FDA and WHO Statements on Safety of CBD — Featuring Dr. Scott Shannon

Although cannabidiol (CBD) has been declared safe for human consumption by the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA) recently published a statement claiming the popular cannabinoid might cause you harm. So now the safety of CBD is suddenly being questioned.

Related: The Dangers of Marijuana Consumption

CBD is gaining popularity in Europe, so you might be wondering which agency is right, the WHO or the FDA? What do experts like Dr. Scott Shannon think? Let’s find out.

 

What harm might CBD cause according to the FDA?

As a European, you might not be familiar with the FDA. In the U.S., the FDA is the government agency responsible for ensuring that every type of food, beverage or drug that enters the market is safe to consume. Up until recently, the FDA stated that CBD is safe to consume and said so on its website.

Now, even though the actions of the FDA don’t affect your average European consumer directly, they still have a lot of influence on the European market. FDA guidelines often influence the guidelines of the European Medicines Agency (EMA) and vice versa, meaning the FDA’s most recent statement on the safety of CBD might cause concern among European CBD producers.

So, what did the FDA say to cause concern among CBD consumers?

Well, the FDA’s updated statement says that CBD has the potential to harm you even before you’re aware of it. The FDA says that CBD can cause liver injury, interact with other drugs and lead to serious side effects as well as increase the risk of sedation and drowsiness when you combine it with alcohol or other central nervous system depressants.

The FDA also states that, by itself, CBD can cause drowsiness or sleepiness, gastrointestinal distress such as diarrhoea, decreased appetite and mood changes, such as irritability and agitation. These symptoms were previously documented, and there are several studies covering them.

Related: The Effects of CBD on the Human Body

But all these side effects pale in comparison with the next one. The FDA says that CBD causes symptoms of male reproductive toxicity. These symptoms translate to a decrease in testicular size and testosterone levels, inhibition of sperm growth and development and more.

The FDA’s statement is surely scary enough to make would-be CBD consumers think twice before making a purchase, but it also goes against most of the things we knew about CBD so far.

 

What the WHO says about the safety of CBD

In a 27-page report published in 2017, the WHO states that there is no evidence indicating that recreational use of CBD could cause any public health-related problems. In addition, the report mentions that CBD has a healing potential and is safe for public consumption.

The experts who worked on the report found that CBD shows promise as a potential treatment for Alzheimer’s disease, epilepsy, psychosis, Parkinson’s disease and even cancer. It’s important to note that the report says that CBD shows promise but recommends further studies before using it as such.

Last year, the FDA approved Epidiolex, a cannabis-derived medicine containing nearly 100 percent CBD, for the treatment of two types of seizure disorders that affect children.

At the time, the FDA Commissioner Dr. Scott Gottlieb said: ‘Because of the adequate and well-controlled clinical studies that supported this approval, prescribers can have confidence in the drug’s uniform strength and consistent delivery that support appropriate dosing needed for treating patients with these complex and serious epilepsy syndromes.’

 

Why the FDA changed its stance on CBD

Now, it seems that the FDA changed its stance on CBD after it approved the treatment of epilepsy with Epidiolex because some of the patients experienced tiredness, diarrhoea and appetite or weight changes.

But a study focusing on the safety of CBD as epilepsy medication stated that ‘in comparison with other drugs, used for the treatment of these medical conditions, CBD has a better side effect profile.’

The thing is, every drug produces side effects. For example, aspirin might cause diarrhoea, fainting, drowsiness, fever, headaches, heartburn, convulsions, chest pain, stomach cramps, panic, restlessness and more.

And it’s not only drugs. Everything you eat or drink has the potential to produce severe side effects, even water. Drinking too much water can lead to muscle cramps, fatigue, headaches, vomiting and confusion. Whereas drinking too little water can lead to heartburn, ulcers and increased blood pressure.

 

What other institutions say about the safety of CBD

Now, the FDA’s statement might contradict the WHO’s statement and even the FDA’s old statements, but what do other institutions say about the safety of CBD?

Well, Harvard Health says that CBD may raise the levels of certain medications in your blood, much like grapefruit does, and that its side effects include nausea, fatigue and irritability. The website also notes that CBD may increase the level of a blood thinner called coumadin in your blood.

