It feels like I've been seeing CBD oil everywhere lately - in the health food stores, in the gas stations, and (yes) even in the pharmacies. It hit us out of nowhere, and now all of a sudden as pharmacists we are getting lots of questions from patients about whether or not they should use it or they are telling us how much it helps them. If you're anything like me you were totally confused and wondering why all of sudden this has happened and where you can go to learn about it.
While there is now an enormous need for pharmacists to learn more than they have ever needed to in the past about cannabis I think there is also a big need out there for pharmacists to fully understand the legal status of it; after all, unlike the gas station attendant or the owner of the health food store, we also have our license and DEA registration we need to protect.
Before we get started, just one note: this article is not about whether Cannabis should be legalized fully and/or researched further in clinical trials and is not an opinion piece. Rather, it is meant to update pharmacists to the rapid legal changes and landscape that has occurred recently.
OK, enough said about that. To start with, let's get on the same page with some vocabulary:
Although often used interchangeably with marijuana, in botanical terms Cannabis is a genus that consists of:
A compound found in all Cannabis plants but in high concentrations in hemp (see below). CBD produces no psychoactive effects and might actually negate the psychoactive effects of THC.
Tetrahydrocannabinol (THC) The primary psychoactive compound found in Cannabis plants.
Cannabis plants that are smoked or consumed for their psychoactive effects, primarily due to the presence of THC. Marijuana refers to Cannabis strains that are high in THC and low in CBD.
Legally, marijuana now refers to any Cannabis plant with a THC concentration greater than 0.3%.
A strain of the Cannabis plant that is grown primarily for fiber and is low in THC and high in CBD. The high levels of CBD help negate the psychoactive effects of the THC, resulting in a plant that cannot be consumed to get high.
Strains of Cannabis plants are grown with varying amounts (measured in percentages) of both THC and CBD. Obviously high THC/low CBD is labeled as more 'potent.'
The 2018 Farm Bill
President Trump signed into law in the "Agriculture Improvement Act of 2018," also known as the 2018 Farm Bill. Under this new law, hemp was removed from the list of Schedule I Controlled Substances and is no longer considered a controlled substance. The government set in place, however, significant legislation on how hemp can be grown, so don't expect to find hemp seeds in your local gardening store anytime soon.
What exactly is the definition of 'hemp' in this law? Like I mentioned, marijuana and hemp are different strains of the same plant but with varying amount of THC and CBD.
Hemp is defined, in this law, as "any Cannabis plant, or derivative thereof, that contains not more than 0.3% [THC]" Basically, any product that has 0.3% THC or less is now legal.
Thus by default, and as stated above, any Cannabis plant with a THC greater than 0.3% is considered marijuana.
One common misunderstanding of the farm bill is that it made CBD legal; it really didn't spell out anything about CBD directly but rather:
1) Removed hemp from Schedule I of the Controlled Substance Act and
2) Made an exception for the THC in hemp so that it is not classified as a Schedule I.
In doing so, however, and in stating that any derivative in hemp is also legal, it also allowed the legal production of hemp derivatives. Thus the market is now flooded with CBD products.
The DEA's Stance
There is one catch to the Farm Bill - because it didn't spell out CBD and only made hemp and hemp-derived products legal, it did not move CBD from the list of Schedule I substances.
So where does that leave CBD products in the eyes of the DEA? Outside of FDA-approved products, CBD products are illegal unless they have been produced in a way consistent with the 2018 Farm Bill (i.e. derived from hemp by a licensed grower, etc).
CBD produced in a lab, for example (and not derived from hemp) is still Schedule I and illegal according to the DEA, and the Farm Bill did not change that status.
The FDA's Stance
The FDA still maintains authority to regulate products under the Food, Drug, and Cosmeti