Semantics Matter in the Law: : An Analysis of the FDA Notice Regarding Cannabinoids

Authored By: Rod Kight

13 April 2018

The FDA is taking public comments on cannabinoids until April 23. It seeks information on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use. I strongly encourage you to comment here: https://www.regulations.gov

Rather than focus this article on the particulars of the FDA request for comments on cannabinoids under docket FDA-2018-N-1072, I am going to use the FDA notice as a vehicle for discussing the use of tricky semantics by the FDA and DEA, which I posit is both intentional and effective in its current war on cannabinoids. This is the sentence on which I’m going to focus:

The Food and Drug Administration (FDA) is seeking comments regarding five “drug substances”: cannabis plant and resin; extracts and tinctures of cannabis; delta-9 tetrahydrocannbinol (THC; stereoisomers of THC; and cannabidiol (CBD).

The grammarians reading this will see that the use of semicolons and parentheses is off. Specifically, there is no closing parenthesis and the sentence structure makes ambiguous whether cannabidiol is a subset of delta-9 tetrahydrocannbinol or is its own category. I am not immune to occasional lapses in grammar, but this is not my error. I copied it directly from the official FDA notice. The notice states that the FDA is seeking comment on five drug substances. Yet, based on its wording there are either three, four, five, or six substances that are being considered. I can’t help but notice that the ambiguity is primarily focused on CBD: is it being considered a subset of delta-9 tetrahydrocannabinol or is it a separate category? Of course, for those who have an understanding of these things, the idea that CBD is a subcategory of THC is ridiculous. THC and CBD are wholly separate chemical compounds that interact with entirely different receptors in the body. THC gets people “high”; CBD doesn’t.

A rational explanation of this ambiguity is that it is the result of a simple typographical error. However, after working in this industry and dealing with the regular use of tricky semantics by the FDA and the DEA regarding cannabinoids and CBD in particular, I cannot help but wonder if this grammar issue was intentional. In my experience, the FDA and DEA routinely muddy the water when addressing CBD. (For instance, the notorious “Marihuana Extract Rule”, which is at the center of a pending lawsuit against the DEA by the Hemp Industries Association, intentionally refers to extracts of “cannabis”, a non-legal botanical term, rather than “marijuana”, a legal term of art. This simple switcheroo has caused incredible difficulties for the industry.) So, it does not surprise me that the FDA muddies the water on this notice. (Later in the notice, the FDA states: “Cannabis, also known as marijuana….” This is inaccurate because not all cannabis is marijuana.)

Why am I spending so much of my allotted word count for this article on tedious semantics? Because federal agencies are currently winning the semantics war, particularly as it relates to CBD. In law, semantics matter. As I’ve written before, the legal status of CBD is clear: it is lawful if it is derived from a lawful plant or part of a plant (such as industrial hemp or the mature stalks of the marijuana plant) and unlawful if it is derived from an unlawful plant (such as marijuana). This is the Source Rule. For whatever reason, the DEA simply does not like this. (Insert your own hypothesis as to why. I’ve certainly got mine.) However, rather than simply accept that CBD is not a scheduled substance unless it is derived from marijuana or challenge the Source Rule directly, the DEA and FDA have taken to using semantic wordplay to create the perception that CBD is unlawful or, at the least, that its legal status is “grey”. Given that most institutions (such as government, law enforcement, and financial) are conservative by nature (by which I mean “little c” conservative), the mere perception that the law is grey is sufficient to cause damage to the hemp/ CBD industry. My wholly lawful hemp/CBD clients still struggle to obtain banking services and are occasionally harassed by law enforcement. I was involved in a meeting just yesterday with the NC Commissioner of Agriculture. His powerful department was extremely supportive of hemp, but openly admitted that it was tethered to the FDA when it came to certain positions on CBD simply because it was not in a position to interpret ambiguities in the law.

So, rather than focus on the substance of the FDA request for comments, I thought that I would use it to address the semantic issue and smoke and mirrors wordplay game that federal agencies are playing in the hope that you will begin to see it, too. Admittedly, the FDA notice later refers to “cannabis plant and cannabis resin, THC, CBD, and stereoisomers of THC”, cleaning up the semantic problem. However, the fact that this later reference to the substances at issue appears to be a direct quote from the Expert Committee on Drug Dependence, an international body, bolsters my theory that the FDA is intentionally creating ambiguity. All it had to do was copy and paste this phrase into the main body of its notice. Instead, it chose to rewrite and misconstrue it. Keep your eyes open for this sort of thing because it is at the heart of the present war on cannabinoids.

Rod Kight is a lawyer based in Asheville, NC. He is licensed in North Carolina and Oregon and represents legal cannabis businesses. You can contact him by clicking here.

Kight on Cannabis
84 West Walnut Street
Asheville, NC 28801