CBD Has Never Been A Controlled Substance

This article by Robert Hoban was originally published on Forbes and appears here with permission.

My job is to shed light. Most specifically on the great intricacies of cannabis law, policy, and regulation. The past several years have seen extensive debate about the legal status of cannabidiol (CBD). Is it legal? Was it ever a controlled substance? How is it regulated? Lawyers, industry professionals, and learned scholars debate this with so much vigor that it creates confusion, if not a misstatement of the facts. It hurts my ears and burns my eyes to hear or see an argument that identifies CBD as a controlled substance, because the law is quite clear in this regard.

For something to be a controlled substance under the Federal Controlled Substances Act (CSA), it must be specifically scheduled and assigned one of five scheduling criteria. Schedule I is the most restrictive, which indicates that this controlled substance has no medicinal value and a high potential for abuse. Schedule V, the least restrictive, indicates a drug with currently accepted medical uses and treatments in the United States and a low potential for abuse. Schedule V drugs typically consist of preparations containing limited quantities of certain narcotics, but not always. When one combs through the CSA, the word “cannabidiol” or “CBD” is nowhere to be found — not in the code of federal regulations or in the enacting legislation. One must look deeper to find out what is scheduled and what is not.

First, let’s look at the definition of marijuana with an “H” (marihuana), which is indeed scheduled. This comprises all parts of the Cannabis Sativa L. plant, excluding non-viable seeds stock and fiber, but including the resins and the remainder of the plant. CBD, of course, is present within the marijuana plant. If you derive CBD from the marijuana plant, it would in fact be controlled, because it came from a controlled substance. This is known as the “source rule” — the source of the material dictates its legality. But what if CBD and other non-psychoactive cannabinoids are derived from a legal source, such as the 25 other plant species that contain levels of cannabinoids or industrial hemp?

The only cannabinoid mentioned in the CSA is tetrahydrocannabinol, THC, the psychoactive compound in cannabis. While it is specifically scheduled, courts have disagreed on whether THC needs to be synthetically or naturally derived to fall within the definition of tetrahydrocannabinol under the CSA. Six years ago, industrial hemp was for the first time ever defined separately from marijuana as holding less than 0.3 Δ9-THC percent by dry weight. The 2014 Farm Bill specifically authorized the use of industrial hemp as a legal substance for purposes of market, scientific, and agricultural-based research. The CBD industry exploded because of the “market-based research exception” — one could only study the plant with a viable market in place for its products. This position was litigated in 2018 in HIA v. DEA III and the restrictions were removed by the 2018 Farm Bill. 

The industrial hemp plant is no longer a controlled substance, including all of its derivatives, not the least of which is THC. Even THC from industrial hemp is no longer defined as a controlled substance (we’ll dive into this in more detail at a later time). The 2018 Farm Bill didn’t remove CBD from the Controlled Substances Act, but clarified that it was never on it. To be perfectly clear, if CBD is derived from a lawful substance, it is not and never has been a controlled substance. That’s a fact and the law. 

Yet complexities and legal challenges remain. Greenwich Biosciences (the North American subsidiary of GW Pharmaceutical) had received approval for the new drug, Epidiolex, which was identified and placed on schedule V. While CBD was not defined as schedule V, Epidiolex was because the CBD present in it is derived from marijuana. But as with every other aspect of the growth of the cannabis industry, the law rules. The makers of Epidiolex requested that it be removed entirely from the schedule of substances and the DEA agreed with this request. 

When derived from lawful materials such as hemp, CBD and other non-psychoactive cannabinoids are not controlled substances because they’re not specifically scheduled. Still, there is pushback. Some folks refer to the Analogue Act, a section of the CSA passed in 1986 allowing any chemical similar to a schedule I or II substance to be listed as schedule I if it's intended for human consumption. However, CBD is not identified as a chemical in schedule I or schedule II and is one of more than 100 identified cannabinoids contained within the cannabis plant.

The nexus of cannabis law, policy, and regulations has evolved a great deal in the past decade. Prior to the 2014 and the 2018 Farm Bill there was no legal distinction - it was all marijuana. Now, our definitions of cannabis are rooted in science and a plant’s legality is judged based on its chemical makeup.

Despite the perceived uncertainty regarding the legality of the compound CBD, we can officially put it to rest. Unless derived specifically and strictly from a marijuana plant, CBD is not now, and has never been, a controlled substance.

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