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CBD: Is DEA Scheduling Justified?

CBD: Is DEA Scheduling Justified?

In the United States, the federal Controlled Substances Act (CSA), 21 USC 812, controls substances that are psychoactive or otherwise have abuse potential. This Act controls all stages of the manufacturing and supply chain processes for controlled substances, and governs the transport and handling of these substances, including control of the substances once received by patients.

Controlled substances are classified into one of five classification groups or “schedules,” organized based on each substance’s medical efficacy, and abuse/addictive potential. One general rule under the CSA is that a substance, and any other chemical compounds or products derived from that substance, require the same classification or schedule. Schedule I substances are those that do not have a clinically accepted medical use, present a lack of safety under medical supervision, and have a high potential for abuse. Schedule II compounds have been approved by the Food and Drug Administration (FDA) for medical use, but still have a high potential for abuse and may result in a physical/psychological dependence on the drug. This schedule includes most opioids and stimulants.

For a substance to be considered acceptable for medical use, and ultimately moved from Schedule I to Schedule II, the Drug Enforcement Administration (DEA) has developed a set of criteria that must be satisfied through a comprehensive evaluation during the FDA’s drug-approval processes. These include:

According to the American Herbal Pharmacopeia , three different strains (species) of the cannabis plant (i.e., marijuana [alternatively spelled marihuana]) have been identified:

1. Cannabis sativa L.
2. Cannabis indica Lam.
3. Cannabis ruderalis Janisch.

The language in the CSA defining the term “marihuana,” is specific to the Cannabis sativa L. strain, “and every compound, manufacture, salt, derivative, mixture of such plant.” It appears that the hundreds of individual cannabinoid compounds which the cannabis plant contains, including
delta-9-tetrahydrocannabinol (referred to as THC here forth) the psychoactive component of cannabis and cannabidiol (CBD), another major cannabinoid, are included in the definition for marijuana, and are consequently listed as Schedule I controlled substances.

Tetrahydrocannabinols are the only group of cannabinoids listed separately in the Code of Federal Regulations (CFR), while CBD is controlled as a Schedule I substance only by definition; as a “derivative” or “compound” of marijuana. Even though CBD and THC have been assigned the same DEA Schedule, there is a significant difference in the effect each of these compounds has on the human body. THC activates the endogenous cannabinoid receptors (CB1 and CB2), with the activation of the CB1 receptor being responsible for the psychoactive properties that it triggers; CBD, on the other hand, does not directly activate those receptors at the doses currently being studied in clinical trials, and as a result, is considered non-psychoactive.

Is CBD guilty by association?

Since 1996, 29 states and the District of Columbia have enacted laws which approve the use of medical cannabis, and another 17 states allow cannabis-based products that are high in CBD and low in THC. In 2013, the Department of Justice (DOJ) issued a memo stating that it was not a federal priority to take enforcement action against individuals or businesses acting in accordance with state cannabis laws. The “Farm Bill” was initially passed in 1933 as part of Roosevelt’s New Deal programs designed to help Americans cope with the Great Depression. The 2014 iteration of the “Farm Bill” (7 USC 5940) authorizes institutions of higher education or State Departments of Agriculture to grow “industrial hemp,” which is defined per the Bill as Cannabis sativa L., having a THC concentration ≤ 0.3%. Certain states have interpreted the bill as providing the authorization to license independent and private cultivators who grow hemp, extract the CBD, and sell those extracts on the open market. Since the passing of the 2014 Farm Bill, the therapeutic potential of CBD has been increasingly explored, resulting in an increased parallel interest in the cultivation of the hemp variety of cannabis from which the cannabinoid is extracted and formulated into an oil-based product (e.g., “CBD oil”). The CSA does not define hemp, but does make exempt certain parts of the cannabis plant (i.e., stalk, fiber, sterilized seeds, and any preparations from those materials) from the definition of “marihuana.”

In August of 2016, the U.S. Department of Agriculture (USDA), in consultation with the DEA, FDA, and Department of Health and Human Service (DHHS), issued a Notice clarifying that the Farm Bill did not remove industrial hemp from Schedule I status. In December of 2016, what appeared to be a response to the increase in production of CBD oil and other marijuana extracts, the DEA introduced 21 CFR Part 1308, “Establishment of a New Drug Code for Marihuana Extract,” which states that marijuana extracts are to be provided with a separate DEA code from marijuana and THC, but those extracts are to remain as Schedule I substances. Under 21 CFR 1038, marijuana extracts are defined as, “… an extract containing one or more cannabinoids that has been derived from any plant of the genus Cannabis, other than the separated resin (whether crude or purified) obtained from the plant.’’ Although it might be theoretically possible to produce a CBD extract (oil) that contains absolutely no amount of other cannabinoids, the DEA was not aware of any industrially utilized methods that have achieved this result at the time 21 CFR 1038 was passed. In summary, if a CBD extract contains one or more cannabinoids, the drug code may be different, but the extract will still be defined as “marijuana” and considered a Schedule I controlled substance, if extracted from any cannabis plant. The intent of the new law may not be enforceable based on the initial definition of marijuana as stated above.

Is the scheduling of CBD justified, and will it ever change? At its 39th meeting of the Expert Committee on Drug Dependence (ECDD), the World Health Organization (WHO), the health agency of the United Nations, explained that there is no existing evidence indicating CBD is likely to be abused or to have other ill effects compared to those substances that are Schedule I controlled substances. The ECDD further concluded that current information does not justify scheduling of CBD, postponing a more comprehensive review of CBD and preparations using CBD until May of this year, when the committee will undertake a comprehensive review of cannabis and cannabis-related substances. Depending on what comes from this review, the current scheduling of CBD as a Schedule I controlled substance may be determined to be unjustified by WHO, and rescheduling could commence.

Historically, a few cannabinoid-based products have been rescheduled from Schedule I to Schedule II following FDA approval in the U.S. Several CBD products are currently in ongoing clinical trials, but a comprehensive evaluation of CBD, in compliance with one of the FDA’s drug-approval processes under the Food, Drug, and Cosmetic Act, warrants the appropriateness of its current scheduling be reviewed. If the safety and efficacy data are favorable and FDA approval is granted for CBD (or preparations of CBD), perhaps then, the DEA will look to reschedule this cannabinoid under the CSA. For now, cannabis and its constituent cannabinoids, including CBD from any source including hemp, remain as Schedule I controlled substances and appear to be subject to DEA enforcement, justified or not.

Stay tuned …