Chaloupka Frank J, Warner Kenneth E, Acemoğlu Daron, Gruber Jonathan, Laux Fritz, Max Wendy, Newhouse Joseph, Schelling Thomas, Sindelar Jody
Department of Economics, University of Illinois at Chicago, Chicago, Illinois, USA.
Department of Health Management & Policy, University of Michigan, Ann Arbor, Michigan, USA.
Tob Control. 2015 Mar;24(2):112-9. doi: 10.1136/tobaccocontrol-2014-052022. Epub 2014 Dec 30.
The Family Smoking Prevention and Tobacco Control Act of 2009 gave the Food and Drug Administration (FDA) regulatory authority over cigarettes and smokeless tobacco products and authorised it to assert jurisdiction over other tobacco products. As with other Federal agencies, FDA is required to assess the costs and benefits of its significant regulatory actions. To date, FDA has issued economic impact analyses of one proposed and one final rule requiring graphic warning labels (GWLs) on cigarette packaging and, most recently, of a proposed rule that would assert FDA's authority over tobacco products other than cigarettes and smokeless tobacco. Given the controversy over the FDA's approach to assessing net economic benefits in its proposed and final rules on GWLs and the importance of having economic impact analyses prepared in accordance with sound economic analysis, a group of prominent economists met in early 2014 to review that approach and, where indicated, to offer suggestions for an improved analysis. We concluded that the analysis of the impact of GWLs on smoking substantially underestimated the benefits and overestimated the costs, leading the FDA to substantially underestimate the net benefits of the GWLs. We hope that the FDA will find our evaluation useful in subsequent analyses, not only of GWLs but also of other regulations regarding tobacco products. Most of what we discuss applies to all instances of evaluating the costs and benefits of tobacco product regulation and, we believe, should be considered in FDA's future analyses of proposed rules.
2009年的《家庭吸烟预防与烟草控制法案》赋予了美国食品药品监督管理局（FDA）对卷烟和无烟烟草制品的监管权，并授权其对其他烟草制品行使管辖权。与其他联邦机构一样，FDA需要评估其重大监管行动的成本和收益。迄今为止，FDA已发布了一份关于要求在卷烟包装上加贴图形警示标签（GWL）的拟议规则和一份最终规则的经济影响分析报告，以及最近一份关于主张FDA对除卷烟和无烟烟草之外的其他烟草制品行使管辖权的拟议规则的经济影响分析报告。鉴于围绕FDA在其关于GWL的拟议规则和最终规则中评估净经济效益的方法存在争议，以及按照合理经济分析编制经济影响分析报告的重要性，一群杰出的经济学家于2014年初会面，审查该方法，并在必要时提出改进分析的建议。我们得出的结论是，对GWL对吸烟影响的分析大幅低估了收益，高估了成本，导致FDA大幅低估了GWL的净收益。我们希望FDA会发现我们的评估在后续分析中有用，不仅是对GWL的分析，也是对其他烟草制品相关法规的分析。我们讨论的大部分内容适用于评估烟草制品监管成本和收益的所有情况，并且我们认为，FDA在未来对拟议规则的分析中应予以考虑。
