Yagi Brian, Veuger Stan, Miller Brian J, Larkin Paul
Division of Hospital Medicine, Department of Medicine, University of Michigan Medical School, Ann Arbor, MI 48109, United States.
Division of Hospital Medicine, Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, MD 21287, United States.
Health Aff Sch. 2024 Aug 16;2(8):qxae101. doi: 10.1093/haschl/qxae101. eCollection 2024 Aug.
Cannabis legalization continues to spread, with 38 states permitting the use of medical marijuana, 22 states permitting recreational use, and growing political momentum for federal legalization. The last time the Food and Drug Administration (FDA) was tasked with regulating a new product occurred with 2009's Family Smoking Prevention and Tobacco Control Act, which created the Center for Tobacco Products (CTP). Thus, the time is ripe to review the history of CTP with particular attention to difficulties the nascent center faced in regulating novel products such as e-cigarettes or electronic nicotine delivery systems (ENDS). Specifically, FDA has struggled with defining its scope of authority, determining which review pathway(s) to utilize, and promulgating timely and transparent product standards for marketing authorization-all of which offer lessons for improving cannabis product oversight and enforcement.
大麻合法化的范围不断扩大，38个州允许使用医用大麻，22个州允许娱乐性使用，并且联邦层面合法化的政治势头也在增强。美国食品药品监督管理局（FDA）上次负责监管一种新产品是在2009年的《家庭吸烟预防与烟草控制法案》之时，该法案设立了烟草制品中心（CTP）。因此，现在是时候回顾CTP的历史了，尤其要关注这个新成立的中心在监管电子烟或电子尼古丁传送系统（ENDS）等新产品时所面临的困难。具体而言，FDA在界定其职权范围、确定采用何种审查途径以及颁布及时且透明的产品上市许可标准方面一直存在困难——所有这些都为改进大麻产品监管和执法提供了经验教训。
