美国食品药品监督管理局的“认定规则”与烟草监管研究
The FDA "Deeming Rule" and Tobacco Regulatory Research.
作者信息
Backinger Cathy L, Meissner Helen I, Ashley David L
机构信息
Research, Office of Science, Center for Tobacco Products, Food and Drug Administration, Silver Spring, MD.
Tobacco Regulatory Science Program, Office of Disease Prevention, National Institutes of Health, Bethesda, MD.
出版信息
Tob Regul Sci. 2016 Jul;2(3):290-293. doi: 10.18001/TRS.2.3.8.
In May 2016, the Food and Drug Administration extended its tobacco regulatory authorities to other products meeting the definition of a tobacco product (Deeming Rule). This authority now includes, but is not limited to, electronic nicotine delivery systems (ENDS), such as electronic cigarettes, as well as all cigars, pipes, and hookahs (waterpipes). The FDA's Center for Tobacco Products has been able to fund research projects addressing these newly deemed tobacco products through a variety of mechanisms, including partnership with the Tobacco Regulatory Science Program, National Institutes of Health. In building the evidence base to inform the regulation of and communications about new and emerging tobacco products, it is important for investigators to be mindful of the goals of tobacco regulatory science, ie, scientific inquiry specifically to inform potential regulatory decisions and actions to protect the public's health. Having solid scientific evidence will allow the FDA to make the most appropriate regulatory decisions regarding newly deemed products.
2016年5月，美国食品药品监督管理局（FDA）将其烟草监管权扩展至其他符合烟草制品定义的产品（《认定规则》）。该权力现在涵盖但不限于电子尼古丁传送系统（ENDS），如电子烟，以及所有雪茄、烟斗和水烟筒。FDA烟草制品中心已能够通过多种机制为针对这些新认定烟草制品的研究项目提供资金，包括与美国国立卫生研究院烟草监管科学项目合作。在建立证据基础以指导对新兴烟草制品的监管和宣传时，研究人员务必牢记烟草监管科学的目标，即专门为告知潜在监管决策和行动以保护公众健康而进行的科学探究。拥有确凿的科学证据将使FDA能够就新认定产品做出最恰当的监管决策。
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