Regulatory Status of Cannabidiol in the United States: A Perspective
Regulatory Status of Cannabidiol in the United States: A Perspective
复制标题
DOI：
10.1089/can.2018.0030
复制
发表时间：
2018-01-01
影响因子：
3.8
通讯作者：
Kight, Rod
中科院分区：
文献类型：
--
作者：
Corroon, Jamie;Kight, Rod
大麻二酚（CBD）是在大麻中发现的100种大麻素之一。（Cannabis spp.或大麻）。尽管其在美国的监管状况复杂且迅速发展，但到2020年，CBD产品（大麻，大麻和药物）的预计零售额高达19亿美元。CBD产品目前可以在网上购买，在柜台上，并在全国大部分地区的大麻专用药房，尽管CBD目前被美国缉毒局视为附表I受控物质，并被美国食品和药物管理局（FDA）放弃作为膳食补充剂成分。这些产品在很大程度上是不受管制的，主要用于治疗特定的医疗条件。最近FDA批准Epidiolex（CBD）作为某些儿科癫痫发作疾病的治疗药物，这将促使CBD的时间表，并可能改变FDA对联邦食品、药品和化妆品法案（FD&C）的执行，迄今为止，该法案主要是以警告信的形式。令人信服的法律的论点认为，生物多样性公约的法律的地位是基于其来源。根据这些论点，有三个法律的来源。CBD来源于：（1）不符合《管制物质法》（CSA）中大麻定义的大麻植物部分;（2）进口的“非精神活性大麻”;以及（3）根据2014年《农业法》作为州试点计划的一部分种植的“工业大麻”。虽然《生物多样性公约》相对于《全面保障协定》的法律地位似乎正在扩大，但其相对于《FD&C法案》的未来监管地位难以预测。
Cannabidiol (CBD) is 1 of >100 cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis). Despite its complex and rapidly evolving regulatory status in the United States, projected retail sales of CBD products-hemp, cannabis and pharmaceutical-are as high as $1.9 billion by 2020. CBD products can currently be purchased online, over the counter, and at cannabis-specific dispensaries throughout most parts of the country, despite the fact that CBD is presently deemed a Schedule I controlled substance by the U.S. Drug Enforcement Administration and renounced as a dietary supplement ingredient by the U.S. Food and Drug Administration (FDA). These products are largely unregulated, and are being used predominantly to treat specific medical conditions. Recent FDA approval of Epidiolex (CBD) as a treatment for certain pediatric seizure disorders will prompt scheduling of CBD and likely alter FDA enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C), which to date has mostly been in the form of warning letters. Persuasive legal arguments contend that CBD's legal status is based on its source. According to these arguments, there are three legal sources. CBD-derived from: (1) parts of the Cannabis plant that do not meet the definition of cannabis in the Controlled Substances Act (CSA); (2) imported "non-psychoactive hemp"; and (3) "Industrial hemp" cultivated as part of a state pilot program per the 2014 Farm Act. Although CBD's lawful status with respect to the CSA appears to be expanding, its future regulatory status with respect to the FD&C Act is difficult to predict.