Science, Regulation & Education, CV Sciences, Inc, San Diego, CA, USA.
J Diet Suppl. 2020;17(5):517-526. doi: 10.1080/19390211.2020.1776806. Epub 2020 Jun 16.
The passage of the 2018 United States Agriculture Improvement Act removed industrial hemp, defined as L. containing less than 0.3% THC content by dry weight, from Schedule I of the Controlled Substances Act and made it an agricultural commodity. Following these changes, the popularity of hemp-derived cannabidiol (CBD) dietary supplements by consumers has greatly exceeded the scientific understanding of purported benefits, safety and composition of these botanical extracts. Further complicating CBD hemp supplement regulation, Food and Drug Administration (FDA) considers CBD to be an approved drug (Epidiolex) in the treatment of severe epilepsy disorders, Dravet and Lennox-Gastaut syndromes. At the same time, hemp-derived CBD supplements can contain a complex phytochemical matrix from the hemp plant, distinguishing the composition of these products from isolated CBD preparations. This work aims to provide clarity on differentiating botanical full-spectrum hemp extracts containing CBD from isolates, from a phytochemical, toxicological and regulatory perspective.
2018 年美国农业改进法案将工业大麻（THC 含量干重低于 0.3%的大麻）从《管制物质法案》附表 I 中移除，并将其归类为农业商品。这些变化之后，消费者对大麻衍生大麻二酚（CBD）膳食补充剂的欢迎程度远远超过了对这些植物提取物的所谓益处、安全性和成分的科学认识。进一步使 CBD 大麻补充剂监管复杂化的是，食品和药物管理局（FDA）认为 CBD 是一种用于治疗严重癫痫疾病、德拉维特和伦诺克斯-加斯特综合征的批准药物（Epidiolex）。与此同时，大麻衍生的 CBD 补充剂可能含有大麻植物的复杂植物化学基质，从而使这些产品的成分与分离的 CBD 制剂区分开来。这项工作旨在从植物化学、毒理学和监管角度阐明含有 CBD 的植物全谱大麻提取物与分离物的区别。
