Charlotte's Web Holdings, Inc. (OTCQX:CWBHF) (TSX:CWEB) shared the conclusions of the combined first and second cohort of the industry-sponsored liver safety study. Cohort two added another 222 adults who daily consumed hemp CBD tinctures orally for 60 days. The second cohort combined with the first study cohort used 17 commercially available brands and 39 hemp CBD products across a total of 1,061 participants, increasing statistical certainty to 98%. The investigation's preliminary findings mirror the first cohort's results: 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. Together, we achieved our goal – with feedback from FDA and participation by 17 brands, we oversubscribed and operated a nationwide, decentralized clinical study in the midst of the COVID pandemic," stated Validcare's COO Rod Nuss.
The Food and Drug Administration's earlier requests for scientific data on liver safety have now been formally addressed through safety investigations of 1,061 adults who supplied blood lab samples and maintained daily journals. Validcare, the contract research organization which ran the study, gained FDA feedback on the IRB approved protocol and augmented the protocol over time to collect additional lab results at the request of FDA.
While liver safety outcomes were the announced primary focus of the study, secondary outcomes from the study include:
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No increase in daytime drowsiness reported per Stanford Sleep Scale.
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CBD use by male study participants does NOT increase prevalence of low testosterone at any age. Data suggests CBD use may be helpful in preventing low testosterone in older individuals.;
"We are excited that these two cohorts will provide the FDA with the scientific data the government agency had requested of the CBD industry on liver safety for those who ingest CBD daily. These results provide further evidence to support policymakers in shaping a much-needed federal regulatory framework for hemp CBD products," stated Charlotte's Web co-founder and COO Jared Stanley. "Charlotte's Web will continue to support and invest in hemp CBD studies as we are a science-driven company."
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