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On June 25, 2018, the U.S. Food and Drug Administration (FDA) announced its first-ever approval of a marijuana-derived pharmaceutical drug. Epidiolex (cannabidiol or CBD) was approved for the treatment of two rare, pediatric seizure disorders, Lennox-Gastaut syndrome and Dravet syndrome.1 On September 27, 2018, the Drug Enforcement Administration (DEA) announced its scheduling of Epidiolex – and future drug products containing CBD derived from marijuana with no more than 0.1 percent tetrahydrocannabinols – in Schedule V of the Controlled Substances Act (CSA).2 These events represent historical milestones in the journey of Cannabis from a source of textiles and medicines in the early nineteenth century to an illicit drug and now an FDA-approved drug.
Cannabidiol (CBD) is one of more than a hundred cannabinoids found in Cannabis sativa L. (Cannabis spp. or Cannabis), a plant more well-known colloquially as “marijuana” or hemp [Please see Author’s Note below].3 CBD was first isolated in 1940 and characterized structurally in 1963.4,5 With projected retail sales of CBD products -hemp, marijuana and pharmaceutical – as high as $1.9 billion by 2020, CBD is poised to become the darling of the medical Cannabis movement.6
Despite its rapidly growing popularity and use, the regulatory status of CBD in the United States remains convoluted, even after the approval and scheduling of Epidiolex. The source of CBD is critically important in determining its legal status. The most common source, botanically speaking, is the plant Cannabis sativa L. (Cannabis), which encompasses both marijuana and hemp. There are various schema for differentiating marijuana from hemp (e.g. Genotype, phenotype, Drug-type Cannabis v. fiber-type Cannabis, etc.), but from a regulatory standpoint, the difference between marijuana and hemp is based on chemical composition, specifically as it relates to the concentration of delta-9 Tetrahydrocannabinol (THC), the primary intoxicating compound found in Cannabis. Hemp is legally defined as a cultivar of Cannabis sativa with low concentrations of THC. Although limitations on THC concentrations for hemp differ internationally, THC concentrations cannot exceed three tenths of one percent (0.3%) in the United States. Hemp-derived and marijuana-derived CBD each have their own unique regulatory status and consequent legal implications.
Despite the scheduling of Epidiolex, CBD from marijuana is still deemed a Schedule I controlled substance by the DEA pursuant to the 1970 Controlled Substances Act. As such, CBD from marijuana is deemed to have no accepted medical use, a lack of accepted safety for use under medical supervision, and a high potential for abuse.1,7-11 While the scheduling of Epidiolex represents the first time that the DEA has acknowledged that marijuana has a “currently accepted medical use”, it did not change the regulatory status of CBD itself.
On May, 22, 2018, the DEA issued an internal directive which stated, “Products and materials that are made from the Cannabis plant and which fall outside the CSA definition of marijuana (such as sterilized seeds, oil or cake made from the seeds, and mature stalks) are not controlled under the CSA”.12 Although these statements clarified that CBD derived from a source other than marijuana was not a controlled substance, they did not specifically state that CBD from industrial hemp was lawful. Furthermore, these parts of the plant are not viable sources of CBD. As a result, confusion remains.
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