电子尼古丁给药系统产品监管对大麻素监管的启示。

Health affairs scholar Pub Date : 2024-08-16 eCollection Date: 2024-08-01 DOI:10.1093/haschl/qxae101
Brian Yagi, Stan Veuger, Brian J Miller, Paul Larkin
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引用次数: 0

摘要

大麻合法化在不断扩大,目前已有 38 个州允许使用医用大麻,22 个州允许使用娱乐性大麻,联邦大麻合法化的政治势头也在不断增强。食品药品管理局(FDA)上一次负责监管新产品是在 2009 年的《家庭吸烟预防和烟草控制法案》中,该法案设立了烟草产品中心(CTP)。因此,回顾烟草制品中心历史的时机已经成熟,尤其要关注新生的中心在监管电子烟或电子尼古丁输送系统(ENDS)等新产品时面临的困难。具体来说,食品和药物管理局在界定其权力范围、确定使用哪种审查途径以及及时颁布透明的产品标准以获得营销授权等方面都遇到了困难,所有这些都为改进大麻产品的监督和执法提供了借鉴。
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Lessons for cannabinoid regulation from electronic nicotine delivery system product regulation.

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.

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