[20180514]IN10901_FDA将考虑是否以及如何降低香烟中允许的尼古丁水平.pdf

CRS INSIGHT Prepared for Members and Committees of Congress INSIGHTINSIGHTi i FDA to Consider Whether and How to Lower Permissible Nicotine Levels in Cigarettes name redacted Section Research Manager May 14, 2018 On March 15, 2018, the U.S. Food and Drug Administration (FDA) issued an advance notice of proposed rulemaking (ANPRM) entitled Tobacco Product Standard for Nicotine Level of Combusted Cigarettes. FDA states that it is considering setting a maximum nicotine level for traditional (a.k.a. “combusted”) cigarettes in order to make them minimally addictive or nonaddictive. This notice begins what could be a complex, contentious, and multi-year process during which FDA will solicit public comments (the public comment period for the initial ANPRM will expire on June 14, 2018) and marry that feedback with its own expertise, evidence, and conclusions to decide whether and how to set such a limit. FDA is pursuing this process due to the potentially significant public health benefit associated with lowering nicotine levels in cigarettes. According to FDA, “lowering nicotine to a minimally or non-addictive level could potentially save millions of lives, both in the near and long-term