The BBC says that CBD is well tolerated by most people but it can cause hypotension and light-headedness in some people. The website also mentions that you should consult with your physician before taking CBD, especially if you’re on blood-thinning medication or calcium channel blockers.

Dr. Brent Bauer, director of the Mayo Clinic Integrative Medicine and Health Research Program, stated that you should talk to your healthcare provider before taking CBD because it may interact with other medications.

He also said that, even though it’s mostly safe, more research on CBD is needed. According to Dr. Bauer, if it’s strong enough to help you, it’s strong enough to hurt you.’

But what do health experts say about the safety of CBD after reading the FDA’s statement? To find out, Strain Insider checked in with Scott Shannon, M.D., Fellow of the American Academy of Child and Adolescent Psychiatry (FAACAP), who is the Assistant Clinical Professor Department of Psychiatry at University of Colorado. If you look up scientific articles on CBD, you’re bound to find an article written by Dr. Shannon. Here’s what he had to say on CBD safety.

This interview was conducted on the 13th of December, 2019.

 

The Interview

Victor Bercea: How long have you been studying cannabis and cannabinoids for?

Dr. Scott Shannon: Probably about five years.

VB: And did some of the subjects that participated in your studies suffer severe side effects from cannabinoids or CBD?

SS: All we’ve been using is hemp-derived CBD, so that’s what I can comment on. But no, nobody has suffered any severe side effects from it.

VB: Regarding the updated FDA statement on CBD safety and comparing that with what the World Health Organization published on CBD, we now see a contradiction between the FDA and the WHO because the WHO states CBD is safe for human use, whereas the FDA states CBD should be used with caution. What’s your opinion on the FDA’s updated statement?

SS: We’ve not found any significant or severe side effects in our work with it. The preclinical data, as I see it, indicates that CBD is safe in the doses that we’re using. The doses that they’ve published in studies are often 10 to almost 100 times the dose that we’re using. And those studies don’t show significant side effects. 

The cost is really the main concern that I see with people. The cost of CBD can be moderately expensive. That is the main issue. To my mind, we need more freedom from the FDA to be able to study cannabinoids, particularly stuff that’s not hemp-derived and contains tetrahydrocannabinol (THC). There’s almost no published literature on edibles, which are becoming a huge thing in the market.

VB: Yeah, indeed, we’ve seen this in the European market, as well. The edible market is really picking up, especially CBD-infused edibles are becoming quite popular in Europe nowadays. What doses of CBD do you use in your studies?

SS: The typical dose rage is often 10 to 30 mg of hemp-derived CBD per day.

VB: I saw some studies that used up to 1,500 mg of CBD per day, as you said, more than 10 to 100 times more than the doses you use, and even those doses seem to be safe. So I was wondering if you could share some ideas on what prompted the FDA to say that CBD could cause liver damage or male sexual toxicity. Do you know anything regarding those side effects of CBD?

SS: Not in the literature I’m familiar with. I know there have been some recent publications about decreased sperm count, but I think that’s true for cannabis in general and is maybe a concern for the larger field. 

I think overall the issue here probably has more to do with the very confused and conflicted regulatory environment in the United States between cannabis and CBD. 

We have CBD growing to hundreds of millions of dollars in sales, we have cannabis as federally illegal but states are legally using it, it’s a very confusing, disorganized and conflicted environment where even the manufacturers are sort of scrambling day to day to know what the guidelines are.

So I think the FDA is trying to maybe put the breaks on the explosion of CBD use and maintain some control and management over a market that’s a bit out of control. That’s my hunch. It’s only an opinion.

VB: OK. Now, regarding your studies, will the new stance of the FDA on CBD affect your studies somehow? Is it difficult for you to find subjects to participate in CBD studies at the moment?

SS: No, we’ve always found it quite easy to recruit subjects. People have an interest in this and recruitment is easy. I think the larger concern is: Is the FDA going to step in and try to regulate CBD because of the conflict that they have now with a marketed CBD-containing compound for treating seizures. Is that going to create some confusion?

