FDA Goes Negative on CBD Products – What Does it Mean?

FDA Goes Negative on CBD Products – What Does it Mean?

On November 25th, 2019, the CBD world was shaken by an updated statement from the Food and Drug Administration (FDA) that has taken a real negative turn when it comes to CBD products.

This shocking warning was carried by numerous publications and news channels, and has had a severe impact on the attitude towards CBD in the USA, at least in the short term.

But why the change? Is there truth in what the FDA say? And why are they saying it now?

What Does the Statement Say?

The FDA are pulling no punches here, stating in no uncertain terms:

“CBD has the potential to harm you, and harm can happen even before you become aware of it”.

This statement comes a few months after the FDA said:

“There are many unanswered questions about the science, safety, and quality of products containing CBD”.

A strong warning indeed, but is it necessary?

As we continue to read through the statement, let’s take a second to fact check as we go, and try and work out the validity of the FDA statement.

Is the FDA Right About CBD Products?

Okay, so let’s get into the nitty gritty of this little ditty, we’ll take the choicest statements in the statement, and discuss them.

CBD Can Cause Liver Injury – This is the first point in the list of risks in the statement, and is worthy of discussion. Yes, there is some evidence to suggest that CBD can create an added risk of liver injury. Earlier this year, tests in mice showed that use of Epidiolex, an FDA approved CBD drug, created liver issues.
There are two points to be aware of, firstly, liver damage is a known side effect of Epidiolex, and is commonly mentioned in articles about the drug. Secondly, this test was carried out in mice, and it is worth mentioning that the FDA does not speak as confidently on the truth of numerous positive results of mice trials that show CBD to have potential medical benefits.

CBD Can Affect the Metabolism of Other Drugs, Causing Serious Side Effects – Yes, this is true, in fact, the 2018 World Health Organisation (WHO) report on CBD stated the same thing, saying “CBD is generally well tolerated with a good safety profile. Reported adverse effects may be as a result of drug-drug interactions between CBD and patients’ existing medications”. We, and any other worthy source for CBD information, have always said that if you are on any other medication, consult your doctor before taking CBD.
Use of CBD with Alcohol or other Central Nervous System Depressants Increases the Risk of Sedation and Drowsiness, Which Can Lead to Injuries – This, as far as we can tell, is a long-winded way of saying “do not drive or operate heavy machinery while under the influence of alcohol and CBD” something that is also true with alcohol alone. That isn’t to say it isn’t a warning worth heading, if you are combining CBD and alcohol, firstly, be careful with your dosage, and secondly, don’t do anything strenuous or that requires focus. However, our advice will always be to not combine CBD with alcohol at all.
Other Side Effects

There are three side effects that “you might notice” listed in the FDA statement on CBD products, these are as follows:

Changes in Alertness, Most Commonly Experienced as Somnolence (Drowsiness or Sleepiness) – Firstly, props to the FDA for getting to the word Somnolence into common usage. Secondly, this is something to be aware of, many speak of the “relaxing” properties of CBD, and in some instances, that sense of relaxation could evolve into a sense of drowsiness. The best way to avoid this is by starting with a low dose, and only moving up if you feel comfortable to.
Gastrointestinal Distress – Diarrhoea and decreased appetite are the big two here. CBD interacts with the body’s endocannabinoid system, which, amongst other things, helps to control appetite. Some anecdotal evidence has suggested an increase in appetite when using CBD, while others have shown a decrease. CBD reacts with different people in different ways, obviously, if these side effects occur, stop taking CBD instantly.
Changes in Mood, Most Commonly Experienced as Irritability and Agitation – Full disclosure, this is a new one to us, but there must be evidence for the FDA to state it. The report says that stopping taking CBD or reducing the amount ingested should alleviate these symptoms. For us, the rule is always to stop if there are negative side effects, and consult your doctor.

Male Reproductive Toxicity

This, along with the liver issues, is the warning that most news outlets are leading with in this story. Tests in laboratory animas have shown “decrease in testicular size, inhibition of sperm growth and development, and decreased circulating testosterone”.

This is early stage research at this point, again, we mention here that there are also many positive results shown from similar tests, which the FDA (understandably) do not deem sufficient for claims to be made, but that rule must hold firm in the other direction too.

This is certainly a concern, and we will keep a firm eye on the results of future tests, if there is any further suggestion of these risks, we will tell you immediately.

