Charlotte’s Web Completes Landmark Liver Safety Study Headed by Local Researcher BY GEOFF BROWN
espite the widespread use and availability of hemp-derived cannabidiol (CBD) products, officials from the Food & Drug Administration (FDA) say they still need to learn more about the safety of CBD before they determine how to regulate it.
that helps answer this question.
normal, healthy population,
CBD products. This means
Dr. Jeff Lombardo, an assistant
but this rate was no different
businesses selling CBD
professor at the University of
than what would be seen
products nationwide are subject
Buffalo’s Center for Integrated
in the general population.
to a labyrinth of state laws that
Global Biomedical Sciences is
In a healthy, disease-free
are constantly in flux. Federal
leading a collaborative research
population you might see
guidance on the issue would
study into CBD’s effects on the
liver enzyme elevations in
provide clarity and validation for
liver. Charlotte’s Web, whose
approximately 2.5% of the
both industry stakeholders and
development lab is located
population. But in the general
consumers.
in Buffalo, is one of twelve
population, from which the
companies participating in the
participants in this study were
study. The initial cohort recently
recruited, there are people with
completed the first portion of
medical conditions and taking
In March of last year, the FDA
the study and investigators,
medications known to increase
including Lombardo, met with
liver function enzymes, so you’d
the FDA to discuss the results.
expect elevations in a higher
D
issued a statement highlighting the importance of filling gaps in current knowledge about CBD and encouraged collaboration from industry stakeholders and researchers to help answer important questions about CBD’s safety. One of the FDA’s concerns was CBD’s potential to cause liver failure. In clinical trials of Epidiolex, the only FDA-approved drug containing CBD, 13% of patients treated with the drug had significant liver enzyme elevations which signal inflammation or damage in the liver. However, treatment with Epidiolex uses higher doses of CBD than are taken under normal circumstances by the average consumer. Whether liver injury from consumption of hemp-derived CBD is still a risk at the doses commonly used by
The study recruited 839 participants that had been using oral CBD products for the past 30 days. Participants first selected their standard CBD regimen which could include CBD isolate, broad-spectrum, or full-spectrum products from a company of their choice. The sponsoring companies then sent participants the products and had them continue their use
this data will help bring the FDA one step closer to developing hemp-derived CBD products.
– Jeff Lombardo
to repeat this study in cohort 2 and expand their analysis
analysis of liver function enzymes.
using feedback provided by the
The study utilized a decentralized
FDA. This portion of the study
clinical research platform created
has support from 7 additional
by ValidCare, LLC. The ValidCare
companies and should be
platform enabled enrollment of
complete by fourth quarter 2021. The completion of this study represents an important
consumers is unknown.
the COVID-19 pandemic.
milestone for the CBD industry.
A local researcher is working
The study found that individuals
rived CBD products has led
with CBD industry pioneer
self-medicating with oral CBD
many states to develop their
and market leader, Charlotte’s
had a higher prevalence of
own set of rules governing
Web, to generate new data
elevated liver function enzymes
the manufacture and sale of
CannaBuff.com SUMMER 2021
the data it requested. Hopefully,
“The new data we’ve provided will assist the FDA in developing their regulatory stance on these products. This helps bring a new level of safety and trust to consumers.”
had to provide blood samples for
continued participation throughout
and work together to get FDA
“The percentage of patients’ experiencing elevated liver enzyme levels in our sample was no different than we’d expect to see in the general population. This data supports the notion that self-medication with CBD is safe and does not cause liver failure” Lombardo says they’ll now look
District of Columbia and allowed for
able to put competition aside
a regulatory approach for
in a journal. Then the participants
individuals from 49 states and the
competing CBD brands were
~5-10%.
for 30 days while documenting it
than would be expected in a 8
percentage of the population
In this landmark study,
Federal inaction on hemp-de-
Jeff Lombardo, PharmD, BCOP is a research assistant professor at the Center of Integrated Global Biomedical Sciences, Translational Pharmacology Research Core, at the University of Buffalo School of Pharmacy & Pharmaceutical Sciences. Dr. Lombardo is also a pharmacist at the Botanist medical cannabis dispensary in downtown Buffalo.
