20 May Legality of CBD
History was made on June 25, 2018, when the United States Food and Drug Administration (FDA) announced its first ever approval of a pharmaceutical derived from the Cannabis sativa plant: Epidiolex. This newly released prescription oral solution contains cannabidiol—commonly known as CBD. It was approved for the treatment of two rare forms of epilepsy and pediatric seizure disorders: Lennox-Gastaut syndrome and Dravet syndrome.
Shortly thereafter, the Department of Justice and the Drug Enforcement Agency (DEA) announced Epidiolex and any future pharmaceuticals containing CBD derived from Cannabis sativa with less than 0.1 percent Tetrahydrocannabinol (THC) would be categorized under Schedule V of the Controlled Substances Act (CSA).
These recent actions reflect the positive progression of Cannabis sativa from being an illicit drug for the past eighty years to being permitted as an FDA-approved drug. Cannabidiol or CBD is just one among the many thousands of chemical compounds, cannabinoids, found in the Cannabis sativa plant species, which is often referred to as marijuana or hemp. The isolation of CBD first began in the 1940s, and recently CBD has become the darling of the medical cannabis movement.
CBD and its use is rapidly gaining popularity in the United States, but its regulatory status still remains complicated. This is even after the approval and scheduling of Epidiolex. The greatest determinant of the legality of CBD is its source. The most common source of CBD is the Cannabis sativa plant. While marijuana and hemp may belong to the same plant species, they are different in some ways. There exists different methods for distinguishing marijuana from hemp such as genotype, phenotype, and drug-type. However, from a regulatory standpoint, the difference between marijuana and hemp is majorly based on its chemical composition. This composition is specifically as relating to the concentration of delta-9 THC, which is the primary intoxicating property found in marijuana.
Legally, hemp is defined as a cultivar of Cannabis sativa with very low concentrations of THC. The limitation of THC concentration in hemp plants differs internationally, but it does not exceed 0.3 percent per dry weight in the United States. There are unique regulatory statues and legal implications of CBD derived from hemp and CBD derived from marijuana.
For instance, Epidiolex is a CBD drug derived from Cannabis sativa, which is not categorized as a Schedule I drug. Nevertheless, CBD derived from marijuana is still deemed a Schedule I controlled substance by the DEA according to the 1970 Controlled Substance Act. This means marijuana-derived CBD is not deemed to have any accepted medical use. It is not accepted for use under medical supervision and has a high potential for abuse. While the DEA may have acknowledged Epidiolex as a currently accepted pharmaceutical, but the legal status of the CBD itself has not changed.
Another convoluted legal situation regarding CBD was a recent DEA directive. It stated any products or materials made from Cannabis sativa that falls outside of the CSA definition of marijuana were not controlled under the CSA. This includes sterilized seeds, oils, or cake made from the seeds and mature stalks. This directive clarified that CBD derived from any source other than marijuana was not a controlled substance, and was not illegal. Unfortunately, it did not specifically state that CBD derived from industrial hemp was lawful. In addition, the parts of the plant mentioned in the directive are not viable sources of CBD. All this directive succeeded in doing was increase confusion on the exact legal status of CBD.
Besides marijuana, CBD can be extracted from some hemp cultivars. Historically, hemp was grown as an industrial crop for use in fabric, rope, and textile production from its long stalks. Industrial hemp may not be explicitly defined or mentioned in the CSA, but it is considered a controlled substance by the DEA since the passage of the CSA in 1970.
The 2018 Farm Bill
On December 20, 2018, The Hemp Farming Act of 2018, S.2667, simply referred to as the 2018 Farm Bill, became law. The bill formally and definitively removed hemp from the list of controlled substances. The bill also redefined hemp as all parts of the Cannabis sativa plant that do not have beyond 0.3 percent delta-9 THC by dry weight including derivatives, extracts, and cannabinoids.
What is even better is that the 2018 Farm Bill explicitly removed popular hemp products like hemp-derived CBD from the purview of the CSA. Before the 2018 Farm Bill, it was only federally lawful to cultivate hemp domestically under state-sanctioned pilot programs.
As of the writing of this article, only a few of the hemp-derived CBD products available in the United States are made from domestically cultivated hemp. The 2018 Farm Bill hopes to change this by encouraging greater investment in this arena.
CBD from industrial hemp is also lawful if it is derived from non-psychoactive hemp, which is imported into the United States. This non-psychoactive hemp defines hemp grown in Canada and Europe whose flowers contain only trace amounts of the THC contained in marijuana varieties grown for psychoactive use. There since has been no distinction if this directive allows the importation of the whole hemp pant as long as it contains no more than trace amount of THC.
This confusion, however, has not affected the production and purchase of products made from hemp-derived CBD. Today, hemp-derived CBD products can be purchased both online and over the counter in many places in the country as easily as if they were dietary supplements. However, marijuana-derived CBD products can only be purchased by patients who qualify in states with medical marijuana laws.
Unfortunately, the distinction of legalities between hemp-derived and marijuana-derived CBD has opened up the opportunity for manufacturers to produce and sell low quality CBD or CBD that is derived from marijuana. They try to pass it off to unsuspecting consumers as hemp-derived CBD. The market for CBD products still remains unregulated. Fortunately, future bills like the 2018 Farm Bill will help to set this multi-billion-dollar industry in the right course for continued growth.