This article by Robert Hoban was originally published on Forbes and is shown here with permission.
It is my job to shed light on the darkness. In particular, on the great intricacies of cannabis law, cannabis policy and regulation. The legal status of cannabidiol (CBD) has been discussed extensively in recent years. Is it legal Was it ever a controlled substance? How is it regulated? Lawyers, industry professionals, and scholars discuss this with so much force that it creates confusion, if not misrepresentation, 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 pretty clear on that.
In order for something to be a regulated substance within the meaning of the Federal Act on Regulated Substances (CSA), it must be specially planned and provided with one of five planning criteria. Appendix I is the most restrictive, indicating that this controlled substance has no medicinal value and has a high potential for abuse. Appendix V, the least restrictive, indicates a drug with currently recognized medical uses and treatments in the United States and with a low potential for abuse. List V drugs typically consist of preparations that contain limited amounts of certain narcotics, but not always. If you comb through the CSA, the word “cannabidiol” or “CBD” is nowhere to be found – neither in the Code of Federal Regulations nor in applicable law. You have to take a closer look to find out what is planned and what is not.
First, let’s look at the definition of marijuana with an “H” (marijuana) that is actually planned. This includes all parts of the Cannabis Sativa L. plant, with the exception of non-viable seed stocks and fiber, but including the resins and the rest of the plant. CBD is naturally present in the marijuana plant. When you derive CBD from the marijuana plant, it is actually controlled because it comes from a controlled substance. This is known as the “source rule” – the source of the material determines its legality. But what if CBD and other non-psychoactive cannabinoids come from a legal source, such as the 25 other plant species that contain cannabinoid or industrial hemp?
The only cannabinoid mentioned in the CSA is tetrahydrocannabinol, THC, the psychoactive compound in cannabis. While this is specifically planned, the courts have disagreed on whether THC must be synthetically or naturally derived to fall under the CSA’s definition of tetrahydrocannabinol. Six years ago, industrial hemp was first defined separately from marijuana as having a dry weight of less than 0.3 Δ9-THC percentage. The 2014 Farm Bill explicitly approved the use of industrial hemp as a legal entity for market, scientific and agricultural research purposes. The CBD industry exploded due to the “market-based research exception” – one could only study the facility with a viable market for its products. That position was negotiated in the HIA v DEA III case in 2018, and the restrictions were lifted by the 2018 Farm Bill.
The industrial hemp plant is no longer a controlled substance, including all of its derivatives, not least THC. Even THC from industrial hemp is no longer defined as a controlled substance (we’ll get into that in more detail at a later date). The 2018 Farm Bill did not remove CBD from the Controlled Substances Act, but made it clear that it was never on it. To be very clear, if CBD comes from a legal substance, it is not and never has been a controlled substance. That is a fact and the law.
However, the complexity 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 included in Appendix V. While CBD wasn’t defined as an Appendix V, Epidiolex was due to the fact that the CBD in it was derived from marijuana. But as with any other aspect of the growth of the cannabis industry, the law applies. The manufacturers of Epidiolex requested that it be completely removed from the list of substances, and the DEA agreed to this request.
If they are made from legal materials like hemp, CBD, and other non-psychoactive cannabinoids, they are not controlled substances as they are not specifically designed. Still there is a pushback. Some people refer to the Analogue Act, a section of the 1986 CSA that allows chemicals similar to List I or List II to be listed as Plan I if they are for human consumption. However, CBD is not identified as a chemical in Appendix I or Appendix II and is one of more than 100 identified cannabinoids found in the cannabis plant.
The relationship between cannabis laws, policies, and regulations has evolved significantly over the past decade. Before the 2014 and 2018 Farm Bill, there was no legal distinction – it was all marijuana. Now our definitions of cannabis are rooted in science and the legality of a plant is being judged by its chemical makeup.
Despite the perceived uncertainty regarding the legality of the connection CBD, we can officially calm it down. Unless CBD is specifically and strictly derived from a marijuana plant, it is not and never has been a controlled substance.
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