But still, the FDA continues to delay the creation of a regulatory framework for the industry. To the casual observer, this lack of regulatory oversight may not seem like a big deal, but many companies are growing weary of the whole “wild west” analogy of the CBD industry.
So what’s holding things up?
FDA leadership has consistently cited the lack of scientific information on CBD’s safety profile (specifically its potential effects on the liver) as a reason for delaying the publication of regulations.
“The lack of regulatory clarity creates risk for the industry and the American consumer,” said Jason Mitchell, CEO of HempFusion. “We realized we have a choice to be part of the process and so we have opted to do so.”
He’s not alone. The new study, which was recently approved by the Institutional Review Board, is being co-sponsored by a group of CBD companies that includes some of the biggest brands in the industry:
- Asterra Labs
- Boulder Botanical & Bioscience Labs
- Care by Design
- CBD American Shaman
- Charlotte’s Web
- Columbia Care
- Global Widget
- Infinite CBD
- Medterra CBD
- SunMed CBD
ValidCare will be conducting a human trial study to ascertain if daily use of full spectrum hemp-derived CBD or CBD isolate has any impact on the human liver.
Colorado-based clinical research company ValidCare initiated and specifically designed the study to help the FDA determine the appropriate regulatory path for hemp-derived CBD products:
“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.”
This observational study relies on the participation of a broad group of CBD consumers. Here’s how it will work:
Each company will provide lot-specific product information for the study and recruit up to 100 consumers to participate. ValidCare will then screen consumers to ensure they meet Inclusion/Exclusion criteria before they are approved and enrolled.
Unlike some studies that require frequent visits to labs, participants in this study only need to be physically present once (at a lab close to their home) to provide a blood sample.
Co-principal investigators Keith Aqua MD and Jeff Lombardo PharmD, BCOP will lead the study itself. According to Dr. Aqua, “ValidCare Study is a game-changer for clinical 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.”
Participant recruitment began the first week of August and is expected to continue through mid-September, 2020 (so there may still be time to sign up!). The results of the study will be shared with the FDA and are expected to be published in a peer-reviewed journal in early 2021.
“There are already over 300 participants actively engaged in the study and building each day,” said Dr. Lombardo. “The protocol has an 80.6% power score based on less than 700 participants.”
“We are excited at the potential to enroll over 1,000 participants. This sample size provides increased reliability in understanding multiple variables across populations, products, and lifestyles for researchers, product companies, and the FDA.”
Essentially, the more people that participate, the more thorough and reliable the results. And so far, it seems likely that the participating companies will have no trouble finding people willing to take part in the investigation.
After all, it’s consumers who will benefit from a federal regulatory framework (assuming it’s a good one) – as well as having better information on CBD’s safety profile – for everyone.