Anonymous
Source: Your CBD Store – Santa Barbara
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 the Dr. Lombardo and Dr. Aqua. SunFlora along with the other twelve cannabinoid product companies sponsoring this research have 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. About SunFlora The mission is all about bringing the highest quality hemp and CBD-containg products to market. We have formulated our products with our customer’s needs in mind. SunFlora, Inc. was founded in 2018 by husband and wife team Rachael and Marcus Quinn. Rachel discovered CBD due to struggles with her own well-being. After trying CBD products with positive results, she opened her first SunFlora store and soon after, they decided to make improvements on products that were available in market by bringing on top scientists and formulators to develope their own products.
Soon, they started opening other stores and saw this as an opportunity to help family and friends become entrepreneurs in a fast-growing industry. Rachael and Marcus observed great promise in the hemp derived and CBD market and were committed to producing a high quality product made with high quality ingredients. The business model of helping entrepreneurs set up brick and mortar “Your CBD Store” locations in the communities where they live, work, and play has been a huge success. About SunFlora Products The line of SunFlora products under the brands “SunMed” and “Sunflora” has grown to over 150 sku’s. There is pride taken in the development of each and every product and it is a true team effort to get them to market.
We use GMP (“Good Manufacturing Practices”) certified manufacturers and FDA certified labs to manufacture and test our product, each of our third-party labs have all of the required registrations with the State of Florida. Our customers experience consistency from one bottle to the next. Every single product contains no more than the legal amounts of THC. We source 100% of our organic hemp from farms authorized to cultivate hemp by their State Department of Agriculture. These farms are subject to very strict testing requirements in order to maintain their hemp cultivation permits which must be recertified for renewal annually. We third party test our hemp material that goes into every single bottle of our products.
Not only do we test the finished good prior to releasing them to consumers, we also test and quarantine the raw material when it arrives to our warehouse. We take pride in our full panel test results and we are committed to transparency, which is demonstrated by our posting of our third-party test results on our website. We have updated our labels to comply with the regulations of the most conservative States and that is the standard that we use across the country and internationally. The quality of our SunMed product is known throughout the United States which has led to the success of our individual stores. Our tincture flavors emote a nostalgic experience for our customers whether they like tropical flavors like orange or seasonal flavors such as our pumpkin spice. We have received awards in many different catagories including designation of Best Tincture, Best Topical Cream, and Best Cosmetic Products by industry peers.
Our Leadership Team is committed to regulatory compliance and recently customized a line to align with regulations in the U.K. for exportation to that market. We spare no expense in creating a consistent, wholesome product. We have made 3rd party QR codes tied to chemical testing integrated with our products labels so our customers can know what’s in each bottle. Having a Ph.D. in chemistry on staff has allowed complex formulation of our products, using not only CBD, but other cannabinoids and terpenes that create unique synergies that increase efficacy, target specific uses, and increase the effectivness of CBD. We believe the customer should understand how we develop our product from soil to oil and they should be seeing the best product on the market along that journey. By setting the standards in the hemp and CBD industry SunFlora is moving plant utilization into the 21st century. For more information, visit www.sunflora.org.
About ValidCare
ValidCare, LLC provides contract research outsourcing (CRO) and virtual research solutions for life sciences and consumer packaged goods industries. ValidCare’s proprietary platform supports decentralized, hybrid and virtual research powered by real world evidence (RWE) to deliver insights that help fuel healthier generations. For more information, visit www.validcare.com or call 844-825-4322.
