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Regulatory Status of Cannabidiol in the United States: A Perspective

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...

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Autores principales: Corroon, Jamie, Kight, Rod
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Mary Ann Liebert, Inc., publishers 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6154432/
https://www.ncbi.nlm.nih.gov/pubmed/30283822
http://dx.doi.org/10.1089/can.2018.0030
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author Corroon, Jamie
Kight, Rod
author_facet Corroon, Jamie
Kight, Rod
author_sort Corroon, Jamie
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description 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.
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spelling pubmed-61544322018-10-03 Regulatory Status of Cannabidiol in the United States: A Perspective Corroon, Jamie Kight, Rod Cannabis Cannabinoid Res Perspective 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. Mary Ann Liebert, Inc., publishers 2018-09-27 /pmc/articles/PMC6154432/ /pubmed/30283822 http://dx.doi.org/10.1089/can.2018.0030 Text en © Jamie Corroon and Rod Kight 2018; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Perspective
Corroon, Jamie
Kight, Rod
Regulatory Status of Cannabidiol in the United States: A Perspective
title Regulatory Status of Cannabidiol in the United States: A Perspective
title_full Regulatory Status of Cannabidiol in the United States: A Perspective
title_fullStr Regulatory Status of Cannabidiol in the United States: A Perspective
title_full_unstemmed Regulatory Status of Cannabidiol in the United States: A Perspective
title_short Regulatory Status of Cannabidiol in the United States: A Perspective
title_sort regulatory status of cannabidiol in the united states: a perspective
topic Perspective
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6154432/
https://www.ncbi.nlm.nih.gov/pubmed/30283822
http://dx.doi.org/10.1089/can.2018.0030
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