SunFlora Inc., the international CBD store brand, has announced today that they are incorporating a Research Division in their multi-tiered approach to their hemp and cannabinoid science enterprise most commonly known as the Your CBD Store Chain of entrepreneur owned hemp and cannabinoid product stores. The flagship project for Research Arm of SunFlora’s expansion is the participation in the ValidCare national clinical trial which will measure potential liver effects in healthy adults ingesting either full/broad spectrum hemp derived extracts or CBD isolate.
The SunFlora Leadership Team responded to the call for participating companies because it is a direct response to the FDA’s repeated request, including the Agency’s March 5, 2020 report to Congress for science-based data, so it can confidently determine the appropriate regulatory path(s) for hemp derived and CBD-containing products.
SunFlora’s CEO Marcus Quinn states, “We started as a Family business in 2018, when my wife who is also my co- founder and I witnessed personally the effect that cannabinoid products had on my wife and her well-being. My desire, in committing our resources to this study, is to translate our observations about our products into scientific data so that we can tell our complete story and help more people. ValidCare has proven themselves to be a trustworthy partner that shares our aspiration to pull back the veil on the science behind the anecdotal information. It is with pride that we carve out a path for other researchers and entrepreneurs to follow.”
Quinn’s enthusiasm is shared by SunFlora Chief Science Officer, Dr. Anthony Ferrari, Ph. D. who has surveyed many trials taking place across the United States before selecting the Valid Care Liver toxicity study. “I pay close attention to what concerns the FDA and respect the work of Dr. Lombardo and Dr. Aqua. SunFlora along with the other twelve cannabinoid product companies sponsoring this research has invested in the study because we believe that the science will validate what we already know and will shift the focus from the need for research to implementing industry-wide standards to ensure product safety while at the same time advancing the science. We are excited to be working with the ValidCare Team”.
There are thousands of participants that have been recruited for the study. Dr. Lombardo from ValidCare states that “This sample size provides increased reliability in understanding multiple variables across populations, products and lifestyles for researcher, product companies and the FDA.”
“It is great to see over a dozen companies make the investment in consumer safety and collaborate to get FDA the data it needs” said Rod Nuss, COO of ValidCare. “Consumer response has been extremely positive to participation.”
Each company provides lot specific product information for the study and recruits up to 100 consumers to participate. Consumers are then screened to ensure they meet Inclusion/Exclusion criteria before they are approved and enrolled.
This decentralized/virtual, observational research is powered by ValidCare StudyTM which collects Real World Evidence (RWE) from consumers across the United States in accordance with the 21st Century Cures Act.
“ValidCare Study is a game changer for research; especially in light of COVID-19. Now we can remotely recruit, screen, consent, monitor, and obtain intra-study feedback from participants in real time.” says Dr. Aqua. “Participants only need to be physically present once during the study to provide a blood sample at a lab close to their home.” Results of the study will be shared with the FDA and are expected to be published in a peer-reviewed journal in early 2021.
For more information, visit www.sunflora.org.