The FDA "Deeming Rule" and Tobacco Regulatory Research.
The FDA "Deeming Rule" and Tobacco Regulatory Research.
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DOI：
10.18001/trs.2.3.8
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发表时间：
2016-07-01
影响因子：
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通讯作者：
Ashley, David L
中科院分区：
文献类型：
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作者：
Backinger, Cathy L;Meissner, Helen I;Ashley, David L
2016年5月，美国食品和药物管理局将其烟草监管机构扩展到符合烟草产品定义的其他产品（推定规则）。这一权力现在包括但不限于电子尼古丁输送系统（ENDS），如电子香烟，以及所有雪茄，烟斗和水烟（水管）。FDA的烟草产品中心已经能够通过各种机制资助针对这些新认定的烟草产品的研究项目，包括与美国国立卫生研究院烟草监管科学计划的合作。在建立证据基础以告知新的和新兴的烟草产品的监管和沟通时，重要的是调查人员要注意烟草监管科学的目标，即专门为保护公众健康的潜在监管决策和行动提供信息的科学调查。拥有可靠的科学证据将使FDA能够对新认定的产品做出最适当的监管决定。
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.