Micah L Berman, M Justin Byron, Natalie Hemmerich, Eric N Lindblom, Allison J Lazard, Ellen Peters, Noel T Brewer
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引用次数: 0
Abstract
The 2009 Family Smoking Prevention and Tobacco Control Act (TCA) requires tobacco companies to disclose information about the harmful chemicals in their products to the U.S. Food and Drug Administration (FDA). The law requires the FDA, in turn, to communicate this information to the public "in a format that is understandable and not misleading to a lay person." But how should the FDA comply with this requirement? What does it mean for information about complex chemicals to be "understandable and not misleading to a lay person"? These questions are not easy ones to answer. Disclosures about the amount of harmful chemicals (constituents) in different tobacco products may help to inform consumers, but may also conversely prompt consumers to reach incorrect or unsupported conclusions about products' relative health risks. This paper first analyzes the FDA's legal obligation to publish tobacco constituent information so that it is "understandable and not misleading to a layperson." Second, it discusses how that legal analysis has guided scientific research examining how members of the public interpret messages regarding tobacco constituents. Lastly, this paper concludes with policy recommendations for the FDA as it considers how to comply with the law's constituent disclosure requirement while still furthering its overall objective of promoting public health.
2009 年《家庭预防吸烟和烟草控制法》(TCA)要求烟草公司向美国食品药品管理局(FDA)披露其产品中有害化学物质的信息。法律要求 FDA "以外行人可以理解且不会误导的方式 "向公众传达这些信息。但 FDA 应如何遵守这一要求呢?关于复杂化学品的信息 "对外行人士来说可以理解且不具误导性 "意味着什么?这些问题并不容易回答。披露不同烟草制品中有害化学物质(成分)的含量可能有助于向消费者提供信息,但也可能反过来促使消费者对产品的相对健康风险得出不正确或无依据的结论。本文首先分析了 FDA 发布烟草成分信息的法律义务,即 "让外行人能够理解且不会产生误导"。其次,本文讨论了法律分析如何指导科学研究,研究公众如何解读烟草成分信息。最后,本文提出了一些政策建议,供食品及药物管理局在考虑如何遵守法律的成分披露要求的同时,进一步实现促进公众健康的总体目标。
期刊介绍:
The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products.
Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law.
All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.