The U.S. Food and Drug Administration (FDA) issued a report last week that suggests more research is necessary to better understand the potential long-term health effects of cannabidiol (CBD) on humans and animals. CBD is the non-intoxicating compound in the cannabis sativa plant. It’s the second-most abundant chemical in marijuana. Hemp-derived CBD that contains a maximum of 0.3% THC (the psychoactive chemical in marijuana) is legal under the 2018 Hemp Farming Act.
HempGrower.com says the FDA report calls for additional research, including extensive use of real-world data (RWD)—data relating to patient health status and health care delivery to better understand potential adverse reactions to CBD.
In the near future, the agency is expected to issue regulatory guidelines. As a result, several CBD lawsuits are in limbo, as judges have prevented the claims from proceeding until the agency’s guidelines are issued.
In the meantime, the FDA report suggests that in order to issue definitive guidelines, information about the non-intoxicating compound is necessary to approve its use to treat various ailments.
FDA Commissioner Stephen M. Hahn and Principal Deputy Commissioner Amy Abernethy co-authored the report, in which they wrote, “While the FDA appreciates the information and engagement from numerous stakeholders on CBD-related issues, many evidence gaps remain.”
Hahn and Abernethy added, “Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods.” For instance, the agency recommends real-world data (RWD) that would provide incremental improvements in the scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations.
How Can RWD Be Provided To FDA?
FDA plans on engaging with various stakeholder groups to obtain the RWD necessary to assess any potential long-term safety risks.
“We strongly believe that RWD, when collected and analyzed using rigorous methods, can be important for moving the science forward—including by aiding hypothesis generation and by refining the design of follow-up studies,” the agency report said.
In addition, FDA says it will also partner with other government agencies, industry stakeholders, and members of academia to develop the foundation for CBD data collection and analysis projects, per HempGrower.com.
These efforts would build upon existing independent state and national quality and safety monitoring efforts, observational study data models, and novel data sources, said Hahn and Abernethy.
However, real-world data is not enough, the agency report cautioned. That’s because RWD is observational data. Observational data is not stringent enough to assess toxicology. Therefore, animal studies should be implemented to determine any potential long-term toxic effects of chronic CBD use.
FDA Issues Guiding Principles For Toxicological Studies
A more sophisticated data infrastructure is required for research projects to assess the safety and quality of CBD products, noted the agency. Furthermore, these initial studies should serve as a foundation for the refinement of future studies. And finally, research projects should be designed to complement existing work by other public health agencies, such as the National Institutes of Health (NIH). These studies should also include input from poison control centers and emergency departments.
Obstacles to Proper CBD Research
Obtaining the safety data presents challenges. First, the collection of adverse event reactions from the likes of poison control centers or hospitals is insufficient. CBD use rates for specific products and population data is also needed for FDA safety assessment.
Also, so-called “longitudinal studies” are needed. These long-term studies take into account subjects’ health over an extended period, which will help provide a clearer picture as to CBD use’s long-term health effects.
One more hindrance is that CBD products lack specific codes (much like a UPC code), which is necessary for data collection.
Getting The Necessary Data For CBD Studies
How will the agency obtain the additional safety data it says it needs to issue regulatory guidelines? The report by Hahn and Abernethy concluded that research projects will work with existing and emerging data systems. This will enable precise identification of CBD products that may be associated with reported adverse events. Also, the best way to accumulate adverse event data will be evaluated. This data will include a crucial element: the specific CBD product used as well as the dosage.