New Study Shows CBD’s Strong Safety Profile

Cannabidiol, or CBD, has gained a lot of popularity over the last few years and is reported as being used by people for a wide variety of conditions, such as inflammation, pain, poor sleep, joint pain, stress, and even for pets. It is also being studied for its potential in COVID-19. But, given its widespread use, the safety of CBD (cannabidiol) products has been the subject of several studies over the past few years.

Many studies have found that CBD is a relatively safe substance. It can be taken by mouth via oils and edibles like gummies, inhaled or applied topically. There is even an FDA-approved cannabidiol medication used to treat certain rare seizure disorders in children, called Epidiolex. However, when Epidiolex was being tested in clinical research trials, there were some reports of elevated liver enzymes. Due to this, the FDA stated they had concerns for liver safety, as well as potentially causing daytime drowsiness, and lower testosterone levels in males. But, a new study shows that hemp-derived CBD products taken daily are actually safe.

The CBD Safety Study

Validcare conducted a new safety study that demonstrated people can safely take orally-ingested CBD. The present study was conducted to build upon the results of a previous safety study that included a cohort (cohort 1) of 839 subjects taking CBD products manufactured by one of 12 different companies. In that study, they found that CBD did not negatively affect liver function, and that the level of elevated liver tests were the same as for the general population, with the majority of elevations being transient.

In a new study completed in March 2022, researchers added 222 more individuals taking CBD from 5 more companies (cohort 2), with a combined 1,061 participants that used CBD products from 17 companies, and they tested CBD’s effects on liver function tests, testosterone levels in men, and daytime drowsiness, in real-world conditions. This is the first study to report on CBD’s effects on testosterone levels and daytime drowsiness in individuals using CBD.

Study Methods

This observational study recruited adults aged 18-75 years old who were taking CBD orally for at least 30 days from 17 different CBD companies. All companies provided a 3rd party certificate of analysis (COA) to ensure the product that was supplied matched the label and supplied COA. At the end of 30 days, liver tests and testosterone levels were measured, and daytime drowsiness was assessed using the Stanford Sleep Scale.

Results

Daily CBD Consumption

The average daily dose of any type of CBD consumed was 50.7 mg with a range of 2.5-390 mg. The daily average dose of full spectrum CBD was 40.5 mg, broad spectrum CBD was 54.2 mg, CBD isolate was 63.6 mg, and one company had nano-treated full spectrum CBD with an average daily dose of 7.6 mg. 

CBD and Liver Function Safety

The prevalence of elevated ALT (9.1%) and AST (4.1%) was similar to those observed in the general population (8.9% and 4.0%, respectively). The prevalence of elevated alkaline phosphatase and total bilirubin was 1.7% for both, which is similar for the general population (2.5%). There was no significant association between CBD dosage and liver function tests. 43 individuals had follow up liver function testing, of which 37 (86%) became normal or stayed at the same level. Of the 6 (14%) that had a further increase in levels, they were also taking substances known to cause elevated liver function tests. The results of liver function testing were consistent regardless of the CBD product used, the source of the product, or the form of CBD.

CBD on Testosterone Levels

The prevalence of low total testosterone and low free testosterone levels were 22% and 12.9% for those <40 years old, and 22.2% and 10.8% for those 40-59 years old, and 20.6% and 20.6% for those over 60 years old. Although the rate of low total testosterone in the under 40 years old group was similar to the general population (22.6%), the rate of low total testosterone in the 2 older groups is actually significantly lower than the general population (35.8% and 34.6%, respectively). There is a significant positive association between total testosterone level and dose of CBD per weight. Another finding is that the prevalence of Type 2 diabetes in all the males and females in the study taking CBD is significantly lower in those over 45 years old as compared to the general population (3.9% vs 14.3%).

CBD and Daytime Drowsiness

Of the 914 individuals who were assessed for daytime drowsiness, those who were taking CBD had significantly lower Standford Sleep Scale scores, which means that using CBD was associated with improved daytime alertness and less drowsiness.

Conclusion

This study provided real-world data regarding the safety of taking hemp-derived CBD daily. The study showed that taking CBD daily for 60 days or longer was safe regarding liver function tests, and had a positive effect on testosterone levels and daytime drowsiness. If there are liver function test elevations, these are likely due to the health conditions or medications for which the individuals are taking CBD. This study provides more data to add to the existing data on the safety of CBD, and addresses some of the concerns the FDA has on CBD’s safety.

It is important, when choosing a CBD product, that you obtain it from a reputable company, with high quality CBD. Therefore, make sure the company can readily provide lab test results for their products. Check out CBD Oil of Dayton’s CBD products here.

Reference:
https://app.hubspot.com/documents/4153268/view/303614964?accessId=54034b

Disclaimer

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease (in humans or animals). These products are not for use by or sale to persons under the age of 18. This product should be used only as directed on the label. It should not be used if you are pregnant or nursing. This website is not offering medical advice. Consult with a physician (or veterinarian for pets) before use if you (or your pet) have a medical condition or use prescription medications. A Doctor’s advice should be sought before using this and any supplemental dietary product.