I think there is going to be a lot of dissent and mass protests if the FDA tried to limit access to CBD. But they could, and I think everyone in this arena is concerned that they could do something unwise.

VB: Yeah, that’s one of the things we want to tackle in the article because, as Europeans, the FDA’s decisions don’t affect us directly, but every decision they make ultimately influences the decisions of the European Medicines Agency because they deal with the same stuff the FDA does.

And when the FDA states that CBD could cause harm, that worries European CBD producers because the legal status of CBD in Europe is not better than what you have in the U.S. Actually, I think that your legal status is superior to what we have in Europe. So the FDA’s updated statement will probably cause some confusion among European producers as well. 

I was wondering, what’s the worst side effect you witnessed in your test subjects so far?

SS: I had one subject who was developmentally delayed who became sexually inappropriate at higher doses. And I think that was mainly because his anxiety was the only thing that held him back from acting out and when we administered CBD he became much more impulsive.

We stopped the medicine and the symptoms went away, but when we started it back up they returned and we just had to formally take him off it. But that was the worst thing we encountered.

We usually get some fatigue, some dried eyes, occasional nausea or upset stomach. They’re very minor problems. Most people tolerated it quite well.

VB: And these are all well-known problems, documented problems with cannabinoids. Fatigue, nausea, diarrhoea — we knew these problems could happen before the FDA’s updated statement.

Talking about your studies, I saw you published a series of articles on the effects of CBD oil on anxiety, insomnia and PTSD especially. What have your results been so far with CBD and anxiety?

Related: Did CBD Help With Your Anxiety or Was it a Bust? This Project Wants Your Feedback!

SS: We find a benefit to anxiety fairly quickly and fairly significant that seems to retain over months. We found very mixed results for sleep.

We think that it helps with trauma and PTSD, and we have some suspicion that it helps with thought disorder or psychosis, but we haven’t been able to confirm that because we don’t have enough numbers.

VB: OK, I get it. You said you had mixed results on sleep and insomnia? A large part of our audience takes CBD for insomnia. What were your results with insomnia?

SS: I think that what we’ve found is that there is some modest benefit at first and it seemed to go away after a few weeks. Our impression is that a lot of people that have sleep problems are quite anxious about it.

VB: So it could be an anxiety issue as well?

SS: No, not totally. But when their anxiety is improved, they may not sleep a lot more but they worry and stress about it less.

VB: So would CBD give them a better quality of sleep?

SS: Yeah, it may, or they may just think they slept more when they didn’t.

VB: Because they don’t worry so much about not sleeping?

SS: Yeah, so either way, they seem to complain about it, but when we actually look at the numbers, the results weren’t that much better, so I don’t know. 

We feel pretty confident about CBD’s ability to help with anxiety. I think one of the things that we do see is that, or at least I’ve seen in the literature, it looks like THC amplifies the effect as a sleep aid.

What I see in the literature is that when you have THC in a compound with CBD, things seem to improve for people who can’t sleep.

VB: OK, I see. So the FDA allowing you to study THC and look into it more for insomnia would really help, wouldn’t it?

SS: It would help a lot. To my mind, that question is not fully resolved.

VB: In light of the FDA’s updated statement saying that CBD could cause liver damage and even sexual toxicity to your subjects, will you continue your studies on CBD?

SS: At this point, our goal is to do a randomised control trial, and so we’re in the process of searching for funding. And that would likely require FDA approval, so it’s going to be complicated and more drawn out, but yes, we hope to pursue this.

Strain Insider would like to thank Dr. Scott Shannon for taking the time to speak with us.

 

CBD is still safe 

Maybe the FDA’s statement is simply their way of trying to control the disorganised environment of CBD in the U.S., like Dr. Shannon says. Or maybe the FDA’s updated statement is part of a long-term plan aiming to discourage cannabis entrepreneurs, as some conspiracy theorists on social media would have you believe. The truth is that we don’t know why the FDA updated its statement.

But you shouldn’t concern yourself too much with the FDA’s updated statement. As far as safety goes, CBD is generally a well-tolerated product. However, the CBD market is full of crappy merchandise, so you should make sure you know what to look for when buying CBD if you want to consume safe products.

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