FDA Update: July 2020 CBD Study

This July, one of the first federally funded studies of cannabis and its effects on the human body will commence. The study by ValidCare, a clinical research company that aims to keep consumers safe and informed, will examine the adverse effects that CBD could potentially have on the liver.

The study was initially scheduled to begin in March. The Food and Drug Administration (FDA), however, was forced to shift its focus to COVID-19, causing delays in regulatory progress regarding CBD and other cannabinoids. ValidCare’s research will notify the FDA of any CBD health risks that could warrant regulation.

Safety Regulations

Epidiolex, a CBD-based pharmaceutical drug that’s thought to elevate liver enzyme levels when taken at high doses, is why the FDA has reservations about the safety of CBD. CBD brands refute these claims pointing to the fact that consumers seldom ask for 700 milligrams of CBD,  which is the supposed amount that could cause unknown consequences.

Just as taking too much ibuprofen or aspirin can have negative consequences, CBD is no different. You may have seen reports from previous studies, one taking place in April of last year, claiming liver toxicity from CBD. These reports, however, framed study results unfairly. These studies actually found that CBD is only toxic when consumed in extremely high doses. The FDA would like to rule out all suspicion.

Previous Research

In April of 2019, a study conducted by the University of Arkansas claimed that CBD can cause liver toxicity. We dove into the study to investigate its credibility and exactly what its findings mean for us in the CBD world.

First, we need to investigate the dosages used. Initially they use conversions from the maximum daily dosage of EPIDIOLEX® (20 mg/kg). For ease of understanding throughout this analysis, I will use human equivalent dosages, a conversion from the mouse equivalent dosages used in the study. For reference, dosages are calculated with regard to a 132 lb (60 kg) person.

UNIVERSITY OF ARKANSAS CBD LIVER TOXICITY STUDY 

First study: 24 hour liver toxicity analysis

• Dosages: control, 1200 mg, 3600 mg, 12000 mg

• 12000 mg showed toxicity in 24 hours and lead to liver toxicity

Second study: 10 day liver toxicity analysis

• Dosages: control, 300 mg/day, 900 mg/day, 3000 mg/day

• 3000 mg/day showed liver toxicity over the 10 day period

• 900 mg/day did not show toxicity but did show swelling of liver cells

Over a 10 day period, liver toxicity was not seen when ingesting 900 mg of CBD in a day, however, there was evidence of cellular swelling in the liver. So, conservatively, if consumers stay below 900 mg a day, they will avoid adverse affects on the liver (according to this study). 

Remember, this research is preliminary and not conducted on humans, so take it with a grain of salt. FDA decisions on exact dosing and other regulations will need to be supported by data from human based research, which has been scarce in the past.

ValidCare Experiment

Fortunately, ValidCare will have no problem providing human based research because several CBD companies have offered support. The study’s official sponsors are Charlotte’s Web Holdings, CBDistillery, Columbia Care, Boulder Botanicals, CBD American Shaman, HempFusion, Infinite CBD, and Kannaway. Each company has donated a generous $100,000 and offered help finding participants to get this study off the ground.

ValidCare will observe 1,000 individuals who have consumed a controlled amount of CBD for 60 days before the study. For the next 30 days, participants will be asked to record their experiences in a journal. For clinical purposes, blood samples and screenings will also be critical components of the process. Using four liver function tests, researchers will determine if there’s a correlation between CBD usage and liver failure. These conclusions will dictate the urgency for CBD regulation.

Outcomes of Study

With so many consumers and CBD companies willing to help, ValidCare has high hopes that they will acquire the clinical data that the industry desperately needs. By September, we should have an update about FDA regulation of CBD. ValidCare is not anticipating any more delays as long as participants are healthy and safe. 

If the results are positive, the FDA may allow CBD to be sold in pharmacies and grocery stores. However, there are still a series of unanswered questions that the FDA is determined to resolve before they proceed.

Company Update

Here at BDX, the health of our consumers is our number one priority. That is why we are unforgiving in our quality assurance protocols. For us, that is not enough. We also make sure to educate ourselves on the latest research and studies. In our minds, knowledge is required to deliver quality products. 

We also know that our hands are not the last to touch a product before consumers receive them. So, we look beyond our products and work in partnership with our customers, brands, to help them understand CBD, its effects and other considerations.

For instance, one of our partner brands came to us with the mission to design a lotion that can help athletes workout without the distraction of pain and inflammation. Looking at the market, you see many lotions with 200-300 mg of CBD per ounce. We knew that would not cut it. This product would need to pack a punch. So, our analytical chemist, Lauren, worked alongside the client to increase CBD dosage per ounce and, further, design an efficient delivery system. If the CBD in your products is not bioavailable, then it is wasted. This partnership has produced a product design that is not only safe, but also solves a serious consumer problem. The lotion has been receiving testimonial reviews, raving about decreased pain and increased ability to perform.

If you are interested in receiving a sample of this lotion to private label or would like to work with us to formulate your next product, don't hesitate to reach out to info@bdxco.com