On Dec. 5, the National Association of County Behavioral Health & Developmental Disability Directors (NACBHDD), together with the National Association for Rural Mental Health (NARMH) and the National Association of Social Workers (NASW), hosted a Congressional briefing for Hill staff on the need for improved regulation of cannabidiol (CBD) products by the Food and Drug Administration (FDA). The event was very well attended by representatives from the advocacy and congressional staff communities.
In recent years, many companies have begun creating a myriad of CBD products largely in the absence of any trusted testing or oversight by FDA. Frequently, CBD products are unlawfully marketed and claim unsubstantiated health benefits, raising serious public health concerns. These CBD products undermine the rigorous process required by FDA to ensure the public’s health and safety. FDA continues to monitor and track CBD products by sending dozens of warning letters to companies that are making unlawful claims, but the proliferation of the products has overwhelmed the current regulatory framework. Public health and safety may be jeopardized in the absence of a strong, clear, science-backed FDA review process for the development of more safe and efficacious cannabinoid medications.
The FDA has approved a CBD medication (Epidiolex), a proprietary oral solution of highly purified plant-derived CBD. Epidiolex development has initially concentrated on treatment of three severe, orphan, early-onset, treatment-resistant epilepsy syndromes – including Dravet syndrome, Lennox-Gastaut syndrome, (LGS) and tuberous sclerosis complex (TSC). This and other similar medications hold great promise for the future.
Headline speakers of the briefing were Reps. Scott Peters (D-CA District 52) and Cathy McMorris Rodgers (R-WA District 5). Peters welcomed the group and emphasized the importance of new research to fully exploit the potential of cannabinoids for medical advances. Rodgers stressed the importance of developments in consumer protections, so that products are labeled accurately according to appropriate purity standards.
A diverse panel followed. Panel members included James Werline, a doctoral pharmacist and parent of a child with severe epilepsy; pharmacist Susan Audino, A2LA lead assessor and instructor, and Board Member of the Center for Research on Environmental Medicine in Maryland; Angelique Lee-Rowley, vice president, global chief ethics & compliance officer, Greenwich Biosciences; and Sally Greenberg, executive director, National Consumers League.
Werline told of the trauma his family suffered as they sought treatment everywhere for his daughter’s very severe epilepsy. Nothing worked for her until the family discovered CBD and Epidiolex. Audino emphasized the tremendous inaccuracies in labeling of over-the-counter CBD products, and the dangers posed by some of the contaminants in these products. Lee-Rowley told of the need for additional research on medical applications of CBD, and of the potential far-reaching promise of this research. Greenberg brought examples of various over the counter CBD products, including gummy bears, and indicated that consumers have no accurate knowledge of what they are ingesting. She expressed concern that the CBD craze is reaching a consumer crisis.
The major messages of this Congressional briefing are twofold: First, CBD is a critical medicine for treating epilepsy, and potentially other very severe disorders as well. Much more research is needed to identify these medical applications. Second, it is critical to regulate non-medical CBD products that are presented to the public as having health or therapeutic effects. FDA has a huge role to play in both of these endeavors, and the Congress can provide appropriate impetus for FDA regulatory and enforcement action.
On Jan. 15, NACBHDD also will cosponsor a CBD Summit: A National Dialogue on Public Safety, Research, and Policy at the Hyatt Regency Hotel on Capitol Hill. For more information or to register for the CBD Summit, visit: https://CBDSummit2020.evenbrite.com
