The results of the first and second cohort of the industry-sponsored liver safety study were shared by Charlotte's Web Holdings, Inc. Cohort two added another 222 adults who consumed hemp CBD tinctures orally for 60 days. The second cohort used 17 commercially available brands and 39 hemp CBD products across a total of 1,061 participants, increasing the statistical certainty to 98%. The findings of the investigation mirror the results of the first cohort: 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 the Congressional leadership to understand and get answers to important safety questions posed by the FDA so they can confidently regulate these products. With feedback from FDA and participation from 17 brands, we oversubscribed and operated a nationwide, centralized clinical study in the midst of the COVID epidemic, stated Validcare's COO Rod Nuss.
The Food and Drug Administration's earlier requests for scientific data on liver safety have now been addressed through safety investigations of 1,061 adults who provided blood lab samples and daily journals. Validcare, the contract research organization that ran the study, gained FDA feedback on the IRB approved protocol and increased the protocol over time to collect additional lab results at the request of FDA.
While liver safety outcomes were the primary focus of the study, secondary outcomes from the study include :
Per Stanford Sleep Scale, there was no increase in daytime drowsiness.
There was no increase in the prevalence of low testosterone at any age with the use of CBD by male study participants. Data shows that the use of CBD may help in preventing low testosterone in older individuals. The FDA will provide the two cohorts with the scientific data that they requested of the CBD industry on liver safety for those who ingest CBD daily. According to Charlotte's Web co- founder and COO Jared Stanley, these results provide further evidence to support policymakers in shaping a much-needed federal regulatory framework for hemp CBD products. Charlotte's Web will continue to support and invest in hemp CBD studies because we are a science-driven company.