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 Cosmetic Act, and one of the things that can get producers in hot water quickly with CBD oil is making specific therapeutic claims, which are not only illegal for CBD products but for any product that is not FDA-approved.
In addition, the FDA has also maintained that it is illegal to sell CBD in both dietary supplements and in food, leaving CBD in limbo with the FDA. Here is a brief summary of their reasonings:
Dietary Supplement: Any product that has been FDA-approved as a drug product cannot also be sold as a dietary supplement. Because Epidiolex, containing CBD, is FDA-approved, CBD cannot be put in dietary supplements.
Food: It is illegal to add any substance to a food product that has been FDA-approved as a drug or to which "substantial clinical investigations have been instituted and for which the existence of such investigations has been made public." While there are exceptions, the FDA maintains that there is no exception for CBD and THC-containing products.
Note that the FDA might not (and not be able to, nor wish to) take enforcement actions on every company producing these products.
Also, you can tell in their statements that the FDA isn't quite sure yet how to handle the explosion of CBD products (obviously being marketed as both food and dietary supplements).
For example, they even say "We are aware that state and local authorities are fielding numerous questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners."
Or here they say "[W]e recognize that there is substantial public interest in marketing and accessing CBD in food, including dietary supplements. The statutory provisions that currently prohibit marketing CBD in these forms also allow the FDA to issue a regulation creating an exception, and some stakeholders have asked that the FDA consider issuing such a regulation to allow for the marketing of CBD in conventional foods or as a dietary supplement, or both. This raises important and challenging questions of regulatory policy and public health."
In other words, keep your eyes peeled because the FDA's position could change.
Update: Since the original publication of this article, the FDA has taken action against 15 companies for illegally selling CBD-containing products.
What they have taken action against, however, is companies 1) making therapeutic claims (like I mentioned above) or 2) not putting in the product what is on the label. This is common to any product though, so whether it is CBD, an herbal supplement, or a cosmetic, you can't do either one of these things without risk of action by the FDA.
State laws regulating marijuana vary widely and have also changed rapidly in recent years. Laws run the spectrum from full legalization to illegal and everything in between.
Keep in mind, states have a right to regulate and schedule substances independent of the Federal government, so while the Federal government might have made hemp and hemp derivatives legal that does not mean states have.
I was going to create pretty state maps for you highlighting the status of marijuana in each state, but then I found an awesome one put together by the folks over at DISA, a company that specializes in corporate drug and alcohol and background screening (among other services). They were nice enough to let me post it here for your reference:
I recommend bookmarking their page on this, as they also provide links to each state's specific law.
Summary - Should You Sell CBD in the Pharmacy?
In short, there is still a lot of confusion surrounding the legal status of CBD and CBD-containing products. So should you sell them? That is ultimately up to you, but here are some things to keep in mind:
Epidiolex: You're on solid ground here, and because it can actually help patients - you shouldn't deny patients this therapy when it is prescribed. There are clear positions from both the FDA and DEA that this product is a Schedule V, and even if your state still classifies CBD as a Schedule I it is extremely unlikely they would go after pharmacies dispensing an FDA-approved drug product pursuant to a valid prescription.
CBD Oil and Food Products: This one is a little shakier because the FDA is not allowing them to be sold as dietary supplements or food, though they are unlikely to go after individual pharmacies and more likely to go after manufacturers. The BOP in your state might, though, decide to take action. Either way as a pharmacist, however, at the very least it is best to only sell products that 1) you can trust have what is stated on the label and 2) do not make therapeutic claims. You also should not make unsubstantiated therapeutic claims to your patients when talking about CBD.
Lastly, if you do decide to sell CBD be sure that the products you sell comply with the 2018 Farm Bill; if not, the product is actually classified as a Schedule I, is clearly illegal, and the DEA (and others) could take enforcement action against you and/or the pharmacy.
References (not otherwise linked within article)
The National Law Review
Keywords: Cannabis, marijuana, CBD, THC, Farm Bill, DEA, FDA, hemp