Or, as the FDA’s statement puts it:

“Further testing and evaluation are needed to better understand this potential risk”.

Further Research

The report also refers to several factors that the FDA is “actively working to learn more about” in terms of the safety of CBD products.

These include:

Cumulative Exposure – This essentially means the effects of combining products, such as ingesting oils and applying creams topically
Special Populations – The effects of CBD on pregnant women, children, the elderly, etc.
CBD and Animals – The safety of using CBD for animals
We don’t believe anyone would argue with the need for further research in all of these areas. The more information we all have about CBD the better.

The Marketing of CBD

Here is where we get to what is the most important, and arguably the most valid part of the FDA report:

“Some CBD Products are Being Marketed with Unproven Medical Claims and Could be Produced with Unsafe Manufacturing Practices”

This is, undoubtedly, a big issue in the CBD world. The lack of regulation in the market means that CBD products do not always match what is on the label, and it’s vital to ensure that you are getting your products from a trustworthy source.

With the exception of Epidiolex, other CBD products “have not been subject to FDA evaluation regarding whether they are effective to treat a particular disease or have other effects that may be claimed. In addition, they have not been evaluated by the FDA to determine what the proper dosage is, how they could interact with other drugs or foods, or whether they have dangerous side effects or other safety concerns”.

This is a genuinely important fact, and something we are personally very invested in. We always ensure to bring honest and fact checked information about CBD< we do not make false claims, and we provide links wherever applicable.

In our mind, the job of either a CBD supplier or a source of information on CBD if to inform, to provide all the facts necessary for you to make your own decisions about CBD, and to lead you down the right avenues for research.

There are, according to the FDA statement, many CBD suppliers who do not do this, however, instead claiming health or dietary benefits of CBD as fact.

Then there is the quality of products from certain suppliers. Again, we, and any other respectable supplier, will also be 100% transparent when it comes to how our products are made, and what goes into them, but in this case too, that isn’t true of everyone.

As the statement says:

“The FDA is also concerned that a lack of appropriate processing controls and practices can put consumers at additional risks.

“For example, the agency has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed.

“We are also investigating reports of CBD potentially containing unsafe levels of contaminants (e.g., pesticides, heavy metals, THC)”.

The main crux of this section of the statement is to make it clear that the FDA has only approved Epidiolex for epilepsy.

Beyond that, no approval has been given to CBD, not for animals, not for dietary reasons, and not for medicinal reasons.

This isn’t to say that these benefits will not be proven to be there, but they have not yet, and that is something to be aware of.

Conclusion

The FDA report is scary at first sight, and it would be fair to take some issue with the language used. For example, the WHO report and the FDA statement both mention the risk of CBD reacting negatively with other drugs, but the language used creates a very, very different tone.

Some outlets reporting the FDA claims have discussed what could best be described as conspiracy theories to explain why the FDA is taking a narrative so different to the WHO and other organisations. We are not going to explore these theories, nor are we going to give credence to their authors by mentioning them, because we do not see them as worthy of discussion.

There are points made in the FDA statement that should be taken seriously, and while the language, at times, borders on the unnecessary, the facts are there.

The FDA’s job is to ensure public health, and with so many false claims being made about “proven benefits” of CBD, another side was necessary.

This is another side we have always tried to bring, and we will do it again here.

Before taking CBD, do your research, look into the possible side effects, and consult your doctor if you are using any other medication.

If you do choose to start using CBD, start with a low dose, the lowest you can find. If you don’t feel like this is working, increase the dose, but do so slowly. When you reach the level you are comfortable with, stay there. There has been no evidence to suggest the body develops a tolerance to CBD, so stick with what works for you.

Finally, and most important, make sure you are buying your CBD for a trusted, well-reputed, respectable supplier. Read reviews, ask questions, make sure you are comfortable that you are being sold what you are being told you are being sold.

These are the important factors to take from the FDA report.

The truth is, there are extreme statements from both sides of the CBD debate, which is why we try and make it our job to stay in the middle of the conversation, and deal in fact, not opinion, and in truth, not hyperbole.

In conclusion, read the FDA report, but don’t be scared by it. If things in it concern you, read this article again, find your perspective, and carry out your own research. Then, make your own decision based on the evidence you have read. It is nobody’s place to tell you what to think, not ours, not the FDA’s, and not any other source of CBD information.