ValidCare, a research outsourcing company that has experience working in the cannabis industry, is organizing a study on the impact cannabidiol (CBD) products have on the liver of adults who use them for longer than 60 days. The Colorado-based firm has gathered seven CBD producers to contribute to the study. Those companies are:
- Charlotte’s Web
- Columbia Care
- Boulder Botanical & Bioscience Labs
- CBD American Shaman
The group is aiming to fill the information gap on how CBD affects the liver, an area of research the U.S. Food and Drug Administration (FDA) has requested be investigated.
Here, Columbia Care’s Chief Scientific Officer Rosemary Mazanet, M.D., Ph.D., explains how this study could help consumers, what the companies hope to discover and it could push the industry forward.
Hemp Grower: Does liver damage appear to be the greatest holdup in the FDA implementing a CBD policy?
Rosemary Mazanet: There is data from research related to a pharmaceutical CBD product that, when administered at high doses in conjunction with other medicines, [research found] demonstrated liver issues. There is significant animal data [from tests on rodents] substantiating the safety of hemp-derived CBD, but little or no data on humans. This study will help the FDA understand whether any issues exist when using hemp-derived products in an otherwise healthy, human adult population.
HG: What has the FDA’s involvement looked like in putting this study together?
RM: The FDA has had no formal role in this study, nor has the agency sanctioned or sponsored the research. The FDA has [however] requested that the industry provide liver safety data to help them determine the appropriate regulatory pathway [whether to regulate CBD as a food substance, a drug or not at all]. For background, starting in late 2019, ValidCare established communication with the FDA and its cannabis work group to better understand the agency’s concerns associated with hemp-derived CBD and liver safety. Through ongoing two-way communication, they provided guidance on the observational protocol as written and affirmed the value of the data to be collected. This is the extent of their current involvement.
HG: What will the CBD companies committed to the study be providing in terms of support?RM: The companies involved are paying ValidCare to act as the third party who will conduct this Institutional Review Board (IRB)-approved observational study, including a blood draw to look at liver function tests. Each involved company will pay an equal share of the costs for ValidCare to conduct, analyze and report the results of this study. This is an observational study, so ValidCare must enroll people who are already using CBD products. The companies involved are helping find the volunteers who are using their CBD products for ValidCare to contact, and the companies may be offering to provide discounted products, or some type of incentive, for those volunteers who complete the study while using their product.
HG: Is 60 days long enough to reach conclusions, especially in the FDA’s view? In other words, could this lead to potential movement in FDA’s CBD policy?
RM: The FDA has guided the methodology of the study and affirmed the value of the data to be collected, so we are confident that the findings will have significant impact.
HG: How will consumers be selected?
RM: Adults over 21 years of age who are currently using oral CBD products for more than 30 days and meet medical history inclusion criteria are welcome to join the study. Each participating brand is inviting current known consumers to their own online portal for enrollment. From there, consumers will be contacted by ValidCare to officially consent and apply to be enrolled.