Something ground-breaking happened in the CBD world in the past few weeks, and it’s ramifications are going to ripple out a positive effect on many sectors for years to come.

In the past years, with the rise of CBD’s popularity, the FDA has erred on the far side of caution, releasing statements like, “CBD can cause liver injury,” and “CBD can affect how other drugs you are taking work, potentially causing serious side effects”. 

With little verified or official research to go on, the FDA’s stance has been very conservative when it came to CBD. They only approved one CBD-based pharmaceutical-grade medication, a drug used to treat seizures related to certain kinds of epilepsy.

However, around 18 months ago, the Food and Drug Administration reached out to the company Validcare, a patient-centered clinical research facility. The FDA wanted to collect safety data on CBD so they could better know how to regulate the CBD-based hemp industry.

Patrick McCarthy, CEO of Validcare, spoke to the weight and importance of the study, “We understand the significance, importance and immediate need for CBD safety research for the FDA, industry and the US consumer. This first of its kind, industry led, multi-branded study required trust, collaboration, operational excellence, innovation, and resilience. It demonstrates the incredible potential for decentralized clinical research to increase participant access and accelerate results – even during the most challenging times. We are excited for our principal investigators to continue, expand and report out on this foundational work in the next few months. Once completed, safety results of this study will be shared with participating brands and FDA. The investigators also plan to publish in a peer reviewed journal.”

From August 2020-February 2021, Validcare performed a study on 839 participants. Their primary end goal of the study was to observe any potential liver effects in adults when ingesting oral forms of hemp-derived CBD, and they wanted to do this for a minimum of 681 people for at least 60 days.

What they observed over the course of 7 months was that there was no clinical evidence of liver disease in any of the participants. According to co-investigator Jeff Lombardo PharmD, BCOP, 

“We observed slight, clinically insignificant elevations of liver function tests in less than ten percent of consumers irrespective of age, product composition and form and the amount consumed. Three of the 839 participants had 3x normal levels of the liver enzyme ALT. These three consumers are taking prescription medications that are known to elevate liver enzymes, and we are investigating whether prescribed medications or other factors contribute to these outliers.” 

Upon further investigation, it was discovered that the 3 participants were already on medications that caused higher levels of this enzyme as a side effect before the study began.

These initial results debunk the idea that CBD can build up in the liver and cause liver toxicity and makes this study even more compelling in regards to the safety factors for the general public.

Not only that, but the researchers were surprised to find that almost 70% of the participants had some kind of medical condition being treated by medication coming into the study, and yet none of them reported an increase in adverse effects taking the CBD in conjunction with their medications.

This means that the idea that CBD could interfere with “ALL” medications in general isn’t necessarily true. For sure more studies need to be completed. Now, this is still something important to talk to your doctor about first, due to the grapefruit warning. If your medication has a grapefruit warning then do not take CBD. Once you have completed that medication, then speak with your caregiver and get the “all clear” from them. But the findings of the study are unexpectedly and undeniably good news!

“We are encouraged by these findings and hopeful this study provides FDA with sufficient science-based data to determine and take action on a safe regulatory path forward,” said Dr. Aqua. “We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions,” says Keith Aqua, MD, co-principal investigator of this IRB-approved study.

Footnotes: 

Here is the study that was just forwarded to the FDA: https://validcare.com/press/validcares-clinical-study-reports-preliminary-results-of-cbd-liver-safety/

The FDA public warning about CBD: https://www.fda.gov/consumers/consumer-updates/what-you-need-know-and-what-were-working-find-out-about-products-containing-cannabis-or-cannabis