FDA-Required Tobacco Product Inserts & Onserts–and the First Amendment.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY Food and drug law journal Pub Date : 2017-01-01
Eric N Lindblom, Micah L Berman, James F Thrasher
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Abstract

In 2012, a federal court of appeals struck down an FDA rule requiring graphic health warnings on cigarettes as violating First Amendment commercial speech protections. Tobacco product inserts and onserts can more readily avoid First Amendment constraints while delivering more extensive information to tobacco users, and can work effectively to support and encourage smoking cessation. This paper examines FDA’s authority to require effective inserts and onserts and shows how FDA could design and support them to avoid First Amendment problems. Through this process, the paper offers helpful insights regarding how key Tobacco Control Act provisions can and should be interpreted and applied to follow and promote the statute’s purposes and objectives. The paper’s rigorous analysis of existing First Amendment case law relating to compelled commercial speech also provides useful guidance for any government efforts either to compel product disclosures or to require government messaging in or on commercial products or their advertising, whether done for remedial, purely informational, or behavior modification purposes.

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fda要求烟草产品说明书和说明书-以及第一修正案。
2012年,一家联邦上诉法院驳回了FDA要求在香烟上印制健康警告的规定,认为这违反了第一修正案对商业言论的保护。烟草产品插页和广告可以更容易地避免第一修正案的限制,同时向烟草使用者提供更广泛的信息,并可以有效地支持和鼓励戒烟。本文考察了FDA要求有效插入和保护的权力,并展示了FDA如何设计和支持它们以避免第一修正案的问题。通过这一过程,本文就如何解释和应用《烟草控制法》的关键条款以遵循和促进法规的宗旨和目标提供了有益的见解。本文对现行《第一修正案》案例法中有关强迫商业言论的严格分析,也为政府强制产品披露或要求在商业产品或其广告中或广告上发布政府信息的任何努力提供了有用的指导,无论这些努力是为了补救、纯粹的信息,还是为了改变行为。
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来源期刊
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
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.
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