Although scientific evidence continues to build for CBD's human health potential, the proof required by law for companies to make concrete claims about CBD's safety and efficacy is a high bar to clear––and for good reason. Vast quantities of data are needed to determine a substance's safety profile and meet the US Food and Drug Administration's consumer protection regulations. And while large scale human safety studies are extremely valuable in gathering such data, this type of research on CBD has, until recently, been difficult to fund and administer.
Fortunately, thanks in part to rapidly growing scientific and consumer interest in CBD, Impact Naturals is proud to join other leaders in the CBD industry in a large-scale human safety study conducted by Validcare (Denver, CO) and overseen by an Institutional Review Board (IRB) in accordance with FDA regulations. Impact Naturals is currently participating in the second cohort of the study, which seeks to enhance the reliability of the study's preliminary findings, which Validcare shared with the FDA on March 15, 2021.
The initial results of the study found neither evidence of liver disease nor an increase in the prevalence of elevated liver function tests in the 839 participants, who ingested hemp-derived CBD for a minimum of 60 days. Additionally, though nearly 70% of participants reported taking medication for a medical condition at the time of the study, there was no commensurate increase in reporting of adverse events (studies of similar populations saw an 11% elevation in liver function tests, compared to about 9% in this study).
In a press release, Keith Aqua, MD, co-principal investigator, remarked:
"We are encouraged by these findings and hopeful this study provides [the] FDA with sufficient science-based data to determine and take action on a safe regulatory path forward. We will continue to analyze these real-world data and are adding a second cohort to this study to increase statistical certainty for liver safety and secondary measures across diverse populations and consumers with various medical conditions."
Aqua goes on to say that this new second cohort of the study "strengthens the statistical reliability of the liver safety results as well as whether drowsiness or testosterone levels are impacted by long-term CBD consumption. All of these measures are important to [the] FDA and consumers."
Impact Naturals has contributed its debut lineup of REVIVE™, RESTORE™, and REST™ CBD capsules to the study, the results of which will be shared with participants and the FDA, as well as published in a peer-reviewed journal upon completion. To follow the progress of this study and other exciting developments in CBD research, visit our website at www.impact-naturals.com or subscribe to our newsletter.