On Wednesday, the Collaborative for CBD Science and Safety hosted “The CBD Summit: A National Dialogue on Public Safety, Research, and Policy” in Washington, D.C. The Collaborative is comprised of several national entities including the Council for Responsible Nutrition, the Food and Drug Law Institute, the Alliance for the Adoption of Innovations in Medicine, and NACBHDD, among others. The venue was packed to capacity, with more than 140 in attendance. Participants represented the federal government and the research, business, not-for-profit and consumer communities.
The purpose of the Summit was to take stock of our current knowledge and practice around CBD (cannabidiol) as a medicine and CBD as a food supplement or cosmetic, and then to begin to plot a course forward. Today, we are in a phase that many would describe as the “CBD craze” in which wild claims— without evidence—are made about the medicinal effects of CBD for a broad array of illnesses.
To date, only one CBD formulation—Epidiolex—has been approved by the Food and Drug Administration (FDA) as a medicine for refractory epilepsy in small children. However, many companies sell over-the-counter CBD salves, oils, tablets, gummies and water products without evidence of their safety or efficacy. Consumers lack knowledge about this dizzying array of choices available in the market.
Morning speakers at the summit documented that research lags far, far behind marketing around CBD. There are more than 120 known cannabinoids, and most have not been the subject of any research. The FDA has yet to define pathways for this research, either for medicines or for over-the-counter products.
Partly in jest, the morning keynote speaker, Dr. Andrew Harris, a Congressman from Maryland’s 1st District, described the current situation as a “delay of game.” Marketing is moving ahead, research is not, and FDA has not defined the rules.
The Summit was privileged to host Dr. Amy Abernethy, the principal deputy commissioner of FDA, for a fireside chat over the lunch period. She concurred in the urgency of the problem, and she reported that FDA will be required to produce a 60-day report and a 180-day report for Congress on progress that the agency is making to address the issue.
Afternoon sessions were focused on identifying solutions to the current log jam. Congressional staff from both the Senate and House reported that they would like to identify these solutions soon. Obviously, the goal is products that are pure, safe and effective.
What became clear in these afternoon discussions is that the Collaborative will need to work both with Congress and the FDA to identify and implement steps going forward. These likely will include the identification of a more rapid pathway for research on cannabinoids and a separate pathway for research on over-the-counter products. In both instances, these changes would involve enhancements to current FDA research and regulatory practices rather than completely new initiatives. By the end of the day, good agreement existed that these are very reasonable steps going forward.
It would be very easy for one to become overwhelmed by the complexity of the CBD and cannabinoid issue. We cannot permit this to happen. Mental health clients are at great risk of being deluded into believing that over-the-counter products will cure mental illness. The “north star” of purity, safety and effectiveness must guide us in this quest.