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美国食品药品监督管理局是否已放弃努力,不再让假雪茄香烟遵守适用于香烟但不适用于雪茄的联邦烟草控制法律?

Has FDA abandoned its efforts to make fake-cigar cigarettes comply with federal tobacco control laws that apply to cigarettes but not cigars?

作者信息

Lindblom Eric N, Mays Darren, Schroth Kevin R J, Delnevo Cristine

机构信息

O'Neill Institute for National & Global Health Law, Georgetown University Law Center, Washington, District of Columbia, USA

Department of Oncology, Georgetown University Medical Center, Lombardi Comprehensive Cancer Center, Washington, District of Columbia, USA.

出版信息

Tob Control. 2020 Feb 26. doi: 10.1136/tobaccocontrol-2019-055395.

Abstract

In the USA, legal definitions of cigarettes and cigars are critical to tobacco control policy because federal, state and local laws typically tax and regulate cigarettes more strictly than cigars. In 2016, near the end of the Obama Administration, the US Food and Drug Administration (FDA) sent warning letters to four filtered 'little cigar' manufacturers stating that their so-called 'cigars' were cigarettes and, therefore, subject to more stringent public health restrictions. Documents produced in response to a Freedom of Information Act request show that without explanation or public notice FDA has abandoned its prior determination that the manufacturers' 'little cigars' were actually cigarettes and, consequently, were violating the ban on flavoured cigarettes in the Family Smoking Prevention and Tobacco Control Act (TCA). The documents also present the manufacturers' arguments against FDA's original position. However, those industry arguments are inconsistent with the research, other evidence and legal analysis indicating that filtered 'little cigars' meet the legal definition of cigarettes under the TCA and other similar federal, state and local definitions. To protect the public health, FDA must renew its efforts to ensure that these filtered 'little cigars' do not continue to evade compliance with the many important restrictions and requirements that apply to cigarettes but not cigars. Other government regulatory and tax-collection agencies with similar definitions need to follow suit.

摘要

在美国,香烟和雪茄的法律定义对烟草控制政策至关重要,因为联邦、州和地方法规对香烟的征税和监管通常比对雪茄更为严格。2016年,在奥巴马政府任期接近尾声时,美国食品药品监督管理局(FDA)向四家生产过滤嘴“小雪茄”的制造商发出警告信,称他们所谓的“雪茄”属于香烟,因此要受到更严格的公共卫生限制。根据《信息自由法》要求提供的文件显示,FDA在没有解释或公开通知的情况下,放弃了其先前认定这些制造商的“小雪茄”实际上属于香烟的决定,因此这些产品违反了《家庭吸烟预防与烟草控制法案》(TCA)中对调味香烟的禁令。这些文件还展示了制造商针对FDA原立场提出的论点。然而,这些行业论点与研究、其他证据以及法律分析不一致,这些研究、证据和分析表明,过滤嘴“小雪茄”符合TCA以及其他类似的联邦、州和地方法规中对香烟的法律定义。为保护公众健康,FDA必须重新努力,确保这些过滤嘴“小雪茄”不再继续规避适用于香烟而非雪茄的诸多重要限制和要求。其他具有类似定义的政府监管和税收征管机构也应效仿。

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