In emerging industries, scientific research stands as the cornerstone for innovation and regulation. As the CBD industry in the United States navigates regulatory frameworks and strives to tackle social stigma, it’s essential to leverage expertise and infrastructure to drive meaningful advancements in research.
Vantage Hemp Co. recognizes the pivotal role of clinical studies in shaping the future of the CBD industry, especially amongst recent news that the U.S. Food and Drug Administration (FDA) has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products like CBD in the last decade. The regulator revealed that more than 800 INDs have been submitted to the FDA since the early 1970s, with a 300% increase in applications over the last 10 years.
The Importance of Clinical Studies
Clinical studies play a crucial role in establishing the efficacy and safety profile of not only the CBD active pharmaceutical ingredient (API) but also the final formulated product. This scientific evidence forms the basis for informed decision-making by consumers, healthcare professionals, and regulatory bodies.
The FDA evaluates CBD just like any other substance it regulates, under a framework defined by law and with rigorous scientific evidence as a basis for its regulatory approach. The only FDA-approved CBD medication is Epidiolex for the treatment of two types of epilepsy. Additional well-controlled clinical trials are needed to establish the safety and efficacy of CBD in other diseases and/or conditions.
Real-world data on CBD use and safety has a crucial role alongside data from other types of studies to fill in the current knowledge gaps. The North Carolina AMVETS Service Foundation, a 501(c)(3) extension of the state’s most inclusive congressionally chartered veterans service organization, has initiated a clinical study on the efficacy of CBD for U.S. veterans in collaboration with the University of Northern Colorado and Vantage. This clinical study will be a single masked, randomized, placebo-controlled examination of a daily fixed dose of CBD over 28 days. An additional goal of the study will involve surveying veterans regarding their lived experiences with CBD. The study’s results are anticipated to generate data that can advocate for further research.
Industry Leadership in Driving Research
At Vantage, we are committed to advancing CBD research by supporting companies, research institutions and academia to execute clinical studies through the supply of pharmaceutical grade CBD, drug products for trials, and regulatory expertise. Through these partnerships, we facilitate collaborative efforts to expand the understanding of CBD’s potential and contribute to the growth of the industry.
Vantage has a very unique position in the clinical study space because of its Drug Master Files (DMFs). In April of 2022, Vantage submitted a DMF to the FDA for its hemp-derived CBD Distillate and then again in April of 2023 for its CBD Isolate. With these in place, organizations can leverage Vantage’s data and infrastructure to supply not only API but also drug products which allow organizations to focus on clinical trial execution.
Vantage’s positive standing with Australia’s Therapeutic Goods Administration which stems from successfully obtaining Good Manufacturing Practice (GMP) certification in February 2024, also allows for partnership with countries that operate under the Pharmaceutical Inspection Co-operation Scheme (PIC/S). Vantage is certified to produce medicinal CBD extracts, isolates, and finished goods and can support PIC/S countries like Australia, Germany, and more looking for clinical opportunities.
On an ongoing basis, leaders in emerging industries play a major role in supporting research providing access to expertise and resources that research institutions and academia may be missing.
Influence on Regulatory Frameworks
Findings from clinical studies play a significant role in informing regulatory decisions and shaping regulatory standards. As the demand for CBD skyrockets, so does the availability of poor-quality products.
Much of the existing data on CBD is anecdotal and stems from unapproved drugs and incorrectly labeled products. The reported adverse events may also be due to things like lead contamination and poor-quality control, underscoring the necessity for more structured clinical studies to inform policy and foster a regulatory environment that promotes innovation and consumer protection.
As a globally accredited plant-based extractor and finished product manufacturer, Vantage is built and operated according to WHO GMP, FDA 21 CFR 210/211, PIC/S, and ICH Q7 standards, ensuring the highest standards of quality and compliance. Vantage’s dedication to raising the industry bar, despite the absence of uniform guidance, has allowed the company to diversify its customer base, support clinical studies in a meaningful way, and expand its footprint in both the United States and broader global markets.
Fostering Wider Acceptance
Clinical studies play a pivotal role not only in shaping regulatory frameworks but also in challenging societal stigmas surrounding CBD. Through rigorous research, scientific evidence can debunk misconceptions and foster wider social acceptance.
One of the main reasons for the stigma around CBD is that it is often associated with the recreational drug use of cannabis which is federally illegal in the United States. According to Invisibly’s Realtime Research survey of more than a thousand US adults, 68% of them were unaware that CBD and tetrahydrocannabinol (THC), the psychoactive compound found in cannabis that causes the “high” associated with recreational use, were two different compounds.
Even as regulatory frameworks develop and consumer education strengthens over time, there will still be a cultural element that will take time to evolve. Through collaborative efforts and continued research, we can work towards a future where stigma no longer impedes access to safe and effective products.
Future Innovations
Looking ahead, clinical studies will continue to drive innovations in research. Emerging trends such as personalized medicine, novel delivery methods, and cannabinoid formulations offer exciting opportunities for the industry to explore. To be recognized as a viable choice for treatments would legitimize CBD on a national level.
At Vantage, we are proud to be at the forefront of this movement, driving meaningful advancements in CBD research and paving the way for breakthroughs in health and wellness. Join us on this journey towards a more informed world.
