Members of the United States Food & Drug Administration (FDA) warned the general public about using CBD products on 26 November, telling consumers that CBD can be potentially harmful. Officials further stated that these hazardous effects can take hold without the consumer noticing. What is the FDA concerned about? Should you be careful about using CBD?
What is the FDA concerned about?
The official announcement by the FDA specifically pointed out the following possible problems with CBD:
- there may be possible interactions between CBD and other drugs that we are not yet aware of;
- consumers may develop positive associations with feeling sedated and drowsy
- it can lead to diarrhea as well as a decrease in appetite
- it may exacerbate irritability and restlessness
- CBD may cause liver damage
Taking a close look at this list, the first four points do not seem severe and are largely expected. The main cause for worry is the last point: that CBD may hurt the liver. That, indeed, is severe, and it is possibly a reason to stop consuming.
The FDA has a complicated history with pain killers that affect the liver, specifically drugs in the category of NSAID; these include products such as ibuprofen and aspirin. These past problems are likely the reason why the agency responds to CBD with such caution.
Why is the FDA worried about liver damage?
During the later 1990s and up to the mid-2000s, several new pain killers of the NSAID category entered the market. Many were later removed sales in countries like the United States, the United Kingdom, the European Union, and others because they were found to have harmful side effects that impact the liver. In the United States, drugs are the number one cause of liver damage.
A study that examined what happened with those anti-inflammatory pain relievers uncovered that high levels of the enzyme ALT should have given medical researchers a clue. The enzyme is mainly located in kidney and liver cells. ALT levels are elevated in the circulatory system whenever liver cells die. Doctors can detect high levels of ALT in your blood, and finding unusual amounts of these enzymes in your blood work is an indication that your liver may be damaged.
To be specific, when the strong anti-inflammatory pain reliever Duract was first tested, 3 % of patients had high levels of ALT. The FDA approved the drug in 1997 but then withdrew it the following year when reports of several liver failures and patient deaths came in. FDA officials felt embarrassed by the experience with Duract, as prominent news outlets such as The Wall Street Journal decried the drug, calling it a “Lethal Failure.”
What does the Duract scandal have to do with CBD?
The most accurate information on CBD which the FDA has are the results of studies on Epodiolex, which is a pharmaceutical substance based on CBD, created by the company GW Pharma. Last year, Epidiolex was approved by the FDA as a treatment for certain serious types of epilepsy. The drug has a high content of CBD and can only be obtained with a prescription.
Tests on Epidiolex show elevated ALT values in 3% of the adult patients who were treated with lower daily doses of CBD, ranging between 550 and 900 mg. For comparison, another group of patients received a placebo that did not contain any CBD. Only 1 % of patients in the second group showed high levels of ALT. However, there is not much reason for concern if we consider the sample size: in the placebo group, two out of 291 people had elevated levels of ALT. The CBD group which received a lower dose comprised 67 people; in that group, two patients had abnormal levels of the enzyme. With only two people showing symptoms, there is not enough evidence to show CBD was the cause.
However, in the patient groups that received higher doses of CBD, the ALT enzyme levels were disconcerting and significant. Elevated levels were reported in 18% out of 228 people, who were given 20 mg of CBD for each kilogram of body weight per day (this meant that amounts ranged from 1100 mg to 1800 mg). This is noteworthy, as it shows that higher amounts of CBD can negatively impact your liver.
How much CBD is too much?
It is important to point out that in the research conducted on Epidiolex, patients took ten times more CBD than a typical over-the-counter dose. The FDA-unregulated CBD products that you can buy today have a range of 50 mg to 1000 mg for each packed unit. For example, an average jar of CBD gummies might contain a total of 30 units with 10mg of CBD per gummy.
People who participated in the Epidiolex research project were given between 550 and 1800 mg CBD every single day.
To be more precise, one group of patients took a placebo, another ingested 10 mg CBD for each kg body weight, others received 20 mg CBD for every kilo of body weight. This means that a man who weighs about 200 pounds (that’s 90kg) who is in the highest-dose-group would take a total of 1800 mg CBD daily. You would have to eat six full CBD gummy jars each day to get that much.
These high doses are not shocking, however, if we consider that they were used to treat serious cases of epilepsy with CBD. Treating an illness may require patient-specific dosing. However, it is unlikely that you will find dosages such as these when you buy CBD over the counter.
How should we interpret the FDA’s warning?
FDA members seem more concerned with potential hazards and side effects of CBD than the health benefits the drug might bring. That, after all, is the FDA’s job: the organization is meant to ensure that the population is not exposed to any hazardous drugs and foods. It is not their job to promote the products they examine. The FDA’s warning about CBD in November last year was not meant to be a final assessment of the drug.
