional; Constitutional Laws; Court Decisions; Cues; Education; Effectiveness; Elements; Emotional; Government; Grant; Health; Hearing; Heart; Hispanics; Image; Judgment; Label; Laboratories; Language; Laws; Legal; Location; Low income; Marketing; Methodology; Methods; Outcome; Participant; Policies; Population; Positioning Attribute; Process; Public Health; Public Policy; Publishing; Randomized; Regulation; Research; Research Personnel; Resistance; Rights; Risk; Rural Community; Saliva; Series; Smoker; Smoking; Smoking Status; Speech; Swab; Teenagers; Testing; Tobacco; Tobacco use; Travel; United States; United States Food and Drug Administration; Variant; Vulnerable Populations; Youth; authority; base; cigarette smoking; communication theory; court; design; emotional reaction; flexibility; inner city; interest; laboratory experiment; low socioeconomic status; multidisciplinary; non-compliance; non-smoker; population health; research study; response

DESCRIPTION (provided by applicant): Tobacco use, primarily cigarette smoking, is responsible for almost half a million preventable deaths in the United States (US) each year, and the vast majority of new smokers are under the legal age to purchase cigarettes. Cigarette smoking rates are also highest among low socio-economic status (SES) populations (including low-education and low-income groups). In 2009, the U.S. Food and Drug Administration (FDA) was granted regulatory authority over the manufacture, marketing, and distribution of tobacco products in order to protect public health. In March, 2013, the U.S. government decided not to pursue a Supreme Court hearing that may have reversed earlier court decisions ruling that a set of package warning labels proposed by the FDA were unconstitutional. The FDA will now revisit the content of the labels to convey the risks of smoking while maintaining the First Amendment rights to commercial speech of the tobacco companies. This project will examine how variations of FDA-regulated antismoking messages can be most effective for priority populations (youth and low SES groups) by testing message strategies that will cue effectiveness and reduce resistance, while maintaining compliance with the First Amendment. Youth and low SES populations are particularly susceptible to attending to and processing contextual elements of a message that can distract from the central anti-tobacco arguments. These contextual elements, such as color, placement, size, and emotional cues, have been the focus of ongoing policy regulation and legal argument. The proposed research will be continually responsive to newly proposed FDA anti-tobacco messaging and subsequent legal arguments. To accomplish these aims we will conduct 7 controlled laboratory experiments with random assignment of participants to conditions and based on methods applied in several previously published studies. We will conduct research with a total of 3,840 participants by traveling in a mobile laboratory to empirically identified locations where vulnerable populations reside. The mobile experiment lab will allow the team to quickly evaluate newly proposed messages and alternative messages with vulnerable populations that have been traditionally hard to reach while biologically confirming smoking status. This project brings together an interdisciplinary team of researchers from communication, population health, Constitutional law, and public policy and will yield findings that can be immediately applied to FDA policy actions and address legal arguments regarding constitutionality.

描述(申请人提供)：在美国，烟草使用，主要是吸烟，每年导致近50万可预防的死亡，而且绝大多数新吸烟者低于购买香烟的法定年龄。低社会经济地位人群(包括低教育和低收入群体)的吸烟率也是最高的。2009年，美国食品和药物管理局(FDA)被授予烟草产品制造、营销和分销的监管权，以保护公众健康。2013年3月，美国政府决定不寻求最高法院的听证会，这可能推翻了法院早些时候裁定FDA提出的一套包装警告标签违宪的裁决。FDA现在将重新审查标签的内容，以传达吸烟的风险，同时保持第一修正案对烟草公司商业言论的权利。该项目将研究FDA监管的禁烟信息的变化如何对优先人群(青年和低SES群体)最有效，方法是测试信息策略，这些策略将提示有效性并减少阻力，同时保持对第一修正案的遵守。青年和低SES人群特别容易注意和处理信息中的上下文因素，这些因素可能会分散对反烟草中心论点的注意力。这些背景因素，如颜色、位置、大小和情感暗示，一直是正在进行的政策监管和法律辩论的焦点。拟议的研究将继续对FDA新提出的反烟草信息和随后的法律争论做出回应。为了实现这些目标，我们将进行7个对照实验室实验，参与者随机分配到不同的条件下，并基于先前发表的几项研究中应用的方法。我们将与3840名参与者一起进行研究，方法是在流动实验室中前往经验性地确定弱势群体居住的地点。移动实验实验室将允许团队快速评估新提出的信息和针对弱势人群的替代信息，这些信息在生物学上确认吸烟状态时传统上很难接触到。该项目汇集了来自传播学、人口健康、宪法和公共政策的跨学科研究人员团队，并将产生可立即应用于FDA政策行动的结果，并解决有关合宪性的法律争论。