One of the cannabidiol (CBD) industry’s most well-known companies has released results from a human safety study’s first and second cohorts.
The study address Food and Drug Administration (FDA) concerns about CBD’s interactions with the liver and possible adverse effects.
On Tuesday, Denver, Colorado-based Charlotte’s Web (CW) announced the conclusions.
CW says the second cohort added 222 adults who consumed hemp-extracted CBD tinctures orally for 60 days.
According to CW, the first and second cohorts used 17 commercially-available brands and 39 hemp-extracted CBD products with 1,061 participants.
CW says statistical certainty increased to 98 percent, and preliminary study findings mirror the first cohort’s results.
According to CW, the findings showed no association of increased prevalence of increased liver function test, no clinical liver disease, zero product-related adverse events, and new data concluding no daytime drowsiness and no testosterone deficiency.
“We were asked by Congressional leadership to understand and get answers to important safety questions posed by the FDA so they can confidently regulate these products,” says Validcare COO Rod Nuss. “Together, we achieved our goal—with feedback by the FDA and participation by 17 brands, we oversubscribed and operated a nationwide, decentralized clinical study in the midst of the COVID pandemic.”
CW says it has formally addressed FDA requests for scientific liver study data by investigating 1,061 adults who supplied blood lab samples and kept daily journals.
CW also says study conductor Validcare acquired FDA feedback on the Institutional Review Board (IRB)-approved protocol, augmenting it to gather additional results.
“The execution of these two cohorts provides proof of the hemp CBD industry working cooperatively to support rigorous scientific research to inform regulators, the FDA, and the U.S. Congress,” says Charlotte’s Web Senior VP Tim Orr. “The 17 leading hemp CBD industry brands have advanced the science for hemp CBD by providing real world, evidence-based outcomes in liver safety, drowsiness, and testosterone levels.”
While the study focused on liver safety, secondary outcomes included no increase in daytime drowsiness (per Stanford Sleepiness Scale) and no testosterone decrease in males of all ages.
CW says the data suggests CBD may be beneficial in preventing low testosterone in older individuals.