On June 25, 2018, the Food and Drug Administration (FDA or the Agency) approved GW Pharmaceuticals’ Epidiolex (cannabidiol). Epidiolex is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older. The approval of this product is significant not only because it is the first drug product approved for the treatment of Dravet syndrome, but also because it is the first botanically extracted cannabis product approved by FDA.
Notably, GW Pharmaceuticals will have to wait for the Drug Enforcement Administration (DEA) to reschedule cannabidiol (CBD) before it can begin marketing of Epidiolex. Currently, DEA’s position is that CBD is a Schedule I drug product with no known medical benefit, but FDA’s approval of Epidiolex will force DEA to change this assessment. DEA is expected to reschedule the product in the next 90 days.
The approval of a drug with CBD as an active ingredient is an exciting development and gives hope to companies that are seeking to develop other drug products derived from cannabis.
This approval also raises questions about what this will mean for the currently thriving CBD market. A chemical compound derived from marijuana previously rumored to have specific medicinal and curative properties, CBD has largely been marketed by manufacturers as a dietary supplement or sold under specific state laws allowing for CBD to be sold. FDA has specifically gone after companies that sold CBD as a dietary supplement by issuing Warning Letters to such companies.
Under the Federal Food, Drug and Cosmetic Act, products containing ingredients that (1) have previously been authorized for clinical investigation as a new drug, (2) for which substantial clinical investigations have occurred, and (3) the existence of such investigations has been made public, fall outside the definition of a dietary supplement. In the case of CBD, GW Pharmaceuticals’ clinical investigations for Epidiolex and previous related drugs containing CBD have been substantial and highly publicized. Accordingly, FDA’s position was that because CBD had already been involved in clinical investigations as a drug product, CBD products fell outside the statutory definition of a dietary supplement and could not be marketed as such.
In FDA Commissioner Dr. Scott Gottlieb’s statement regarding the approval of Epidiolex, Gottlieb reiterated that FDA was “concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims.” Gottlieb stated that FDA will “continue to take action when we see the illegal marketing of CBD-containing products with unproven medical claims” and that FDA was especially concerned “when these products are marketed for serious or life threatening diseases, where the illegal promotion of an unproven compound could discourage a patient from seeking other therapies that have proven benefits.” See Gottlieb statement available here.
Those in the CBD space without approvals from FDA should be careful given these new developments.